Trial Outcomes & Findings for A Study to Evaluate the Efficacy and Safety of Brivaracetam in Study Participants (>=16 to 80 Years of Age) With Epilepsy (NCT NCT03083665)
NCT ID: NCT03083665
Last Updated: 2025-10-14
Results Overview
An AE is any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment. Treatment-Emergent AEs were defined as AEs which had onset on or after the first dose of IMP. As per planned analysis, safety data for all study periods was combined excluding Open-Label Temporary period.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
449 participants
Primary outcome timeframe
From start of the Treatment Period (Week 0) until Safety Visit (up to Week 18); only for OLTP- From last visit of Transition Period to beginning of MAP (up to 4 Years 10 Months)
Results posted on
2025-10-14
Participant Flow
The study started to enroll participants in August 2017 and concluded in June 2022.
The Participant Flow refers to the Randomized Set. Double-Blind Period included Treatment Period and the Down-Titration Period plus Study Drug-Free Period or the Transition Period.
Participant milestones
| Measure |
Placebo
Participants received matching Placebo as film-coated tablets, administered orally, twice daily (bid), during 12 weeks of Treatment Period. At the end of the Treatment Period, participants who entered long-term follow-up (LTFU) study (EP0085 (NCT03250377)) or managed access program (MAP), the same matching Placebo dose was kept during 2 weeks of Transition Period and brivaracetam (BRV) 100 milligrams/day (mg/day) in LTFU study or MAP. Participants who did not enter the LTFU study or MAP had 4 weeks Down-Titration Period followed by a Study Drug-Free Period (no drug for 2 weeks). During Down-Titration Period, participants received the same Placebo dose for 4 weeks.
|
BRV 50 mg/Day
Participants received BRV 50 mg/day as film-coated tablets, administered orally, bid, during 12 weeks of Treatment Period. At the end of the Treatment Period, participants who entered the LTFU study or MAP received BRV 50 mg/day during 2 weeks of Transition Period and BRV 100 mg/day in LTFU study or MAP. Participants who did not enter the LTFU study or MAP had 4 weeks Down-Titration Period followed by a Study Drug-Free Period (no drug for 2 weeks). During Down-Titration Period, participants received BRV 25 mg/day for 1 week followed by Placebo for 3 weeks.
|
BRV 200 mg/Day
Participants received BRV 200 mg/day as film-coated tablets, administered orally, bid, during 12 weeks of Treatment Period. At the end of the Treatment Period, participants who entered LTFU study or MAP received BRV 150 mg/day during 2 weeks of Transition Period and BRV 100 mg/day in LTFU study or MAP. Participants who did not enter the LTFU study or MAP had 4 weeks Down-Titration Period followed by a Study Drug-Free Period (no drug for 2 weeks). During Down-Titration Period, participants received BRV 150 mg/day for 1 week followed by BRV 100 mg/day for 1 week, followed by BRV 50 mg/day for 1 week, followed by BRV 25 mg/day for 1 week.
|
Placebo to OLTP BRV
Participants who received Placebo during Treatment Period and were eligible to enter MAP received BRV 100 mg/day due to delayed importation of medication during OLTP. BRV dose might be adjusted for an individual participant (between 50 mg/day to 200 mg/day) during the OLTP. The period was defined from immediately after the last visit of the Transition Period (Week 14) and until a visit when the participant could convert to MAP.
|
BRV 50 mg/Day to OLTP BRV
Participants who received BRV 50 mg/day during Treatment Period and were eligible to enter MAP received BRV 100 mg/day due to delayed importation of medication during Open-Label Temporary Period (OLTP). BRV dose might be adjusted for an individual participant (between 50 mg/day to 200 mg/day) during the OLTP. The period was defined from immediately after the last visit of the Transition Period (Week 14) and until a visit when the participant could convert to MAP.
|
BRV 200 mg/Day to OLTP BRV
Participants who received BRV 200 mg/day during Treatment Period and were eligible to enter MAP received BRV 100 mg/day due to delayed importation of medication during Open-Label Temporary Period (OLTP). BRV dose might be adjusted for an individual participant (between 50 mg/day to 200 mg/day) during the OLTP. The period was defined from immediately after the last visit of the Transition Period (Week 14) and until a visit when the participant could convert to MAP.
|
|---|---|---|---|---|---|---|
|
Double-Blind Period
STARTED
|
149
|
152
|
148
|
0
|
0
|
0
|
|
Double-Blind Period
Started Treatment Period (12 Weeks)
|
149
|
152
|
148
|
0
|
0
|
0
|
|
Double-Blind Period
Started Down-Titration Period (4 Weeks)
|
7
|
9
|
7
|
0
|
0
|
0
|
|
Double-Blind Period
Started Study Drug-Free Period (2 Weeks)
|
7
|
9
|
7
|
0
|
0
|
0
|
|
Double-Blind Period
Started Transition Period (2 Weeks)
|
133
|
139
|
137
|
0
|
0
|
0
|
|
Double-Blind Period
COMPLETED
|
138
|
147
|
140
|
0
|
0
|
0
|
|
Double-Blind Period
NOT COMPLETED
|
11
|
5
|
8
|
0
|
0
|
0
|
|
Open-Label Temporary Period (OLTP)
STARTED
|
0
|
0
|
0
|
64
|
68
|
74
|
|
Open-Label Temporary Period (OLTP)
COMPLETED
|
0
|
0
|
0
|
60
|
67
|
68
|
|
Open-Label Temporary Period (OLTP)
NOT COMPLETED
|
0
|
0
|
0
|
4
|
1
|
6
|
Reasons for withdrawal
| Measure |
Placebo
Participants received matching Placebo as film-coated tablets, administered orally, twice daily (bid), during 12 weeks of Treatment Period. At the end of the Treatment Period, participants who entered long-term follow-up (LTFU) study (EP0085 (NCT03250377)) or managed access program (MAP), the same matching Placebo dose was kept during 2 weeks of Transition Period and brivaracetam (BRV) 100 milligrams/day (mg/day) in LTFU study or MAP. Participants who did not enter the LTFU study or MAP had 4 weeks Down-Titration Period followed by a Study Drug-Free Period (no drug for 2 weeks). During Down-Titration Period, participants received the same Placebo dose for 4 weeks.
|
BRV 50 mg/Day
Participants received BRV 50 mg/day as film-coated tablets, administered orally, bid, during 12 weeks of Treatment Period. At the end of the Treatment Period, participants who entered the LTFU study or MAP received BRV 50 mg/day during 2 weeks of Transition Period and BRV 100 mg/day in LTFU study or MAP. Participants who did not enter the LTFU study or MAP had 4 weeks Down-Titration Period followed by a Study Drug-Free Period (no drug for 2 weeks). During Down-Titration Period, participants received BRV 25 mg/day for 1 week followed by Placebo for 3 weeks.
|
BRV 200 mg/Day
Participants received BRV 200 mg/day as film-coated tablets, administered orally, bid, during 12 weeks of Treatment Period. At the end of the Treatment Period, participants who entered LTFU study or MAP received BRV 150 mg/day during 2 weeks of Transition Period and BRV 100 mg/day in LTFU study or MAP. Participants who did not enter the LTFU study or MAP had 4 weeks Down-Titration Period followed by a Study Drug-Free Period (no drug for 2 weeks). During Down-Titration Period, participants received BRV 150 mg/day for 1 week followed by BRV 100 mg/day for 1 week, followed by BRV 50 mg/day for 1 week, followed by BRV 25 mg/day for 1 week.
|
Placebo to OLTP BRV
Participants who received Placebo during Treatment Period and were eligible to enter MAP received BRV 100 mg/day due to delayed importation of medication during OLTP. BRV dose might be adjusted for an individual participant (between 50 mg/day to 200 mg/day) during the OLTP. The period was defined from immediately after the last visit of the Transition Period (Week 14) and until a visit when the participant could convert to MAP.
|
BRV 50 mg/Day to OLTP BRV
Participants who received BRV 50 mg/day during Treatment Period and were eligible to enter MAP received BRV 100 mg/day due to delayed importation of medication during Open-Label Temporary Period (OLTP). BRV dose might be adjusted for an individual participant (between 50 mg/day to 200 mg/day) during the OLTP. The period was defined from immediately after the last visit of the Transition Period (Week 14) and until a visit when the participant could convert to MAP.
|
BRV 200 mg/Day to OLTP BRV
Participants who received BRV 200 mg/day during Treatment Period and were eligible to enter MAP received BRV 100 mg/day due to delayed importation of medication during Open-Label Temporary Period (OLTP). BRV dose might be adjusted for an individual participant (between 50 mg/day to 200 mg/day) during the OLTP. The period was defined from immediately after the last visit of the Transition Period (Week 14) and until a visit when the participant could convert to MAP.
|
|---|---|---|---|---|---|---|
|
Double-Blind Period
Adverse Event
|
5
|
4
|
5
|
0
|
0
|
0
|
|
Double-Blind Period
Lack of Efficacy
|
0
|
0
|
1
|
0
|
0
|
0
|
|
Double-Blind Period
Protocol Violation
|
1
|
0
|
1
|
0
|
0
|
0
|
|
Double-Blind Period
Lost to Follow-up
|
1
|
0
|
1
|
0
|
0
|
0
|
|
Double-Blind Period
Withdrawal by Subject
|
3
|
0
|
0
|
0
|
0
|
0
|
|
Double-Blind Period
Consent withdrawn by subject due to concern on AE
|
1
|
0
|
0
|
0
|
0
|
0
|
|
Double-Blind Period
Subjects were able to never take a study drug
|
0
|
1
|
0
|
0
|
0
|
0
|
|
Open-Label Temporary Period (OLTP)
Adverse Event
|
0
|
0
|
0
|
2
|
0
|
0
|
|
Open-Label Temporary Period (OLTP)
Lack of Efficacy
|
0
|
0
|
0
|
0
|
0
|
2
|
|
Open-Label Temporary Period (OLTP)
Withdrawal by Subject
|
0
|
0
|
0
|
1
|
1
|
1
|
|
Open-Label Temporary Period (OLTP)
Withdrawal by parent/guardian
|
0
|
0
|
0
|
0
|
0
|
1
|
|
Open-Label Temporary Period (OLTP)
Patient not keen to continue open label
|
0
|
0
|
0
|
1
|
0
|
0
|
|
Open-Label Temporary Period (OLTP)
Patient non compliant to open label study drug
|
0
|
0
|
0
|
0
|
0
|
1
|
|
Open-Label Temporary Period (OLTP)
Subject enrolled to compassionate use program
|
0
|
0
|
0
|
0
|
0
|
1
|
Baseline Characteristics
A Study to Evaluate the Efficacy and Safety of Brivaracetam in Study Participants (>=16 to 80 Years of Age) With Epilepsy
Baseline characteristics by cohort
| Measure |
Placebo
n=149 Participants
Participants received matching Placebo as film-coated tablets, administered orally, twice daily (bid), during 12 weeks of Treatment Period. At the end of the Treatment Period, participants who entered long-term follow-up (LTFU) study (EP0085 (NCT03250377)) or managed access program (MAP), the same matching Placebo dose was kept during 2 weeks of Transition Period and brivaracetam (BRV) 100 milligrams/day (mg/day) in LTFU study or MAP. Participants who did not enter the LTFU study or MAP had 4 weeks Down-Titration Period followed by a Study Drug-Free Period (no drug for 2 weeks). During Down-Titration Period, participants received the same Placebo dose for 4 weeks.
|
BRV 50 mg/Day
n=152 Participants
Participants received BRV 50 mg/day as film-coated tablets, administered orally, bid, during 12 weeks of Treatment Period. At the end of the Treatment Period, participants who entered the LTFU study or MAP received BRV 50 mg/day during 2 weeks of Transition Period and BRV 100 mg/day in LTFU study or MAP. Participants who did not enter the LTFU study or MAP had 4 weeks Down-Titration Period followed by a Study Drug-Free Period (no drug for 2 weeks). During Down-Titration Period, participants received BRV 25 mg/day for 1 week followed by Placebo for 3 weeks.
|
BRV 200 mg/Day
n=148 Participants
Participants received BRV 200 mg/day as film-coated tablets, administered orally, bid, during 12 weeks of Treatment Period. At the end of the Treatment Period, participants who entered LTFU study or MAP received BRV 150 mg/day during 2 weeks of Transition Period and BRV 100 mg/day in LTFU study or MAP. Participants who did not enter the LTFU study or MAP had 4 weeks Down-Titration Period followed by a Study Drug-Free Period (no drug for 2 weeks). During Down-Titration Period, participants received BRV 150 mg/day for 1 week followed by BRV 100 mg/day for 1 week, followed by BRV 50 mg/day for 1 week, followed by BRV 25 mg/day for 1 week.
|
Total
n=449 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
9 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
31 Participants
n=4 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
137 Participants
n=5 Participants
|
135 Participants
n=7 Participants
|
138 Participants
n=5 Participants
|
410 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
|
Age, Continuous
|
34.5 years
STANDARD_DEVIATION 13.2 • n=5 Participants
|
33.7 years
STANDARD_DEVIATION 12.6 • n=7 Participants
|
35.2 years
STANDARD_DEVIATION 13.2 • n=5 Participants
|
34.5 years
STANDARD_DEVIATION 13.0 • n=4 Participants
|
|
Sex: Female, Male
Female
|
82 Participants
n=5 Participants
|
77 Participants
n=7 Participants
|
83 Participants
n=5 Participants
|
242 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
67 Participants
n=5 Participants
|
75 Participants
n=7 Participants
|
65 Participants
n=5 Participants
|
207 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Asian
|
149 Participants
n=5 Participants
|
152 Participants
n=7 Participants
|
148 Participants
n=5 Participants
|
449 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Hispanic or Latino
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Not Hispanic or Latino
|
148 Participants
n=5 Participants
|
151 Participants
n=7 Participants
|
147 Participants
n=5 Participants
|
446 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: From start of the Treatment Period (Week 0) until Safety Visit (up to Week 18); only for OLTP- From last visit of Transition Period to beginning of MAP (up to 4 Years 10 Months)Population: The Safety Set (SS) included all randomized study participants who received at least 1 dose of IMP.
An AE is any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment. Treatment-Emergent AEs were defined as AEs which had onset on or after the first dose of IMP. As per planned analysis, safety data for all study periods was combined excluding Open-Label Temporary period.
Outcome measures
| Measure |
Placebo
n=149 Participants
Participants received matching Placebo as film-coated tablets, administered orally, twice daily (bid), during 12 weeks of Treatment Period. At the end of the Treatment Period, participants who entered long-term follow-up (LTFU) study (EP0085 (NCT03250377)) or managed access program (MAP), the same matching Placebo dose was kept during 2 weeks of Transition Period and brivaracetam (BRV) 100 milligrams/day (mg/day) in LTFU study or MAP. Participants who did not enter the LTFU study or MAP had 4 weeks Down-Titration Period followed by a Study Drug-Free Period (no drug for 2 weeks). During Down-Titration Period, participants received the same Placebo dose for 4 weeks.
|
BRV 50 mg/Day
n=151 Participants
Participants received BRV 50 mg/day as film-coated tablets, administered orally, bid, during 12 weeks of Treatment Period. At the end of the Treatment Period, participants who entered the LTFU study or MAP received BRV 50 mg/day during 2 weeks of Transition Period and BRV 100 mg/day in LTFU study or MAP. Participants who did not enter the LTFU study or MAP had 4 weeks Down-Titration Period followed by a Study Drug-Free Period (no drug for 2 weeks). During Down-Titration Period, participants received BRV 25 mg/day for 1 week followed by Placebo for 3 weeks.
|
BRV 200 mg/Day
n=148 Participants
Participants received BRV 200 mg/day as film-coated tablets, administered orally, bid, during 12 weeks of Treatment Period. At the end of the Treatment Period, participants who entered LTFU study or MAP received BRV 150 mg/day during 2 weeks of Transition Period and BRV 100 mg/day in LTFU study or MAP. Participants who did not enter the LTFU study or MAP had 4 weeks Down-Titration Period followed by a Study Drug-Free Period (no drug for 2 weeks). During Down-Titration Period, participants received BRV 150 mg/day for 1 week followed by BRV 100 mg/day for 1 week, followed by BRV 50 mg/day for 1 week, followed by BRV 25 mg/day for 1 week.
|
Placebo to OLTP BRV
n=64 Participants
Participants who received Placebo during Treatment Period and were eligible to enter MAP received BRV 100 mg/day due to delayed importation of medication during OLTP. BRV dose might be adjusted for an individual participant (between 50 mg/day to 200 mg/day) during the OLTP. The period was defined from immediately after the last visit of the Transition Period (Week 14) and until a visit when the participant could convert to MAP.
|
BRV 50 mg/Day to OLTP BRV
n=68 Participants
Participants who received BRV 50 mg/day during Treatment Period and were eligible to enter MAP received BRV 100 mg/day due to delayed importation of medication during Open-Label Temporary Period (OLTP). BRV dose might be adjusted for an individual participant (between 50 mg/day to 200 mg/day) during the OLTP. The period was defined from immediately after the last visit of the Transition Period (Week 14) and until a visit when the participant could convert to MAP.
|
BRV 200 mg/Day to OLTP BRV
n=74 Participants
Participants who received BRV 200 mg/day during Treatment Period and were eligible to enter MAP received BRV 100 mg/day due to delayed importation of medication during Open-Label Temporary Period (OLTP). BRV dose might be adjusted for an individual participant (between 50 mg/day to 200 mg/day) during the OLTP. The period was defined from immediately after the last visit of the Transition Period (Week 14) and until a visit when the participant could convert to MAP.
|
|---|---|---|---|---|---|---|
|
Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs)
|
58.4 percentage of participants
|
57.0 percentage of participants
|
60.1 percentage of participants
|
26.6 percentage of participants
|
19.1 percentage of participants
|
23.0 percentage of participants
|
PRIMARY outcome
Timeframe: From start of the Treatment Period (Week 0) until Safety Visit (up to Week 18); only for OLTP- From last visit of Transition Period to beginning of MAP (up to 4 Years 10 Months)Population: The SS included all randomized study participants who received at least 1 dose of IMP.
An AE is any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment. Treatment-Emergent AEs were defined as AEs which had onset on or after the first dose of IMP. As per planned analysis, safety data for all study periods was combined excluding Open-Label Temporary period.
Outcome measures
| Measure |
Placebo
n=149 Participants
Participants received matching Placebo as film-coated tablets, administered orally, twice daily (bid), during 12 weeks of Treatment Period. At the end of the Treatment Period, participants who entered long-term follow-up (LTFU) study (EP0085 (NCT03250377)) or managed access program (MAP), the same matching Placebo dose was kept during 2 weeks of Transition Period and brivaracetam (BRV) 100 milligrams/day (mg/day) in LTFU study or MAP. Participants who did not enter the LTFU study or MAP had 4 weeks Down-Titration Period followed by a Study Drug-Free Period (no drug for 2 weeks). During Down-Titration Period, participants received the same Placebo dose for 4 weeks.
|
BRV 50 mg/Day
n=151 Participants
Participants received BRV 50 mg/day as film-coated tablets, administered orally, bid, during 12 weeks of Treatment Period. At the end of the Treatment Period, participants who entered the LTFU study or MAP received BRV 50 mg/day during 2 weeks of Transition Period and BRV 100 mg/day in LTFU study or MAP. Participants who did not enter the LTFU study or MAP had 4 weeks Down-Titration Period followed by a Study Drug-Free Period (no drug for 2 weeks). During Down-Titration Period, participants received BRV 25 mg/day for 1 week followed by Placebo for 3 weeks.
|
BRV 200 mg/Day
n=148 Participants
Participants received BRV 200 mg/day as film-coated tablets, administered orally, bid, during 12 weeks of Treatment Period. At the end of the Treatment Period, participants who entered LTFU study or MAP received BRV 150 mg/day during 2 weeks of Transition Period and BRV 100 mg/day in LTFU study or MAP. Participants who did not enter the LTFU study or MAP had 4 weeks Down-Titration Period followed by a Study Drug-Free Period (no drug for 2 weeks). During Down-Titration Period, participants received BRV 150 mg/day for 1 week followed by BRV 100 mg/day for 1 week, followed by BRV 50 mg/day for 1 week, followed by BRV 25 mg/day for 1 week.
|
Placebo to OLTP BRV
n=64 Participants
Participants who received Placebo during Treatment Period and were eligible to enter MAP received BRV 100 mg/day due to delayed importation of medication during OLTP. BRV dose might be adjusted for an individual participant (between 50 mg/day to 200 mg/day) during the OLTP. The period was defined from immediately after the last visit of the Transition Period (Week 14) and until a visit when the participant could convert to MAP.
|
BRV 50 mg/Day to OLTP BRV
n=68 Participants
Participants who received BRV 50 mg/day during Treatment Period and were eligible to enter MAP received BRV 100 mg/day due to delayed importation of medication during Open-Label Temporary Period (OLTP). BRV dose might be adjusted for an individual participant (between 50 mg/day to 200 mg/day) during the OLTP. The period was defined from immediately after the last visit of the Transition Period (Week 14) and until a visit when the participant could convert to MAP.
|
BRV 200 mg/Day to OLTP BRV
n=74 Participants
Participants who received BRV 200 mg/day during Treatment Period and were eligible to enter MAP received BRV 100 mg/day due to delayed importation of medication during Open-Label Temporary Period (OLTP). BRV dose might be adjusted for an individual participant (between 50 mg/day to 200 mg/day) during the OLTP. The period was defined from immediately after the last visit of the Transition Period (Week 14) and until a visit when the participant could convert to MAP.
|
|---|---|---|---|---|---|---|
|
Percentage of Participants With Treatment-Emergent AEs (TEAEs) Leading to Study Withdrawal
|
4.7 percentage of participants
|
2.6 percentage of participants
|
3.4 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
PRIMARY outcome
Timeframe: From start of the Treatment Period (Week 0) until Safety Visit (up to Week 18); only for OLTP- From last visit of Transition Period to beginning of MAP (up to 4 Years 10 Months)Population: The SS included all randomized study participants who received at least 1 dose of IMP.
Serious Adverse event (SAE) was defined as any events which: • results in death, • is life-threatening threatening (note that this did not include a reaction that might have caused death had it occurred in a more severe form.), •results in significant or persistent disability/incapacity, • results in a congenital anomaly/birth defect (including that occurring in a fetus), • results in Important medical event that, based upon appropriate medical judgment, may jeopardize the participant and might require medical or surgical intervention to prevent 1 of the other outcomes listed here, and • results in initial inpatient hospitalization or prolongation of hospitalization. As per planned analysis, safety data for all study periods was combined excluding Open-Label Temporary period.
Outcome measures
| Measure |
Placebo
n=149 Participants
Participants received matching Placebo as film-coated tablets, administered orally, twice daily (bid), during 12 weeks of Treatment Period. At the end of the Treatment Period, participants who entered long-term follow-up (LTFU) study (EP0085 (NCT03250377)) or managed access program (MAP), the same matching Placebo dose was kept during 2 weeks of Transition Period and brivaracetam (BRV) 100 milligrams/day (mg/day) in LTFU study or MAP. Participants who did not enter the LTFU study or MAP had 4 weeks Down-Titration Period followed by a Study Drug-Free Period (no drug for 2 weeks). During Down-Titration Period, participants received the same Placebo dose for 4 weeks.
|
BRV 50 mg/Day
n=151 Participants
Participants received BRV 50 mg/day as film-coated tablets, administered orally, bid, during 12 weeks of Treatment Period. At the end of the Treatment Period, participants who entered the LTFU study or MAP received BRV 50 mg/day during 2 weeks of Transition Period and BRV 100 mg/day in LTFU study or MAP. Participants who did not enter the LTFU study or MAP had 4 weeks Down-Titration Period followed by a Study Drug-Free Period (no drug for 2 weeks). During Down-Titration Period, participants received BRV 25 mg/day for 1 week followed by Placebo for 3 weeks.
|
BRV 200 mg/Day
n=148 Participants
Participants received BRV 200 mg/day as film-coated tablets, administered orally, bid, during 12 weeks of Treatment Period. At the end of the Treatment Period, participants who entered LTFU study or MAP received BRV 150 mg/day during 2 weeks of Transition Period and BRV 100 mg/day in LTFU study or MAP. Participants who did not enter the LTFU study or MAP had 4 weeks Down-Titration Period followed by a Study Drug-Free Period (no drug for 2 weeks). During Down-Titration Period, participants received BRV 150 mg/day for 1 week followed by BRV 100 mg/day for 1 week, followed by BRV 50 mg/day for 1 week, followed by BRV 25 mg/day for 1 week.
|
Placebo to OLTP BRV
n=64 Participants
Participants who received Placebo during Treatment Period and were eligible to enter MAP received BRV 100 mg/day due to delayed importation of medication during OLTP. BRV dose might be adjusted for an individual participant (between 50 mg/day to 200 mg/day) during the OLTP. The period was defined from immediately after the last visit of the Transition Period (Week 14) and until a visit when the participant could convert to MAP.
|
BRV 50 mg/Day to OLTP BRV
n=68 Participants
Participants who received BRV 50 mg/day during Treatment Period and were eligible to enter MAP received BRV 100 mg/day due to delayed importation of medication during Open-Label Temporary Period (OLTP). BRV dose might be adjusted for an individual participant (between 50 mg/day to 200 mg/day) during the OLTP. The period was defined from immediately after the last visit of the Transition Period (Week 14) and until a visit when the participant could convert to MAP.
|
BRV 200 mg/Day to OLTP BRV
n=74 Participants
Participants who received BRV 200 mg/day during Treatment Period and were eligible to enter MAP received BRV 100 mg/day due to delayed importation of medication during Open-Label Temporary Period (OLTP). BRV dose might be adjusted for an individual participant (between 50 mg/day to 200 mg/day) during the OLTP. The period was defined from immediately after the last visit of the Transition Period (Week 14) and until a visit when the participant could convert to MAP.
|
|---|---|---|---|---|---|---|
|
Percentage of Participants With Treatment-Emergent Serious Adverse Events (SAEs)
|
0.7 percentage of participants
|
1.3 percentage of participants
|
2.7 percentage of participants
|
4.7 percentage of participants
|
0 percentage of participants
|
2.7 percentage of participants
|
PRIMARY outcome
Timeframe: From Baseline to 12-week Treatment PeriodPopulation: The Full Analysis Set (FAS) consisted of all randomized study participants who received at least 1 dose of IMP and had at least 1 post Baseline seizure daily record card (DRC) data during the Treatment Period.
According to International League Against Epilepsy (ILAE) classification (1981), seizures were classified as type IA (IA1, IA2, IA3, and IA4), IB, IC, II (IIA, IIB, IIC, IID, IIE, and IIF) or III. 28 day adjusted seizure frequency for partial seizures (seizure types IA+IB+IC) was calculated for treatment period by dividing the number of partial seizures by the number of days for which the DRC was completed for treatment period and multiplying the resulting value by 28.
Outcome measures
| Measure |
Placebo
n=147 Participants
Participants received matching Placebo as film-coated tablets, administered orally, twice daily (bid), during 12 weeks of Treatment Period. At the end of the Treatment Period, participants who entered long-term follow-up (LTFU) study (EP0085 (NCT03250377)) or managed access program (MAP), the same matching Placebo dose was kept during 2 weeks of Transition Period and brivaracetam (BRV) 100 milligrams/day (mg/day) in LTFU study or MAP. Participants who did not enter the LTFU study or MAP had 4 weeks Down-Titration Period followed by a Study Drug-Free Period (no drug for 2 weeks). During Down-Titration Period, participants received the same Placebo dose for 4 weeks.
|
BRV 50 mg/Day
n=151 Participants
Participants received BRV 50 mg/day as film-coated tablets, administered orally, bid, during 12 weeks of Treatment Period. At the end of the Treatment Period, participants who entered the LTFU study or MAP received BRV 50 mg/day during 2 weeks of Transition Period and BRV 100 mg/day in LTFU study or MAP. Participants who did not enter the LTFU study or MAP had 4 weeks Down-Titration Period followed by a Study Drug-Free Period (no drug for 2 weeks). During Down-Titration Period, participants received BRV 25 mg/day for 1 week followed by Placebo for 3 weeks.
|
BRV 200 mg/Day
n=148 Participants
Participants received BRV 200 mg/day as film-coated tablets, administered orally, bid, during 12 weeks of Treatment Period. At the end of the Treatment Period, participants who entered LTFU study or MAP received BRV 150 mg/day during 2 weeks of Transition Period and BRV 100 mg/day in LTFU study or MAP. Participants who did not enter the LTFU study or MAP had 4 weeks Down-Titration Period followed by a Study Drug-Free Period (no drug for 2 weeks). During Down-Titration Period, participants received BRV 150 mg/day for 1 week followed by BRV 100 mg/day for 1 week, followed by BRV 50 mg/day for 1 week, followed by BRV 25 mg/day for 1 week.
|
Placebo to OLTP BRV
Participants who received Placebo during Treatment Period and were eligible to enter MAP received BRV 100 mg/day due to delayed importation of medication during OLTP. BRV dose might be adjusted for an individual participant (between 50 mg/day to 200 mg/day) during the OLTP. The period was defined from immediately after the last visit of the Transition Period (Week 14) and until a visit when the participant could convert to MAP.
|
BRV 50 mg/Day to OLTP BRV
Participants who received BRV 50 mg/day during Treatment Period and were eligible to enter MAP received BRV 100 mg/day due to delayed importation of medication during Open-Label Temporary Period (OLTP). BRV dose might be adjusted for an individual participant (between 50 mg/day to 200 mg/day) during the OLTP. The period was defined from immediately after the last visit of the Transition Period (Week 14) and until a visit when the participant could convert to MAP.
|
BRV 200 mg/Day to OLTP BRV
Participants who received BRV 200 mg/day during Treatment Period and were eligible to enter MAP received BRV 100 mg/day due to delayed importation of medication during Open-Label Temporary Period (OLTP). BRV dose might be adjusted for an individual participant (between 50 mg/day to 200 mg/day) during the OLTP. The period was defined from immediately after the last visit of the Transition Period (Week 14) and until a visit when the participant could convert to MAP.
|
|---|---|---|---|---|---|---|
|
Partial Seizure Frequency Per 28 Days During the 12-week Treatment Period
|
7.17 seizures per 28 days
Interval 1.0 to 317.0
|
5.93 seizures per 28 days
Interval 0.0 to 123.7
|
4.19 seizures per 28 days
Interval 0.0 to 269.4
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: From Baseline to 12-week Treatment PeriodPopulation: The FAS consisted of all randomized study participants who received at least 1 dose of IMP and had at least 1 post Baseline seizure DRC data during the Treatment Period.
Responders were those participants with at least 50% reduction from Baseline to the 12-week Treatment Period in partial seizure frequency per 28 days. 50% Responder rate was calculated for treatment period by dividing the number of 50% responders by the number of participants in the analysis set and multiplying the resulting value by 100.
Outcome measures
| Measure |
Placebo
n=147 Participants
Participants received matching Placebo as film-coated tablets, administered orally, twice daily (bid), during 12 weeks of Treatment Period. At the end of the Treatment Period, participants who entered long-term follow-up (LTFU) study (EP0085 (NCT03250377)) or managed access program (MAP), the same matching Placebo dose was kept during 2 weeks of Transition Period and brivaracetam (BRV) 100 milligrams/day (mg/day) in LTFU study or MAP. Participants who did not enter the LTFU study or MAP had 4 weeks Down-Titration Period followed by a Study Drug-Free Period (no drug for 2 weeks). During Down-Titration Period, participants received the same Placebo dose for 4 weeks.
|
BRV 50 mg/Day
n=151 Participants
Participants received BRV 50 mg/day as film-coated tablets, administered orally, bid, during 12 weeks of Treatment Period. At the end of the Treatment Period, participants who entered the LTFU study or MAP received BRV 50 mg/day during 2 weeks of Transition Period and BRV 100 mg/day in LTFU study or MAP. Participants who did not enter the LTFU study or MAP had 4 weeks Down-Titration Period followed by a Study Drug-Free Period (no drug for 2 weeks). During Down-Titration Period, participants received BRV 25 mg/day for 1 week followed by Placebo for 3 weeks.
|
BRV 200 mg/Day
n=148 Participants
Participants received BRV 200 mg/day as film-coated tablets, administered orally, bid, during 12 weeks of Treatment Period. At the end of the Treatment Period, participants who entered LTFU study or MAP received BRV 150 mg/day during 2 weeks of Transition Period and BRV 100 mg/day in LTFU study or MAP. Participants who did not enter the LTFU study or MAP had 4 weeks Down-Titration Period followed by a Study Drug-Free Period (no drug for 2 weeks). During Down-Titration Period, participants received BRV 150 mg/day for 1 week followed by BRV 100 mg/day for 1 week, followed by BRV 50 mg/day for 1 week, followed by BRV 25 mg/day for 1 week.
|
Placebo to OLTP BRV
Participants who received Placebo during Treatment Period and were eligible to enter MAP received BRV 100 mg/day due to delayed importation of medication during OLTP. BRV dose might be adjusted for an individual participant (between 50 mg/day to 200 mg/day) during the OLTP. The period was defined from immediately after the last visit of the Transition Period (Week 14) and until a visit when the participant could convert to MAP.
|
BRV 50 mg/Day to OLTP BRV
Participants who received BRV 50 mg/day during Treatment Period and were eligible to enter MAP received BRV 100 mg/day due to delayed importation of medication during Open-Label Temporary Period (OLTP). BRV dose might be adjusted for an individual participant (between 50 mg/day to 200 mg/day) during the OLTP. The period was defined from immediately after the last visit of the Transition Period (Week 14) and until a visit when the participant could convert to MAP.
|
BRV 200 mg/Day to OLTP BRV
Participants who received BRV 200 mg/day during Treatment Period and were eligible to enter MAP received BRV 100 mg/day due to delayed importation of medication during Open-Label Temporary Period (OLTP). BRV dose might be adjusted for an individual participant (between 50 mg/day to 200 mg/day) during the OLTP. The period was defined from immediately after the last visit of the Transition Period (Week 14) and until a visit when the participant could convert to MAP.
|
|---|---|---|---|---|---|---|
|
50% Responder Rate Based on Percent Change in Partial Seizure Frequency Per 28 Days From Baseline to the 12-week Treatment Period
|
19.0 percentage of responders
Interval 13.0 to 26.3
|
41.1 percentage of responders
Interval 33.1 to 49.3
|
49.3 percentage of responders
Interval 41.0 to 57.7
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: From Baseline to 12-week Treatment PeriodPopulation: The FAS consisted of all randomized study participants who received at least 1 dose of IMP and had at least 1 post Baseline seizure DRC data during the Treatment Period.
Percent change from Baseline to the Treatment Period in partial seizure frequency was calculated by subtracting 28-day adjusted Treatment Period partial seizure frequency from 28-day adjusted Baseline Period partial seizure frequency, and multiplying the resulting quantity by 100 and dividing by the Baseline Period 28-day adjusted partial seizure frequency. A negative value in percent change from Baseline indicates a decrease in partial seizure frequency from Baseline to the Treatment Period.
Outcome measures
| Measure |
Placebo
n=147 Participants
Participants received matching Placebo as film-coated tablets, administered orally, twice daily (bid), during 12 weeks of Treatment Period. At the end of the Treatment Period, participants who entered long-term follow-up (LTFU) study (EP0085 (NCT03250377)) or managed access program (MAP), the same matching Placebo dose was kept during 2 weeks of Transition Period and brivaracetam (BRV) 100 milligrams/day (mg/day) in LTFU study or MAP. Participants who did not enter the LTFU study or MAP had 4 weeks Down-Titration Period followed by a Study Drug-Free Period (no drug for 2 weeks). During Down-Titration Period, participants received the same Placebo dose for 4 weeks.
|
BRV 50 mg/Day
n=151 Participants
Participants received BRV 50 mg/day as film-coated tablets, administered orally, bid, during 12 weeks of Treatment Period. At the end of the Treatment Period, participants who entered the LTFU study or MAP received BRV 50 mg/day during 2 weeks of Transition Period and BRV 100 mg/day in LTFU study or MAP. Participants who did not enter the LTFU study or MAP had 4 weeks Down-Titration Period followed by a Study Drug-Free Period (no drug for 2 weeks). During Down-Titration Period, participants received BRV 25 mg/day for 1 week followed by Placebo for 3 weeks.
|
BRV 200 mg/Day
n=148 Participants
Participants received BRV 200 mg/day as film-coated tablets, administered orally, bid, during 12 weeks of Treatment Period. At the end of the Treatment Period, participants who entered LTFU study or MAP received BRV 150 mg/day during 2 weeks of Transition Period and BRV 100 mg/day in LTFU study or MAP. Participants who did not enter the LTFU study or MAP had 4 weeks Down-Titration Period followed by a Study Drug-Free Period (no drug for 2 weeks). During Down-Titration Period, participants received BRV 150 mg/day for 1 week followed by BRV 100 mg/day for 1 week, followed by BRV 50 mg/day for 1 week, followed by BRV 25 mg/day for 1 week.
|
Placebo to OLTP BRV
Participants who received Placebo during Treatment Period and were eligible to enter MAP received BRV 100 mg/day due to delayed importation of medication during OLTP. BRV dose might be adjusted for an individual participant (between 50 mg/day to 200 mg/day) during the OLTP. The period was defined from immediately after the last visit of the Transition Period (Week 14) and until a visit when the participant could convert to MAP.
|
BRV 50 mg/Day to OLTP BRV
Participants who received BRV 50 mg/day during Treatment Period and were eligible to enter MAP received BRV 100 mg/day due to delayed importation of medication during Open-Label Temporary Period (OLTP). BRV dose might be adjusted for an individual participant (between 50 mg/day to 200 mg/day) during the OLTP. The period was defined from immediately after the last visit of the Transition Period (Week 14) and until a visit when the participant could convert to MAP.
|
BRV 200 mg/Day to OLTP BRV
Participants who received BRV 200 mg/day during Treatment Period and were eligible to enter MAP received BRV 100 mg/day due to delayed importation of medication during Open-Label Temporary Period (OLTP). BRV dose might be adjusted for an individual participant (between 50 mg/day to 200 mg/day) during the OLTP. The period was defined from immediately after the last visit of the Transition Period (Week 14) and until a visit when the participant could convert to MAP.
|
|---|---|---|---|---|---|---|
|
Percent Change in Partial Seizure Frequency Per 28 Days From Baseline to the 12-week Treatment Period
|
21.3 percent change
Interval -123.0 to 87.0
|
38.9 percent change
Interval -233.0 to 100.0
|
46.7 percent change
Interval -1097.0 to 100.0
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: From Baseline to 12-week Treatment PeriodPopulation: The FAS consisted of all randomized study participants who received at least 1 dose of IMP and had at least 1 post Baseline seizure DRC data during the Treatment Period.
The percentage of participants within each of the following categories of percent change in partial seizure frequency from Baseline to the Treatment Period were summarized for each treatment group: 100%, 75% to less than 100%, 50% to less than 75%, 25% to less than 50%, -25% to less than 25%, and less than -25%. Percent change from Baseline to the Treatment Period in partial seizure frequency was calculated by subtracting 28-day adjusted Treatment Period partial seizure frequency from 28-day adjusted Baseline Period partial seizure frequency and multiplying the resulting quantity by 100 and dividing by the Baseline Period 28-day adjusted partial seizure frequency.
Outcome measures
| Measure |
Placebo
n=147 Participants
Participants received matching Placebo as film-coated tablets, administered orally, twice daily (bid), during 12 weeks of Treatment Period. At the end of the Treatment Period, participants who entered long-term follow-up (LTFU) study (EP0085 (NCT03250377)) or managed access program (MAP), the same matching Placebo dose was kept during 2 weeks of Transition Period and brivaracetam (BRV) 100 milligrams/day (mg/day) in LTFU study or MAP. Participants who did not enter the LTFU study or MAP had 4 weeks Down-Titration Period followed by a Study Drug-Free Period (no drug for 2 weeks). During Down-Titration Period, participants received the same Placebo dose for 4 weeks.
|
BRV 50 mg/Day
n=151 Participants
Participants received BRV 50 mg/day as film-coated tablets, administered orally, bid, during 12 weeks of Treatment Period. At the end of the Treatment Period, participants who entered the LTFU study or MAP received BRV 50 mg/day during 2 weeks of Transition Period and BRV 100 mg/day in LTFU study or MAP. Participants who did not enter the LTFU study or MAP had 4 weeks Down-Titration Period followed by a Study Drug-Free Period (no drug for 2 weeks). During Down-Titration Period, participants received BRV 25 mg/day for 1 week followed by Placebo for 3 weeks.
|
BRV 200 mg/Day
n=148 Participants
Participants received BRV 200 mg/day as film-coated tablets, administered orally, bid, during 12 weeks of Treatment Period. At the end of the Treatment Period, participants who entered LTFU study or MAP received BRV 150 mg/day during 2 weeks of Transition Period and BRV 100 mg/day in LTFU study or MAP. Participants who did not enter the LTFU study or MAP had 4 weeks Down-Titration Period followed by a Study Drug-Free Period (no drug for 2 weeks). During Down-Titration Period, participants received BRV 150 mg/day for 1 week followed by BRV 100 mg/day for 1 week, followed by BRV 50 mg/day for 1 week, followed by BRV 25 mg/day for 1 week.
|
Placebo to OLTP BRV
Participants who received Placebo during Treatment Period and were eligible to enter MAP received BRV 100 mg/day due to delayed importation of medication during OLTP. BRV dose might be adjusted for an individual participant (between 50 mg/day to 200 mg/day) during the OLTP. The period was defined from immediately after the last visit of the Transition Period (Week 14) and until a visit when the participant could convert to MAP.
|
BRV 50 mg/Day to OLTP BRV
Participants who received BRV 50 mg/day during Treatment Period and were eligible to enter MAP received BRV 100 mg/day due to delayed importation of medication during Open-Label Temporary Period (OLTP). BRV dose might be adjusted for an individual participant (between 50 mg/day to 200 mg/day) during the OLTP. The period was defined from immediately after the last visit of the Transition Period (Week 14) and until a visit when the participant could convert to MAP.
|
BRV 200 mg/Day to OLTP BRV
Participants who received BRV 200 mg/day during Treatment Period and were eligible to enter MAP received BRV 100 mg/day due to delayed importation of medication during Open-Label Temporary Period (OLTP). BRV dose might be adjusted for an individual participant (between 50 mg/day to 200 mg/day) during the OLTP. The period was defined from immediately after the last visit of the Transition Period (Week 14) and until a visit when the participant could convert to MAP.
|
|---|---|---|---|---|---|---|
|
Percentage of Participants With Categorized Percent Change in Partial Seizure Frequency Per 28 Days From Baseline to the 12-week Treatment Period
100%
|
0 percentage of participants
|
5.3 percentage of participants
|
7.4 percentage of participants
|
—
|
—
|
—
|
|
Percentage of Participants With Categorized Percent Change in Partial Seizure Frequency Per 28 Days From Baseline to the 12-week Treatment Period
75% to less than 100%
|
3.4 percentage of participants
|
14.6 percentage of participants
|
17.6 percentage of participants
|
—
|
—
|
—
|
|
Percentage of Participants With Categorized Percent Change in Partial Seizure Frequency Per 28 Days From Baseline to the 12-week Treatment Period
50% to less than 75%
|
15.6 percentage of participants
|
21.2 percentage of participants
|
24.3 percentage of participants
|
—
|
—
|
—
|
|
Percentage of Participants With Categorized Percent Change in Partial Seizure Frequency Per 28 Days From Baseline to the 12-week Treatment Period
25% to less than 50%
|
27.2 percentage of participants
|
16.6 percentage of participants
|
20.9 percentage of participants
|
—
|
—
|
—
|
|
Percentage of Participants With Categorized Percent Change in Partial Seizure Frequency Per 28 Days From Baseline to the 12-week Treatment Period
-25% to less than 25%
|
42.9 percentage of participants
|
31.1 percentage of participants
|
18.2 percentage of participants
|
—
|
—
|
—
|
|
Percentage of Participants With Categorized Percent Change in Partial Seizure Frequency Per 28 Days From Baseline to the 12-week Treatment Period
less than-25%
|
10.9 percentage of participants
|
11.3 percentage of participants
|
11.5 percentage of participants
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: During the 12-week Treatment PeriodPopulation: The FAS consisted of all randomized study participants who received at least 1 dose of IMP and had at least 1 post Baseline seizure DRC data during the Treatment Period.
There were three types of epileptic seizures: Partial epileptic seizures (Type I), Generalized epileptic seizures (Type II) and unclassified epileptic seizures (Type III). 28 day adjusted seizure frequency for all seizure types was calculated for treatment period by dividing the number of targeted seizures by the number of days for which the DRC was completed for treatment period and multiplying the resulting value by 28.
Outcome measures
| Measure |
Placebo
n=147 Participants
Participants received matching Placebo as film-coated tablets, administered orally, twice daily (bid), during 12 weeks of Treatment Period. At the end of the Treatment Period, participants who entered long-term follow-up (LTFU) study (EP0085 (NCT03250377)) or managed access program (MAP), the same matching Placebo dose was kept during 2 weeks of Transition Period and brivaracetam (BRV) 100 milligrams/day (mg/day) in LTFU study or MAP. Participants who did not enter the LTFU study or MAP had 4 weeks Down-Titration Period followed by a Study Drug-Free Period (no drug for 2 weeks). During Down-Titration Period, participants received the same Placebo dose for 4 weeks.
|
BRV 50 mg/Day
n=151 Participants
Participants received BRV 50 mg/day as film-coated tablets, administered orally, bid, during 12 weeks of Treatment Period. At the end of the Treatment Period, participants who entered the LTFU study or MAP received BRV 50 mg/day during 2 weeks of Transition Period and BRV 100 mg/day in LTFU study or MAP. Participants who did not enter the LTFU study or MAP had 4 weeks Down-Titration Period followed by a Study Drug-Free Period (no drug for 2 weeks). During Down-Titration Period, participants received BRV 25 mg/day for 1 week followed by Placebo for 3 weeks.
|
BRV 200 mg/Day
n=148 Participants
Participants received BRV 200 mg/day as film-coated tablets, administered orally, bid, during 12 weeks of Treatment Period. At the end of the Treatment Period, participants who entered LTFU study or MAP received BRV 150 mg/day during 2 weeks of Transition Period and BRV 100 mg/day in LTFU study or MAP. Participants who did not enter the LTFU study or MAP had 4 weeks Down-Titration Period followed by a Study Drug-Free Period (no drug for 2 weeks). During Down-Titration Period, participants received BRV 150 mg/day for 1 week followed by BRV 100 mg/day for 1 week, followed by BRV 50 mg/day for 1 week, followed by BRV 25 mg/day for 1 week.
|
Placebo to OLTP BRV
Participants who received Placebo during Treatment Period and were eligible to enter MAP received BRV 100 mg/day due to delayed importation of medication during OLTP. BRV dose might be adjusted for an individual participant (between 50 mg/day to 200 mg/day) during the OLTP. The period was defined from immediately after the last visit of the Transition Period (Week 14) and until a visit when the participant could convert to MAP.
|
BRV 50 mg/Day to OLTP BRV
Participants who received BRV 50 mg/day during Treatment Period and were eligible to enter MAP received BRV 100 mg/day due to delayed importation of medication during Open-Label Temporary Period (OLTP). BRV dose might be adjusted for an individual participant (between 50 mg/day to 200 mg/day) during the OLTP. The period was defined from immediately after the last visit of the Transition Period (Week 14) and until a visit when the participant could convert to MAP.
|
BRV 200 mg/Day to OLTP BRV
Participants who received BRV 200 mg/day during Treatment Period and were eligible to enter MAP received BRV 100 mg/day due to delayed importation of medication during Open-Label Temporary Period (OLTP). BRV dose might be adjusted for an individual participant (between 50 mg/day to 200 mg/day) during the OLTP. The period was defined from immediately after the last visit of the Transition Period (Week 14) and until a visit when the participant could convert to MAP.
|
|---|---|---|---|---|---|---|
|
All Seizure Frequency (Partial, Generalized, and Unclassified Epileptic Seizures) Per 28 Days During the 12-week Treatment Period
|
7.17 seizures per 28 days
Interval 1.0 to 317.0
|
5.93 seizures per 28 days
Interval 0.0 to 123.7
|
4.19 seizures per 28 days
Interval 0.0 to 269.4
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: During the 12-week Treatment PeriodPopulation: The FAS consisted of all randomized study participants who received at least 1 dose of IMP and had at least 1 post Baseline seizure DRC data during the Treatment Period.
Participants were defined as seizure free, if they did not have missing diary days and no reported seizures during the Treatment Period.
Outcome measures
| Measure |
Placebo
n=147 Participants
Participants received matching Placebo as film-coated tablets, administered orally, twice daily (bid), during 12 weeks of Treatment Period. At the end of the Treatment Period, participants who entered long-term follow-up (LTFU) study (EP0085 (NCT03250377)) or managed access program (MAP), the same matching Placebo dose was kept during 2 weeks of Transition Period and brivaracetam (BRV) 100 milligrams/day (mg/day) in LTFU study or MAP. Participants who did not enter the LTFU study or MAP had 4 weeks Down-Titration Period followed by a Study Drug-Free Period (no drug for 2 weeks). During Down-Titration Period, participants received the same Placebo dose for 4 weeks.
|
BRV 50 mg/Day
n=151 Participants
Participants received BRV 50 mg/day as film-coated tablets, administered orally, bid, during 12 weeks of Treatment Period. At the end of the Treatment Period, participants who entered the LTFU study or MAP received BRV 50 mg/day during 2 weeks of Transition Period and BRV 100 mg/day in LTFU study or MAP. Participants who did not enter the LTFU study or MAP had 4 weeks Down-Titration Period followed by a Study Drug-Free Period (no drug for 2 weeks). During Down-Titration Period, participants received BRV 25 mg/day for 1 week followed by Placebo for 3 weeks.
|
BRV 200 mg/Day
n=148 Participants
Participants received BRV 200 mg/day as film-coated tablets, administered orally, bid, during 12 weeks of Treatment Period. At the end of the Treatment Period, participants who entered LTFU study or MAP received BRV 150 mg/day during 2 weeks of Transition Period and BRV 100 mg/day in LTFU study or MAP. Participants who did not enter the LTFU study or MAP had 4 weeks Down-Titration Period followed by a Study Drug-Free Period (no drug for 2 weeks). During Down-Titration Period, participants received BRV 150 mg/day for 1 week followed by BRV 100 mg/day for 1 week, followed by BRV 50 mg/day for 1 week, followed by BRV 25 mg/day for 1 week.
|
Placebo to OLTP BRV
Participants who received Placebo during Treatment Period and were eligible to enter MAP received BRV 100 mg/day due to delayed importation of medication during OLTP. BRV dose might be adjusted for an individual participant (between 50 mg/day to 200 mg/day) during the OLTP. The period was defined from immediately after the last visit of the Transition Period (Week 14) and until a visit when the participant could convert to MAP.
|
BRV 50 mg/Day to OLTP BRV
Participants who received BRV 50 mg/day during Treatment Period and were eligible to enter MAP received BRV 100 mg/day due to delayed importation of medication during Open-Label Temporary Period (OLTP). BRV dose might be adjusted for an individual participant (between 50 mg/day to 200 mg/day) during the OLTP. The period was defined from immediately after the last visit of the Transition Period (Week 14) and until a visit when the participant could convert to MAP.
|
BRV 200 mg/Day to OLTP BRV
Participants who received BRV 200 mg/day during Treatment Period and were eligible to enter MAP received BRV 100 mg/day due to delayed importation of medication during Open-Label Temporary Period (OLTP). BRV dose might be adjusted for an individual participant (between 50 mg/day to 200 mg/day) during the OLTP. The period was defined from immediately after the last visit of the Transition Period (Week 14) and until a visit when the participant could convert to MAP.
|
|---|---|---|---|---|---|---|
|
Percentage of Participants Who Are Seizure Free (Partial, All Epileptic Seizures) During the 12-week Treatment Period
All epileptic seizures
|
0 percentage of participants
|
4.6 percentage of participants
|
6.8 percentage of participants
|
—
|
—
|
—
|
|
Percentage of Participants Who Are Seizure Free (Partial, All Epileptic Seizures) During the 12-week Treatment Period
Partial onset seizures
|
0 percentage of participants
|
4.6 percentage of participants
|
6.8 percentage of participants
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: During the 12-week Treatment PeriodPopulation: The FAS consisted of all randomized study participants who received at least 1 dose of IMP and had at least 1 post Baseline seizure DRC data during the Treatment Period.
The evaluation of time to 1st partial seizure was based on the relative day of occurrence of the 1st partial seizure during the Treatment Period.
Outcome measures
| Measure |
Placebo
n=147 Participants
Participants received matching Placebo as film-coated tablets, administered orally, twice daily (bid), during 12 weeks of Treatment Period. At the end of the Treatment Period, participants who entered long-term follow-up (LTFU) study (EP0085 (NCT03250377)) or managed access program (MAP), the same matching Placebo dose was kept during 2 weeks of Transition Period and brivaracetam (BRV) 100 milligrams/day (mg/day) in LTFU study or MAP. Participants who did not enter the LTFU study or MAP had 4 weeks Down-Titration Period followed by a Study Drug-Free Period (no drug for 2 weeks). During Down-Titration Period, participants received the same Placebo dose for 4 weeks.
|
BRV 50 mg/Day
n=151 Participants
Participants received BRV 50 mg/day as film-coated tablets, administered orally, bid, during 12 weeks of Treatment Period. At the end of the Treatment Period, participants who entered the LTFU study or MAP received BRV 50 mg/day during 2 weeks of Transition Period and BRV 100 mg/day in LTFU study or MAP. Participants who did not enter the LTFU study or MAP had 4 weeks Down-Titration Period followed by a Study Drug-Free Period (no drug for 2 weeks). During Down-Titration Period, participants received BRV 25 mg/day for 1 week followed by Placebo for 3 weeks.
|
BRV 200 mg/Day
n=148 Participants
Participants received BRV 200 mg/day as film-coated tablets, administered orally, bid, during 12 weeks of Treatment Period. At the end of the Treatment Period, participants who entered LTFU study or MAP received BRV 150 mg/day during 2 weeks of Transition Period and BRV 100 mg/day in LTFU study or MAP. Participants who did not enter the LTFU study or MAP had 4 weeks Down-Titration Period followed by a Study Drug-Free Period (no drug for 2 weeks). During Down-Titration Period, participants received BRV 150 mg/day for 1 week followed by BRV 100 mg/day for 1 week, followed by BRV 50 mg/day for 1 week, followed by BRV 25 mg/day for 1 week.
|
Placebo to OLTP BRV
Participants who received Placebo during Treatment Period and were eligible to enter MAP received BRV 100 mg/day due to delayed importation of medication during OLTP. BRV dose might be adjusted for an individual participant (between 50 mg/day to 200 mg/day) during the OLTP. The period was defined from immediately after the last visit of the Transition Period (Week 14) and until a visit when the participant could convert to MAP.
|
BRV 50 mg/Day to OLTP BRV
Participants who received BRV 50 mg/day during Treatment Period and were eligible to enter MAP received BRV 100 mg/day due to delayed importation of medication during Open-Label Temporary Period (OLTP). BRV dose might be adjusted for an individual participant (between 50 mg/day to 200 mg/day) during the OLTP. The period was defined from immediately after the last visit of the Transition Period (Week 14) and until a visit when the participant could convert to MAP.
|
BRV 200 mg/Day to OLTP BRV
Participants who received BRV 200 mg/day during Treatment Period and were eligible to enter MAP received BRV 100 mg/day due to delayed importation of medication during Open-Label Temporary Period (OLTP). BRV dose might be adjusted for an individual participant (between 50 mg/day to 200 mg/day) during the OLTP. The period was defined from immediately after the last visit of the Transition Period (Week 14) and until a visit when the participant could convert to MAP.
|
|---|---|---|---|---|---|---|
|
Time to 1st Partial Seizure During the 12-week Treatment Period
|
3 days
Interval 2.0 to 3.0
|
5 days
Interval 3.0 to 6.0
|
6 days
Interval 5.0 to 8.0
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: During the 12-week Treatment PeriodPopulation: The FAS consisted of all randomized study participants who received at least 1 dose of IMP and had at least 1 post Baseline seizure DRC data during the Treatment Period.
The evaluation of time to 5th partial seizure was based on the relative day of occurrence of the 5th partial seizure during the Treatment Period.
Outcome measures
| Measure |
Placebo
n=147 Participants
Participants received matching Placebo as film-coated tablets, administered orally, twice daily (bid), during 12 weeks of Treatment Period. At the end of the Treatment Period, participants who entered long-term follow-up (LTFU) study (EP0085 (NCT03250377)) or managed access program (MAP), the same matching Placebo dose was kept during 2 weeks of Transition Period and brivaracetam (BRV) 100 milligrams/day (mg/day) in LTFU study or MAP. Participants who did not enter the LTFU study or MAP had 4 weeks Down-Titration Period followed by a Study Drug-Free Period (no drug for 2 weeks). During Down-Titration Period, participants received the same Placebo dose for 4 weeks.
|
BRV 50 mg/Day
n=151 Participants
Participants received BRV 50 mg/day as film-coated tablets, administered orally, bid, during 12 weeks of Treatment Period. At the end of the Treatment Period, participants who entered the LTFU study or MAP received BRV 50 mg/day during 2 weeks of Transition Period and BRV 100 mg/day in LTFU study or MAP. Participants who did not enter the LTFU study or MAP had 4 weeks Down-Titration Period followed by a Study Drug-Free Period (no drug for 2 weeks). During Down-Titration Period, participants received BRV 25 mg/day for 1 week followed by Placebo for 3 weeks.
|
BRV 200 mg/Day
n=148 Participants
Participants received BRV 200 mg/day as film-coated tablets, administered orally, bid, during 12 weeks of Treatment Period. At the end of the Treatment Period, participants who entered LTFU study or MAP received BRV 150 mg/day during 2 weeks of Transition Period and BRV 100 mg/day in LTFU study or MAP. Participants who did not enter the LTFU study or MAP had 4 weeks Down-Titration Period followed by a Study Drug-Free Period (no drug for 2 weeks). During Down-Titration Period, participants received BRV 150 mg/day for 1 week followed by BRV 100 mg/day for 1 week, followed by BRV 50 mg/day for 1 week, followed by BRV 25 mg/day for 1 week.
|
Placebo to OLTP BRV
Participants who received Placebo during Treatment Period and were eligible to enter MAP received BRV 100 mg/day due to delayed importation of medication during OLTP. BRV dose might be adjusted for an individual participant (between 50 mg/day to 200 mg/day) during the OLTP. The period was defined from immediately after the last visit of the Transition Period (Week 14) and until a visit when the participant could convert to MAP.
|
BRV 50 mg/Day to OLTP BRV
Participants who received BRV 50 mg/day during Treatment Period and were eligible to enter MAP received BRV 100 mg/day due to delayed importation of medication during Open-Label Temporary Period (OLTP). BRV dose might be adjusted for an individual participant (between 50 mg/day to 200 mg/day) during the OLTP. The period was defined from immediately after the last visit of the Transition Period (Week 14) and until a visit when the participant could convert to MAP.
|
BRV 200 mg/Day to OLTP BRV
Participants who received BRV 200 mg/day during Treatment Period and were eligible to enter MAP received BRV 100 mg/day due to delayed importation of medication during Open-Label Temporary Period (OLTP). BRV dose might be adjusted for an individual participant (between 50 mg/day to 200 mg/day) during the OLTP. The period was defined from immediately after the last visit of the Transition Period (Week 14) and until a visit when the participant could convert to MAP.
|
|---|---|---|---|---|---|---|
|
Time to 5th Partial Seizure During the 12-week Treatment Period
|
17 days
Interval 15.0 to 21.0
|
28 days
Interval 23.0 to 36.0
|
32 days
Interval 29.0 to 38.0
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: During the 12-week Treatment PeriodPopulation: The FAS consisted of all randomized study participants who received at least 1 dose of IMP and had at least 1 post Baseline seizure DRC data during the Treatment Period.
The evaluation of time to 10th partial seizure was based on the relative day of occurrence of the 10th partial seizure during the Treatment Period.
Outcome measures
| Measure |
Placebo
n=147 Participants
Participants received matching Placebo as film-coated tablets, administered orally, twice daily (bid), during 12 weeks of Treatment Period. At the end of the Treatment Period, participants who entered long-term follow-up (LTFU) study (EP0085 (NCT03250377)) or managed access program (MAP), the same matching Placebo dose was kept during 2 weeks of Transition Period and brivaracetam (BRV) 100 milligrams/day (mg/day) in LTFU study or MAP. Participants who did not enter the LTFU study or MAP had 4 weeks Down-Titration Period followed by a Study Drug-Free Period (no drug for 2 weeks). During Down-Titration Period, participants received the same Placebo dose for 4 weeks.
|
BRV 50 mg/Day
n=151 Participants
Participants received BRV 50 mg/day as film-coated tablets, administered orally, bid, during 12 weeks of Treatment Period. At the end of the Treatment Period, participants who entered the LTFU study or MAP received BRV 50 mg/day during 2 weeks of Transition Period and BRV 100 mg/day in LTFU study or MAP. Participants who did not enter the LTFU study or MAP had 4 weeks Down-Titration Period followed by a Study Drug-Free Period (no drug for 2 weeks). During Down-Titration Period, participants received BRV 25 mg/day for 1 week followed by Placebo for 3 weeks.
|
BRV 200 mg/Day
n=148 Participants
Participants received BRV 200 mg/day as film-coated tablets, administered orally, bid, during 12 weeks of Treatment Period. At the end of the Treatment Period, participants who entered LTFU study or MAP received BRV 150 mg/day during 2 weeks of Transition Period and BRV 100 mg/day in LTFU study or MAP. Participants who did not enter the LTFU study or MAP had 4 weeks Down-Titration Period followed by a Study Drug-Free Period (no drug for 2 weeks). During Down-Titration Period, participants received BRV 150 mg/day for 1 week followed by BRV 100 mg/day for 1 week, followed by BRV 50 mg/day for 1 week, followed by BRV 25 mg/day for 1 week.
|
Placebo to OLTP BRV
Participants who received Placebo during Treatment Period and were eligible to enter MAP received BRV 100 mg/day due to delayed importation of medication during OLTP. BRV dose might be adjusted for an individual participant (between 50 mg/day to 200 mg/day) during the OLTP. The period was defined from immediately after the last visit of the Transition Period (Week 14) and until a visit when the participant could convert to MAP.
|
BRV 50 mg/Day to OLTP BRV
Participants who received BRV 50 mg/day during Treatment Period and were eligible to enter MAP received BRV 100 mg/day due to delayed importation of medication during Open-Label Temporary Period (OLTP). BRV dose might be adjusted for an individual participant (between 50 mg/day to 200 mg/day) during the OLTP. The period was defined from immediately after the last visit of the Transition Period (Week 14) and until a visit when the participant could convert to MAP.
|
BRV 200 mg/Day to OLTP BRV
Participants who received BRV 200 mg/day during Treatment Period and were eligible to enter MAP received BRV 100 mg/day due to delayed importation of medication during Open-Label Temporary Period (OLTP). BRV dose might be adjusted for an individual participant (between 50 mg/day to 200 mg/day) during the OLTP. The period was defined from immediately after the last visit of the Transition Period (Week 14) and until a visit when the participant could convert to MAP.
|
|---|---|---|---|---|---|---|
|
Time to 10th Partial Seizure During the 12-week Treatment Period
|
43 days
Interval 32.0 to 52.0
|
59 days
Interval 48.0 to 76.0
|
69 days
Interval 59.0 to
Upper limit of 95% Confidence interval (CI) was not calculated due to less number of participants with events.
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Plasma samples were collected at >0-4hours, >4-8hours, >8hours in weeks 2, 4, 8, 12, and 14Population: The Pharmacokinetic Per-Protocol Set (PK-PPS) consisted of all study participants who took at least 1 dose of BRV and for whom at least 1 valid BRV plasma concentration time and dosing information were available. Here, 'n' (Number analyzed) signifies participants who were evaluable at specified time points.
Blood samples were collected at indicated time points for the 50mg/day and 200mg/day groups to determine the brivaracetam plasma concentration. Participants of arm 'BRV 200 mg/day' received BRV 200 mg/day until Week 12 only and 150 mg/day during the Transition Period at Week 14. Therefore, the data is reported according to the dosage information at specified time point. As per planned analysis, one blood sample was collected for BRV plasma levels during each dosing interval between 0 to 4 hours, 4 to 8 hours, and 8 to 12 hours postdose.
Outcome measures
| Measure |
Placebo
n=150 Participants
Participants received matching Placebo as film-coated tablets, administered orally, twice daily (bid), during 12 weeks of Treatment Period. At the end of the Treatment Period, participants who entered long-term follow-up (LTFU) study (EP0085 (NCT03250377)) or managed access program (MAP), the same matching Placebo dose was kept during 2 weeks of Transition Period and brivaracetam (BRV) 100 milligrams/day (mg/day) in LTFU study or MAP. Participants who did not enter the LTFU study or MAP had 4 weeks Down-Titration Period followed by a Study Drug-Free Period (no drug for 2 weeks). During Down-Titration Period, participants received the same Placebo dose for 4 weeks.
|
BRV 50 mg/Day
n=146 Participants
Participants received BRV 50 mg/day as film-coated tablets, administered orally, bid, during 12 weeks of Treatment Period. At the end of the Treatment Period, participants who entered the LTFU study or MAP received BRV 50 mg/day during 2 weeks of Transition Period and BRV 100 mg/day in LTFU study or MAP. Participants who did not enter the LTFU study or MAP had 4 weeks Down-Titration Period followed by a Study Drug-Free Period (no drug for 2 weeks). During Down-Titration Period, participants received BRV 25 mg/day for 1 week followed by Placebo for 3 weeks.
|
BRV 200 mg/Day
n=128 Participants
Participants received BRV 200 mg/day as film-coated tablets, administered orally, bid, during 12 weeks of Treatment Period. At the end of the Treatment Period, participants who entered LTFU study or MAP received BRV 150 mg/day during 2 weeks of Transition Period and BRV 100 mg/day in LTFU study or MAP. Participants who did not enter the LTFU study or MAP had 4 weeks Down-Titration Period followed by a Study Drug-Free Period (no drug for 2 weeks). During Down-Titration Period, participants received BRV 150 mg/day for 1 week followed by BRV 100 mg/day for 1 week, followed by BRV 50 mg/day for 1 week, followed by BRV 25 mg/day for 1 week.
|
Placebo to OLTP BRV
Participants who received Placebo during Treatment Period and were eligible to enter MAP received BRV 100 mg/day due to delayed importation of medication during OLTP. BRV dose might be adjusted for an individual participant (between 50 mg/day to 200 mg/day) during the OLTP. The period was defined from immediately after the last visit of the Transition Period (Week 14) and until a visit when the participant could convert to MAP.
|
BRV 50 mg/Day to OLTP BRV
Participants who received BRV 50 mg/day during Treatment Period and were eligible to enter MAP received BRV 100 mg/day due to delayed importation of medication during Open-Label Temporary Period (OLTP). BRV dose might be adjusted for an individual participant (between 50 mg/day to 200 mg/day) during the OLTP. The period was defined from immediately after the last visit of the Transition Period (Week 14) and until a visit when the participant could convert to MAP.
|
BRV 200 mg/Day to OLTP BRV
Participants who received BRV 200 mg/day during Treatment Period and were eligible to enter MAP received BRV 100 mg/day due to delayed importation of medication during Open-Label Temporary Period (OLTP). BRV dose might be adjusted for an individual participant (between 50 mg/day to 200 mg/day) during the OLTP. The period was defined from immediately after the last visit of the Transition Period (Week 14) and until a visit when the participant could convert to MAP.
|
|---|---|---|---|---|---|---|
|
Brivaracetam Plasma Concentration
Week 2: > 0 - 4 hours
|
0.68556 microgram/ millilitre (ug/mL)
Geometric Coefficient of Variation 95.6
|
3.4340 microgram/ millilitre (ug/mL)
Geometric Coefficient of Variation 42.5
|
—
|
—
|
—
|
—
|
|
Brivaracetam Plasma Concentration
Week 2: > 4 - 8 hours
|
0.66523 microgram/ millilitre (ug/mL)
Geometric Coefficient of Variation 38.6
|
2.0615 microgram/ millilitre (ug/mL)
Geometric Coefficient of Variation 334.4
|
—
|
—
|
—
|
—
|
|
Brivaracetam Plasma Concentration
Week 2: > 8 hours
|
0.18427 microgram/ millilitre (ug/mL)
Geometric Coefficient of Variation 979.4
|
1.2144 microgram/ millilitre (ug/mL)
Geometric Coefficient of Variation 100.1
|
—
|
—
|
—
|
—
|
|
Brivaracetam Plasma Concentration
Week 4: > 0 - 4 hours
|
0.75902 microgram/ millilitre (ug/mL)
Geometric Coefficient of Variation 88.8
|
3.0038 microgram/ millilitre (ug/mL)
Geometric Coefficient of Variation 120.2
|
—
|
—
|
—
|
—
|
|
Brivaracetam Plasma Concentration
Week 4: > 4 - 8 hours
|
0.64781 microgram/ millilitre (ug/mL)
Geometric Coefficient of Variation 39.2
|
2.8516 microgram/ millilitre (ug/mL)
Geometric Coefficient of Variation 43.2
|
—
|
—
|
—
|
—
|
|
Brivaracetam Plasma Concentration
Week 4: > 8 hours
|
0.39652 microgram/ millilitre (ug/mL)
Geometric Coefficient of Variation 54.7
|
1.1054 microgram/ millilitre (ug/mL)
Geometric Coefficient of Variation 74.4
|
—
|
—
|
—
|
—
|
|
Brivaracetam Plasma Concentration
Week 8: > 0 - 4 hours
|
0.76942 microgram/ millilitre (ug/mL)
Geometric Coefficient of Variation 87.3
|
2.9983 microgram/ millilitre (ug/mL)
Geometric Coefficient of Variation 127.7
|
—
|
—
|
—
|
—
|
|
Brivaracetam Plasma Concentration
Week 8: > 4 - 8 hours
|
0.76172 microgram/ millilitre (ug/mL)
Geometric Coefficient of Variation 34.0
|
2.7030 microgram/ millilitre (ug/mL)
Geometric Coefficient of Variation 54.9
|
—
|
—
|
—
|
—
|
|
Brivaracetam Plasma Concentration
Week 8: > 8 hours
|
0.27840 microgram/ millilitre (ug/mL)
Geometric Coefficient of Variation 10.9
|
1.5590 microgram/ millilitre (ug/mL)
Geometric Coefficient of Variation 67.7
|
—
|
—
|
—
|
—
|
|
Brivaracetam Plasma Concentration
Week 12: > 0 - 4 hours
|
0.77400 microgram/ millilitre (ug/mL)
Geometric Coefficient of Variation 89.5
|
3.2508 microgram/ millilitre (ug/mL)
Geometric Coefficient of Variation 121.1
|
—
|
—
|
—
|
—
|
|
Brivaracetam Plasma Concentration
Week 12: > 4 - 8 hours
|
0.65274 microgram/ millilitre (ug/mL)
Geometric Coefficient of Variation 39.4
|
1.6017 microgram/ millilitre (ug/mL)
Geometric Coefficient of Variation 838.9
|
—
|
—
|
—
|
—
|
|
Brivaracetam Plasma Concentration
Week 12: > 8 hours
|
0.18229 microgram/ millilitre (ug/mL)
Geometric Coefficient of Variation 579.5
|
1.5001 microgram/ millilitre (ug/mL)
Geometric Coefficient of Variation 45.4
|
—
|
—
|
—
|
—
|
|
Brivaracetam Plasma Concentration
Week 14 (Transition): > 0 - 4 hours
|
0.75949 microgram/ millilitre (ug/mL)
Geometric Coefficient of Variation 85.3
|
—
|
2.4989 microgram/ millilitre (ug/mL)
Geometric Coefficient of Variation 54.8
|
—
|
—
|
—
|
|
Brivaracetam Plasma Concentration
Week 14 (Transition): > 4 - 8 hours
|
0.75692 microgram/ millilitre (ug/mL)
Geometric Coefficient of Variation 34.6
|
—
|
1.4383 microgram/ millilitre (ug/mL)
Geometric Coefficient of Variation 309.5
|
—
|
—
|
—
|
|
Brivaracetam Plasma Concentration
Week 14 (Transition): > 8 hours
|
0.41286 microgram/ millilitre (ug/mL)
Geometric Coefficient of Variation 66.4
|
—
|
0.82681 microgram/ millilitre (ug/mL)
Geometric Coefficient of Variation 30.6
|
—
|
—
|
—
|
Adverse Events
Placebo
Serious events: 1 serious events
Other events: 39 other events
Deaths: 0 deaths
BRV 50 mg/Day
Serious events: 2 serious events
Other events: 42 other events
Deaths: 1 deaths
BRV 200 mg/Day
Serious events: 4 serious events
Other events: 54 other events
Deaths: 0 deaths
Placebo to OLTP BRV
Serious events: 3 serious events
Other events: 3 other events
Deaths: 0 deaths
BRV 50 mg/Day to OLTP BRV
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
BRV 200 mg/Day to OLTP BRV
Serious events: 2 serious events
Other events: 4 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo
n=149 participants at risk
Participants received matching Placebo as film-coated tablets, administered orally, twice daily (bid), during 12 weeks of Treatment Period. At the end of the Treatment Period, participants who entered long-term follow-up (LTFU) study (EP0085 (NCT03250377)) or managed access program (MAP), the same matching Placebo dose was kept during 2 weeks of Transition Period and brivaracetam (BRV) 100 milligrams/day (mg/day) in LTFU study or MAP. Participants who did not enter the LTFU study or MAP had 4 weeks Down-Titration Period followed by a Study Drug-Free Period (no drug for 2 weeks). During Down-Titration Period, participants received the same Placebo dose for 4 weeks.
|
BRV 50 mg/Day
n=151 participants at risk
Participants received BRV 50 mg/day as film-coated tablets, administered orally, bid, during 12 weeks of Treatment Period. At the end of the Treatment Period, participants who entered the LTFU study or MAP received BRV 50 mg/day during 2 weeks of Transition Period and BRV 100 mg/day in LTFU study or MAP. Participants who did not enter the LTFU study or MAP had 4 weeks Down-Titration Period followed by a Study Drug-Free Period (no drug for 2 weeks). During Down-Titration Period, participants received BRV 25 mg/day for 1 week followed by Placebo for 3 weeks.
|
BRV 200 mg/Day
n=148 participants at risk
Participants received BRV 200 mg/day as film-coated tablets, administered orally, bid, during 12 weeks of Treatment Period. At the end of the Treatment Period, participants who entered LTFU study or MAP received BRV 150 mg/day during 2 weeks of Transition Period and BRV 100 mg/day in LTFU study or MAP. Participants who did not enter the LTFU study or MAP had 4 weeks Down-Titration Period followed by a Study Drug-Free Period (no drug for 2 weeks). During Down-Titration Period, participants received BRV 150 mg/day for 1 week followed by BRV 100 mg/day for 1 week, followed by BRV 50 mg/day for 1 week, followed by BRV 25 mg/day for 1 week.
|
Placebo to OLTP BRV
n=64 participants at risk
Participants who received Placebo during Treatment Period and were eligible to enter MAP received BRV 100 mg/day due to delayed importation of medication during OLTP. BRV dose might be adjusted for an individual participant (between 50 mg/day to 200 mg/day) during the OLTP. The period was defined from immediately after the last visit of the Transition Period (Week 14) and until a visit when the participant could convert to MAP.
|
BRV 50 mg/Day to OLTP BRV
n=68 participants at risk
Participants who received BRV 50 mg/day during Treatment Period and were eligible to enter MAP received BRV 100 mg/day due to delayed importation of medication during Open-Label Temporary Period (OLTP). BRV dose might be adjusted for an individual participant (between 50 mg/day to 200 mg/day) during the OLTP. The period was defined from immediately after the last visit of the Transition Period (Week 14) and until a visit when the participant could convert to MAP.
|
BRV 200 mg/Day to OLTP BRV
n=74 participants at risk
Participants who received BRV 200 mg/day during Treatment Period and were eligible to enter MAP received BRV 100 mg/day due to delayed importation of medication during Open-Label Temporary Period (OLTP). BRV dose might be adjusted for an individual participant (between 50 mg/day to 200 mg/day) during the OLTP. The period was defined from immediately after the last visit of the Transition Period (Week 14) and until a visit when the participant could convert to MAP.
|
|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
Large intestine polyp
|
0.00%
0/149 • From start of the Treatment Period (Week 0) until Safety Visit (up to Week 18); only for OLTP- From last visit of Transition Period to beginning of MAP (Up to 4 Years 10 Months)
TEAEs were defined as AEs which had onset on or after the first dose of investigational medicinal product (IMP). The Safety Set (SS) included all randomized participants who took at least 1 dose of study medication. As per planned analysis, safety data for all study periods was combined excluding Open-Label Temporary period.
|
0.00%
0/151 • From start of the Treatment Period (Week 0) until Safety Visit (up to Week 18); only for OLTP- From last visit of Transition Period to beginning of MAP (Up to 4 Years 10 Months)
TEAEs were defined as AEs which had onset on or after the first dose of investigational medicinal product (IMP). The Safety Set (SS) included all randomized participants who took at least 1 dose of study medication. As per planned analysis, safety data for all study periods was combined excluding Open-Label Temporary period.
|
0.68%
1/148 • Number of events 1 • From start of the Treatment Period (Week 0) until Safety Visit (up to Week 18); only for OLTP- From last visit of Transition Period to beginning of MAP (Up to 4 Years 10 Months)
TEAEs were defined as AEs which had onset on or after the first dose of investigational medicinal product (IMP). The Safety Set (SS) included all randomized participants who took at least 1 dose of study medication. As per planned analysis, safety data for all study periods was combined excluding Open-Label Temporary period.
|
0.00%
0/64 • From start of the Treatment Period (Week 0) until Safety Visit (up to Week 18); only for OLTP- From last visit of Transition Period to beginning of MAP (Up to 4 Years 10 Months)
TEAEs were defined as AEs which had onset on or after the first dose of investigational medicinal product (IMP). The Safety Set (SS) included all randomized participants who took at least 1 dose of study medication. As per planned analysis, safety data for all study periods was combined excluding Open-Label Temporary period.
|
0.00%
0/68 • From start of the Treatment Period (Week 0) until Safety Visit (up to Week 18); only for OLTP- From last visit of Transition Period to beginning of MAP (Up to 4 Years 10 Months)
TEAEs were defined as AEs which had onset on or after the first dose of investigational medicinal product (IMP). The Safety Set (SS) included all randomized participants who took at least 1 dose of study medication. As per planned analysis, safety data for all study periods was combined excluding Open-Label Temporary period.
|
0.00%
0/74 • From start of the Treatment Period (Week 0) until Safety Visit (up to Week 18); only for OLTP- From last visit of Transition Period to beginning of MAP (Up to 4 Years 10 Months)
TEAEs were defined as AEs which had onset on or after the first dose of investigational medicinal product (IMP). The Safety Set (SS) included all randomized participants who took at least 1 dose of study medication. As per planned analysis, safety data for all study periods was combined excluding Open-Label Temporary period.
|
|
General disorders
Drowning
|
0.00%
0/149 • From start of the Treatment Period (Week 0) until Safety Visit (up to Week 18); only for OLTP- From last visit of Transition Period to beginning of MAP (Up to 4 Years 10 Months)
TEAEs were defined as AEs which had onset on or after the first dose of investigational medicinal product (IMP). The Safety Set (SS) included all randomized participants who took at least 1 dose of study medication. As per planned analysis, safety data for all study periods was combined excluding Open-Label Temporary period.
|
0.66%
1/151 • Number of events 1 • From start of the Treatment Period (Week 0) until Safety Visit (up to Week 18); only for OLTP- From last visit of Transition Period to beginning of MAP (Up to 4 Years 10 Months)
TEAEs were defined as AEs which had onset on or after the first dose of investigational medicinal product (IMP). The Safety Set (SS) included all randomized participants who took at least 1 dose of study medication. As per planned analysis, safety data for all study periods was combined excluding Open-Label Temporary period.
|
0.00%
0/148 • From start of the Treatment Period (Week 0) until Safety Visit (up to Week 18); only for OLTP- From last visit of Transition Period to beginning of MAP (Up to 4 Years 10 Months)
TEAEs were defined as AEs which had onset on or after the first dose of investigational medicinal product (IMP). The Safety Set (SS) included all randomized participants who took at least 1 dose of study medication. As per planned analysis, safety data for all study periods was combined excluding Open-Label Temporary period.
|
0.00%
0/64 • From start of the Treatment Period (Week 0) until Safety Visit (up to Week 18); only for OLTP- From last visit of Transition Period to beginning of MAP (Up to 4 Years 10 Months)
TEAEs were defined as AEs which had onset on or after the first dose of investigational medicinal product (IMP). The Safety Set (SS) included all randomized participants who took at least 1 dose of study medication. As per planned analysis, safety data for all study periods was combined excluding Open-Label Temporary period.
|
0.00%
0/68 • From start of the Treatment Period (Week 0) until Safety Visit (up to Week 18); only for OLTP- From last visit of Transition Period to beginning of MAP (Up to 4 Years 10 Months)
TEAEs were defined as AEs which had onset on or after the first dose of investigational medicinal product (IMP). The Safety Set (SS) included all randomized participants who took at least 1 dose of study medication. As per planned analysis, safety data for all study periods was combined excluding Open-Label Temporary period.
|
0.00%
0/74 • From start of the Treatment Period (Week 0) until Safety Visit (up to Week 18); only for OLTP- From last visit of Transition Period to beginning of MAP (Up to 4 Years 10 Months)
TEAEs were defined as AEs which had onset on or after the first dose of investigational medicinal product (IMP). The Safety Set (SS) included all randomized participants who took at least 1 dose of study medication. As per planned analysis, safety data for all study periods was combined excluding Open-Label Temporary period.
|
|
General disorders
Pyrexia
|
0.00%
0/149 • From start of the Treatment Period (Week 0) until Safety Visit (up to Week 18); only for OLTP- From last visit of Transition Period to beginning of MAP (Up to 4 Years 10 Months)
TEAEs were defined as AEs which had onset on or after the first dose of investigational medicinal product (IMP). The Safety Set (SS) included all randomized participants who took at least 1 dose of study medication. As per planned analysis, safety data for all study periods was combined excluding Open-Label Temporary period.
|
0.00%
0/151 • From start of the Treatment Period (Week 0) until Safety Visit (up to Week 18); only for OLTP- From last visit of Transition Period to beginning of MAP (Up to 4 Years 10 Months)
TEAEs were defined as AEs which had onset on or after the first dose of investigational medicinal product (IMP). The Safety Set (SS) included all randomized participants who took at least 1 dose of study medication. As per planned analysis, safety data for all study periods was combined excluding Open-Label Temporary period.
|
0.68%
1/148 • Number of events 1 • From start of the Treatment Period (Week 0) until Safety Visit (up to Week 18); only for OLTP- From last visit of Transition Period to beginning of MAP (Up to 4 Years 10 Months)
TEAEs were defined as AEs which had onset on or after the first dose of investigational medicinal product (IMP). The Safety Set (SS) included all randomized participants who took at least 1 dose of study medication. As per planned analysis, safety data for all study periods was combined excluding Open-Label Temporary period.
|
0.00%
0/64 • From start of the Treatment Period (Week 0) until Safety Visit (up to Week 18); only for OLTP- From last visit of Transition Period to beginning of MAP (Up to 4 Years 10 Months)
TEAEs were defined as AEs which had onset on or after the first dose of investigational medicinal product (IMP). The Safety Set (SS) included all randomized participants who took at least 1 dose of study medication. As per planned analysis, safety data for all study periods was combined excluding Open-Label Temporary period.
|
0.00%
0/68 • From start of the Treatment Period (Week 0) until Safety Visit (up to Week 18); only for OLTP- From last visit of Transition Period to beginning of MAP (Up to 4 Years 10 Months)
TEAEs were defined as AEs which had onset on or after the first dose of investigational medicinal product (IMP). The Safety Set (SS) included all randomized participants who took at least 1 dose of study medication. As per planned analysis, safety data for all study periods was combined excluding Open-Label Temporary period.
|
0.00%
0/74 • From start of the Treatment Period (Week 0) until Safety Visit (up to Week 18); only for OLTP- From last visit of Transition Period to beginning of MAP (Up to 4 Years 10 Months)
TEAEs were defined as AEs which had onset on or after the first dose of investigational medicinal product (IMP). The Safety Set (SS) included all randomized participants who took at least 1 dose of study medication. As per planned analysis, safety data for all study periods was combined excluding Open-Label Temporary period.
|
|
Infections and infestations
Corona virus infection
|
0.67%
1/149 • Number of events 1 • From start of the Treatment Period (Week 0) until Safety Visit (up to Week 18); only for OLTP- From last visit of Transition Period to beginning of MAP (Up to 4 Years 10 Months)
TEAEs were defined as AEs which had onset on or after the first dose of investigational medicinal product (IMP). The Safety Set (SS) included all randomized participants who took at least 1 dose of study medication. As per planned analysis, safety data for all study periods was combined excluding Open-Label Temporary period.
|
0.00%
0/151 • From start of the Treatment Period (Week 0) until Safety Visit (up to Week 18); only for OLTP- From last visit of Transition Period to beginning of MAP (Up to 4 Years 10 Months)
TEAEs were defined as AEs which had onset on or after the first dose of investigational medicinal product (IMP). The Safety Set (SS) included all randomized participants who took at least 1 dose of study medication. As per planned analysis, safety data for all study periods was combined excluding Open-Label Temporary period.
|
0.00%
0/148 • From start of the Treatment Period (Week 0) until Safety Visit (up to Week 18); only for OLTP- From last visit of Transition Period to beginning of MAP (Up to 4 Years 10 Months)
TEAEs were defined as AEs which had onset on or after the first dose of investigational medicinal product (IMP). The Safety Set (SS) included all randomized participants who took at least 1 dose of study medication. As per planned analysis, safety data for all study periods was combined excluding Open-Label Temporary period.
|
0.00%
0/64 • From start of the Treatment Period (Week 0) until Safety Visit (up to Week 18); only for OLTP- From last visit of Transition Period to beginning of MAP (Up to 4 Years 10 Months)
TEAEs were defined as AEs which had onset on or after the first dose of investigational medicinal product (IMP). The Safety Set (SS) included all randomized participants who took at least 1 dose of study medication. As per planned analysis, safety data for all study periods was combined excluding Open-Label Temporary period.
|
0.00%
0/68 • From start of the Treatment Period (Week 0) until Safety Visit (up to Week 18); only for OLTP- From last visit of Transition Period to beginning of MAP (Up to 4 Years 10 Months)
TEAEs were defined as AEs which had onset on or after the first dose of investigational medicinal product (IMP). The Safety Set (SS) included all randomized participants who took at least 1 dose of study medication. As per planned analysis, safety data for all study periods was combined excluding Open-Label Temporary period.
|
0.00%
0/74 • From start of the Treatment Period (Week 0) until Safety Visit (up to Week 18); only for OLTP- From last visit of Transition Period to beginning of MAP (Up to 4 Years 10 Months)
TEAEs were defined as AEs which had onset on or after the first dose of investigational medicinal product (IMP). The Safety Set (SS) included all randomized participants who took at least 1 dose of study medication. As per planned analysis, safety data for all study periods was combined excluding Open-Label Temporary period.
|
|
Psychiatric disorders
Postictal psychosis
|
0.00%
0/149 • From start of the Treatment Period (Week 0) until Safety Visit (up to Week 18); only for OLTP- From last visit of Transition Period to beginning of MAP (Up to 4 Years 10 Months)
TEAEs were defined as AEs which had onset on or after the first dose of investigational medicinal product (IMP). The Safety Set (SS) included all randomized participants who took at least 1 dose of study medication. As per planned analysis, safety data for all study periods was combined excluding Open-Label Temporary period.
|
0.66%
1/151 • Number of events 1 • From start of the Treatment Period (Week 0) until Safety Visit (up to Week 18); only for OLTP- From last visit of Transition Period to beginning of MAP (Up to 4 Years 10 Months)
TEAEs were defined as AEs which had onset on or after the first dose of investigational medicinal product (IMP). The Safety Set (SS) included all randomized participants who took at least 1 dose of study medication. As per planned analysis, safety data for all study periods was combined excluding Open-Label Temporary period.
|
0.00%
0/148 • From start of the Treatment Period (Week 0) until Safety Visit (up to Week 18); only for OLTP- From last visit of Transition Period to beginning of MAP (Up to 4 Years 10 Months)
TEAEs were defined as AEs which had onset on or after the first dose of investigational medicinal product (IMP). The Safety Set (SS) included all randomized participants who took at least 1 dose of study medication. As per planned analysis, safety data for all study periods was combined excluding Open-Label Temporary period.
|
0.00%
0/64 • From start of the Treatment Period (Week 0) until Safety Visit (up to Week 18); only for OLTP- From last visit of Transition Period to beginning of MAP (Up to 4 Years 10 Months)
TEAEs were defined as AEs which had onset on or after the first dose of investigational medicinal product (IMP). The Safety Set (SS) included all randomized participants who took at least 1 dose of study medication. As per planned analysis, safety data for all study periods was combined excluding Open-Label Temporary period.
|
0.00%
0/68 • From start of the Treatment Period (Week 0) until Safety Visit (up to Week 18); only for OLTP- From last visit of Transition Period to beginning of MAP (Up to 4 Years 10 Months)
TEAEs were defined as AEs which had onset on or after the first dose of investigational medicinal product (IMP). The Safety Set (SS) included all randomized participants who took at least 1 dose of study medication. As per planned analysis, safety data for all study periods was combined excluding Open-Label Temporary period.
|
0.00%
0/74 • From start of the Treatment Period (Week 0) until Safety Visit (up to Week 18); only for OLTP- From last visit of Transition Period to beginning of MAP (Up to 4 Years 10 Months)
TEAEs were defined as AEs which had onset on or after the first dose of investigational medicinal product (IMP). The Safety Set (SS) included all randomized participants who took at least 1 dose of study medication. As per planned analysis, safety data for all study periods was combined excluding Open-Label Temporary period.
|
|
Renal and urinary disorders
Calculus ureteric
|
0.00%
0/149 • From start of the Treatment Period (Week 0) until Safety Visit (up to Week 18); only for OLTP- From last visit of Transition Period to beginning of MAP (Up to 4 Years 10 Months)
TEAEs were defined as AEs which had onset on or after the first dose of investigational medicinal product (IMP). The Safety Set (SS) included all randomized participants who took at least 1 dose of study medication. As per planned analysis, safety data for all study periods was combined excluding Open-Label Temporary period.
|
0.00%
0/151 • From start of the Treatment Period (Week 0) until Safety Visit (up to Week 18); only for OLTP- From last visit of Transition Period to beginning of MAP (Up to 4 Years 10 Months)
TEAEs were defined as AEs which had onset on or after the first dose of investigational medicinal product (IMP). The Safety Set (SS) included all randomized participants who took at least 1 dose of study medication. As per planned analysis, safety data for all study periods was combined excluding Open-Label Temporary period.
|
0.68%
1/148 • Number of events 1 • From start of the Treatment Period (Week 0) until Safety Visit (up to Week 18); only for OLTP- From last visit of Transition Period to beginning of MAP (Up to 4 Years 10 Months)
TEAEs were defined as AEs which had onset on or after the first dose of investigational medicinal product (IMP). The Safety Set (SS) included all randomized participants who took at least 1 dose of study medication. As per planned analysis, safety data for all study periods was combined excluding Open-Label Temporary period.
|
0.00%
0/64 • From start of the Treatment Period (Week 0) until Safety Visit (up to Week 18); only for OLTP- From last visit of Transition Period to beginning of MAP (Up to 4 Years 10 Months)
TEAEs were defined as AEs which had onset on or after the first dose of investigational medicinal product (IMP). The Safety Set (SS) included all randomized participants who took at least 1 dose of study medication. As per planned analysis, safety data for all study periods was combined excluding Open-Label Temporary period.
|
0.00%
0/68 • From start of the Treatment Period (Week 0) until Safety Visit (up to Week 18); only for OLTP- From last visit of Transition Period to beginning of MAP (Up to 4 Years 10 Months)
TEAEs were defined as AEs which had onset on or after the first dose of investigational medicinal product (IMP). The Safety Set (SS) included all randomized participants who took at least 1 dose of study medication. As per planned analysis, safety data for all study periods was combined excluding Open-Label Temporary period.
|
0.00%
0/74 • From start of the Treatment Period (Week 0) until Safety Visit (up to Week 18); only for OLTP- From last visit of Transition Period to beginning of MAP (Up to 4 Years 10 Months)
TEAEs were defined as AEs which had onset on or after the first dose of investigational medicinal product (IMP). The Safety Set (SS) included all randomized participants who took at least 1 dose of study medication. As per planned analysis, safety data for all study periods was combined excluding Open-Label Temporary period.
|
|
Social circumstances
Miscarriage of partner
|
0.00%
0/149 • From start of the Treatment Period (Week 0) until Safety Visit (up to Week 18); only for OLTP- From last visit of Transition Period to beginning of MAP (Up to 4 Years 10 Months)
TEAEs were defined as AEs which had onset on or after the first dose of investigational medicinal product (IMP). The Safety Set (SS) included all randomized participants who took at least 1 dose of study medication. As per planned analysis, safety data for all study periods was combined excluding Open-Label Temporary period.
|
0.00%
0/151 • From start of the Treatment Period (Week 0) until Safety Visit (up to Week 18); only for OLTP- From last visit of Transition Period to beginning of MAP (Up to 4 Years 10 Months)
TEAEs were defined as AEs which had onset on or after the first dose of investigational medicinal product (IMP). The Safety Set (SS) included all randomized participants who took at least 1 dose of study medication. As per planned analysis, safety data for all study periods was combined excluding Open-Label Temporary period.
|
0.68%
1/148 • Number of events 1 • From start of the Treatment Period (Week 0) until Safety Visit (up to Week 18); only for OLTP- From last visit of Transition Period to beginning of MAP (Up to 4 Years 10 Months)
TEAEs were defined as AEs which had onset on or after the first dose of investigational medicinal product (IMP). The Safety Set (SS) included all randomized participants who took at least 1 dose of study medication. As per planned analysis, safety data for all study periods was combined excluding Open-Label Temporary period.
|
0.00%
0/64 • From start of the Treatment Period (Week 0) until Safety Visit (up to Week 18); only for OLTP- From last visit of Transition Period to beginning of MAP (Up to 4 Years 10 Months)
TEAEs were defined as AEs which had onset on or after the first dose of investigational medicinal product (IMP). The Safety Set (SS) included all randomized participants who took at least 1 dose of study medication. As per planned analysis, safety data for all study periods was combined excluding Open-Label Temporary period.
|
0.00%
0/68 • From start of the Treatment Period (Week 0) until Safety Visit (up to Week 18); only for OLTP- From last visit of Transition Period to beginning of MAP (Up to 4 Years 10 Months)
TEAEs were defined as AEs which had onset on or after the first dose of investigational medicinal product (IMP). The Safety Set (SS) included all randomized participants who took at least 1 dose of study medication. As per planned analysis, safety data for all study periods was combined excluding Open-Label Temporary period.
|
0.00%
0/74 • From start of the Treatment Period (Week 0) until Safety Visit (up to Week 18); only for OLTP- From last visit of Transition Period to beginning of MAP (Up to 4 Years 10 Months)
TEAEs were defined as AEs which had onset on or after the first dose of investigational medicinal product (IMP). The Safety Set (SS) included all randomized participants who took at least 1 dose of study medication. As per planned analysis, safety data for all study periods was combined excluding Open-Label Temporary period.
|
|
Injury, poisoning and procedural complications
Near drowning
|
0.00%
0/149 • From start of the Treatment Period (Week 0) until Safety Visit (up to Week 18); only for OLTP- From last visit of Transition Period to beginning of MAP (Up to 4 Years 10 Months)
TEAEs were defined as AEs which had onset on or after the first dose of investigational medicinal product (IMP). The Safety Set (SS) included all randomized participants who took at least 1 dose of study medication. As per planned analysis, safety data for all study periods was combined excluding Open-Label Temporary period.
|
0.00%
0/151 • From start of the Treatment Period (Week 0) until Safety Visit (up to Week 18); only for OLTP- From last visit of Transition Period to beginning of MAP (Up to 4 Years 10 Months)
TEAEs were defined as AEs which had onset on or after the first dose of investigational medicinal product (IMP). The Safety Set (SS) included all randomized participants who took at least 1 dose of study medication. As per planned analysis, safety data for all study periods was combined excluding Open-Label Temporary period.
|
0.00%
0/148 • From start of the Treatment Period (Week 0) until Safety Visit (up to Week 18); only for OLTP- From last visit of Transition Period to beginning of MAP (Up to 4 Years 10 Months)
TEAEs were defined as AEs which had onset on or after the first dose of investigational medicinal product (IMP). The Safety Set (SS) included all randomized participants who took at least 1 dose of study medication. As per planned analysis, safety data for all study periods was combined excluding Open-Label Temporary period.
|
1.6%
1/64 • Number of events 1 • From start of the Treatment Period (Week 0) until Safety Visit (up to Week 18); only for OLTP- From last visit of Transition Period to beginning of MAP (Up to 4 Years 10 Months)
TEAEs were defined as AEs which had onset on or after the first dose of investigational medicinal product (IMP). The Safety Set (SS) included all randomized participants who took at least 1 dose of study medication. As per planned analysis, safety data for all study periods was combined excluding Open-Label Temporary period.
|
0.00%
0/68 • From start of the Treatment Period (Week 0) until Safety Visit (up to Week 18); only for OLTP- From last visit of Transition Period to beginning of MAP (Up to 4 Years 10 Months)
TEAEs were defined as AEs which had onset on or after the first dose of investigational medicinal product (IMP). The Safety Set (SS) included all randomized participants who took at least 1 dose of study medication. As per planned analysis, safety data for all study periods was combined excluding Open-Label Temporary period.
|
0.00%
0/74 • From start of the Treatment Period (Week 0) until Safety Visit (up to Week 18); only for OLTP- From last visit of Transition Period to beginning of MAP (Up to 4 Years 10 Months)
TEAEs were defined as AEs which had onset on or after the first dose of investigational medicinal product (IMP). The Safety Set (SS) included all randomized participants who took at least 1 dose of study medication. As per planned analysis, safety data for all study periods was combined excluding Open-Label Temporary period.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/149 • From start of the Treatment Period (Week 0) until Safety Visit (up to Week 18); only for OLTP- From last visit of Transition Period to beginning of MAP (Up to 4 Years 10 Months)
TEAEs were defined as AEs which had onset on or after the first dose of investigational medicinal product (IMP). The Safety Set (SS) included all randomized participants who took at least 1 dose of study medication. As per planned analysis, safety data for all study periods was combined excluding Open-Label Temporary period.
|
0.00%
0/151 • From start of the Treatment Period (Week 0) until Safety Visit (up to Week 18); only for OLTP- From last visit of Transition Period to beginning of MAP (Up to 4 Years 10 Months)
TEAEs were defined as AEs which had onset on or after the first dose of investigational medicinal product (IMP). The Safety Set (SS) included all randomized participants who took at least 1 dose of study medication. As per planned analysis, safety data for all study periods was combined excluding Open-Label Temporary period.
|
0.00%
0/148 • From start of the Treatment Period (Week 0) until Safety Visit (up to Week 18); only for OLTP- From last visit of Transition Period to beginning of MAP (Up to 4 Years 10 Months)
TEAEs were defined as AEs which had onset on or after the first dose of investigational medicinal product (IMP). The Safety Set (SS) included all randomized participants who took at least 1 dose of study medication. As per planned analysis, safety data for all study periods was combined excluding Open-Label Temporary period.
|
0.00%
0/64 • From start of the Treatment Period (Week 0) until Safety Visit (up to Week 18); only for OLTP- From last visit of Transition Period to beginning of MAP (Up to 4 Years 10 Months)
TEAEs were defined as AEs which had onset on or after the first dose of investigational medicinal product (IMP). The Safety Set (SS) included all randomized participants who took at least 1 dose of study medication. As per planned analysis, safety data for all study periods was combined excluding Open-Label Temporary period.
|
0.00%
0/68 • From start of the Treatment Period (Week 0) until Safety Visit (up to Week 18); only for OLTP- From last visit of Transition Period to beginning of MAP (Up to 4 Years 10 Months)
TEAEs were defined as AEs which had onset on or after the first dose of investigational medicinal product (IMP). The Safety Set (SS) included all randomized participants who took at least 1 dose of study medication. As per planned analysis, safety data for all study periods was combined excluding Open-Label Temporary period.
|
1.4%
1/74 • Number of events 1 • From start of the Treatment Period (Week 0) until Safety Visit (up to Week 18); only for OLTP- From last visit of Transition Period to beginning of MAP (Up to 4 Years 10 Months)
TEAEs were defined as AEs which had onset on or after the first dose of investigational medicinal product (IMP). The Safety Set (SS) included all randomized participants who took at least 1 dose of study medication. As per planned analysis, safety data for all study periods was combined excluding Open-Label Temporary period.
|
|
Nervous system disorders
Seizure
|
0.00%
0/149 • From start of the Treatment Period (Week 0) until Safety Visit (up to Week 18); only for OLTP- From last visit of Transition Period to beginning of MAP (Up to 4 Years 10 Months)
TEAEs were defined as AEs which had onset on or after the first dose of investigational medicinal product (IMP). The Safety Set (SS) included all randomized participants who took at least 1 dose of study medication. As per planned analysis, safety data for all study periods was combined excluding Open-Label Temporary period.
|
0.00%
0/151 • From start of the Treatment Period (Week 0) until Safety Visit (up to Week 18); only for OLTP- From last visit of Transition Period to beginning of MAP (Up to 4 Years 10 Months)
TEAEs were defined as AEs which had onset on or after the first dose of investigational medicinal product (IMP). The Safety Set (SS) included all randomized participants who took at least 1 dose of study medication. As per planned analysis, safety data for all study periods was combined excluding Open-Label Temporary period.
|
0.00%
0/148 • From start of the Treatment Period (Week 0) until Safety Visit (up to Week 18); only for OLTP- From last visit of Transition Period to beginning of MAP (Up to 4 Years 10 Months)
TEAEs were defined as AEs which had onset on or after the first dose of investigational medicinal product (IMP). The Safety Set (SS) included all randomized participants who took at least 1 dose of study medication. As per planned analysis, safety data for all study periods was combined excluding Open-Label Temporary period.
|
3.1%
2/64 • Number of events 2 • From start of the Treatment Period (Week 0) until Safety Visit (up to Week 18); only for OLTP- From last visit of Transition Period to beginning of MAP (Up to 4 Years 10 Months)
TEAEs were defined as AEs which had onset on or after the first dose of investigational medicinal product (IMP). The Safety Set (SS) included all randomized participants who took at least 1 dose of study medication. As per planned analysis, safety data for all study periods was combined excluding Open-Label Temporary period.
|
0.00%
0/68 • From start of the Treatment Period (Week 0) until Safety Visit (up to Week 18); only for OLTP- From last visit of Transition Period to beginning of MAP (Up to 4 Years 10 Months)
TEAEs were defined as AEs which had onset on or after the first dose of investigational medicinal product (IMP). The Safety Set (SS) included all randomized participants who took at least 1 dose of study medication. As per planned analysis, safety data for all study periods was combined excluding Open-Label Temporary period.
|
0.00%
0/74 • From start of the Treatment Period (Week 0) until Safety Visit (up to Week 18); only for OLTP- From last visit of Transition Period to beginning of MAP (Up to 4 Years 10 Months)
TEAEs were defined as AEs which had onset on or after the first dose of investigational medicinal product (IMP). The Safety Set (SS) included all randomized participants who took at least 1 dose of study medication. As per planned analysis, safety data for all study periods was combined excluding Open-Label Temporary period.
|
|
Nervous system disorders
Cervicogenic headache
|
0.00%
0/149 • From start of the Treatment Period (Week 0) until Safety Visit (up to Week 18); only for OLTP- From last visit of Transition Period to beginning of MAP (Up to 4 Years 10 Months)
TEAEs were defined as AEs which had onset on or after the first dose of investigational medicinal product (IMP). The Safety Set (SS) included all randomized participants who took at least 1 dose of study medication. As per planned analysis, safety data for all study periods was combined excluding Open-Label Temporary period.
|
0.00%
0/151 • From start of the Treatment Period (Week 0) until Safety Visit (up to Week 18); only for OLTP- From last visit of Transition Period to beginning of MAP (Up to 4 Years 10 Months)
TEAEs were defined as AEs which had onset on or after the first dose of investigational medicinal product (IMP). The Safety Set (SS) included all randomized participants who took at least 1 dose of study medication. As per planned analysis, safety data for all study periods was combined excluding Open-Label Temporary period.
|
0.00%
0/148 • From start of the Treatment Period (Week 0) until Safety Visit (up to Week 18); only for OLTP- From last visit of Transition Period to beginning of MAP (Up to 4 Years 10 Months)
TEAEs were defined as AEs which had onset on or after the first dose of investigational medicinal product (IMP). The Safety Set (SS) included all randomized participants who took at least 1 dose of study medication. As per planned analysis, safety data for all study periods was combined excluding Open-Label Temporary period.
|
0.00%
0/64 • From start of the Treatment Period (Week 0) until Safety Visit (up to Week 18); only for OLTP- From last visit of Transition Period to beginning of MAP (Up to 4 Years 10 Months)
TEAEs were defined as AEs which had onset on or after the first dose of investigational medicinal product (IMP). The Safety Set (SS) included all randomized participants who took at least 1 dose of study medication. As per planned analysis, safety data for all study periods was combined excluding Open-Label Temporary period.
|
0.00%
0/68 • From start of the Treatment Period (Week 0) until Safety Visit (up to Week 18); only for OLTP- From last visit of Transition Period to beginning of MAP (Up to 4 Years 10 Months)
TEAEs were defined as AEs which had onset on or after the first dose of investigational medicinal product (IMP). The Safety Set (SS) included all randomized participants who took at least 1 dose of study medication. As per planned analysis, safety data for all study periods was combined excluding Open-Label Temporary period.
|
1.4%
1/74 • Number of events 1 • From start of the Treatment Period (Week 0) until Safety Visit (up to Week 18); only for OLTP- From last visit of Transition Period to beginning of MAP (Up to 4 Years 10 Months)
TEAEs were defined as AEs which had onset on or after the first dose of investigational medicinal product (IMP). The Safety Set (SS) included all randomized participants who took at least 1 dose of study medication. As per planned analysis, safety data for all study periods was combined excluding Open-Label Temporary period.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/149 • From start of the Treatment Period (Week 0) until Safety Visit (up to Week 18); only for OLTP- From last visit of Transition Period to beginning of MAP (Up to 4 Years 10 Months)
TEAEs were defined as AEs which had onset on or after the first dose of investigational medicinal product (IMP). The Safety Set (SS) included all randomized participants who took at least 1 dose of study medication. As per planned analysis, safety data for all study periods was combined excluding Open-Label Temporary period.
|
0.00%
0/151 • From start of the Treatment Period (Week 0) until Safety Visit (up to Week 18); only for OLTP- From last visit of Transition Period to beginning of MAP (Up to 4 Years 10 Months)
TEAEs were defined as AEs which had onset on or after the first dose of investigational medicinal product (IMP). The Safety Set (SS) included all randomized participants who took at least 1 dose of study medication. As per planned analysis, safety data for all study periods was combined excluding Open-Label Temporary period.
|
0.00%
0/148 • From start of the Treatment Period (Week 0) until Safety Visit (up to Week 18); only for OLTP- From last visit of Transition Period to beginning of MAP (Up to 4 Years 10 Months)
TEAEs were defined as AEs which had onset on or after the first dose of investigational medicinal product (IMP). The Safety Set (SS) included all randomized participants who took at least 1 dose of study medication. As per planned analysis, safety data for all study periods was combined excluding Open-Label Temporary period.
|
0.00%
0/64 • From start of the Treatment Period (Week 0) until Safety Visit (up to Week 18); only for OLTP- From last visit of Transition Period to beginning of MAP (Up to 4 Years 10 Months)
TEAEs were defined as AEs which had onset on or after the first dose of investigational medicinal product (IMP). The Safety Set (SS) included all randomized participants who took at least 1 dose of study medication. As per planned analysis, safety data for all study periods was combined excluding Open-Label Temporary period.
|
0.00%
0/68 • From start of the Treatment Period (Week 0) until Safety Visit (up to Week 18); only for OLTP- From last visit of Transition Period to beginning of MAP (Up to 4 Years 10 Months)
TEAEs were defined as AEs which had onset on or after the first dose of investigational medicinal product (IMP). The Safety Set (SS) included all randomized participants who took at least 1 dose of study medication. As per planned analysis, safety data for all study periods was combined excluding Open-Label Temporary period.
|
1.4%
1/74 • Number of events 1 • From start of the Treatment Period (Week 0) until Safety Visit (up to Week 18); only for OLTP- From last visit of Transition Period to beginning of MAP (Up to 4 Years 10 Months)
TEAEs were defined as AEs which had onset on or after the first dose of investigational medicinal product (IMP). The Safety Set (SS) included all randomized participants who took at least 1 dose of study medication. As per planned analysis, safety data for all study periods was combined excluding Open-Label Temporary period.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia aspiration
|
0.00%
0/149 • From start of the Treatment Period (Week 0) until Safety Visit (up to Week 18); only for OLTP- From last visit of Transition Period to beginning of MAP (Up to 4 Years 10 Months)
TEAEs were defined as AEs which had onset on or after the first dose of investigational medicinal product (IMP). The Safety Set (SS) included all randomized participants who took at least 1 dose of study medication. As per planned analysis, safety data for all study periods was combined excluding Open-Label Temporary period.
|
0.00%
0/151 • From start of the Treatment Period (Week 0) until Safety Visit (up to Week 18); only for OLTP- From last visit of Transition Period to beginning of MAP (Up to 4 Years 10 Months)
TEAEs were defined as AEs which had onset on or after the first dose of investigational medicinal product (IMP). The Safety Set (SS) included all randomized participants who took at least 1 dose of study medication. As per planned analysis, safety data for all study periods was combined excluding Open-Label Temporary period.
|
0.00%
0/148 • From start of the Treatment Period (Week 0) until Safety Visit (up to Week 18); only for OLTP- From last visit of Transition Period to beginning of MAP (Up to 4 Years 10 Months)
TEAEs were defined as AEs which had onset on or after the first dose of investigational medicinal product (IMP). The Safety Set (SS) included all randomized participants who took at least 1 dose of study medication. As per planned analysis, safety data for all study periods was combined excluding Open-Label Temporary period.
|
1.6%
1/64 • Number of events 1 • From start of the Treatment Period (Week 0) until Safety Visit (up to Week 18); only for OLTP- From last visit of Transition Period to beginning of MAP (Up to 4 Years 10 Months)
TEAEs were defined as AEs which had onset on or after the first dose of investigational medicinal product (IMP). The Safety Set (SS) included all randomized participants who took at least 1 dose of study medication. As per planned analysis, safety data for all study periods was combined excluding Open-Label Temporary period.
|
0.00%
0/68 • From start of the Treatment Period (Week 0) until Safety Visit (up to Week 18); only for OLTP- From last visit of Transition Period to beginning of MAP (Up to 4 Years 10 Months)
TEAEs were defined as AEs which had onset on or after the first dose of investigational medicinal product (IMP). The Safety Set (SS) included all randomized participants who took at least 1 dose of study medication. As per planned analysis, safety data for all study periods was combined excluding Open-Label Temporary period.
|
0.00%
0/74 • From start of the Treatment Period (Week 0) until Safety Visit (up to Week 18); only for OLTP- From last visit of Transition Period to beginning of MAP (Up to 4 Years 10 Months)
TEAEs were defined as AEs which had onset on or after the first dose of investigational medicinal product (IMP). The Safety Set (SS) included all randomized participants who took at least 1 dose of study medication. As per planned analysis, safety data for all study periods was combined excluding Open-Label Temporary period.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.00%
0/149 • From start of the Treatment Period (Week 0) until Safety Visit (up to Week 18); only for OLTP- From last visit of Transition Period to beginning of MAP (Up to 4 Years 10 Months)
TEAEs were defined as AEs which had onset on or after the first dose of investigational medicinal product (IMP). The Safety Set (SS) included all randomized participants who took at least 1 dose of study medication. As per planned analysis, safety data for all study periods was combined excluding Open-Label Temporary period.
|
0.00%
0/151 • From start of the Treatment Period (Week 0) until Safety Visit (up to Week 18); only for OLTP- From last visit of Transition Period to beginning of MAP (Up to 4 Years 10 Months)
TEAEs were defined as AEs which had onset on or after the first dose of investigational medicinal product (IMP). The Safety Set (SS) included all randomized participants who took at least 1 dose of study medication. As per planned analysis, safety data for all study periods was combined excluding Open-Label Temporary period.
|
0.00%
0/148 • From start of the Treatment Period (Week 0) until Safety Visit (up to Week 18); only for OLTP- From last visit of Transition Period to beginning of MAP (Up to 4 Years 10 Months)
TEAEs were defined as AEs which had onset on or after the first dose of investigational medicinal product (IMP). The Safety Set (SS) included all randomized participants who took at least 1 dose of study medication. As per planned analysis, safety data for all study periods was combined excluding Open-Label Temporary period.
|
1.6%
1/64 • Number of events 1 • From start of the Treatment Period (Week 0) until Safety Visit (up to Week 18); only for OLTP- From last visit of Transition Period to beginning of MAP (Up to 4 Years 10 Months)
TEAEs were defined as AEs which had onset on or after the first dose of investigational medicinal product (IMP). The Safety Set (SS) included all randomized participants who took at least 1 dose of study medication. As per planned analysis, safety data for all study periods was combined excluding Open-Label Temporary period.
|
0.00%
0/68 • From start of the Treatment Period (Week 0) until Safety Visit (up to Week 18); only for OLTP- From last visit of Transition Period to beginning of MAP (Up to 4 Years 10 Months)
TEAEs were defined as AEs which had onset on or after the first dose of investigational medicinal product (IMP). The Safety Set (SS) included all randomized participants who took at least 1 dose of study medication. As per planned analysis, safety data for all study periods was combined excluding Open-Label Temporary period.
|
0.00%
0/74 • From start of the Treatment Period (Week 0) until Safety Visit (up to Week 18); only for OLTP- From last visit of Transition Period to beginning of MAP (Up to 4 Years 10 Months)
TEAEs were defined as AEs which had onset on or after the first dose of investigational medicinal product (IMP). The Safety Set (SS) included all randomized participants who took at least 1 dose of study medication. As per planned analysis, safety data for all study periods was combined excluding Open-Label Temporary period.
|
|
Injury, poisoning and procedural complications
Concussion
|
0.00%
0/149 • From start of the Treatment Period (Week 0) until Safety Visit (up to Week 18); only for OLTP- From last visit of Transition Period to beginning of MAP (Up to 4 Years 10 Months)
TEAEs were defined as AEs which had onset on or after the first dose of investigational medicinal product (IMP). The Safety Set (SS) included all randomized participants who took at least 1 dose of study medication. As per planned analysis, safety data for all study periods was combined excluding Open-Label Temporary period.
|
0.00%
0/151 • From start of the Treatment Period (Week 0) until Safety Visit (up to Week 18); only for OLTP- From last visit of Transition Period to beginning of MAP (Up to 4 Years 10 Months)
TEAEs were defined as AEs which had onset on or after the first dose of investigational medicinal product (IMP). The Safety Set (SS) included all randomized participants who took at least 1 dose of study medication. As per planned analysis, safety data for all study periods was combined excluding Open-Label Temporary period.
|
0.00%
0/148 • From start of the Treatment Period (Week 0) until Safety Visit (up to Week 18); only for OLTP- From last visit of Transition Period to beginning of MAP (Up to 4 Years 10 Months)
TEAEs were defined as AEs which had onset on or after the first dose of investigational medicinal product (IMP). The Safety Set (SS) included all randomized participants who took at least 1 dose of study medication. As per planned analysis, safety data for all study periods was combined excluding Open-Label Temporary period.
|
1.6%
1/64 • Number of events 1 • From start of the Treatment Period (Week 0) until Safety Visit (up to Week 18); only for OLTP- From last visit of Transition Period to beginning of MAP (Up to 4 Years 10 Months)
TEAEs were defined as AEs which had onset on or after the first dose of investigational medicinal product (IMP). The Safety Set (SS) included all randomized participants who took at least 1 dose of study medication. As per planned analysis, safety data for all study periods was combined excluding Open-Label Temporary period.
|
0.00%
0/68 • From start of the Treatment Period (Week 0) until Safety Visit (up to Week 18); only for OLTP- From last visit of Transition Period to beginning of MAP (Up to 4 Years 10 Months)
TEAEs were defined as AEs which had onset on or after the first dose of investigational medicinal product (IMP). The Safety Set (SS) included all randomized participants who took at least 1 dose of study medication. As per planned analysis, safety data for all study periods was combined excluding Open-Label Temporary period.
|
1.4%
1/74 • Number of events 1 • From start of the Treatment Period (Week 0) until Safety Visit (up to Week 18); only for OLTP- From last visit of Transition Period to beginning of MAP (Up to 4 Years 10 Months)
TEAEs were defined as AEs which had onset on or after the first dose of investigational medicinal product (IMP). The Safety Set (SS) included all randomized participants who took at least 1 dose of study medication. As per planned analysis, safety data for all study periods was combined excluding Open-Label Temporary period.
|
Other adverse events
| Measure |
Placebo
n=149 participants at risk
Participants received matching Placebo as film-coated tablets, administered orally, twice daily (bid), during 12 weeks of Treatment Period. At the end of the Treatment Period, participants who entered long-term follow-up (LTFU) study (EP0085 (NCT03250377)) or managed access program (MAP), the same matching Placebo dose was kept during 2 weeks of Transition Period and brivaracetam (BRV) 100 milligrams/day (mg/day) in LTFU study or MAP. Participants who did not enter the LTFU study or MAP had 4 weeks Down-Titration Period followed by a Study Drug-Free Period (no drug for 2 weeks). During Down-Titration Period, participants received the same Placebo dose for 4 weeks.
|
BRV 50 mg/Day
n=151 participants at risk
Participants received BRV 50 mg/day as film-coated tablets, administered orally, bid, during 12 weeks of Treatment Period. At the end of the Treatment Period, participants who entered the LTFU study or MAP received BRV 50 mg/day during 2 weeks of Transition Period and BRV 100 mg/day in LTFU study or MAP. Participants who did not enter the LTFU study or MAP had 4 weeks Down-Titration Period followed by a Study Drug-Free Period (no drug for 2 weeks). During Down-Titration Period, participants received BRV 25 mg/day for 1 week followed by Placebo for 3 weeks.
|
BRV 200 mg/Day
n=148 participants at risk
Participants received BRV 200 mg/day as film-coated tablets, administered orally, bid, during 12 weeks of Treatment Period. At the end of the Treatment Period, participants who entered LTFU study or MAP received BRV 150 mg/day during 2 weeks of Transition Period and BRV 100 mg/day in LTFU study or MAP. Participants who did not enter the LTFU study or MAP had 4 weeks Down-Titration Period followed by a Study Drug-Free Period (no drug for 2 weeks). During Down-Titration Period, participants received BRV 150 mg/day for 1 week followed by BRV 100 mg/day for 1 week, followed by BRV 50 mg/day for 1 week, followed by BRV 25 mg/day for 1 week.
|
Placebo to OLTP BRV
n=64 participants at risk
Participants who received Placebo during Treatment Period and were eligible to enter MAP received BRV 100 mg/day due to delayed importation of medication during OLTP. BRV dose might be adjusted for an individual participant (between 50 mg/day to 200 mg/day) during the OLTP. The period was defined from immediately after the last visit of the Transition Period (Week 14) and until a visit when the participant could convert to MAP.
|
BRV 50 mg/Day to OLTP BRV
n=68 participants at risk
Participants who received BRV 50 mg/day during Treatment Period and were eligible to enter MAP received BRV 100 mg/day due to delayed importation of medication during Open-Label Temporary Period (OLTP). BRV dose might be adjusted for an individual participant (between 50 mg/day to 200 mg/day) during the OLTP. The period was defined from immediately after the last visit of the Transition Period (Week 14) and until a visit when the participant could convert to MAP.
|
BRV 200 mg/Day to OLTP BRV
n=74 participants at risk
Participants who received BRV 200 mg/day during Treatment Period and were eligible to enter MAP received BRV 100 mg/day due to delayed importation of medication during Open-Label Temporary Period (OLTP). BRV dose might be adjusted for an individual participant (between 50 mg/day to 200 mg/day) during the OLTP. The period was defined from immediately after the last visit of the Transition Period (Week 14) and until a visit when the participant could convert to MAP.
|
|---|---|---|---|---|---|---|
|
Infections and infestations
Upper respiratory tract infection
|
4.7%
7/149 • Number of events 8 • From start of the Treatment Period (Week 0) until Safety Visit (up to Week 18); only for OLTP- From last visit of Transition Period to beginning of MAP (Up to 4 Years 10 Months)
TEAEs were defined as AEs which had onset on or after the first dose of investigational medicinal product (IMP). The Safety Set (SS) included all randomized participants who took at least 1 dose of study medication. As per planned analysis, safety data for all study periods was combined excluding Open-Label Temporary period.
|
6.6%
10/151 • Number of events 14 • From start of the Treatment Period (Week 0) until Safety Visit (up to Week 18); only for OLTP- From last visit of Transition Period to beginning of MAP (Up to 4 Years 10 Months)
TEAEs were defined as AEs which had onset on or after the first dose of investigational medicinal product (IMP). The Safety Set (SS) included all randomized participants who took at least 1 dose of study medication. As per planned analysis, safety data for all study periods was combined excluding Open-Label Temporary period.
|
5.4%
8/148 • Number of events 9 • From start of the Treatment Period (Week 0) until Safety Visit (up to Week 18); only for OLTP- From last visit of Transition Period to beginning of MAP (Up to 4 Years 10 Months)
TEAEs were defined as AEs which had onset on or after the first dose of investigational medicinal product (IMP). The Safety Set (SS) included all randomized participants who took at least 1 dose of study medication. As per planned analysis, safety data for all study periods was combined excluding Open-Label Temporary period.
|
0.00%
0/64 • From start of the Treatment Period (Week 0) until Safety Visit (up to Week 18); only for OLTP- From last visit of Transition Period to beginning of MAP (Up to 4 Years 10 Months)
TEAEs were defined as AEs which had onset on or after the first dose of investigational medicinal product (IMP). The Safety Set (SS) included all randomized participants who took at least 1 dose of study medication. As per planned analysis, safety data for all study periods was combined excluding Open-Label Temporary period.
|
0.00%
0/68 • From start of the Treatment Period (Week 0) until Safety Visit (up to Week 18); only for OLTP- From last visit of Transition Period to beginning of MAP (Up to 4 Years 10 Months)
TEAEs were defined as AEs which had onset on or after the first dose of investigational medicinal product (IMP). The Safety Set (SS) included all randomized participants who took at least 1 dose of study medication. As per planned analysis, safety data for all study periods was combined excluding Open-Label Temporary period.
|
0.00%
0/74 • From start of the Treatment Period (Week 0) until Safety Visit (up to Week 18); only for OLTP- From last visit of Transition Period to beginning of MAP (Up to 4 Years 10 Months)
TEAEs were defined as AEs which had onset on or after the first dose of investigational medicinal product (IMP). The Safety Set (SS) included all randomized participants who took at least 1 dose of study medication. As per planned analysis, safety data for all study periods was combined excluding Open-Label Temporary period.
|
|
Infections and infestations
Nasopharyngitis
|
6.7%
10/149 • Number of events 11 • From start of the Treatment Period (Week 0) until Safety Visit (up to Week 18); only for OLTP- From last visit of Transition Period to beginning of MAP (Up to 4 Years 10 Months)
TEAEs were defined as AEs which had onset on or after the first dose of investigational medicinal product (IMP). The Safety Set (SS) included all randomized participants who took at least 1 dose of study medication. As per planned analysis, safety data for all study periods was combined excluding Open-Label Temporary period.
|
4.6%
7/151 • Number of events 10 • From start of the Treatment Period (Week 0) until Safety Visit (up to Week 18); only for OLTP- From last visit of Transition Period to beginning of MAP (Up to 4 Years 10 Months)
TEAEs were defined as AEs which had onset on or after the first dose of investigational medicinal product (IMP). The Safety Set (SS) included all randomized participants who took at least 1 dose of study medication. As per planned analysis, safety data for all study periods was combined excluding Open-Label Temporary period.
|
6.8%
10/148 • Number of events 10 • From start of the Treatment Period (Week 0) until Safety Visit (up to Week 18); only for OLTP- From last visit of Transition Period to beginning of MAP (Up to 4 Years 10 Months)
TEAEs were defined as AEs which had onset on or after the first dose of investigational medicinal product (IMP). The Safety Set (SS) included all randomized participants who took at least 1 dose of study medication. As per planned analysis, safety data for all study periods was combined excluding Open-Label Temporary period.
|
4.7%
3/64 • Number of events 3 • From start of the Treatment Period (Week 0) until Safety Visit (up to Week 18); only for OLTP- From last visit of Transition Period to beginning of MAP (Up to 4 Years 10 Months)
TEAEs were defined as AEs which had onset on or after the first dose of investigational medicinal product (IMP). The Safety Set (SS) included all randomized participants who took at least 1 dose of study medication. As per planned analysis, safety data for all study periods was combined excluding Open-Label Temporary period.
|
5.9%
4/68 • Number of events 5 • From start of the Treatment Period (Week 0) until Safety Visit (up to Week 18); only for OLTP- From last visit of Transition Period to beginning of MAP (Up to 4 Years 10 Months)
TEAEs were defined as AEs which had onset on or after the first dose of investigational medicinal product (IMP). The Safety Set (SS) included all randomized participants who took at least 1 dose of study medication. As per planned analysis, safety data for all study periods was combined excluding Open-Label Temporary period.
|
5.4%
4/74 • Number of events 4 • From start of the Treatment Period (Week 0) until Safety Visit (up to Week 18); only for OLTP- From last visit of Transition Period to beginning of MAP (Up to 4 Years 10 Months)
TEAEs were defined as AEs which had onset on or after the first dose of investigational medicinal product (IMP). The Safety Set (SS) included all randomized participants who took at least 1 dose of study medication. As per planned analysis, safety data for all study periods was combined excluding Open-Label Temporary period.
|
|
Nervous system disorders
Somnolence
|
8.1%
12/149 • Number of events 14 • From start of the Treatment Period (Week 0) until Safety Visit (up to Week 18); only for OLTP- From last visit of Transition Period to beginning of MAP (Up to 4 Years 10 Months)
TEAEs were defined as AEs which had onset on or after the first dose of investigational medicinal product (IMP). The Safety Set (SS) included all randomized participants who took at least 1 dose of study medication. As per planned analysis, safety data for all study periods was combined excluding Open-Label Temporary period.
|
9.9%
15/151 • Number of events 15 • From start of the Treatment Period (Week 0) until Safety Visit (up to Week 18); only for OLTP- From last visit of Transition Period to beginning of MAP (Up to 4 Years 10 Months)
TEAEs were defined as AEs which had onset on or after the first dose of investigational medicinal product (IMP). The Safety Set (SS) included all randomized participants who took at least 1 dose of study medication. As per planned analysis, safety data for all study periods was combined excluding Open-Label Temporary period.
|
18.9%
28/148 • Number of events 29 • From start of the Treatment Period (Week 0) until Safety Visit (up to Week 18); only for OLTP- From last visit of Transition Period to beginning of MAP (Up to 4 Years 10 Months)
TEAEs were defined as AEs which had onset on or after the first dose of investigational medicinal product (IMP). The Safety Set (SS) included all randomized participants who took at least 1 dose of study medication. As per planned analysis, safety data for all study periods was combined excluding Open-Label Temporary period.
|
0.00%
0/64 • From start of the Treatment Period (Week 0) until Safety Visit (up to Week 18); only for OLTP- From last visit of Transition Period to beginning of MAP (Up to 4 Years 10 Months)
TEAEs were defined as AEs which had onset on or after the first dose of investigational medicinal product (IMP). The Safety Set (SS) included all randomized participants who took at least 1 dose of study medication. As per planned analysis, safety data for all study periods was combined excluding Open-Label Temporary period.
|
0.00%
0/68 • From start of the Treatment Period (Week 0) until Safety Visit (up to Week 18); only for OLTP- From last visit of Transition Period to beginning of MAP (Up to 4 Years 10 Months)
TEAEs were defined as AEs which had onset on or after the first dose of investigational medicinal product (IMP). The Safety Set (SS) included all randomized participants who took at least 1 dose of study medication. As per planned analysis, safety data for all study periods was combined excluding Open-Label Temporary period.
|
0.00%
0/74 • From start of the Treatment Period (Week 0) until Safety Visit (up to Week 18); only for OLTP- From last visit of Transition Period to beginning of MAP (Up to 4 Years 10 Months)
TEAEs were defined as AEs which had onset on or after the first dose of investigational medicinal product (IMP). The Safety Set (SS) included all randomized participants who took at least 1 dose of study medication. As per planned analysis, safety data for all study periods was combined excluding Open-Label Temporary period.
|
|
Nervous system disorders
Dizziness
|
4.0%
6/149 • Number of events 6 • From start of the Treatment Period (Week 0) until Safety Visit (up to Week 18); only for OLTP- From last visit of Transition Period to beginning of MAP (Up to 4 Years 10 Months)
TEAEs were defined as AEs which had onset on or after the first dose of investigational medicinal product (IMP). The Safety Set (SS) included all randomized participants who took at least 1 dose of study medication. As per planned analysis, safety data for all study periods was combined excluding Open-Label Temporary period.
|
11.3%
17/151 • Number of events 19 • From start of the Treatment Period (Week 0) until Safety Visit (up to Week 18); only for OLTP- From last visit of Transition Period to beginning of MAP (Up to 4 Years 10 Months)
TEAEs were defined as AEs which had onset on or after the first dose of investigational medicinal product (IMP). The Safety Set (SS) included all randomized participants who took at least 1 dose of study medication. As per planned analysis, safety data for all study periods was combined excluding Open-Label Temporary period.
|
14.2%
21/148 • Number of events 24 • From start of the Treatment Period (Week 0) until Safety Visit (up to Week 18); only for OLTP- From last visit of Transition Period to beginning of MAP (Up to 4 Years 10 Months)
TEAEs were defined as AEs which had onset on or after the first dose of investigational medicinal product (IMP). The Safety Set (SS) included all randomized participants who took at least 1 dose of study medication. As per planned analysis, safety data for all study periods was combined excluding Open-Label Temporary period.
|
0.00%
0/64 • From start of the Treatment Period (Week 0) until Safety Visit (up to Week 18); only for OLTP- From last visit of Transition Period to beginning of MAP (Up to 4 Years 10 Months)
TEAEs were defined as AEs which had onset on or after the first dose of investigational medicinal product (IMP). The Safety Set (SS) included all randomized participants who took at least 1 dose of study medication. As per planned analysis, safety data for all study periods was combined excluding Open-Label Temporary period.
|
0.00%
0/68 • From start of the Treatment Period (Week 0) until Safety Visit (up to Week 18); only for OLTP- From last visit of Transition Period to beginning of MAP (Up to 4 Years 10 Months)
TEAEs were defined as AEs which had onset on or after the first dose of investigational medicinal product (IMP). The Safety Set (SS) included all randomized participants who took at least 1 dose of study medication. As per planned analysis, safety data for all study periods was combined excluding Open-Label Temporary period.
|
0.00%
0/74 • From start of the Treatment Period (Week 0) until Safety Visit (up to Week 18); only for OLTP- From last visit of Transition Period to beginning of MAP (Up to 4 Years 10 Months)
TEAEs were defined as AEs which had onset on or after the first dose of investigational medicinal product (IMP). The Safety Set (SS) included all randomized participants who took at least 1 dose of study medication. As per planned analysis, safety data for all study periods was combined excluding Open-Label Temporary period.
|
|
Nervous system disorders
Headache
|
7.4%
11/149 • Number of events 15 • From start of the Treatment Period (Week 0) until Safety Visit (up to Week 18); only for OLTP- From last visit of Transition Period to beginning of MAP (Up to 4 Years 10 Months)
TEAEs were defined as AEs which had onset on or after the first dose of investigational medicinal product (IMP). The Safety Set (SS) included all randomized participants who took at least 1 dose of study medication. As per planned analysis, safety data for all study periods was combined excluding Open-Label Temporary period.
|
7.3%
11/151 • Number of events 16 • From start of the Treatment Period (Week 0) until Safety Visit (up to Week 18); only for OLTP- From last visit of Transition Period to beginning of MAP (Up to 4 Years 10 Months)
TEAEs were defined as AEs which had onset on or after the first dose of investigational medicinal product (IMP). The Safety Set (SS) included all randomized participants who took at least 1 dose of study medication. As per planned analysis, safety data for all study periods was combined excluding Open-Label Temporary period.
|
4.7%
7/148 • Number of events 8 • From start of the Treatment Period (Week 0) until Safety Visit (up to Week 18); only for OLTP- From last visit of Transition Period to beginning of MAP (Up to 4 Years 10 Months)
TEAEs were defined as AEs which had onset on or after the first dose of investigational medicinal product (IMP). The Safety Set (SS) included all randomized participants who took at least 1 dose of study medication. As per planned analysis, safety data for all study periods was combined excluding Open-Label Temporary period.
|
0.00%
0/64 • From start of the Treatment Period (Week 0) until Safety Visit (up to Week 18); only for OLTP- From last visit of Transition Period to beginning of MAP (Up to 4 Years 10 Months)
TEAEs were defined as AEs which had onset on or after the first dose of investigational medicinal product (IMP). The Safety Set (SS) included all randomized participants who took at least 1 dose of study medication. As per planned analysis, safety data for all study periods was combined excluding Open-Label Temporary period.
|
0.00%
0/68 • From start of the Treatment Period (Week 0) until Safety Visit (up to Week 18); only for OLTP- From last visit of Transition Period to beginning of MAP (Up to 4 Years 10 Months)
TEAEs were defined as AEs which had onset on or after the first dose of investigational medicinal product (IMP). The Safety Set (SS) included all randomized participants who took at least 1 dose of study medication. As per planned analysis, safety data for all study periods was combined excluding Open-Label Temporary period.
|
0.00%
0/74 • From start of the Treatment Period (Week 0) until Safety Visit (up to Week 18); only for OLTP- From last visit of Transition Period to beginning of MAP (Up to 4 Years 10 Months)
TEAEs were defined as AEs which had onset on or after the first dose of investigational medicinal product (IMP). The Safety Set (SS) included all randomized participants who took at least 1 dose of study medication. As per planned analysis, safety data for all study periods was combined excluding Open-Label Temporary period.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60