Trial Outcomes & Findings for A Study of Intravenous Perampanel in Japanese Participants With Epilepsy (NCT NCT03754582)
NCT ID: NCT03754582
Last Updated: 2021-01-05
Results Overview
A SAE was defined as any untoward medical occurrence that at any dose: Resulted in death; was life-threatening; required inpatient hospitalization or prolongation of existing hospitalization; resulted in persistent or significant disability/incapacity; was a congenital anomaly/birth defect.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
21 participants
Primary outcome timeframe
Up to 60 days (Pretreatment Phase: up to 28 days, Treatment Phase: up to 4 days, Follow-up Phase: up to 28 days after last dose)
Results posted on
2021-01-05
Participant Flow
Participants took part in this study at 13 investigative sites in Japan from 27 November 2018 to 10 December 2019.
A total of 27 participants were consented, of which 6 were screen failures and 21 were enrolled and received the study treatment.
Participant milestones
| Measure |
Pretreatment Phase: Oral Perampanel 8 to 12 mg/Day
Participants with partial onset-seizures (POS) with or without secondarily generalized seizures or primary generalized tonic clonic (PGTC) seizures received perampanel 8 milligram (mg) up to 12 mg (stable-dosage), tablets, orally, once daily for 28 days (Day -28 to Day -1) as an adjunctive therapy along with 1 to a maximum of 3 marketed concomitant antiepileptic drugs (AEDs). Eligible participants who completed Pretreatment Phase entered in Treatment Phase.
|
Treatment Phase: Intravenous Perampanel 8 to 12 mg/Day
Participants with POS with or without secondarily generalized seizures or PGTC seizures were hospitalized and received perampanel 8 mg up to 12 mg (stable-dosage) equivalent to the oral dose, as intravenous infusion for 30 minutes, once daily on Day 1 to Day 4 as an adjunctive therapy along with 1 to a maximum of 3 marketed concomitant AEDs. Eligible participants who completed Treatment Phase entered Follow-up Phase.
|
Follow-up Phase: Oral Perampanel 8 to 12 mg/Day
Participants with POS with or without secondarily generalized seizures or PGTC seizures received perampanel 8 mg up to 12 mg (stable-dosage), tablets, orally, once daily on Day 5 to Day 11 (Follow-up Visit) as an adjunctive therapy along with 1 to a maximum of 3 marketed concomitant AEDs.
|
|---|---|---|---|
|
Pretreatment Phase
STARTED
|
21
|
0
|
0
|
|
Pretreatment Phase
COMPLETED
|
21
|
0
|
0
|
|
Pretreatment Phase
NOT COMPLETED
|
0
|
0
|
0
|
|
Treatment Phase
STARTED
|
0
|
21
|
0
|
|
Treatment Phase
COMPLETED
|
0
|
20
|
0
|
|
Treatment Phase
NOT COMPLETED
|
0
|
1
|
0
|
|
Follow-up Phase
STARTED
|
0
|
0
|
21
|
|
Follow-up Phase
COMPLETED
|
0
|
0
|
20
|
|
Follow-up Phase
NOT COMPLETED
|
0
|
0
|
1
|
Reasons for withdrawal
| Measure |
Pretreatment Phase: Oral Perampanel 8 to 12 mg/Day
Participants with partial onset-seizures (POS) with or without secondarily generalized seizures or primary generalized tonic clonic (PGTC) seizures received perampanel 8 milligram (mg) up to 12 mg (stable-dosage), tablets, orally, once daily for 28 days (Day -28 to Day -1) as an adjunctive therapy along with 1 to a maximum of 3 marketed concomitant antiepileptic drugs (AEDs). Eligible participants who completed Pretreatment Phase entered in Treatment Phase.
|
Treatment Phase: Intravenous Perampanel 8 to 12 mg/Day
Participants with POS with or without secondarily generalized seizures or PGTC seizures were hospitalized and received perampanel 8 mg up to 12 mg (stable-dosage) equivalent to the oral dose, as intravenous infusion for 30 minutes, once daily on Day 1 to Day 4 as an adjunctive therapy along with 1 to a maximum of 3 marketed concomitant AEDs. Eligible participants who completed Treatment Phase entered Follow-up Phase.
|
Follow-up Phase: Oral Perampanel 8 to 12 mg/Day
Participants with POS with or without secondarily generalized seizures or PGTC seizures received perampanel 8 mg up to 12 mg (stable-dosage), tablets, orally, once daily on Day 5 to Day 11 (Follow-up Visit) as an adjunctive therapy along with 1 to a maximum of 3 marketed concomitant AEDs.
|
|---|---|---|---|
|
Treatment Phase
Adverse Event
|
0
|
1
|
0
|
|
Follow-up Phase
Other
|
0
|
0
|
1
|
Baseline Characteristics
A Study of Intravenous Perampanel in Japanese Participants With Epilepsy
Baseline characteristics by cohort
| Measure |
Perampanel 8 to 12 mg/Day
n=21 Participants
Participants with POS with or without secondarily generalized seizures or PGTC seizures received maintenance dose of perampanel 8 to 12 mg, tablets, orally, once daily for 28 days (Day -28 to Day -1) in Pretreatment Phase followed by 8 to 12 mg maintenance dose of perampanel equivalent to the oral dose, as intravenous infusion for 30 minutes, once daily from Day 1 to Day 4 in Treatment Phase, and then 8 to 12 mg maintenance dose of perampanel, tablets, orally, once daily from Day 5 to Day 11 (Follow-up Visit) in Follow-up Phase as an adjunctive therapy along with 1 to a maximum of 3 marketed concomitant AEDs.
|
|---|---|
|
Age, Continuous
|
40.7 years
STANDARD_DEVIATION 12.76 • n=5 Participants
|
|
Sex: Female, Male
Female
|
12 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
21 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Japanese
|
21 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Up to 60 days (Pretreatment Phase: up to 28 days, Treatment Phase: up to 4 days, Follow-up Phase: up to 28 days after last dose)Population: All participants who received at least 1 dose of study drug.
A SAE was defined as any untoward medical occurrence that at any dose: Resulted in death; was life-threatening; required inpatient hospitalization or prolongation of existing hospitalization; resulted in persistent or significant disability/incapacity; was a congenital anomaly/birth defect.
Outcome measures
| Measure |
Pretreatment Phase: Oral Perampanel 8 to 12 mg/Day
n=21 Participants
Participants with POS with or without secondarily generalized seizures or PGTC seizures received perampanel 8 mg up to 12 mg (stable-dosage), tablets, orally, once daily for 28 days (Day -28 to Day -1) as an adjunctive therapy along with 1 to a maximum of 3 marketed concomitant AEDs. Eligible participants who completed Pretreatment Phase entered in Treatment Phase.
|
Treatment Phase: Intravenous Perampanel 8 to 12 mg/Day
n=21 Participants
Participants with POS with or without secondarily generalized seizures or PGTC seizures were hospitalized and received perampanel 8 mg up to 12 mg (stable-dosage) equivalent to the oral dose, as intravenous infusion for 30 minutes, once daily on Day 1 to Day 4 as an adjunctive therapy along with 1 to a maximum of 3 marketed concomitant AEDs. Eligible participants who completed Treatment Phase entered Follow-up Phase.
|
Follow-up Phase: Oral Perampanel 8 to 12 mg/Day
n=21 Participants
Participants with POS with or without secondarily generalized seizures or PGTC seizures received perampanel 8 mg up to 12 mg (stable-dosage), tablets, orally, once daily on Day 5 to Day 11 (Follow-up Visit) as an adjunctive therapy along with 1 to a maximum of 3 marketed concomitant AEDs.
|
Treatment Phase: Intravenous Perampanel 8 mg/Day
Participants with POS with or without secondarily generalized seizures or PGTC seizures were hospitalized and received perampanel 8 mg (stable-dosage) equivalent to the oral dose, as intravenous infusion for 30 minutes, once daily on Day 1 to Day 4 as an adjunctive therapy along with 1 to a maximum of 3 marketed concomitant AEDs.
|
Treatment Phase: Intravenous Perampanel 10 mg/Day
Participants with POS with or without secondarily generalized seizures or PGTC seizures were hospitalized and received perampanel 10 mg (stable-dosage) equivalent to the oral dose, as intravenous infusion for 30 minutes, once daily on Day 1 to Day 4 as an adjunctive therapy along with 1 to a maximum of 3 marketed concomitant AEDs.
|
Treatment Phase: Intravenous Perampanel 12 mg/Day
Participants with POS with or without secondarily generalized seizures or PGTC seizures were hospitalized and received perampanel 12 mg (stable-dosage) equivalent to the oral dose, as intravenous infusion for 30 minutes, once daily on Day 1 to Day 4 as an adjunctive therapy along with 1 to a maximum of 3 marketed concomitant AEDs.
|
|---|---|---|---|---|---|---|
|
Number of Participants With Serious Adverse Events (SAEs)
|
0 Participants
|
1 Participants
|
2 Participants
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Up to 60 days (Pretreatment Phase: up to 28 days, Treatment Phase: up to 4 days, Follow-up Phase: up to 28 days after last dose)Population: All participants who received at least 1 dose of study drug.
An AE was defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an investigational product, whether or not considered related to the investigational product, any new disease or exacerbation of an existing disease, any deterioration in nonprotocol-required measurements of a laboratory value or other clinical test that resulted in symptoms, a change in treatment, or discontinuation of study drug, recurrence of an intermittent medical condition not present pretreatment, an abnormal laboratory test result was considered an AE if the identified laboratory abnormality led to any type of intervention, withdrawal of study drug, or withholding of study drug, whether prescribed in the protocol or not.
Outcome measures
| Measure |
Pretreatment Phase: Oral Perampanel 8 to 12 mg/Day
n=21 Participants
Participants with POS with or without secondarily generalized seizures or PGTC seizures received perampanel 8 mg up to 12 mg (stable-dosage), tablets, orally, once daily for 28 days (Day -28 to Day -1) as an adjunctive therapy along with 1 to a maximum of 3 marketed concomitant AEDs. Eligible participants who completed Pretreatment Phase entered in Treatment Phase.
|
Treatment Phase: Intravenous Perampanel 8 to 12 mg/Day
n=21 Participants
Participants with POS with or without secondarily generalized seizures or PGTC seizures were hospitalized and received perampanel 8 mg up to 12 mg (stable-dosage) equivalent to the oral dose, as intravenous infusion for 30 minutes, once daily on Day 1 to Day 4 as an adjunctive therapy along with 1 to a maximum of 3 marketed concomitant AEDs. Eligible participants who completed Treatment Phase entered Follow-up Phase.
|
Follow-up Phase: Oral Perampanel 8 to 12 mg/Day
n=21 Participants
Participants with POS with or without secondarily generalized seizures or PGTC seizures received perampanel 8 mg up to 12 mg (stable-dosage), tablets, orally, once daily on Day 5 to Day 11 (Follow-up Visit) as an adjunctive therapy along with 1 to a maximum of 3 marketed concomitant AEDs.
|
Treatment Phase: Intravenous Perampanel 8 mg/Day
Participants with POS with or without secondarily generalized seizures or PGTC seizures were hospitalized and received perampanel 8 mg (stable-dosage) equivalent to the oral dose, as intravenous infusion for 30 minutes, once daily on Day 1 to Day 4 as an adjunctive therapy along with 1 to a maximum of 3 marketed concomitant AEDs.
|
Treatment Phase: Intravenous Perampanel 10 mg/Day
Participants with POS with or without secondarily generalized seizures or PGTC seizures were hospitalized and received perampanel 10 mg (stable-dosage) equivalent to the oral dose, as intravenous infusion for 30 minutes, once daily on Day 1 to Day 4 as an adjunctive therapy along with 1 to a maximum of 3 marketed concomitant AEDs.
|
Treatment Phase: Intravenous Perampanel 12 mg/Day
Participants with POS with or without secondarily generalized seizures or PGTC seizures were hospitalized and received perampanel 12 mg (stable-dosage) equivalent to the oral dose, as intravenous infusion for 30 minutes, once daily on Day 1 to Day 4 as an adjunctive therapy along with 1 to a maximum of 3 marketed concomitant AEDs.
|
|---|---|---|---|---|---|---|
|
Number of Participants With Adverse Events (AEs)
|
3 Participants
|
15 Participants
|
6 Participants
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Up to Day 11 (Treatment Phase: at Day 4, Follow-up Phase: up to 7 days after last dose)Population: All participants who received at least 1 dose of study drug.
Outcome measures
| Measure |
Pretreatment Phase: Oral Perampanel 8 to 12 mg/Day
n=21 Participants
Participants with POS with or without secondarily generalized seizures or PGTC seizures received perampanel 8 mg up to 12 mg (stable-dosage), tablets, orally, once daily for 28 days (Day -28 to Day -1) as an adjunctive therapy along with 1 to a maximum of 3 marketed concomitant AEDs. Eligible participants who completed Pretreatment Phase entered in Treatment Phase.
|
Treatment Phase: Intravenous Perampanel 8 to 12 mg/Day
n=21 Participants
Participants with POS with or without secondarily generalized seizures or PGTC seizures were hospitalized and received perampanel 8 mg up to 12 mg (stable-dosage) equivalent to the oral dose, as intravenous infusion for 30 minutes, once daily on Day 1 to Day 4 as an adjunctive therapy along with 1 to a maximum of 3 marketed concomitant AEDs. Eligible participants who completed Treatment Phase entered Follow-up Phase.
|
Follow-up Phase: Oral Perampanel 8 to 12 mg/Day
Participants with POS with or without secondarily generalized seizures or PGTC seizures received perampanel 8 mg up to 12 mg (stable-dosage), tablets, orally, once daily on Day 5 to Day 11 (Follow-up Visit) as an adjunctive therapy along with 1 to a maximum of 3 marketed concomitant AEDs.
|
Treatment Phase: Intravenous Perampanel 8 mg/Day
Participants with POS with or without secondarily generalized seizures or PGTC seizures were hospitalized and received perampanel 8 mg (stable-dosage) equivalent to the oral dose, as intravenous infusion for 30 minutes, once daily on Day 1 to Day 4 as an adjunctive therapy along with 1 to a maximum of 3 marketed concomitant AEDs.
|
Treatment Phase: Intravenous Perampanel 10 mg/Day
Participants with POS with or without secondarily generalized seizures or PGTC seizures were hospitalized and received perampanel 10 mg (stable-dosage) equivalent to the oral dose, as intravenous infusion for 30 minutes, once daily on Day 1 to Day 4 as an adjunctive therapy along with 1 to a maximum of 3 marketed concomitant AEDs.
|
Treatment Phase: Intravenous Perampanel 12 mg/Day
Participants with POS with or without secondarily generalized seizures or PGTC seizures were hospitalized and received perampanel 12 mg (stable-dosage) equivalent to the oral dose, as intravenous infusion for 30 minutes, once daily on Day 1 to Day 4 as an adjunctive therapy along with 1 to a maximum of 3 marketed concomitant AEDs.
|
|---|---|---|---|---|---|---|
|
Number of Participants With Markedly Abnormal Clinical Laboratory Parameter Values During Treatment and Follow-up Phase
Triglycerides: Markedly Abnormal High
|
1 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Number of Participants With Markedly Abnormal Clinical Laboratory Parameter Values During Treatment and Follow-up Phase
Urate: Markedly Abnormal High
|
0 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Up to 11 days (Treatment Phase: up to 4 days, Follow-up Phase: up to 7 days after the last dose)Population: All participants who received at least 1 dose of study drug.
Outcome measures
| Measure |
Pretreatment Phase: Oral Perampanel 8 to 12 mg/Day
n=21 Participants
Participants with POS with or without secondarily generalized seizures or PGTC seizures received perampanel 8 mg up to 12 mg (stable-dosage), tablets, orally, once daily for 28 days (Day -28 to Day -1) as an adjunctive therapy along with 1 to a maximum of 3 marketed concomitant AEDs. Eligible participants who completed Pretreatment Phase entered in Treatment Phase.
|
Treatment Phase: Intravenous Perampanel 8 to 12 mg/Day
n=21 Participants
Participants with POS with or without secondarily generalized seizures or PGTC seizures were hospitalized and received perampanel 8 mg up to 12 mg (stable-dosage) equivalent to the oral dose, as intravenous infusion for 30 minutes, once daily on Day 1 to Day 4 as an adjunctive therapy along with 1 to a maximum of 3 marketed concomitant AEDs. Eligible participants who completed Treatment Phase entered Follow-up Phase.
|
Follow-up Phase: Oral Perampanel 8 to 12 mg/Day
Participants with POS with or without secondarily generalized seizures or PGTC seizures received perampanel 8 mg up to 12 mg (stable-dosage), tablets, orally, once daily on Day 5 to Day 11 (Follow-up Visit) as an adjunctive therapy along with 1 to a maximum of 3 marketed concomitant AEDs.
|
Treatment Phase: Intravenous Perampanel 8 mg/Day
Participants with POS with or without secondarily generalized seizures or PGTC seizures were hospitalized and received perampanel 8 mg (stable-dosage) equivalent to the oral dose, as intravenous infusion for 30 minutes, once daily on Day 1 to Day 4 as an adjunctive therapy along with 1 to a maximum of 3 marketed concomitant AEDs.
|
Treatment Phase: Intravenous Perampanel 10 mg/Day
Participants with POS with or without secondarily generalized seizures or PGTC seizures were hospitalized and received perampanel 10 mg (stable-dosage) equivalent to the oral dose, as intravenous infusion for 30 minutes, once daily on Day 1 to Day 4 as an adjunctive therapy along with 1 to a maximum of 3 marketed concomitant AEDs.
|
Treatment Phase: Intravenous Perampanel 12 mg/Day
Participants with POS with or without secondarily generalized seizures or PGTC seizures were hospitalized and received perampanel 12 mg (stable-dosage) equivalent to the oral dose, as intravenous infusion for 30 minutes, once daily on Day 1 to Day 4 as an adjunctive therapy along with 1 to a maximum of 3 marketed concomitant AEDs.
|
|---|---|---|---|---|---|---|
|
Number of Participants With Abnormal Vital Sign Values During Treatment and Follow-up Phase
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Up to 11 days (Treatment Phase: up to 4 days, Follow-up Phase: up to 7 days after the last dose)Population: All participants who received at least 1 dose of study drug.
Outcome measures
| Measure |
Pretreatment Phase: Oral Perampanel 8 to 12 mg/Day
n=21 Participants
Participants with POS with or without secondarily generalized seizures or PGTC seizures received perampanel 8 mg up to 12 mg (stable-dosage), tablets, orally, once daily for 28 days (Day -28 to Day -1) as an adjunctive therapy along with 1 to a maximum of 3 marketed concomitant AEDs. Eligible participants who completed Pretreatment Phase entered in Treatment Phase.
|
Treatment Phase: Intravenous Perampanel 8 to 12 mg/Day
n=21 Participants
Participants with POS with or without secondarily generalized seizures or PGTC seizures were hospitalized and received perampanel 8 mg up to 12 mg (stable-dosage) equivalent to the oral dose, as intravenous infusion for 30 minutes, once daily on Day 1 to Day 4 as an adjunctive therapy along with 1 to a maximum of 3 marketed concomitant AEDs. Eligible participants who completed Treatment Phase entered Follow-up Phase.
|
Follow-up Phase: Oral Perampanel 8 to 12 mg/Day
Participants with POS with or without secondarily generalized seizures or PGTC seizures received perampanel 8 mg up to 12 mg (stable-dosage), tablets, orally, once daily on Day 5 to Day 11 (Follow-up Visit) as an adjunctive therapy along with 1 to a maximum of 3 marketed concomitant AEDs.
|
Treatment Phase: Intravenous Perampanel 8 mg/Day
Participants with POS with or without secondarily generalized seizures or PGTC seizures were hospitalized and received perampanel 8 mg (stable-dosage) equivalent to the oral dose, as intravenous infusion for 30 minutes, once daily on Day 1 to Day 4 as an adjunctive therapy along with 1 to a maximum of 3 marketed concomitant AEDs.
|
Treatment Phase: Intravenous Perampanel 10 mg/Day
Participants with POS with or without secondarily generalized seizures or PGTC seizures were hospitalized and received perampanel 10 mg (stable-dosage) equivalent to the oral dose, as intravenous infusion for 30 minutes, once daily on Day 1 to Day 4 as an adjunctive therapy along with 1 to a maximum of 3 marketed concomitant AEDs.
|
Treatment Phase: Intravenous Perampanel 12 mg/Day
Participants with POS with or without secondarily generalized seizures or PGTC seizures were hospitalized and received perampanel 12 mg (stable-dosage) equivalent to the oral dose, as intravenous infusion for 30 minutes, once daily on Day 1 to Day 4 as an adjunctive therapy along with 1 to a maximum of 3 marketed concomitant AEDs.
|
|---|---|---|---|---|---|---|
|
Number of Participants With Abnormal Body Weight During Treatment and Follow-up Phase
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Up to Day 11 (Treatment Phase: at Day 4, Follow-up Phase: up to 7 days after the last dose)Population: All participants who received at least 1 dose of study drug.
Outcome measures
| Measure |
Pretreatment Phase: Oral Perampanel 8 to 12 mg/Day
n=21 Participants
Participants with POS with or without secondarily generalized seizures or PGTC seizures received perampanel 8 mg up to 12 mg (stable-dosage), tablets, orally, once daily for 28 days (Day -28 to Day -1) as an adjunctive therapy along with 1 to a maximum of 3 marketed concomitant AEDs. Eligible participants who completed Pretreatment Phase entered in Treatment Phase.
|
Treatment Phase: Intravenous Perampanel 8 to 12 mg/Day
n=21 Participants
Participants with POS with or without secondarily generalized seizures or PGTC seizures were hospitalized and received perampanel 8 mg up to 12 mg (stable-dosage) equivalent to the oral dose, as intravenous infusion for 30 minutes, once daily on Day 1 to Day 4 as an adjunctive therapy along with 1 to a maximum of 3 marketed concomitant AEDs. Eligible participants who completed Treatment Phase entered Follow-up Phase.
|
Follow-up Phase: Oral Perampanel 8 to 12 mg/Day
Participants with POS with or without secondarily generalized seizures or PGTC seizures received perampanel 8 mg up to 12 mg (stable-dosage), tablets, orally, once daily on Day 5 to Day 11 (Follow-up Visit) as an adjunctive therapy along with 1 to a maximum of 3 marketed concomitant AEDs.
|
Treatment Phase: Intravenous Perampanel 8 mg/Day
Participants with POS with or without secondarily generalized seizures or PGTC seizures were hospitalized and received perampanel 8 mg (stable-dosage) equivalent to the oral dose, as intravenous infusion for 30 minutes, once daily on Day 1 to Day 4 as an adjunctive therapy along with 1 to a maximum of 3 marketed concomitant AEDs.
|
Treatment Phase: Intravenous Perampanel 10 mg/Day
Participants with POS with or without secondarily generalized seizures or PGTC seizures were hospitalized and received perampanel 10 mg (stable-dosage) equivalent to the oral dose, as intravenous infusion for 30 minutes, once daily on Day 1 to Day 4 as an adjunctive therapy along with 1 to a maximum of 3 marketed concomitant AEDs.
|
Treatment Phase: Intravenous Perampanel 12 mg/Day
Participants with POS with or without secondarily generalized seizures or PGTC seizures were hospitalized and received perampanel 12 mg (stable-dosage) equivalent to the oral dose, as intravenous infusion for 30 minutes, once daily on Day 1 to Day 4 as an adjunctive therapy along with 1 to a maximum of 3 marketed concomitant AEDs.
|
|---|---|---|---|---|---|---|
|
Number of Participants With Clinically Significant Markedly Abnormal Electrocardiogram (ECG) Value During Treatment and Follow-up Phase
|
1 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to 39 days (Pretreatment Phase: up to 28 days; Treatment Phase: up to 4 days; Follow-up Phase: up to 7 days after the last dose)Population: All participants who received at least 1 dose of study drug. Here "Number Analyzed" signifies participants who were evaluable for this outcome measure for POS and PGTC seizures.
Seizure frequency was based on number of seizures per day, calculated as the number of seizures over the entire time interval divided by the number of days in the interval.
Outcome measures
| Measure |
Pretreatment Phase: Oral Perampanel 8 to 12 mg/Day
n=21 Participants
Participants with POS with or without secondarily generalized seizures or PGTC seizures received perampanel 8 mg up to 12 mg (stable-dosage), tablets, orally, once daily for 28 days (Day -28 to Day -1) as an adjunctive therapy along with 1 to a maximum of 3 marketed concomitant AEDs. Eligible participants who completed Pretreatment Phase entered in Treatment Phase.
|
Treatment Phase: Intravenous Perampanel 8 to 12 mg/Day
n=21 Participants
Participants with POS with or without secondarily generalized seizures or PGTC seizures were hospitalized and received perampanel 8 mg up to 12 mg (stable-dosage) equivalent to the oral dose, as intravenous infusion for 30 minutes, once daily on Day 1 to Day 4 as an adjunctive therapy along with 1 to a maximum of 3 marketed concomitant AEDs. Eligible participants who completed Treatment Phase entered Follow-up Phase.
|
Follow-up Phase: Oral Perampanel 8 to 12 mg/Day
n=21 Participants
Participants with POS with or without secondarily generalized seizures or PGTC seizures received perampanel 8 mg up to 12 mg (stable-dosage), tablets, orally, once daily on Day 5 to Day 11 (Follow-up Visit) as an adjunctive therapy along with 1 to a maximum of 3 marketed concomitant AEDs.
|
Treatment Phase: Intravenous Perampanel 8 mg/Day
Participants with POS with or without secondarily generalized seizures or PGTC seizures were hospitalized and received perampanel 8 mg (stable-dosage) equivalent to the oral dose, as intravenous infusion for 30 minutes, once daily on Day 1 to Day 4 as an adjunctive therapy along with 1 to a maximum of 3 marketed concomitant AEDs.
|
Treatment Phase: Intravenous Perampanel 10 mg/Day
Participants with POS with or without secondarily generalized seizures or PGTC seizures were hospitalized and received perampanel 10 mg (stable-dosage) equivalent to the oral dose, as intravenous infusion for 30 minutes, once daily on Day 1 to Day 4 as an adjunctive therapy along with 1 to a maximum of 3 marketed concomitant AEDs.
|
Treatment Phase: Intravenous Perampanel 12 mg/Day
Participants with POS with or without secondarily generalized seizures or PGTC seizures were hospitalized and received perampanel 12 mg (stable-dosage) equivalent to the oral dose, as intravenous infusion for 30 minutes, once daily on Day 1 to Day 4 as an adjunctive therapy along with 1 to a maximum of 3 marketed concomitant AEDs.
|
|---|---|---|---|---|---|---|
|
Mean Seizure Frequency Per Day in Pretreatment Phase, Treatment Phase and Follow-up Phase
POS
|
0.46 seizures per day
Standard Deviation 0.578
|
0.39 seizures per day
Standard Deviation 0.838
|
0.24 seizures per day
Standard Deviation 0.287
|
—
|
—
|
—
|
|
Mean Seizure Frequency Per Day in Pretreatment Phase, Treatment Phase and Follow-up Phase
PGTC Seizures
|
0 seizures per day
Standard Deviation NA
Standard Deviation could not be estimated as only 1 participant was available for analysis.
|
0 seizures per day
Standard Deviation NA
Standard Deviation could not be estimated as only 1 participant was available for analysis.
|
0 seizures per day
Standard Deviation NA
Standard Deviation could not be estimated as only 1 participant was available for analysis.
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Pretreatment Phase-Day -1: Pre-dose, 0.5 hours, 1 hours and 1.5 hours post-dose; Treatment Phase-Day 1, Day 2, Day 3 and Day 4: Pre-dose and 0.5 hours after start of intravenous infusionsPopulation: All participants who received at least 1 dose of study drug. Here "Number Analyzed" signifies participants who were evaluable for this outcome measure at given time points.
Outcome measures
| Measure |
Pretreatment Phase: Oral Perampanel 8 to 12 mg/Day
n=11 Participants
Participants with POS with or without secondarily generalized seizures or PGTC seizures received perampanel 8 mg up to 12 mg (stable-dosage), tablets, orally, once daily for 28 days (Day -28 to Day -1) as an adjunctive therapy along with 1 to a maximum of 3 marketed concomitant AEDs. Eligible participants who completed Pretreatment Phase entered in Treatment Phase.
|
Treatment Phase: Intravenous Perampanel 8 to 12 mg/Day
n=5 Participants
Participants with POS with or without secondarily generalized seizures or PGTC seizures were hospitalized and received perampanel 8 mg up to 12 mg (stable-dosage) equivalent to the oral dose, as intravenous infusion for 30 minutes, once daily on Day 1 to Day 4 as an adjunctive therapy along with 1 to a maximum of 3 marketed concomitant AEDs. Eligible participants who completed Treatment Phase entered Follow-up Phase.
|
Follow-up Phase: Oral Perampanel 8 to 12 mg/Day
n=5 Participants
Participants with POS with or without secondarily generalized seizures or PGTC seizures received perampanel 8 mg up to 12 mg (stable-dosage), tablets, orally, once daily on Day 5 to Day 11 (Follow-up Visit) as an adjunctive therapy along with 1 to a maximum of 3 marketed concomitant AEDs.
|
Treatment Phase: Intravenous Perampanel 8 mg/Day
n=11 Participants
Participants with POS with or without secondarily generalized seizures or PGTC seizures were hospitalized and received perampanel 8 mg (stable-dosage) equivalent to the oral dose, as intravenous infusion for 30 minutes, once daily on Day 1 to Day 4 as an adjunctive therapy along with 1 to a maximum of 3 marketed concomitant AEDs.
|
Treatment Phase: Intravenous Perampanel 10 mg/Day
n=5 Participants
Participants with POS with or without secondarily generalized seizures or PGTC seizures were hospitalized and received perampanel 10 mg (stable-dosage) equivalent to the oral dose, as intravenous infusion for 30 minutes, once daily on Day 1 to Day 4 as an adjunctive therapy along with 1 to a maximum of 3 marketed concomitant AEDs.
|
Treatment Phase: Intravenous Perampanel 12 mg/Day
n=5 Participants
Participants with POS with or without secondarily generalized seizures or PGTC seizures were hospitalized and received perampanel 12 mg (stable-dosage) equivalent to the oral dose, as intravenous infusion for 30 minutes, once daily on Day 1 to Day 4 as an adjunctive therapy along with 1 to a maximum of 3 marketed concomitant AEDs.
|
|---|---|---|---|---|---|---|
|
Plasma Concentration of Perampanel Before and After Switching From Oral Perampanel to 30-minute Intravenous Infusions of Perampanel
Day 4: Pre-dose
|
—
|
—
|
—
|
394 nanogram per milliliter (ng/mL)
Standard Deviation 307
|
297 nanogram per milliliter (ng/mL)
Standard Deviation 184
|
552 nanogram per milliliter (ng/mL)
Standard Deviation 259
|
|
Plasma Concentration of Perampanel Before and After Switching From Oral Perampanel to 30-minute Intravenous Infusions of Perampanel
Day 4: 0.5 hour post-dose
|
—
|
—
|
—
|
554 nanogram per milliliter (ng/mL)
Standard Deviation 300
|
541 nanogram per milliliter (ng/mL)
Standard Deviation 209
|
841 nanogram per milliliter (ng/mL)
Standard Deviation 312
|
|
Plasma Concentration of Perampanel Before and After Switching From Oral Perampanel to 30-minute Intravenous Infusions of Perampanel
Day -1: Pre-dose
|
430 nanogram per milliliter (ng/mL)
Standard Deviation 336
|
352 nanogram per milliliter (ng/mL)
Standard Deviation 172
|
556 nanogram per milliliter (ng/mL)
Standard Deviation 255
|
—
|
—
|
—
|
|
Plasma Concentration of Perampanel Before and After Switching From Oral Perampanel to 30-minute Intravenous Infusions of Perampanel
Day -1: 0.5 hour post-dose
|
464 nanogram per milliliter (ng/mL)
Standard Deviation 369
|
435 nanogram per milliliter (ng/mL)
Standard Deviation 216
|
608 nanogram per milliliter (ng/mL)
Standard Deviation 271
|
—
|
—
|
—
|
|
Plasma Concentration of Perampanel Before and After Switching From Oral Perampanel to 30-minute Intravenous Infusions of Perampanel
Day -1: 1 hour post-dose
|
538 nanogram per milliliter (ng/mL)
Standard Deviation 385
|
499 nanogram per milliliter (ng/mL)
Standard Deviation 226
|
664 nanogram per milliliter (ng/mL)
Standard Deviation 282
|
—
|
—
|
—
|
|
Plasma Concentration of Perampanel Before and After Switching From Oral Perampanel to 30-minute Intravenous Infusions of Perampanel
Day -1: 1.5 hour post-dose
|
555 nanogram per milliliter (ng/mL)
Standard Deviation 356
|
521 nanogram per milliliter (ng/mL)
Standard Deviation 227
|
658 nanogram per milliliter (ng/mL)
Standard Deviation 284
|
—
|
—
|
—
|
|
Plasma Concentration of Perampanel Before and After Switching From Oral Perampanel to 30-minute Intravenous Infusions of Perampanel
Day 1: Pre-dose
|
—
|
—
|
—
|
402 nanogram per milliliter (ng/mL)
Standard Deviation 304
|
316 nanogram per milliliter (ng/mL)
Standard Deviation 156
|
554 nanogram per milliliter (ng/mL)
Standard Deviation 234
|
|
Plasma Concentration of Perampanel Before and After Switching From Oral Perampanel to 30-minute Intravenous Infusions of Perampanel
Day 1: 0.5 hour post-dose
|
—
|
—
|
—
|
609 nanogram per milliliter (ng/mL)
Standard Deviation 303
|
591 nanogram per milliliter (ng/mL)
Standard Deviation 172
|
837 nanogram per milliliter (ng/mL)
Standard Deviation 282
|
|
Plasma Concentration of Perampanel Before and After Switching From Oral Perampanel to 30-minute Intravenous Infusions of Perampanel
Day 2: Pre-dose
|
—
|
—
|
—
|
382 nanogram per milliliter (ng/mL)
Standard Deviation 298
|
297 nanogram per milliliter (ng/mL)
Standard Deviation 170
|
540 nanogram per milliliter (ng/mL)
Standard Deviation 232
|
|
Plasma Concentration of Perampanel Before and After Switching From Oral Perampanel to 30-minute Intravenous Infusions of Perampanel
Day 2: 0.5 hour post-dose
|
—
|
—
|
—
|
614 nanogram per milliliter (ng/mL)
Standard Deviation 315
|
520 nanogram per milliliter (ng/mL)
Standard Deviation 184
|
760 nanogram per milliliter (ng/mL)
Standard Deviation 261
|
|
Plasma Concentration of Perampanel Before and After Switching From Oral Perampanel to 30-minute Intravenous Infusions of Perampanel
Day 3: Pre-dose
|
—
|
—
|
—
|
372 nanogram per milliliter (ng/mL)
Standard Deviation 277
|
296 nanogram per milliliter (ng/mL)
Standard Deviation 175
|
560 nanogram per milliliter (ng/mL)
Standard Deviation 256
|
|
Plasma Concentration of Perampanel Before and After Switching From Oral Perampanel to 30-minute Intravenous Infusions of Perampanel
Day 3: 0.5 hour post-dose
|
—
|
—
|
—
|
557 nanogram per milliliter (ng/mL)
Standard Deviation 301
|
547 nanogram per milliliter (ng/mL)
Standard Deviation 169
|
815 nanogram per milliliter (ng/mL)
Standard Deviation 276
|
Adverse Events
Pretreatment Phase: Oral Perampanel 8 to 12 mg/Day
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Treatment Phase: Intravenous Perampanel 8 to 12 mg/Day
Serious events: 1 serious events
Other events: 11 other events
Deaths: 0 deaths
Follow-up Phase: Oral Perampanel 8 to 12 mg/Day
Serious events: 2 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Pretreatment Phase: Oral Perampanel 8 to 12 mg/Day
n=21 participants at risk
Participants with POS with or without secondarily generalized seizures or PGTC seizures received perampanel 8 mg up to 12 mg (stable-dosage), tablets, orally, once daily for 28 days (Day -28 to Day -1) as an adjunctive therapy along with 1 to a maximum of 3 marketed concomitant AEDs. Eligible participants who completed Pretreatment Phase entered in Treatment Phase.
|
Treatment Phase: Intravenous Perampanel 8 to 12 mg/Day
n=21 participants at risk
Participants with POS with or without secondarily generalized seizures or PGTC seizures were hospitalized and received perampanel 8 mg up to 12 mg (stable-dosage) equivalent to the oral dose, as intravenous infusion for 30 minutes, once daily on Day 1 to Day 4 as an adjunctive therapy along with 1 to a maximum of 3 marketed concomitant AEDs. Eligible participants who completed Treatment Phase entered Follow-up Phase.
|
Follow-up Phase: Oral Perampanel 8 to 12 mg/Day
n=21 participants at risk
Participants with POS with or without secondarily generalized seizures or PGTC seizures received perampanel 8 mg up to 12 mg (stable-dosage), tablets, orally, once daily on Day 5 to Day 11 (Follow-up Visit) as an adjunctive therapy along with 1 to a maximum of 3 marketed concomitant AEDs.
|
|---|---|---|---|
|
Nervous system disorders
Hypoaesthesia
|
0.00%
0/21 • Up to 60 days (Pretreatment Phase: up to 28 days, Treatment Phase: up to 4 days, Follow-up Phase: up to 28 days after the last dose)
All participants who received at least 1 dose of study drug.
|
0.00%
0/21 • Up to 60 days (Pretreatment Phase: up to 28 days, Treatment Phase: up to 4 days, Follow-up Phase: up to 28 days after the last dose)
All participants who received at least 1 dose of study drug.
|
4.8%
1/21 • Up to 60 days (Pretreatment Phase: up to 28 days, Treatment Phase: up to 4 days, Follow-up Phase: up to 28 days after the last dose)
All participants who received at least 1 dose of study drug.
|
|
Psychiatric disorders
Delusion
|
0.00%
0/21 • Up to 60 days (Pretreatment Phase: up to 28 days, Treatment Phase: up to 4 days, Follow-up Phase: up to 28 days after the last dose)
All participants who received at least 1 dose of study drug.
|
4.8%
1/21 • Up to 60 days (Pretreatment Phase: up to 28 days, Treatment Phase: up to 4 days, Follow-up Phase: up to 28 days after the last dose)
All participants who received at least 1 dose of study drug.
|
0.00%
0/21 • Up to 60 days (Pretreatment Phase: up to 28 days, Treatment Phase: up to 4 days, Follow-up Phase: up to 28 days after the last dose)
All participants who received at least 1 dose of study drug.
|
|
Nervous system disorders
Loss of consciousness
|
0.00%
0/21 • Up to 60 days (Pretreatment Phase: up to 28 days, Treatment Phase: up to 4 days, Follow-up Phase: up to 28 days after the last dose)
All participants who received at least 1 dose of study drug.
|
0.00%
0/21 • Up to 60 days (Pretreatment Phase: up to 28 days, Treatment Phase: up to 4 days, Follow-up Phase: up to 28 days after the last dose)
All participants who received at least 1 dose of study drug.
|
4.8%
1/21 • Up to 60 days (Pretreatment Phase: up to 28 days, Treatment Phase: up to 4 days, Follow-up Phase: up to 28 days after the last dose)
All participants who received at least 1 dose of study drug.
|
Other adverse events
| Measure |
Pretreatment Phase: Oral Perampanel 8 to 12 mg/Day
n=21 participants at risk
Participants with POS with or without secondarily generalized seizures or PGTC seizures received perampanel 8 mg up to 12 mg (stable-dosage), tablets, orally, once daily for 28 days (Day -28 to Day -1) as an adjunctive therapy along with 1 to a maximum of 3 marketed concomitant AEDs. Eligible participants who completed Pretreatment Phase entered in Treatment Phase.
|
Treatment Phase: Intravenous Perampanel 8 to 12 mg/Day
n=21 participants at risk
Participants with POS with or without secondarily generalized seizures or PGTC seizures were hospitalized and received perampanel 8 mg up to 12 mg (stable-dosage) equivalent to the oral dose, as intravenous infusion for 30 minutes, once daily on Day 1 to Day 4 as an adjunctive therapy along with 1 to a maximum of 3 marketed concomitant AEDs. Eligible participants who completed Treatment Phase entered Follow-up Phase.
|
Follow-up Phase: Oral Perampanel 8 to 12 mg/Day
n=21 participants at risk
Participants with POS with or without secondarily generalized seizures or PGTC seizures received perampanel 8 mg up to 12 mg (stable-dosage), tablets, orally, once daily on Day 5 to Day 11 (Follow-up Visit) as an adjunctive therapy along with 1 to a maximum of 3 marketed concomitant AEDs.
|
|---|---|---|---|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/21 • Up to 60 days (Pretreatment Phase: up to 28 days, Treatment Phase: up to 4 days, Follow-up Phase: up to 28 days after the last dose)
All participants who received at least 1 dose of study drug.
|
9.5%
2/21 • Up to 60 days (Pretreatment Phase: up to 28 days, Treatment Phase: up to 4 days, Follow-up Phase: up to 28 days after the last dose)
All participants who received at least 1 dose of study drug.
|
0.00%
0/21 • Up to 60 days (Pretreatment Phase: up to 28 days, Treatment Phase: up to 4 days, Follow-up Phase: up to 28 days after the last dose)
All participants who received at least 1 dose of study drug.
|
|
General disorders
Feeling abnormal
|
0.00%
0/21 • Up to 60 days (Pretreatment Phase: up to 28 days, Treatment Phase: up to 4 days, Follow-up Phase: up to 28 days after the last dose)
All participants who received at least 1 dose of study drug.
|
9.5%
2/21 • Up to 60 days (Pretreatment Phase: up to 28 days, Treatment Phase: up to 4 days, Follow-up Phase: up to 28 days after the last dose)
All participants who received at least 1 dose of study drug.
|
0.00%
0/21 • Up to 60 days (Pretreatment Phase: up to 28 days, Treatment Phase: up to 4 days, Follow-up Phase: up to 28 days after the last dose)
All participants who received at least 1 dose of study drug.
|
|
Nervous system disorders
Dizziness
|
4.8%
1/21 • Up to 60 days (Pretreatment Phase: up to 28 days, Treatment Phase: up to 4 days, Follow-up Phase: up to 28 days after the last dose)
All participants who received at least 1 dose of study drug.
|
28.6%
6/21 • Up to 60 days (Pretreatment Phase: up to 28 days, Treatment Phase: up to 4 days, Follow-up Phase: up to 28 days after the last dose)
All participants who received at least 1 dose of study drug.
|
4.8%
1/21 • Up to 60 days (Pretreatment Phase: up to 28 days, Treatment Phase: up to 4 days, Follow-up Phase: up to 28 days after the last dose)
All participants who received at least 1 dose of study drug.
|
|
Nervous system disorders
Hypoaesthesia
|
4.8%
1/21 • Up to 60 days (Pretreatment Phase: up to 28 days, Treatment Phase: up to 4 days, Follow-up Phase: up to 28 days after the last dose)
All participants who received at least 1 dose of study drug.
|
9.5%
2/21 • Up to 60 days (Pretreatment Phase: up to 28 days, Treatment Phase: up to 4 days, Follow-up Phase: up to 28 days after the last dose)
All participants who received at least 1 dose of study drug.
|
0.00%
0/21 • Up to 60 days (Pretreatment Phase: up to 28 days, Treatment Phase: up to 4 days, Follow-up Phase: up to 28 days after the last dose)
All participants who received at least 1 dose of study drug.
|
|
Nervous system disorders
Somnolence
|
0.00%
0/21 • Up to 60 days (Pretreatment Phase: up to 28 days, Treatment Phase: up to 4 days, Follow-up Phase: up to 28 days after the last dose)
All participants who received at least 1 dose of study drug.
|
14.3%
3/21 • Up to 60 days (Pretreatment Phase: up to 28 days, Treatment Phase: up to 4 days, Follow-up Phase: up to 28 days after the last dose)
All participants who received at least 1 dose of study drug.
|
0.00%
0/21 • Up to 60 days (Pretreatment Phase: up to 28 days, Treatment Phase: up to 4 days, Follow-up Phase: up to 28 days after the last dose)
All participants who received at least 1 dose of study drug.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place