Trial Outcomes & Findings for eValuation of the Efficacy and toleRability of Vimpat When Added to lEvetiracetam (NCT NCT01484977)
NCT ID: NCT01484977
Last Updated: 2018-07-18
Results Overview
Retention is a summary measure that integrates both the patient's and clinician's assessment of efficacy and tolerability in epilepsy clinical studies to provide a measure of effectiveness.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
120 participants
Primary outcome timeframe
Duration of the Treatment Period (21 Weeks)
Results posted on
2018-07-18
Participant Flow
The recruitment for the SP0980 study began in December 2011. It concluded in January 2014. This was a multicenter study with subjects enrolled by 30 sites across North America, 12 in Western Europe, 10 in Eastern Europe, and 2 in Oceania.
The participant flow consists of subjects in the Safety Set (SS). The SS is all subjects who received at least 1 dose of lacosamide.
Participant milestones
| Measure |
Lacosamide
Lacosamide will be added to levetiracetam while withdrawing the sodium channel blocking antiepileptic drug (AED).
Lacosamide: 50 mg and 100 mg lacosamide tablets will be combined and taken in two equal doses per day to provide the required total daily dosage of 100 - 600 mg/day. Subjects were titrated to a minimum of 200 mg/ day during the Treatment Period.
Maximum duration of study drug administration is approximately 23 weeks.
|
|---|---|
|
Overall Study
STARTED
|
120
|
|
Overall Study
COMPLETED
|
93
|
|
Overall Study
NOT COMPLETED
|
27
|
Reasons for withdrawal
| Measure |
Lacosamide
Lacosamide will be added to levetiracetam while withdrawing the sodium channel blocking antiepileptic drug (AED).
Lacosamide: 50 mg and 100 mg lacosamide tablets will be combined and taken in two equal doses per day to provide the required total daily dosage of 100 - 600 mg/day. Subjects were titrated to a minimum of 200 mg/ day during the Treatment Period.
Maximum duration of study drug administration is approximately 23 weeks.
|
|---|---|
|
Overall Study
Adverse Event
|
8
|
|
Overall Study
Lack of Efficacy
|
4
|
|
Overall Study
Protocol Violation
|
6
|
|
Overall Study
Lost to Follow-up
|
1
|
|
Overall Study
Withdrawal by Subject
|
4
|
|
Overall Study
Subject Protocol Non-compliant
|
1
|
|
Overall Study
Moving Overseas
|
1
|
|
Overall Study
Low White Blood Cell Count
|
1
|
|
Overall Study
Lack of Compliance
|
1
|
Baseline Characteristics
eValuation of the Efficacy and toleRability of Vimpat When Added to lEvetiracetam
Baseline characteristics by cohort
| Measure |
Lacosamide
n=120 Participants
Lacosamide will be added to levetiracetam while withdrawing the sodium channel blocking antiepileptic drug (AED).
Lacosamide: 50 mg and 100 mg lacosamide tablets will be combined and taken in two equal doses per day to provide the required total daily dosage of 100 - 600 mg/day. Subjects were titrated to a minimum of 200 mg/ day during the Treatment Period.
Maximum duration of study drug administration is approximately 23 weeks.
|
|---|---|
|
Age, Categorical
<=18 years
|
1 Participants
n=93 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
114 Participants
n=93 Participants
|
|
Age, Categorical
>=65 years
|
5 Participants
n=93 Participants
|
|
Age, Continuous
|
39.7 years
STANDARD_DEVIATION 12.6 • n=93 Participants
|
|
Sex: Female, Male
Female
|
74 Participants
n=93 Participants
|
|
Sex: Female, Male
Male
|
46 Participants
n=93 Participants
|
|
Weight
|
76.39 kilograms
STANDARD_DEVIATION 19.98 • n=93 Participants
|
|
Height
|
168.02 centimeters
STANDARD_DEVIATION 10.55 • n=93 Participants
|
|
BMI
|
27.00 kilogram/ square meter
STANDARD_DEVIATION 6.45 • n=93 Participants
|
|
Racial Group
American Indian/Alaskan Native
|
1 participants
n=93 Participants
|
|
Racial Group
Asian
|
3 participants
n=93 Participants
|
|
Racial Group
Black
|
8 participants
n=93 Participants
|
|
Racial Group
Native Hawaiian or other Pacific Islander
|
0 participants
n=93 Participants
|
|
Racial Group
White
|
96 participants
n=93 Participants
|
|
Racial Group
Other/Mixed
|
12 participants
n=93 Participants
|
|
Ethnicity
Hispanic or Latino
|
17 participants
n=93 Participants
|
|
Ethnicity
Not Hispanic or Latino
|
103 participants
n=93 Participants
|
PRIMARY outcome
Timeframe: Duration of the Treatment Period (21 Weeks)Population: The primary analysis consists of subjects in the Safety Set (SS). The SS is all subjects who received at least 1 dose of lacosamide.
Retention is a summary measure that integrates both the patient's and clinician's assessment of efficacy and tolerability in epilepsy clinical studies to provide a measure of effectiveness.
Outcome measures
| Measure |
Lacosamide
n=120 Participants
Lacosamide will be added to levetiracetam while withdrawing the sodium channel blocking antiepileptic drug (AED).
Lacosamide: 50 mg and 100 mg lacosamide tablets will be combined and taken in two equal doses per day to provide the required total daily dosage of 100 - 600 mg/day. Subjects were titrated to a minimum of 200 mg/ day during the Treatment Period.
Maximum duration of study drug administration is approximately 23 weeks.
|
|---|---|
|
Retention at the End of the 21-week Treatment Period
|
73.3 percentage of participants
|
Adverse Events
Lacosamide
Serious events: 8 serious events
Other events: 52 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Lacosamide
n=120 participants at risk
Lacosamide will be added to levetiracetam while withdrawing the sodium channel blocking antiepileptic drug (AED).
Lacosamide: 50 mg and 100 mg lacosamide tablets will be combined and taken in two equal doses per day to provide the required total daily dosage of 100 - 600 mg/day. Subjects were titrated to a minimum of 200 mg/ day during the Treatment Period.
Maximum duration of study drug administration is approximately 23 weeks.
|
|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.83%
1/120 • Number of events 1 • Treatment Emergent Adverse Events (TEAEs) were recorded during the course of the SP0980 study, which began in December 2011 and concluded in January 2014.
TEAE reporting refers to the Safety Set (SS). The SS is all subjects who received at least 1 dose of lacosamide.
|
|
Blood and lymphatic system disorders
Leukocytosis
|
0.83%
1/120 • Number of events 1 • Treatment Emergent Adverse Events (TEAEs) were recorded during the course of the SP0980 study, which began in December 2011 and concluded in January 2014.
TEAE reporting refers to the Safety Set (SS). The SS is all subjects who received at least 1 dose of lacosamide.
|
|
Cardiac disorders
Acute Myocardial Infarction
|
0.83%
1/120 • Number of events 1 • Treatment Emergent Adverse Events (TEAEs) were recorded during the course of the SP0980 study, which began in December 2011 and concluded in January 2014.
TEAE reporting refers to the Safety Set (SS). The SS is all subjects who received at least 1 dose of lacosamide.
|
|
Cardiac disorders
Angina Pectoris
|
0.83%
1/120 • Number of events 1 • Treatment Emergent Adverse Events (TEAEs) were recorded during the course of the SP0980 study, which began in December 2011 and concluded in January 2014.
TEAE reporting refers to the Safety Set (SS). The SS is all subjects who received at least 1 dose of lacosamide.
|
|
Gastrointestinal disorders
Toothache
|
0.83%
1/120 • Number of events 1 • Treatment Emergent Adverse Events (TEAEs) were recorded during the course of the SP0980 study, which began in December 2011 and concluded in January 2014.
TEAE reporting refers to the Safety Set (SS). The SS is all subjects who received at least 1 dose of lacosamide.
|
|
Infections and infestations
Pneumonia
|
1.7%
2/120 • Number of events 2 • Treatment Emergent Adverse Events (TEAEs) were recorded during the course of the SP0980 study, which began in December 2011 and concluded in January 2014.
TEAE reporting refers to the Safety Set (SS). The SS is all subjects who received at least 1 dose of lacosamide.
|
|
Infections and infestations
Appendicitis
|
0.83%
1/120 • Number of events 1 • Treatment Emergent Adverse Events (TEAEs) were recorded during the course of the SP0980 study, which began in December 2011 and concluded in January 2014.
TEAE reporting refers to the Safety Set (SS). The SS is all subjects who received at least 1 dose of lacosamide.
|
|
Infections and infestations
Infection
|
0.83%
1/120 • Number of events 1 • Treatment Emergent Adverse Events (TEAEs) were recorded during the course of the SP0980 study, which began in December 2011 and concluded in January 2014.
TEAE reporting refers to the Safety Set (SS). The SS is all subjects who received at least 1 dose of lacosamide.
|
|
Infections and infestations
Urinary Tract Infection
|
0.83%
1/120 • Number of events 1 • Treatment Emergent Adverse Events (TEAEs) were recorded during the course of the SP0980 study, which began in December 2011 and concluded in January 2014.
TEAE reporting refers to the Safety Set (SS). The SS is all subjects who received at least 1 dose of lacosamide.
|
|
Infections and infestations
Vulvovaginitis Trichomonal
|
0.83%
1/120 • Number of events 1 • Treatment Emergent Adverse Events (TEAEs) were recorded during the course of the SP0980 study, which began in December 2011 and concluded in January 2014.
TEAE reporting refers to the Safety Set (SS). The SS is all subjects who received at least 1 dose of lacosamide.
|
|
Nervous system disorders
Migraine
|
0.83%
1/120 • Number of events 1 • Treatment Emergent Adverse Events (TEAEs) were recorded during the course of the SP0980 study, which began in December 2011 and concluded in January 2014.
TEAE reporting refers to the Safety Set (SS). The SS is all subjects who received at least 1 dose of lacosamide.
|
|
Psychiatric disorders
Anxiety
|
0.83%
1/120 • Number of events 1 • Treatment Emergent Adverse Events (TEAEs) were recorded during the course of the SP0980 study, which began in December 2011 and concluded in January 2014.
TEAE reporting refers to the Safety Set (SS). The SS is all subjects who received at least 1 dose of lacosamide.
|
|
Psychiatric disorders
Mental Status Changes
|
0.83%
1/120 • Number of events 1 • Treatment Emergent Adverse Events (TEAEs) were recorded during the course of the SP0980 study, which began in December 2011 and concluded in January 2014.
TEAE reporting refers to the Safety Set (SS). The SS is all subjects who received at least 1 dose of lacosamide.
|
|
Psychiatric disorders
Suicidal Ideation
|
0.83%
1/120 • Number of events 1 • Treatment Emergent Adverse Events (TEAEs) were recorded during the course of the SP0980 study, which began in December 2011 and concluded in January 2014.
TEAE reporting refers to the Safety Set (SS). The SS is all subjects who received at least 1 dose of lacosamide.
|
|
Reproductive system and breast disorders
Asthma
|
0.83%
1/120 • Number of events 1 • Treatment Emergent Adverse Events (TEAEs) were recorded during the course of the SP0980 study, which began in December 2011 and concluded in January 2014.
TEAE reporting refers to the Safety Set (SS). The SS is all subjects who received at least 1 dose of lacosamide.
|
Other adverse events
| Measure |
Lacosamide
n=120 participants at risk
Lacosamide will be added to levetiracetam while withdrawing the sodium channel blocking antiepileptic drug (AED).
Lacosamide: 50 mg and 100 mg lacosamide tablets will be combined and taken in two equal doses per day to provide the required total daily dosage of 100 - 600 mg/day. Subjects were titrated to a minimum of 200 mg/ day during the Treatment Period.
Maximum duration of study drug administration is approximately 23 weeks.
|
|---|---|
|
Gastrointestinal disorders
Nausea
|
5.8%
7/120 • Number of events 7 • Treatment Emergent Adverse Events (TEAEs) were recorded during the course of the SP0980 study, which began in December 2011 and concluded in January 2014.
TEAE reporting refers to the Safety Set (SS). The SS is all subjects who received at least 1 dose of lacosamide.
|
|
General disorders
Fatigue
|
8.3%
10/120 • Number of events 13 • Treatment Emergent Adverse Events (TEAEs) were recorded during the course of the SP0980 study, which began in December 2011 and concluded in January 2014.
TEAE reporting refers to the Safety Set (SS). The SS is all subjects who received at least 1 dose of lacosamide.
|
|
Nervous system disorders
Dizziness
|
23.3%
28/120 • Number of events 40 • Treatment Emergent Adverse Events (TEAEs) were recorded during the course of the SP0980 study, which began in December 2011 and concluded in January 2014.
TEAE reporting refers to the Safety Set (SS). The SS is all subjects who received at least 1 dose of lacosamide.
|
|
Nervous system disorders
Headache
|
15.0%
18/120 • Number of events 21 • Treatment Emergent Adverse Events (TEAEs) were recorded during the course of the SP0980 study, which began in December 2011 and concluded in January 2014.
TEAE reporting refers to the Safety Set (SS). The SS is all subjects who received at least 1 dose of lacosamide.
|
|
Nervous system disorders
Convulsion
|
5.8%
7/120 • Number of events 8 • Treatment Emergent Adverse Events (TEAEs) were recorded during the course of the SP0980 study, which began in December 2011 and concluded in January 2014.
TEAE reporting refers to the Safety Set (SS). The SS is all subjects who received at least 1 dose of lacosamide.
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Additional Information
Study Director
UCB Clinical Trial Call Center
Phone: +1 887 822 9493
Results disclosure agreements
- Principal investigator is a sponsor employee UCB has \> 60 but \<= 180 days to review results communications prior to public release and may delete information that is confidential and compromises ongoing studies or is considered proprietary. This restriction is not intended to compromise the objective scientific integrity of the manuscript, it being understood that the results shall be published regardless of outcome.
- Publication restrictions are in place
Restriction type: OTHER