Trial Outcomes & Findings for Levetiracetam Versus Topiramate as Adjunctive Therapy to Evaluate Efficacy and Safety in Subjects With Refractory Partial Onset Seizures (NCT NCT01229735)
NCT ID: NCT01229735
Last Updated: 2017-08-15
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
343 participants
Primary outcome timeframe
From Baseline to Week 52
Results posted on
2017-08-15
Participant Flow
447 subjects were screened, 343 subjects were randomized.
Participant Flow refers to the Randomized Set which consists of all subjects who were randomized in this study.
Participant milestones
| Measure |
Levetiracetam
250 mg and 500 mg levetiracetam tablet; titration from 1000 mg/day (500 mg bid) to 3000 mg/day (1500 mg bid) levetiracetam with treatment duration up to 52 weeks
|
Topiramate
25 mg and 100 mg topiramate tablet; titration from 100 mg/day (50 mg bid) to 400 mg/day (200 mg bid) topiramate with treatment duration up to 52 weeks
|
|---|---|---|
|
Overall Study
STARTED
|
177
|
166
|
|
Overall Study
COMPLETED
|
111
|
100
|
|
Overall Study
NOT COMPLETED
|
66
|
66
|
Reasons for withdrawal
| Measure |
Levetiracetam
250 mg and 500 mg levetiracetam tablet; titration from 1000 mg/day (500 mg bid) to 3000 mg/day (1500 mg bid) levetiracetam with treatment duration up to 52 weeks
|
Topiramate
25 mg and 100 mg topiramate tablet; titration from 100 mg/day (50 mg bid) to 400 mg/day (200 mg bid) topiramate with treatment duration up to 52 weeks
|
|---|---|---|
|
Overall Study
Lack of Efficacy
|
8
|
8
|
|
Overall Study
Protocol Violation
|
13
|
8
|
|
Overall Study
Lost to Follow-up
|
0
|
2
|
|
Overall Study
Withdrawal by Subject
|
18
|
17
|
|
Overall Study
Other Reason
|
13
|
10
|
|
Overall Study
SAE, non-fatal
|
0
|
4
|
|
Overall Study
AE, non-serious non-fatal
|
13
|
17
|
|
Overall Study
SAE, non-fatal+AE, non-serious non-fatal
|
1
|
0
|
Baseline Characteristics
Levetiracetam Versus Topiramate as Adjunctive Therapy to Evaluate Efficacy and Safety in Subjects With Refractory Partial Onset Seizures
Baseline characteristics by cohort
| Measure |
Levetiracetam
n=177 Participants
250 mg and 500 mg levetiracetam tablet; titration from 1000 mg/day (500 mg bid) to 3000 mg/day (1500 mg bid) levetiracetam with treatment duration up to 52 weeks
|
Topiramate
n=166 Participants
25 mg and 100 mg topiramate tablet; titration from 100 mg/day (50 mg bid) to 400 mg/day (200 mg bid) topiramate with treatment duration up to 52 weeks
|
Total Title
n=343 Participants
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
4 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
165 Participants
n=99 Participants
|
162 Participants
n=107 Participants
|
327 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
8 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
12 Participants
n=206 Participants
|
|
Age, Continuous
|
40.9 years
STANDARD_DEVIATION 13.6 • n=99 Participants
|
39.7 years
STANDARD_DEVIATION 11.8 • n=107 Participants
|
40.3 years
STANDARD_DEVIATION 12.8 • n=206 Participants
|
|
Sex: Female, Male
Female
|
71 Participants
n=99 Participants
|
64 Participants
n=107 Participants
|
135 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
106 Participants
n=99 Participants
|
102 Participants
n=107 Participants
|
208 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: From Baseline to Week 52Population: The Full Analysis Set (FAS) consisted of all subjects in the Safety Set who returned at least 1 post-baseline seizure diary.
Outcome measures
| Measure |
Levetiracetam (Full Analysis Set)
n=176 Participants
250 mg and 500 mg levetiracetam tablet; titration from 1000 mg/day (500 mg bid) to 3000 mg/day (1500 mg bid) levetiracetam with treatment duration up to 52 weeks
|
Topiramate (Full Analysis Set)
n=166 Participants
25 mg and 100 mg topiramate tablet; titration from 100 mg/day (50 mg bid) to 400 mg/day (200 mg bid) topiramate with treatment duration up to 52 weeks
|
|---|---|---|
|
Percentage of Subjects Continuing the Allocated Investigational Treatment From the First Study Treatment Intake to Week 52, After the Beginning of Investigational Treatment With Levetiracetam Compared to Topiramate
|
59.1 percentage of subjects
|
56.6 percentage of subjects
|
SECONDARY outcome
Timeframe: From Baseline to Week 52Population: The Safety Set (SS) consists of all subjects who were randomized and received at least 1 (partial) dose of study medication.
Outcome measures
| Measure |
Levetiracetam (Full Analysis Set)
n=177 Participants
250 mg and 500 mg levetiracetam tablet; titration from 1000 mg/day (500 mg bid) to 3000 mg/day (1500 mg bid) levetiracetam with treatment duration up to 52 weeks
|
Topiramate (Full Analysis Set)
n=166 Participants
25 mg and 100 mg topiramate tablet; titration from 100 mg/day (50 mg bid) to 400 mg/day (200 mg bid) topiramate with treatment duration up to 52 weeks
|
|---|---|---|
|
Number of Subjects With at Least One Adverse Event Reported During the Trial Period From Baseline to Week 52
|
125 Participants
|
128 Participants
|
SECONDARY outcome
Timeframe: From Baseline to Week 52Population: The Safety Set (SS) consists of all subjects who were randomized and received at least 1 (partial) dose of study medication.
Outcome measures
| Measure |
Levetiracetam (Full Analysis Set)
n=177 Participants
250 mg and 500 mg levetiracetam tablet; titration from 1000 mg/day (500 mg bid) to 3000 mg/day (1500 mg bid) levetiracetam with treatment duration up to 52 weeks
|
Topiramate (Full Analysis Set)
n=166 Participants
25 mg and 100 mg topiramate tablet; titration from 100 mg/day (50 mg bid) to 400 mg/day (200 mg bid) topiramate with treatment duration up to 52 weeks
|
|---|---|---|
|
Time From the First Study Treatment Intake to Drug Discontinuation Due to Adverse Event (AE)
|
NA month
For time to Study Drug Discontinuation due to AE, Kaplan-Meier estimation of event-free subjects does not fall to or below 75%, therefore no first quartile, median or third quartile of the time to event could be estimated in either group.
|
NA month
For time to Study Drug Discontinuation due to AE, Kaplan-Meier estimation of event-free subjects does not fall to or below 75%, therefore no first quartile, median or third quartile of the time to event could be estimated in either group.
|
SECONDARY outcome
Timeframe: From Baseline to Week 52Population: The Full Analysis Set (FAS) consists of all subjects in the Safety Set (SS) who returned at least 1 postbaseline seizure diary.
Reduction from baseline was defined as baseline value minus post-baseline value and therefore is the negative of the change from baseline value.
Outcome measures
| Measure |
Levetiracetam (Full Analysis Set)
n=174 Participants
250 mg and 500 mg levetiracetam tablet; titration from 1000 mg/day (500 mg bid) to 3000 mg/day (1500 mg bid) levetiracetam with treatment duration up to 52 weeks
|
Topiramate (Full Analysis Set)
n=165 Participants
25 mg and 100 mg topiramate tablet; titration from 100 mg/day (50 mg bid) to 400 mg/day (200 mg bid) topiramate with treatment duration up to 52 weeks
|
|---|---|---|
|
Median Percent Reduction in the Weekly Partial Onset Seizure (POS) Frequency From Baseline During the Total Treatment Period From Baseline to Week 52
|
74.47 percent reduction
Interval 38.0 to 96.28
|
67.86 percent reduction
Interval 29.21 to 87.24
|
SECONDARY outcome
Timeframe: From Baseline to Week 52Population: The Full Analysis Set (FAS) consists of all subjects in the SS who returned at least 1 postbaseline seizure diary.
Outcome measures
| Measure |
Levetiracetam (Full Analysis Set)
n=174 Participants
250 mg and 500 mg levetiracetam tablet; titration from 1000 mg/day (500 mg bid) to 3000 mg/day (1500 mg bid) levetiracetam with treatment duration up to 52 weeks
|
Topiramate (Full Analysis Set)
n=165 Participants
25 mg and 100 mg topiramate tablet; titration from 100 mg/day (50 mg bid) to 400 mg/day (200 mg bid) topiramate with treatment duration up to 52 weeks
|
|---|---|---|
|
Responders Defined as Number of Subjects With at Least 50 % Reduction in the Weekly POS Frequency From Baseline During the Total Treatment Period From Baseline to Week 52
|
120 responders
|
107 responders
|
Adverse Events
Levetiracetam
Serious events: 10 serious events
Other events: 86 other events
Deaths: 0 deaths
Topiramate
Serious events: 15 serious events
Other events: 91 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Levetiracetam
n=177 participants at risk
250 mg and 500 mg levetiracetam tablet; titration from 1000 mg/day (500 mg bid) to 3000 mg/day (1500 mg bid) levetiracetam with treatment duration up to 52 weeks
|
Topiramate
n=166 participants at risk
25 mg and 100 mg topiramate tablet; titration from 100 mg/day (50 mg bid) to 400 mg/day (200 mg bid) topiramate with treatment duration up to 52 weeks
|
|---|---|---|
|
Cardiac disorders
Arrhythmia
|
0.56%
1/177 • Number of events 1 • Adverse Events (AEs) were collected from Visit 1 (Week -4) until final Visit 12 (Week 53).
The Safety Set (SS) consisted of all subjects who were randomized and received at least 1 (partial) dose of study medication.
|
0.00%
0/166 • Adverse Events (AEs) were collected from Visit 1 (Week -4) until final Visit 12 (Week 53).
The Safety Set (SS) consisted of all subjects who were randomized and received at least 1 (partial) dose of study medication.
|
|
Congenital, familial and genetic disorders
Arteriovenous malformation
|
0.56%
1/177 • Number of events 1 • Adverse Events (AEs) were collected from Visit 1 (Week -4) until final Visit 12 (Week 53).
The Safety Set (SS) consisted of all subjects who were randomized and received at least 1 (partial) dose of study medication.
|
0.00%
0/166 • Adverse Events (AEs) were collected from Visit 1 (Week -4) until final Visit 12 (Week 53).
The Safety Set (SS) consisted of all subjects who were randomized and received at least 1 (partial) dose of study medication.
|
|
Congenital, familial and genetic disorders
Atrial septal defect
|
0.56%
1/177 • Number of events 1 • Adverse Events (AEs) were collected from Visit 1 (Week -4) until final Visit 12 (Week 53).
The Safety Set (SS) consisted of all subjects who were randomized and received at least 1 (partial) dose of study medication.
|
0.00%
0/166 • Adverse Events (AEs) were collected from Visit 1 (Week -4) until final Visit 12 (Week 53).
The Safety Set (SS) consisted of all subjects who were randomized and received at least 1 (partial) dose of study medication.
|
|
Eye disorders
Photophobia
|
0.56%
1/177 • Number of events 1 • Adverse Events (AEs) were collected from Visit 1 (Week -4) until final Visit 12 (Week 53).
The Safety Set (SS) consisted of all subjects who were randomized and received at least 1 (partial) dose of study medication.
|
0.00%
0/166 • Adverse Events (AEs) were collected from Visit 1 (Week -4) until final Visit 12 (Week 53).
The Safety Set (SS) consisted of all subjects who were randomized and received at least 1 (partial) dose of study medication.
|
|
Gastrointestinal disorders
Alcoholic pancreatitis
|
0.56%
1/177 • Number of events 1 • Adverse Events (AEs) were collected from Visit 1 (Week -4) until final Visit 12 (Week 53).
The Safety Set (SS) consisted of all subjects who were randomized and received at least 1 (partial) dose of study medication.
|
0.00%
0/166 • Adverse Events (AEs) were collected from Visit 1 (Week -4) until final Visit 12 (Week 53).
The Safety Set (SS) consisted of all subjects who were randomized and received at least 1 (partial) dose of study medication.
|
|
Gastrointestinal disorders
Ileus
|
0.56%
1/177 • Number of events 1 • Adverse Events (AEs) were collected from Visit 1 (Week -4) until final Visit 12 (Week 53).
The Safety Set (SS) consisted of all subjects who were randomized and received at least 1 (partial) dose of study medication.
|
0.00%
0/166 • Adverse Events (AEs) were collected from Visit 1 (Week -4) until final Visit 12 (Week 53).
The Safety Set (SS) consisted of all subjects who were randomized and received at least 1 (partial) dose of study medication.
|
|
Gastrointestinal disorders
Duodenal ulcer
|
0.00%
0/177 • Adverse Events (AEs) were collected from Visit 1 (Week -4) until final Visit 12 (Week 53).
The Safety Set (SS) consisted of all subjects who were randomized and received at least 1 (partial) dose of study medication.
|
0.60%
1/166 • Number of events 1 • Adverse Events (AEs) were collected from Visit 1 (Week -4) until final Visit 12 (Week 53).
The Safety Set (SS) consisted of all subjects who were randomized and received at least 1 (partial) dose of study medication.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/177 • Adverse Events (AEs) were collected from Visit 1 (Week -4) until final Visit 12 (Week 53).
The Safety Set (SS) consisted of all subjects who were randomized and received at least 1 (partial) dose of study medication.
|
0.60%
1/166 • Number of events 1 • Adverse Events (AEs) were collected from Visit 1 (Week -4) until final Visit 12 (Week 53).
The Safety Set (SS) consisted of all subjects who were randomized and received at least 1 (partial) dose of study medication.
|
|
Gastrointestinal disorders
Pancreatitis acute
|
0.00%
0/177 • Adverse Events (AEs) were collected from Visit 1 (Week -4) until final Visit 12 (Week 53).
The Safety Set (SS) consisted of all subjects who were randomized and received at least 1 (partial) dose of study medication.
|
0.60%
1/166 • Number of events 1 • Adverse Events (AEs) were collected from Visit 1 (Week -4) until final Visit 12 (Week 53).
The Safety Set (SS) consisted of all subjects who were randomized and received at least 1 (partial) dose of study medication.
|
|
General disorders
Asthenia
|
0.56%
1/177 • Number of events 1 • Adverse Events (AEs) were collected from Visit 1 (Week -4) until final Visit 12 (Week 53).
The Safety Set (SS) consisted of all subjects who were randomized and received at least 1 (partial) dose of study medication.
|
0.00%
0/166 • Adverse Events (AEs) were collected from Visit 1 (Week -4) until final Visit 12 (Week 53).
The Safety Set (SS) consisted of all subjects who were randomized and received at least 1 (partial) dose of study medication.
|
|
Infections and infestations
Chronic tonsillitis
|
0.56%
1/177 • Number of events 1 • Adverse Events (AEs) were collected from Visit 1 (Week -4) until final Visit 12 (Week 53).
The Safety Set (SS) consisted of all subjects who were randomized and received at least 1 (partial) dose of study medication.
|
0.00%
0/166 • Adverse Events (AEs) were collected from Visit 1 (Week -4) until final Visit 12 (Week 53).
The Safety Set (SS) consisted of all subjects who were randomized and received at least 1 (partial) dose of study medication.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/177 • Adverse Events (AEs) were collected from Visit 1 (Week -4) until final Visit 12 (Week 53).
The Safety Set (SS) consisted of all subjects who were randomized and received at least 1 (partial) dose of study medication.
|
0.60%
1/166 • Number of events 1 • Adverse Events (AEs) were collected from Visit 1 (Week -4) until final Visit 12 (Week 53).
The Safety Set (SS) consisted of all subjects who were randomized and received at least 1 (partial) dose of study medication.
|
|
Injury, poisoning and procedural complications
Face injury
|
0.56%
1/177 • Number of events 1 • Adverse Events (AEs) were collected from Visit 1 (Week -4) until final Visit 12 (Week 53).
The Safety Set (SS) consisted of all subjects who were randomized and received at least 1 (partial) dose of study medication.
|
0.00%
0/166 • Adverse Events (AEs) were collected from Visit 1 (Week -4) until final Visit 12 (Week 53).
The Safety Set (SS) consisted of all subjects who were randomized and received at least 1 (partial) dose of study medication.
|
|
Injury, poisoning and procedural complications
Fall
|
0.56%
1/177 • Number of events 1 • Adverse Events (AEs) were collected from Visit 1 (Week -4) until final Visit 12 (Week 53).
The Safety Set (SS) consisted of all subjects who were randomized and received at least 1 (partial) dose of study medication.
|
0.00%
0/166 • Adverse Events (AEs) were collected from Visit 1 (Week -4) until final Visit 12 (Week 53).
The Safety Set (SS) consisted of all subjects who were randomized and received at least 1 (partial) dose of study medication.
|
|
Injury, poisoning and procedural complications
Hip fracture
|
0.56%
1/177 • Number of events 1 • Adverse Events (AEs) were collected from Visit 1 (Week -4) until final Visit 12 (Week 53).
The Safety Set (SS) consisted of all subjects who were randomized and received at least 1 (partial) dose of study medication.
|
0.00%
0/166 • Adverse Events (AEs) were collected from Visit 1 (Week -4) until final Visit 12 (Week 53).
The Safety Set (SS) consisted of all subjects who were randomized and received at least 1 (partial) dose of study medication.
|
|
Injury, poisoning and procedural complications
Joint dislocation
|
0.00%
0/177 • Adverse Events (AEs) were collected from Visit 1 (Week -4) until final Visit 12 (Week 53).
The Safety Set (SS) consisted of all subjects who were randomized and received at least 1 (partial) dose of study medication.
|
0.60%
1/166 • Number of events 1 • Adverse Events (AEs) were collected from Visit 1 (Week -4) until final Visit 12 (Week 53).
The Safety Set (SS) consisted of all subjects who were randomized and received at least 1 (partial) dose of study medication.
|
|
Injury, poisoning and procedural complications
Radius fracture
|
0.00%
0/177 • Adverse Events (AEs) were collected from Visit 1 (Week -4) until final Visit 12 (Week 53).
The Safety Set (SS) consisted of all subjects who were randomized and received at least 1 (partial) dose of study medication.
|
0.60%
1/166 • Number of events 1 • Adverse Events (AEs) were collected from Visit 1 (Week -4) until final Visit 12 (Week 53).
The Safety Set (SS) consisted of all subjects who were randomized and received at least 1 (partial) dose of study medication.
|
|
Injury, poisoning and procedural complications
Spinal compression fracture
|
0.00%
0/177 • Adverse Events (AEs) were collected from Visit 1 (Week -4) until final Visit 12 (Week 53).
The Safety Set (SS) consisted of all subjects who were randomized and received at least 1 (partial) dose of study medication.
|
0.60%
1/166 • Number of events 1 • Adverse Events (AEs) were collected from Visit 1 (Week -4) until final Visit 12 (Week 53).
The Safety Set (SS) consisted of all subjects who were randomized and received at least 1 (partial) dose of study medication.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/177 • Adverse Events (AEs) were collected from Visit 1 (Week -4) until final Visit 12 (Week 53).
The Safety Set (SS) consisted of all subjects who were randomized and received at least 1 (partial) dose of study medication.
|
0.60%
1/166 • Number of events 1 • Adverse Events (AEs) were collected from Visit 1 (Week -4) until final Visit 12 (Week 53).
The Safety Set (SS) consisted of all subjects who were randomized and received at least 1 (partial) dose of study medication.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.56%
1/177 • Number of events 2 • Adverse Events (AEs) were collected from Visit 1 (Week -4) until final Visit 12 (Week 53).
The Safety Set (SS) consisted of all subjects who were randomized and received at least 1 (partial) dose of study medication.
|
0.00%
0/166 • Adverse Events (AEs) were collected from Visit 1 (Week -4) until final Visit 12 (Week 53).
The Safety Set (SS) consisted of all subjects who were randomized and received at least 1 (partial) dose of study medication.
|
|
Musculoskeletal and connective tissue disorders
Trigger finger
|
0.00%
0/177 • Adverse Events (AEs) were collected from Visit 1 (Week -4) until final Visit 12 (Week 53).
The Safety Set (SS) consisted of all subjects who were randomized and received at least 1 (partial) dose of study medication.
|
0.60%
1/166 • Number of events 1 • Adverse Events (AEs) were collected from Visit 1 (Week -4) until final Visit 12 (Week 53).
The Safety Set (SS) consisted of all subjects who were randomized and received at least 1 (partial) dose of study medication.
|
|
Nervous system disorders
Dizziness
|
1.1%
2/177 • Number of events 2 • Adverse Events (AEs) were collected from Visit 1 (Week -4) until final Visit 12 (Week 53).
The Safety Set (SS) consisted of all subjects who were randomized and received at least 1 (partial) dose of study medication.
|
0.00%
0/166 • Adverse Events (AEs) were collected from Visit 1 (Week -4) until final Visit 12 (Week 53).
The Safety Set (SS) consisted of all subjects who were randomized and received at least 1 (partial) dose of study medication.
|
|
Nervous system disorders
Dyskinesia
|
0.56%
1/177 • Number of events 1 • Adverse Events (AEs) were collected from Visit 1 (Week -4) until final Visit 12 (Week 53).
The Safety Set (SS) consisted of all subjects who were randomized and received at least 1 (partial) dose of study medication.
|
0.00%
0/166 • Adverse Events (AEs) were collected from Visit 1 (Week -4) until final Visit 12 (Week 53).
The Safety Set (SS) consisted of all subjects who were randomized and received at least 1 (partial) dose of study medication.
|
|
Nervous system disorders
Headache
|
0.56%
1/177 • Number of events 1 • Adverse Events (AEs) were collected from Visit 1 (Week -4) until final Visit 12 (Week 53).
The Safety Set (SS) consisted of all subjects who were randomized and received at least 1 (partial) dose of study medication.
|
0.00%
0/166 • Adverse Events (AEs) were collected from Visit 1 (Week -4) until final Visit 12 (Week 53).
The Safety Set (SS) consisted of all subjects who were randomized and received at least 1 (partial) dose of study medication.
|
|
Nervous system disorders
Loss of consciousness
|
0.56%
1/177 • Number of events 1 • Adverse Events (AEs) were collected from Visit 1 (Week -4) until final Visit 12 (Week 53).
The Safety Set (SS) consisted of all subjects who were randomized and received at least 1 (partial) dose of study medication.
|
0.00%
0/166 • Adverse Events (AEs) were collected from Visit 1 (Week -4) until final Visit 12 (Week 53).
The Safety Set (SS) consisted of all subjects who were randomized and received at least 1 (partial) dose of study medication.
|
|
Nervous system disorders
Seizure
|
0.56%
1/177 • Number of events 1 • Adverse Events (AEs) were collected from Visit 1 (Week -4) until final Visit 12 (Week 53).
The Safety Set (SS) consisted of all subjects who were randomized and received at least 1 (partial) dose of study medication.
|
3.0%
5/166 • Number of events 6 • Adverse Events (AEs) were collected from Visit 1 (Week -4) until final Visit 12 (Week 53).
The Safety Set (SS) consisted of all subjects who were randomized and received at least 1 (partial) dose of study medication.
|
|
Nervous system disorders
Stupor
|
0.56%
1/177 • Number of events 1 • Adverse Events (AEs) were collected from Visit 1 (Week -4) until final Visit 12 (Week 53).
The Safety Set (SS) consisted of all subjects who were randomized and received at least 1 (partial) dose of study medication.
|
0.00%
0/166 • Adverse Events (AEs) were collected from Visit 1 (Week -4) until final Visit 12 (Week 53).
The Safety Set (SS) consisted of all subjects who were randomized and received at least 1 (partial) dose of study medication.
|
|
Nervous system disorders
Epilepsy
|
0.00%
0/177 • Adverse Events (AEs) were collected from Visit 1 (Week -4) until final Visit 12 (Week 53).
The Safety Set (SS) consisted of all subjects who were randomized and received at least 1 (partial) dose of study medication.
|
0.60%
1/166 • Number of events 1 • Adverse Events (AEs) were collected from Visit 1 (Week -4) until final Visit 12 (Week 53).
The Safety Set (SS) consisted of all subjects who were randomized and received at least 1 (partial) dose of study medication.
|
|
Pregnancy, puerperium and perinatal conditions
Abortion spontaneous
|
0.00%
0/177 • Adverse Events (AEs) were collected from Visit 1 (Week -4) until final Visit 12 (Week 53).
The Safety Set (SS) consisted of all subjects who were randomized and received at least 1 (partial) dose of study medication.
|
0.60%
1/166 • Number of events 1 • Adverse Events (AEs) were collected from Visit 1 (Week -4) until final Visit 12 (Week 53).
The Safety Set (SS) consisted of all subjects who were randomized and received at least 1 (partial) dose of study medication.
|
|
Renal and urinary disorders
Calculus ureteric
|
0.00%
0/177 • Adverse Events (AEs) were collected from Visit 1 (Week -4) until final Visit 12 (Week 53).
The Safety Set (SS) consisted of all subjects who were randomized and received at least 1 (partial) dose of study medication.
|
0.60%
1/166 • Number of events 1 • Adverse Events (AEs) were collected from Visit 1 (Week -4) until final Visit 12 (Week 53).
The Safety Set (SS) consisted of all subjects who were randomized and received at least 1 (partial) dose of study medication.
|
|
Vascular disorders
Deep vein thrombosis
|
0.00%
0/177 • Adverse Events (AEs) were collected from Visit 1 (Week -4) until final Visit 12 (Week 53).
The Safety Set (SS) consisted of all subjects who were randomized and received at least 1 (partial) dose of study medication.
|
0.60%
1/166 • Number of events 1 • Adverse Events (AEs) were collected from Visit 1 (Week -4) until final Visit 12 (Week 53).
The Safety Set (SS) consisted of all subjects who were randomized and received at least 1 (partial) dose of study medication.
|
Other adverse events
| Measure |
Levetiracetam
n=177 participants at risk
250 mg and 500 mg levetiracetam tablet; titration from 1000 mg/day (500 mg bid) to 3000 mg/day (1500 mg bid) levetiracetam with treatment duration up to 52 weeks
|
Topiramate
n=166 participants at risk
25 mg and 100 mg topiramate tablet; titration from 100 mg/day (50 mg bid) to 400 mg/day (200 mg bid) topiramate with treatment duration up to 52 weeks
|
|---|---|---|
|
Gastrointestinal disorders
Dyspepsia
|
5.1%
9/177 • Number of events 10 • Adverse Events (AEs) were collected from Visit 1 (Week -4) until final Visit 12 (Week 53).
The Safety Set (SS) consisted of all subjects who were randomized and received at least 1 (partial) dose of study medication.
|
4.2%
7/166 • Number of events 8 • Adverse Events (AEs) were collected from Visit 1 (Week -4) until final Visit 12 (Week 53).
The Safety Set (SS) consisted of all subjects who were randomized and received at least 1 (partial) dose of study medication.
|
|
Gastrointestinal disorders
Nausea
|
5.1%
9/177 • Number of events 11 • Adverse Events (AEs) were collected from Visit 1 (Week -4) until final Visit 12 (Week 53).
The Safety Set (SS) consisted of all subjects who were randomized and received at least 1 (partial) dose of study medication.
|
6.0%
10/166 • Number of events 10 • Adverse Events (AEs) were collected from Visit 1 (Week -4) until final Visit 12 (Week 53).
The Safety Set (SS) consisted of all subjects who were randomized and received at least 1 (partial) dose of study medication.
|
|
Infections and infestations
Nasopharyngitis
|
13.6%
24/177 • Number of events 32 • Adverse Events (AEs) were collected from Visit 1 (Week -4) until final Visit 12 (Week 53).
The Safety Set (SS) consisted of all subjects who were randomized and received at least 1 (partial) dose of study medication.
|
9.6%
16/166 • Number of events 22 • Adverse Events (AEs) were collected from Visit 1 (Week -4) until final Visit 12 (Week 53).
The Safety Set (SS) consisted of all subjects who were randomized and received at least 1 (partial) dose of study medication.
|
|
Investigations
Weight decreased
|
1.7%
3/177 • Number of events 3 • Adverse Events (AEs) were collected from Visit 1 (Week -4) until final Visit 12 (Week 53).
The Safety Set (SS) consisted of all subjects who were randomized and received at least 1 (partial) dose of study medication.
|
10.2%
17/166 • Number of events 19 • Adverse Events (AEs) were collected from Visit 1 (Week -4) until final Visit 12 (Week 53).
The Safety Set (SS) consisted of all subjects who were randomized and received at least 1 (partial) dose of study medication.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
1.7%
3/177 • Number of events 3 • Adverse Events (AEs) were collected from Visit 1 (Week -4) until final Visit 12 (Week 53).
The Safety Set (SS) consisted of all subjects who were randomized and received at least 1 (partial) dose of study medication.
|
15.7%
26/166 • Number of events 32 • Adverse Events (AEs) were collected from Visit 1 (Week -4) until final Visit 12 (Week 53).
The Safety Set (SS) consisted of all subjects who were randomized and received at least 1 (partial) dose of study medication.
|
|
Nervous system disorders
Somnolence
|
20.3%
36/177 • Number of events 40 • Adverse Events (AEs) were collected from Visit 1 (Week -4) until final Visit 12 (Week 53).
The Safety Set (SS) consisted of all subjects who were randomized and received at least 1 (partial) dose of study medication.
|
12.0%
20/166 • Number of events 21 • Adverse Events (AEs) were collected from Visit 1 (Week -4) until final Visit 12 (Week 53).
The Safety Set (SS) consisted of all subjects who were randomized and received at least 1 (partial) dose of study medication.
|
|
Nervous system disorders
Dizziness
|
16.9%
30/177 • Number of events 47 • Adverse Events (AEs) were collected from Visit 1 (Week -4) until final Visit 12 (Week 53).
The Safety Set (SS) consisted of all subjects who were randomized and received at least 1 (partial) dose of study medication.
|
14.5%
24/166 • Number of events 29 • Adverse Events (AEs) were collected from Visit 1 (Week -4) until final Visit 12 (Week 53).
The Safety Set (SS) consisted of all subjects who were randomized and received at least 1 (partial) dose of study medication.
|
|
Nervous system disorders
Headache
|
9.6%
17/177 • Number of events 24 • Adverse Events (AEs) were collected from Visit 1 (Week -4) until final Visit 12 (Week 53).
The Safety Set (SS) consisted of all subjects who were randomized and received at least 1 (partial) dose of study medication.
|
14.5%
24/166 • Number of events 25 • Adverse Events (AEs) were collected from Visit 1 (Week -4) until final Visit 12 (Week 53).
The Safety Set (SS) consisted of all subjects who were randomized and received at least 1 (partial) dose of study medication.
|
|
Nervous system disorders
Tremor
|
5.1%
9/177 • Number of events 9 • Adverse Events (AEs) were collected from Visit 1 (Week -4) until final Visit 12 (Week 53).
The Safety Set (SS) consisted of all subjects who were randomized and received at least 1 (partial) dose of study medication.
|
0.00%
0/166 • Adverse Events (AEs) were collected from Visit 1 (Week -4) until final Visit 12 (Week 53).
The Safety Set (SS) consisted of all subjects who were randomized and received at least 1 (partial) dose of study medication.
|
|
Nervous system disorders
Memory impairment
|
0.56%
1/177 • Number of events 1 • Adverse Events (AEs) were collected from Visit 1 (Week -4) until final Visit 12 (Week 53).
The Safety Set (SS) consisted of all subjects who were randomized and received at least 1 (partial) dose of study medication.
|
5.4%
9/166 • Number of events 9 • Adverse Events (AEs) were collected from Visit 1 (Week -4) until final Visit 12 (Week 53).
The Safety Set (SS) consisted of all subjects who were randomized and received at least 1 (partial) dose of study medication.
|
|
Nervous system disorders
Paraesthesia
|
1.1%
2/177 • Number of events 2 • Adverse Events (AEs) were collected from Visit 1 (Week -4) until final Visit 12 (Week 53).
The Safety Set (SS) consisted of all subjects who were randomized and received at least 1 (partial) dose of study medication.
|
9.6%
16/166 • Number of events 19 • Adverse Events (AEs) were collected from Visit 1 (Week -4) until final Visit 12 (Week 53).
The Safety Set (SS) consisted of all subjects who were randomized and received at least 1 (partial) dose of study medication.
|
Additional Information
UCB Clinical Trial Call Center
UCB Pharma
Phone: +1877 822
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60