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Trial record 1 of 1 for:    NCT01229735
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Levetiracetam Versus Topiramate as Adjunctive Therapy to Evaluate Efficacy and Safety in Subjects With Refractory Partial Onset Seizures

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ClinicalTrials.gov Identifier: NCT01229735
Recruitment Status : Completed
First Posted : October 28, 2010
Results First Posted : February 12, 2016
Last Update Posted : August 15, 2017
Sponsor:
Information provided by (Responsible Party):
UCB Pharma ( UCB Korea Co., Ltd. )

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Epilepsy
Interventions Drug: Levetiracetam
Drug: Topiramate
Enrollment 343
Recruitment Details 447 subjects were screened, 343 subjects were randomized.
Pre-assignment Details Participant Flow refers to the Randomized Set which consists of all subjects who were randomized in this study.
Arm/Group Title Levetiracetam Topiramate
Hide Arm/Group Description 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 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
Period Title: Overall Study
Started 177 166
Completed 111 100
Not Completed 66 66
Reason Not Completed
Lack of Efficacy             8             8
Protocol Violation             13             8
Lost to Follow-up             0             2
Withdrawal by Subject             18             17
Other Reason             13             10
SAE, non-fatal             0             4
AE, non-serious non-fatal             13             17
SAE, non-fatal+AE, non-serious non-fatal             1             0
Arm/Group Title Levetiracetam Topiramate Total Title
Hide Arm/Group Description 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 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 [Not Specified]
Overall Number of Baseline Participants 177 166 343
Hide Baseline Analysis Population Description
The Baseline Characteristics refers to the Safety Set which consists of all subjects who were randomized and received at least 1 dose of trial medication.
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 177 participants 166 participants 343 participants
<=18 years
4
   2.3%
0
   0.0%
4
   1.2%
Between 18 and 65 years
165
  93.2%
162
  97.6%
327
  95.3%
>=65 years
8
   4.5%
4
   2.4%
12
   3.5%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 177 participants 166 participants 343 participants
40.9  (13.6) 39.7  (11.8) 40.3  (12.8)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 177 participants 166 participants 343 participants
Female
71
  40.1%
64
  38.6%
135
  39.4%
Male
106
  59.9%
102
  61.4%
208
  60.6%
1.Primary Outcome
Title 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
Hide Description [Not Specified]
Time Frame From Baseline to Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
The Full Analysis Set (FAS) consisted of all subjects in the Safety Set who returned at least 1 post-baseline seizure diary.
Arm/Group Title Levetiracetam (Full Analysis Set) Topiramate (Full Analysis Set)
Hide Arm/Group Description:
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
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 Number of Participants Analyzed 176 166
Measure Type: Number
Unit of Measure: percentage of subjects
59.1 56.6
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Levetiracetam (Full Analysis Set), Topiramate (Full Analysis Set)
Comments The Odds Ratio (OR) for LEV vs TPM is based on logistic regression modeling of subject retention by treatment and center pooling category. A profile likelihood confidence interval for the OR is presented.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value =0.7007
Comments P-value is from likelihood ratio test of treatment group regression coefficient against 0.
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.1
Confidence Interval (2-Sided) 95%
0.7 to 1.7
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Number of Subjects With at Least One Adverse Event Reported During the Trial Period From Baseline to Week 52
Hide Description [Not Specified]
Time Frame From Baseline to Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
The Safety Set (SS) consists of all subjects who were randomized and received at least 1 (partial) dose of study medication.
Arm/Group Title Levetiracetam Topiramate
Hide Arm/Group Description:
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
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 Number of Participants Analyzed 177 166
Measure Type: Number
Unit of Measure: Participants
125 128
3.Secondary Outcome
Title Time From the First Study Treatment Intake to Drug Discontinuation Due to Adverse Event (AE)
Hide Description [Not Specified]
Time Frame From Baseline to Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
The Safety Set (SS) consists of all subjects who were randomized and received at least 1 (partial) dose of study medication.
Arm/Group Title Levetiracetam Topiramate
Hide Arm/Group Description:
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
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 Number of Participants Analyzed 177 166
Median (Inter-Quartile Range)
Unit of Measure: month
NA [1] 
(NA to NA)
NA [1] 
(NA to NA)
[1]
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.
4.Secondary Outcome
Title Median Percent Reduction in the Weekly Partial Onset Seizure (POS) Frequency From Baseline During the Total Treatment Period From Baseline to Week 52
Hide Description Reduction from baseline was defined as baseline value minus post-baseline value and therefore is the negative of the change from baseline value.
Time Frame From Baseline to Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
The Full Analysis Set (FAS) consists of all subjects in the Safety Set (SS) who returned at least 1 postbaseline seizure diary.
Arm/Group Title Levetiracetam (Full Analysis Set) Topiramate (Full Analysis Set)
Hide Arm/Group Description:
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
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 Number of Participants Analyzed 174 165
Median (Inter-Quartile Range)
Unit of Measure: percent reduction
74.47
(38.00 to 96.28)
67.86
(29.21 to 87.24)
5.Secondary Outcome
Title 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
Hide Description [Not Specified]
Time Frame From Baseline to Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
The Full Analysis Set (FAS) consists of all subjects in the SS who returned at least 1 postbaseline seizure diary.
Arm/Group Title Levetiracetam (Full Analysis Set) Topiramate (Full Analysis Set)
Hide Arm/Group Description:
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
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 Number of Participants Analyzed 174 165
Measure Type: Number
Unit of Measure: responders
120 107
Time Frame Adverse Events (AEs) were collected from Visit 1 (Week -4) until final Visit 12 (Week 53).
Adverse Event Reporting Description The Safety Set (SS) consisted of all subjects who were randomized and received at least 1 (partial) dose of study medication.
 
Arm/Group Title Levetiracetam Topiramate
Hide Arm/Group Description 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 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
All-Cause Mortality
Levetiracetam Topiramate
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Hide Serious Adverse Events
Levetiracetam Topiramate
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   10/177 (5.65%)      15/166 (9.04%)    
Cardiac disorders     
Arrhythmia * 1  1/177 (0.56%)  1 0/166 (0.00%)  0
Congenital, familial and genetic disorders     
Arteriovenous malformation * 1  1/177 (0.56%)  1 0/166 (0.00%)  0
Atrial septal defect * 1  1/177 (0.56%)  1 0/166 (0.00%)  0
Eye disorders     
Photophobia * 1  1/177 (0.56%)  1 0/166 (0.00%)  0
Gastrointestinal disorders     
Alcoholic pancreatitis * 1  1/177 (0.56%)  1 0/166 (0.00%)  0
Ileus * 1  1/177 (0.56%)  1 0/166 (0.00%)  0
Duodenal ulcer * 1  0/177 (0.00%)  0 1/166 (0.60%)  1
Gastrooesophageal reflux disease * 1  0/177 (0.00%)  0 1/166 (0.60%)  1
Pancreatitis acute * 1  0/177 (0.00%)  0 1/166 (0.60%)  1
General disorders     
Asthenia * 1  1/177 (0.56%)  1 0/166 (0.00%)  0
Infections and infestations     
Chronic tonsillitis * 1  1/177 (0.56%)  1 0/166 (0.00%)  0
Pneumonia * 1  0/177 (0.00%)  0 1/166 (0.60%)  1
Injury, poisoning and procedural complications     
Face injury * 1  1/177 (0.56%)  1 0/166 (0.00%)  0
Fall * 1  1/177 (0.56%)  1 0/166 (0.00%)  0
Hip fracture * 1  1/177 (0.56%)  1 0/166 (0.00%)  0
Joint dislocation * 1  0/177 (0.00%)  0 1/166 (0.60%)  1
Radius fracture * 1  0/177 (0.00%)  0 1/166 (0.60%)  1
Spinal compression fracture * 1  0/177 (0.00%)  0 1/166 (0.60%)  1
Metabolism and nutrition disorders     
Hyperglycaemia * 1  0/177 (0.00%)  0 1/166 (0.60%)  1
Musculoskeletal and connective tissue disorders     
Muscle spasms * 1  1/177 (0.56%)  2 0/166 (0.00%)  0
Trigger finger * 1  0/177 (0.00%)  0 1/166 (0.60%)  1
Nervous system disorders     
Dizziness * 1  2/177 (1.13%)  2 0/166 (0.00%)  0
Dyskinesia * 1  1/177 (0.56%)  1 0/166 (0.00%)  0
Headache * 1  1/177 (0.56%)  1 0/166 (0.00%)  0
Loss of consciousness * 1  1/177 (0.56%)  1 0/166 (0.00%)  0
Seizure * 1  1/177 (0.56%)  1 5/166 (3.01%)  6
Stupor * 1  1/177 (0.56%)  1 0/166 (0.00%)  0
Epilepsy * 1  0/177 (0.00%)  0 1/166 (0.60%)  1
Pregnancy, puerperium and perinatal conditions     
Abortion spontaneous * 1  0/177 (0.00%)  0 1/166 (0.60%)  1
Renal and urinary disorders     
Calculus ureteric * 1  0/177 (0.00%)  0 1/166 (0.60%)  1
Vascular disorders     
Deep vein thrombosis * 1  0/177 (0.00%)  0 1/166 (0.60%)  1
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA18.0
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Levetiracetam Topiramate
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   86/177 (48.59%)      91/166 (54.82%)    
Gastrointestinal disorders     
Dyspepsia * 1  9/177 (5.08%)  10 7/166 (4.22%)  8
Nausea * 1  9/177 (5.08%)  11 10/166 (6.02%)  10
Infections and infestations     
Nasopharyngitis * 1  24/177 (13.56%)  32 16/166 (9.64%)  22
Investigations     
Weight decreased * 1  3/177 (1.69%)  3 17/166 (10.24%)  19
Metabolism and nutrition disorders     
Decreased appetite * 1  3/177 (1.69%)  3 26/166 (15.66%)  32
Nervous system disorders     
Somnolence * 1  36/177 (20.34%)  40 20/166 (12.05%)  21
Dizziness * 1  30/177 (16.95%)  47 24/166 (14.46%)  29
Headache * 1  17/177 (9.60%)  24 24/166 (14.46%)  25
Tremor * 1  9/177 (5.08%)  9 0/166 (0.00%)  0
Memory impairment * 1  1/177 (0.56%)  1 9/166 (5.42%)  9
Paraesthesia * 1  2/177 (1.13%)  2 16/166 (9.64%)  19
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA18.0
[Not Specified]
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: UCB Clinical Trial Call Center
Organization: UCB Pharma
Phone: +1877 822 ext 9493
Layout table for additonal information
Responsible Party: UCB Pharma ( UCB Korea Co., Ltd. )
ClinicalTrials.gov Identifier: NCT01229735    
Other Study ID Numbers: N01353
First Submitted: October 26, 2010
First Posted: October 28, 2010
Results First Submitted: November 9, 2015
Results First Posted: February 12, 2016
Last Update Posted: August 15, 2017