- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01229735
Levetiracetam Versus Topiramate as Adjunctive Therapy to Evaluate Efficacy and Safety in Subjects With Refractory Partial Onset Seizures
July 6, 2017 updated by: UCB Korea Co., Ltd.
A Randomized, Open-label, Parallel Group, Multi-center, Comparative, Phase IV Trial of Levetiracetam (LEV) Versus Topiramate (TPM) as Adjunctive Therapy to Evaluate Efficacy and Safety in Subjects With Refractory Partial Onset Seizures
To assess the long-term effects of levetiracetam on retention rate in subjects with refractory partial onset seizure that are not fully controlled with 1 to 3 concomitant antiepileptic drugs, compared to topiramate as add-on therapy during 52 weeks.
Study Overview
Study Type
Interventional
Enrollment (Actual)
343
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Busan, Korea, Republic of
- 14
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Busan, Korea, Republic of
- 21
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Busan, Korea, Republic of
- 8
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Busan, Korea, Republic of
- 9
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Daegu, Korea, Republic of
- 12
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Daegu, Korea, Republic of
- 13
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Daejeon, Korea, Republic of
- 10
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Daejeon, Korea, Republic of
- 25
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Gwangju, Korea, Republic of
- 15
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Incheon, Korea, Republic of
- 7
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Kyunggi-Do, Korea, Republic of
- 11
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Kyunggi-Do, Korea, Republic of
- 23
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Kyunggi-Do, Korea, Republic of
- 24
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Kyunggi-do, Korea, Republic of
- 19
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Seoul, Korea, Republic of
- 17
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Seoul, Korea, Republic of
- 18
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Seoul, Korea, Republic of
- 16
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Seoul, Korea, Republic of
- 1
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Seoul, Korea, Republic of
- 2
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Seoul, Korea, Republic of
- 3
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Seoul, Korea, Republic of
- 4
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Seoul, Korea, Republic of
- 5
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Seoul, Korea, Republic of
- 6
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Ulsan, Korea, Republic of
- 22
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
16 years to 80 years (Child, Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Male or female subjects from 16 to 80 years, inclusive. Subjects under 20 years may only be included where legally permitted and ethically accepted
- Subjects with refractory epilepsy with partial onset seizure classifiable according to the International League Against Epilepsy (ILAE).
- Subjects having at least 2 partial onset seizures whether or not secondarily generalized during the 8 weeks historical baseline preceding V1 according to ILAE classification
- Subjects having at least 1 partial onset seizures whether or not secondarily generalized per 4 weeks preceding V2 according to ILAE classification
- Subjects with each interval of partial onset seizures less than 6 weeks during entire 12 weeks (8 weeks preceding V1 and 4 weeks preceding V2)
- Subjects being uncontrolled while treated by 1 to 3 permitted concomitant AEDs.
- Permitted concomitant AEDs having been stable and at optimal dosage for the subject from at least 4 week before V1 and during 4 weeks preceding V2 and expected to be kept stable during the Treatment Period.
Exclusion Criteria:
- Subjects presenting any generalized epilepsies classified as type II according to the ILAE classification (ref to publication from 1981)
- Subjects suffering from epilepsies and syndromes undetermined whether focal or generalized (classification III according to the ILAE classification)
- Subjects suffering from special syndromes (classification IV according to the ILAE classification)
- History or occurring only in clusters (too frequently or indistinctly separated to be reliably counted) before V2.
- Presence of exclusively type IA non-motor seizures.
- History or presence of status epilepticus within last 3 months preceding V1 or during Baseline
- History or presence of known pseudo-seizures
- Subjects who are currently on vigabatrin. (Subjects who received vigabatrin in the past and have a normal visual field test are allowed.)
- Subject taking 1 or more of the following medications on a regular basis within 28 days prior to Visit 1: antipsychotics drugs, and psychostimulant (amphetamine derivatives)
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 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
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250 mg and 500 mg levetiracetam tablet 1000 mg/day (500 mg bid) levetiracetam (maximum to 3000 mg/day) Duration: maximum 52 weeks
Other Names:
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Active Comparator: 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
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25 mg and 100 mg topiramate tablet 100 mg/day(50 mg bid) topiramate (maximum to 400 mg/day) Duration: maximum 52 weeks
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
Time Frame: From Baseline to Week 52
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From Baseline to Week 52
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of Subjects With at Least One Adverse Event Reported During the Trial Period From Baseline to Week 52
Time Frame: From Baseline to Week 52
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From Baseline to Week 52
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Time From the First Study Treatment Intake to Drug Discontinuation Due to Adverse Event (AE)
Time Frame: From Baseline to Week 52
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From Baseline to Week 52
|
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Median Percent Reduction in the Weekly Partial Onset Seizure (POS) Frequency From Baseline During the Total Treatment Period From Baseline to Week 52
Time Frame: From Baseline to Week 52
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Reduction from baseline was defined as baseline value minus post-baseline value and therefore is the negative of the change from baseline value.
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From Baseline to Week 52
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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
Time Frame: From Baseline to Week 52
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From Baseline to Week 52
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: UCB Clinical Trial Call Center, 1 877 822 9493 (UCB)
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
November 1, 2010
Primary Completion (Actual)
May 1, 2015
Study Completion (Actual)
May 1, 2015
Study Registration Dates
First Submitted
October 26, 2010
First Submitted That Met QC Criteria
October 27, 2010
First Posted (Estimate)
October 28, 2010
Study Record Updates
Last Update Posted (Actual)
August 15, 2017
Last Update Submitted That Met QC Criteria
July 6, 2017
Last Verified
July 1, 2017
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- N01353
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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