A Dose-ranging Study With Brivaracetam in Patients From 16 to 65 Years With Refractory Partial Onset Seizures.
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ClinicalTrials.gov Identifier: NCT00175825 |
Recruitment Status
:
Completed
First Posted
: September 15, 2005
Last Update Posted
: August 29, 2012
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Epilepsy | Other: Placebo Drug: Brivaracetam Drug: Brivaracetam 20 mg/day | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 210 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
Primary Purpose: | Treatment |
Official Title: | A Double-blind, Randomized, Placebo-controlled, Dose-ranging Trial Evaluating the Efficacy and Safety of Brivaracetam as Adjunctive Treatment at Doses of 5, 20 and 50 mg/Day in Subjects From 16 to 65 Years With Refractory Epilepsy Suffering From Partial Onset Seizures. |
Study Start Date : | November 2005 |
Actual Primary Completion Date : | June 2006 |
Actual Study Completion Date : | June 2006 |

Arm | Intervention/treatment |
---|---|
Placebo Comparator: Placebo
Matching Placebo tablets administered twice a day
|
Other: Placebo
Daily oral dose of two equal intakes, morning and evening, of Placebo in a double-blinded way for the 7-week Treatment Period
|
Experimental: Brivaracetam 5 mg/day
Brivaracetam 5 mg/day, 2.5 mg administered twice a day
|
Drug: Brivaracetam
Daily oral dose of two equal intakes, morning and evening, of Brivaracetam 5 mg/day in a double-blinded way for the 7-week Treatment period
|
Experimental: Brivaracetam 20 mg/day
Brivaracetam 20 mg/day, 10 mg administered twice a day
|
Drug: Brivaracetam 20 mg/day
Daily oral dose of two equal intakes, morning and evening, of Brivaracetam 20 mg/day in a double-blinded way for the 7-week Treatment period
|
Experimental: Brivaracetam 50 mg/day
Brivaracetam 50 mg/day, 25 mg administered twice a day
|
Drug: Brivaracetam
Daily oral dose of two equal intakes, morning and evening, of Brivaracetam 50 mg/day in a double-blinded way for the 7-week Treatment period
|
- Partial onset seizure frequency (Type 1) per week over the 7-week Treatment Period [ Time Frame: Baseline to 7-week Treatment Period ]Partial onset seizure frequency (Type 1) per week over the 7-week Treatment Period
- Percent change from Baseline to the 7-week Treatment Period in seizure frequency per week for partial onset seizures (Type 1) [ Time Frame: Baseline to the 7-week Treatment Period ]Percent change from Baseline to the 7-week Treatment Period in seizure frequency per week for partial onset seizures (Type 1)
- 50 percent responder rate in partial onset seizures (Type I) frequency over the 7-week Treatment Period [ Time Frame: 7-week Treatment Period ]50 percent responder rate in partial onset seizures (Type I) frequency over the 7-week Treatment Period
- Percentage of seizure-free subjects (all seizure types) over the 7-week treatment period. [ Time Frame: 7-week Treatment Period ]Percentage of seizure-free subjects (all seizure types) over the 7-week treatment period.

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Ages Eligible for Study: | 16 Years to 65 Years (Child, Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Male/female from 16 to 65 years.
- Well-characterized focal epilepsy or epileptic syndrome according to the International League Against Epilepsy (ILAE) classification.
- History of partial onset seizures.
- Subjects having at least 4 partial onset seizures during the 4-week Baseline Period and at least 2 partial onset seizures during the 3 months prior to Visit 1.
- Subjects taking 1 or 2 concomitant Antiepileptic drugs (AED(s)) that have been at a stable dose.
Exclusion Criteria:
- Seizure type IA non-motor as only seizure type.
- Seizures occurring only in clusters.
- Status epilepticus during the last 2 years before Visit 1.
- History of cerebrovascular accident (CVA).
- Presence of any sign suggesting rapidly progressing brain disorder or brain tumor.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00175825

Study Director: | UCB Clinical Trial Call Center | +1 877 822 9493 (UCB) |
Responsible Party: | Study Director, UCB, Inc. |
ClinicalTrials.gov Identifier: | NCT00175825 History of Changes |
Other Study ID Numbers: |
N01193 |
First Posted: | September 15, 2005 Key Record Dates |
Last Update Posted: | August 29, 2012 |
Last Verified: | August 2012 |
Keywords provided by UCB Pharma:
Epilepsy: partial onset seizures brivaracetam |
Additional relevant MeSH terms:
Epilepsy Seizures Brain Diseases Central Nervous System Diseases Nervous System Diseases |
Neurologic Manifestations Signs and Symptoms Brivaracetam Anticonvulsants |