A Dose-ranging Study With Brivaracetam in Patients From 16 to 65 Years With Refractory Partial Onset Seizures.

Study Description

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Brief Summary:

This trial will evaluate the efficacy and safety of brivaracetam (at doses of 5, 20 and 50 mg/day in twice a day administration) as add-on therapy in subjects with focal epilepsy.

Condition or disease	Intervention/treatment	Phase
Epilepsy	Other: Placebo; Drug: Brivaracetam; Drug: Brivaracetam 20 mg/day	Phase 2

Study Design

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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

Arms and Interventions

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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

Outcome Measures

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Primary Outcome Measures :

1. 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

Secondary Outcome Measures :

1. 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)
2. 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
3. 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.

Eligibility Criteria

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Ages Eligible for Study:	16 Years to 65 Years (Child, Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

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.

Contacts and Locations

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  Show 42 Study Locations

Sponsors and Collaborators

UCB Pharma

Investigators

Study Director:	UCB Clinical Trial Call Center	+1 877 822 9493 (UCB)

More Information

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Responsible Party:	Study Director, UCB, Inc.
ClinicalTrials.gov Identifier:	NCT00175825 History of Changes
Other Study ID Numbers:	N01193
First Posted:	September 15, 2005
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