A Study of Brivaracetam in Subjects With Partial Onset Seizures

Epilepsy, Focal Clinical Trial

Official title:

A Multicenter, Double-blind, Randomized, Placebo-controlled, 3 Parallel Groups, Dose-ranging Trial Evaluating the Efficacy and Safety of Ucb 34714 Used as Adjunctive Treatment at Doses of 50 and 150 mg/Day in b.i.d. Administration (Oral Capsules of 25 mg) for a Maximum of 12 Weeks in Subjects From 16 to 65 Years With Refractory Epilepsy Suffering From Partial Onset Seizures Whether or Not Secondarily Generalized

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00175929
• Other study ID #: N01114
• Secondary ID: 2004-001856-35
• Status: Completed
• Phase: Phase 2
• First received: September 9, 2005
• Last updated: April 10, 2015
• Start date: May 2005
• Est. completion date: March 2006

Study information

• Verified date: April 2015
• Source: UCB Pharma
• Contact: n/a
• Is FDA regulated: No
• Health authority: Belgium: Federal Agency for Medicines and Health Products, FAMHPCzech Republic: State Institute for Drug ControlFinland: Finnish Medicines AgencyFrance: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)Germany: Federal Institute for Drugs and Medical DevicesNetherlands: Medicines Evaluation Board (MEB)Poland: Ministry of HealthSpain: Ministry of Health and ConsumptionUnited Kingdom: Medicines and Healthcare Products Regulatory Agency
• Study type: Interventional

Clinical Trial Summary

This trial will evaluate the efficacy and safety of brivaracetam (at doses of 50 and 150 mg/day in twice a day administration) as add on therapy in subjects with focal epilepsy

Recruitment information / eligibility

• Status: Completed
• Enrollment: 157
• Est. completion date: March 2006
• Est. primary completion date: March 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 16 Years to 65 Years

Eligibility

Inclusion Criteria:

• Well-characterized focal epilepsy or epileptic syndrome according to the International League Against Epilepsy (ILAE) classification

• Subjects with a history of partial onset seizures

• Subjects having at least 4 partial onset seizures during the Baseline period and at least 2 partial onset seizures per month during the 3 months preceding Visit 1

• Subjects being uncontrolled while treated by 1 or 2 concomitant Antiepileptic drug(s) AED(s) being stable

• Male/ female subjects from 16 to 65 years, both inclusive. Subjects under 18 years may only be included where legally permitted and ethically accepted

Exclusion Criteria:

• Seizure type IA non-motor as only seizure type

• History or presence of seizures occurring only in clustered patterns

• History of cerebrovascular accident (CVA)

• Presence of any sign suggesting rapidly progressing brain disorder or brain tumor

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Epilepsies, Partial
• Epilepsy
• Epilepsy, Focal

Intervention

Other:
• Placebo
Daily oral dose of two equal intakes, morning and evening, of placebo in a double-blinded way for the 10-week Treatment Period (3 weeks up-titration followed by 7-week maintenance period)

Drug:
• Brivaracetam
Daily oral dose of two equal intakes, morning and evening, of Brivaracetam 50 mg/day in a double-blinded way for the 10-week Treatment Period (3 weeks up-titration followed by 7-week maintenance period)
• Brivaracetam
Daily oral dose of two equal intakes, morning and evening, of Brivaracetam 150 mg/day in a double-blinded way for the 10-week Treatment Period (3 weeks up-titration followed by 7-week maintenance period)

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
UCB Pharma

Countries where clinical trial is conducted

Belgium,  Czech Republic,  Finland,  France,  Germany,  Netherlands,  Poland,  Spain,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Partial onset seizure frequency (Type I) per week over the 7-week maintenance period	Partial onset seizure frequency (Type I) per week over the 7-week maintenance period	7-week maintenance period	No
Secondary	Seizure frequency per week for all seizures (types I+II+III) over the 7-week Maintenance period		During the Maintenance period (approximately 7 weeks)	No
Secondary	Percentage of reduction from Baseline in seizure frequency per week for partial onset seizures (type I) over the 7-week Maintenance period		During the Maintenance period (approximately 7 weeks)	No
Secondary	Percentage of reduction from Baseline in seizure frequency per week for all seizures (types I+II+III) over the 7-week Maintenance period		During the Maintenance period (approximately 7 weeks)	No
Secondary	Responder rate in partial onset seizures (type I) over the 7-week Maintenance period	A responder was defined as a subject with a = 50% reduction in seizure frequency per week from the Baseline period to the Maintenance period.	During the Maintenance period (approximately 7 weeks)	No
Secondary	Response to treatment in partial onset seizures (type I) over the 7-week Maintenance period	The percentage reduction from Baseline in partial seizure frequency per week over the Maintenance period was grouped in 5 categories: < -25%, -25% to < 25%, 25% to < 75%, 75% to = 100%, and 100%.	During the Maintenance period (approximately 7 weeks)	No
Secondary	Percentage of seizure-free subjects over the 7-week Maintenance period		During the Maintenance period (approximately 7 weeks)	No
Secondary	Percentage of seizure-free days per 4 weeks over Baseline and Maintenance periods		Baseline through Maintenance period (approximately 11 weeks)	No
Secondary	Time to N-th seizure in the Maintenance period		During the Maintenance period (approximately 7 weeks)	No