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

Epilepsy Clinical Trial

Official title:

A Multicenter, Double-blind, Randomized, Placebo-controlled, 4 Parallel Groups, Dose-ranging Trial Evaluating the Efficacy and Safety of Brivaracetam Used as Adjunctive Treatment at Doses of 5, 20 and 50 mg/Day in b.i.d. Administration (Oral Tablets of 2.5 or 10 mg) for a Maximum of 7 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: NCT00175825
• Other study ID #: N01193
• Status: Completed
• Phase: Phase 2
• Start date: November 7, 2005
• Est. completion date: June 29, 2006

Study information

• Verified date: September 2018
• Source: UCB Pharma
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 210
• Est. completion date: June 29, 2006
• Est. primary completion date: June 29, 2006
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Epilepsy
• Seizures

Intervention

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

Drug:
• Brivaracetam
Daily oral dose of two equal intakes, morning and evening, of Brivaracetam over the 7-week Treatment Period

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
UCB Pharma

Countries where clinical trial is conducted

United States,  Brazil,  India,  Mexico, 

References & Publications (1)

Toledo M, Whitesides J, Schiemann J, Johnson ME, Eckhardt K, McDonough B, Borghs S, Kwan P. Safety, tolerability, and seizure control during long-term treatment with adjunctive brivaracetam for partial-onset seizures. Epilepsia. 2016 Jul;57(7):1139-51. do — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Partial Onset Seizure Frequency Per Week During the 7-week Treatment Period	Calculated as 7-day partial onset seizure frequency.	During the 7-week Treatment Period
Secondary	Percentage Change From Baseline in Partial Onset Seizure Frequency Per Week (Type I) Over the 7-week Treatment Period	Calculated as 7-day seizure frequency during the 7-week Treatment Period - 7-day seizure frequency during the Baseline Period, divided by the 7-day seizure frequency during the Baseline Period with this quantity multiplied by 100. A negative value in percent change from Baseline indicates a decrease in partial seizure frequency from Baseline.	Baseline, during the 7-week Treatment Period
Secondary	Seizure Frequency Per Week for All Seizures (Types I +II +III) Over the Treatment Period	Types I+II+III seizure frequency (Type I: Partial (focal, local), Type II: Generalized (convulsive or nonconvulsive), Type III: Unclassified) per week will be derived from the seizure count information recorded on the daily record card (e.g. date, number, type of epileptic seizures) and is defined as the number of seizures standardized to a 7-day period.	During the 7-week Treatment Period
Secondary	Absolute Change From Baseline in Seizure Frequency Per Week for Partial Onset Seizures (Type I) Over the Treatment Period	Calculated as 7-day Partial Onset Seizures (Type I) frequency during the 7-week Treatment Period 7-day seizure frequency during the Baseline Period. A negative value from Baseline indicates a decrease in partial seizure frequency from Baseline.	During the 7-week Treatment Period
Secondary	Absolute Change From Baseline in Seizure Frequency Per Week for All Seizures (Types I + II + III) Over the Treatment Period	Calculated as 7-day seizure frequency during the 7-week Treatment Period 7-day seizure (Types I + II + III) frequency during the Baseline Period. A negative value from Baseline indicates a decrease in partial seizure frequency from Baseline.	During the 7-week Treatment Period
Secondary	Percentage Change From Baseline in Seizure Frequency Per Week for All Seizures (Types I + II + III) Over the Treatment Period	Calculated as 7-day seizure frequency during the 7-week Treatment Period - 7-day seizure frequency during the Baseline Period, divided by the 7-day seizure frequency during the Baseline Period with this quantity multiplied by 100. A negative value in percent change from Baseline indicates a decrease in partial seizure frequency from Baseline.	During the 7-week Treatment Period
Secondary	Responder Rate in Partial Onset Seizures (Type I) Over the Treatment Period	A responder was defined as a subject with a >= 50 % reduction in seizure frequency per week from the Baseline Period to the end of the Treatment Period.	During the 7-week Treatment Period
Secondary	Percentage of Subjects With Categorized Response to the Treatment in Partial Onset Seizures (Type I) Over the Treatment Period	Categories of percentage reductions in seizures from baseline were as following: < -25 %; -25 % to <25 %; 25 % to <75 %; 75 % to <100 %; 100 %.	During the 7-week Treatment Period
Secondary	Percentage of Subjects Who Are Seizure Free During the 7-week Treatment Period	A subject was considered seizure free, if no seizure was reported during the 7-week Treatment Period.	During the 7-week Treatment Period
Secondary	Number of Seizure-free Days Per 4 Weeks	A day was considered seizure-free, if no seizure was reported during 24 hours.	Baseline, during the 7-week Treatment Period
Secondary	Time to Nth (n= 1, 5, 10) Seizure During the 7-week Treatment Period	Number of days to first, fifth, and tenth seizure after baseline.	During the 7-week Treatment Period

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