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

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT00175825
• Date of registration: 09/09/2005
• Prospective Registration: Yes
• Primary sponsor: UCB Pharma
• Public title: A Dose-ranging Study With Brivaracetam in Patients From 16 to 65 Years With Refractory Partial Onset Seizures.
• Scientific 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
• Date of first enrolment: November 7, 2005
• Target sample size: 210
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT00175825
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
• Phase: Phase 2

Countries of recruitment

Brazil, India, Mexico, Panama, United States

Contacts

• Name: UCB Cares
• Affiliation: [phone] (UCB)

Key inclusion & exclusion 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



Age minimum: 16 Years
Age maximum: 65 Years
Gender: All

Health Condition(s) or Problem(s) studied

Epilepsy

Intervention(s)

Drug: Brivaracetam

Other: Placebo

Primary Outcome(s)

Partial Onset Seizure Frequency Per Week During the 7-week Treatment Period [Time Frame: During the 7-week Treatment Period]

Secondary Outcome(s)

Absolute Change From Baseline in Seizure Frequency Per Week for All Seizures (Types I + II + III) Over the Treatment Period [Time Frame: During the 7-week Treatment Period]

Absolute Change From Baseline in Seizure Frequency Per Week for Partial Onset Seizures (Type I) Over the Treatment Period [Time Frame: During the 7-week Treatment Period]

Responder Rate in Partial Onset Seizures (Type I) Over the Treatment Period [Time Frame: During the 7-week Treatment Period]

Percentage of Subjects With Categorized Response to the Treatment in Partial Onset Seizures (Type I) Over the Treatment Period [Time Frame: During the 7-week Treatment Period]

Percentage Change From Baseline in Partial Onset Seizure Frequency Per Week (Type I) Over the 7-week Treatment Period [Time Frame: Baseline, during the 7-week Treatment Period]

Percentage of Subjects Who Are Seizure Free During the 7-week Treatment Period [Time Frame: During the 7-week Treatment Period]

Number of Seizure-free Days Per 4 Weeks [Time Frame: Baseline, during the 7-week Treatment Period]

Time to Nth (n= 1, 5, 10) Seizure During the 7-week Treatment Period [Time Frame: During the 7-week Treatment Period]

Seizure Frequency Per Week for All Seizures (Types I +II +III) Over the Treatment Period [Time Frame: During the 7-week Treatment Period]

Percentage Change From Baseline in Seizure Frequency Per Week for All Seizures (Types I + II + III) Over the Treatment Period [Time Frame: During the 7-week Treatment Period]

Secondary ID(s)

N01193

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 22/08/2018
• URL: https://clinicaltrials.gov/ct2/show/results/NCT00175825