A Double-blind, Randomized Conversion to Monotherapy Study to Evaluate the Efficacy and Safety of Brivaracetam in Subjects (≥ 16 to 75 Years Old) With Partial Onset Seizures

Epilepsy Clinical Trial

Official title:

An International, Double-blind, Randomized, Multi-center, Parallel Group, Historical-control Conversion to Monotherapy Study to Evaluate the Efficacy and Safety of Brivaracetam in Subjects (≥ 16 to 75 Years Old) With Partial Onset Seizures With or Without Secondary Generalization

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00698581
• Other study ID #: N01276
• Secondary ID: 2008-000144-14
• Status: Terminated
• Phase: Phase 3
• Start date: August 2008
• Est. completion date: February 2010

Study information

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

Clinical Trial Summary

Antiepileptic drugs (AEDs) are the main treatment for epilepsy; however, only a limited number of AEDs are approved for use as monotherapy. The objective of this study is to evaluate the efficacy of Brivaracetam (BRV) in the conversion of partial onset seizure patients from combination treatment to monotherapy

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 88
• Est. completion date: February 2010
• Est. primary completion date: January 2010
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years to 75 Years

Eligibility

Inclusion Criteria:

• Subjects from 16 to 75 years, both inclusive

• Well-characterized focal epilepsy or epileptic syndrome

• Subjects having at least 2 but not exceeding 40 partial onset seizures, whether or not secondarily generalized per 4 weeks during the 8-week Baseline Period

• Subjects on a stable dose of at least 1 but no more than 2 concomitant Antiepileptic Drugs (AEDs) with the second AED = 50 % of the minimum recommended maintenance dose

Exclusion Criteria:

• Seizure type IA non-motor as only seizure type

• History or presence of seizures occurring too frequently or indistinctly separated to be reliably counted during the 6 months preceding Visit 1 or during Baseline

• Other serious uncontrolled disease

Related Conditions & MeSH terms

• Epilepsy
• Seizures

Intervention

Drug:
• Brivaracetam
25 mg tablet - 50 mg daily for 17 weeks (or 21 weeks if down-titrated (50 mg > 20 mg) for subjects not participating in the follow-up study)
• Brivaracetam
25 mg tablet - 100 mg daily for 17 weeks (or 21 weeks if down-titrated (100 mg > 50 mg > 20 mg) for subjects not participating in the follow-up study)

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
UCB Pharma

Countries where clinical trial is conducted

United States,  Australia,  Belgium,  Canada,  Czechia,  Germany,  Sweden, 

References & Publications (1)

Arnold S, Badalamenti V, Diaz A, Gasalla T, McShea C, Whitesides J, Fakhoury T. Conversion to brivaracetam monotherapy for the treatment of patients with focal seizures: Two double-blind, randomized, multicenter, historical control, Phase III studies. Epi — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The Cumulative Exit Rate at 112 Days After the Beginning of the Baseline Antiepileptic Drug (AED) Tapering Phase	The cumulative exit rate was estimated using Kaplan-Meier methods and was based on the duration between start of the Evaluation Period (EP) and the earliest date the first exit criterion was met for each subject. Subjects completing the EP without meeting an exit criterion were censored on Day 112. The primary comparison was BRV 50 mg/day vs a historical control. The upper limit of the 2-sided 95 % Confidence Interval for the estimate was compared to the historical lower bound estimate of 0.722.	From Week 1 up to Week 17
Secondary	The Number of Patients Reporting at Least One Treatment-Emergent Adverse Event (TEAE) During the Course of the Study		Baseline through Re-conversion (approximately 31 weeks)
Secondary	The Number of Patient Withdrawal Due to Adverse Events (AEs) During the Course of the Study		Baseline through Re-conversion (approximately 31 weeks)
Secondary	The Number of Patients Reporting at Least One Serious Adverse Event (SAE) During the Course of the Study		Baseline through Re-conversion (approximately 31 weeks)