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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT00699283
Other study ID # N01306
Secondary ID RPCE07F12162008-
Status Terminated
Phase Phase 3
First received
Last updated
Start date August 2008
Est. completion date March 2010

Study information

Verified date March 2018
Source UCB Pharma
Contact n/a
Is FDA regulated No
Health authority
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 BRV in the conversion of partial onset seizure patients from combination treatment to monotherapy.


Recruitment information / eligibility

Status Terminated
Enrollment 62
Est. completion date March 2010
Est. primary completion date March 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

Study Design


Related Conditions & MeSH terms


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,  France,  Germany,  Hungary,  Italy,  Spain, 

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 Visit 4 (week 1) to the end of the Evaluation Period (week 17) (approximately 16 weeks)
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