Expired Study
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Riverside, California


Purpose:

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.


Criteria:

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 is Available At:


Original ID:

N01306


NCT ID:

NCT00699283


Secondary ID:

RPCE07F1216


Study Acronym:


Brief Title:

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


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


Overall Status:

Terminated


Study Phase:

Phase 3


Genders:

N/A


Minimum Age:

16 Years


Maximum Age:

75 Years


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

UCB Pharma


Oversight Authority:

  • United States: Food and Drug Administration
  • France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
  • Finland: Finnish Medicines Agency
  • Germany: Federal Institute for Drugs and Medical Devices
  • Hungary: National Institute of Pharmacy
  • Italy: Ministry of Health
  • Spain: Ministry of Health


Reasons Why Stopped:

An interim analysis revealed the study was u


Study Type:

Interventional


Study Design:


Number of Arms:

2


Number of Groups:

0


Total Enrollment:

62


Enrollment Type:

Actual


Overall Contact Information

Official Name:UCB Clinical Trial Call Center
Study Director
+1 877 822 9493 (UCB)

Study Dates

Start Date:August 2008
Completion Date:March 2010
Completion Type:Actual
Primary Completion Date:March 2010
Primary Completion Type:Actual
Verification Date:March 2018
Last Changed Date:June 13, 2018
First Received Date:June 12, 2008
First Results Date:March 14, 2016

Study Outcomes

Outcome Type:Primary Outcome
Measure:The Cumulative Exit Rate at 112 Days After the Beginning of the Baseline Antiepileptic Drug (AED) Tapering Phase
Time Frame:From Visit 4 (week 1) to the end of the Evaluation Period (week 17) (approximately 16 weeks)
Safety Issues:False
Description: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

Study Interventions

Intervention Type:Drug
Name:Brivaracetam
Description: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)
Arm Name:Brivaracetam (BRV) 1
Other Name:ucb 34714
Intervention Type:Drug
Name:Brivaracetam
Description: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)
Arm Name:Brivaracetam (BRV) 2
Other Name:ucb 34714

Study Arms

Study Arm Type:Experimental
Arm Name:Brivaracetam (BRV) 2
Description:100 mg daily
Study Arm Type:Experimental
Arm Name:Brivaracetam (BRV) 1
Description:50 mg daily

Study Agencies

Agency Class:Industry
Agency Type:Lead Sponsor
Agency Name:UCB Pharma

Sample and Retention Information

There are no available Sample and Retention Information

Study References

Reference Type:Results Reference
Citation: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. Epilepsy Res. 2018 Mar;141:73-82. doi: 10.1016/j.eplepsyres.2018.02.005. Epub 2018 Feb 12.
PMID:29486396

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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