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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

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ClinicalTrials.gov Identifier: NCT00698581
Recruitment Status : Terminated (An interim analysis revealed the study was unlikely to attain a positive outcome for the efficacy analysis. No safety concerns were detected.)
First Posted : June 17, 2008
Results First Posted : April 13, 2016
Last Update Posted : July 11, 2018
Sponsor:
Information provided by (Responsible Party):
UCB Pharma

Brief 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

Condition or disease Intervention/treatment Phase
Epilepsy Drug: Brivaracetam Phase 3

Expanded Access : An investigational treatment associated with this study is available outside the clinical trial.   More info ...

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 88 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
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
Study Start Date : August 2008
Actual Primary Completion Date : January 2010
Actual Study Completion Date : February 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Epilepsy Seizures

Arm Intervention/treatment
Experimental: Brivaracetam 50 mg
50 mg/day
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)
Other Name: ucb 34714

Experimental: Brivaracetam 100 mg
100 mg/day
Drug: 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)
Other Name: ucb 34714




Primary Outcome Measures :
  1. The Cumulative Exit Rate at 112 Days After the Beginning of the Baseline Antiepileptic Drug (AED) Tapering Phase [ Time Frame: From Week 1 up to Week 17 ]
    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.


Secondary Outcome Measures :
  1. The Number of Patients Reporting at Least One Treatment-Emergent Adverse Event (TEAE) During the Course of the Study [ Time Frame: Baseline through Re-conversion (approximately 31 weeks) ]
  2. The Number of Patient Withdrawal Due to Adverse Events (AEs) During the Course of the Study [ Time Frame: Baseline through Re-conversion (approximately 31 weeks) ]
  3. The Number of Patients Reporting at Least One Serious Adverse Event (SAE) During the Course of the Study [ Time Frame: Baseline through Re-conversion (approximately 31 weeks) ]


Information from the National Library of Medicine

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Ages Eligible for Study:   16 Years to 75 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00698581


  Show 53 Study Locations
Sponsors and Collaborators
UCB Pharma
Investigators
Study Director: UCB Clinical Trial Call Center +1 877 822 9493 (UCB)

Publications of Results:
Responsible Party: UCB Pharma
ClinicalTrials.gov Identifier: NCT00698581     History of Changes
Other Study ID Numbers: N01276
2008-000144-14 ( EudraCT Number )
First Posted: June 17, 2008    Key Record Dates
Results First Posted: April 13, 2016
Last Update Posted: July 11, 2018
Last Verified: March 2018

Keywords provided by UCB Pharma:
Epilepsy; Monotherapy
Partial Onset Seizures
Adults and Adolescents

Additional relevant MeSH terms:
Epilepsy
Seizures
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms
Brivaracetam
Anticonvulsants