Back to resultsEffect of Brivaracetam in Photosensitive Epileptic Subjects
Primary Purpose
Epilepsy
Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Brivaracetam
Sponsored by
About this trial
This is an interventional treatment trial for Epilepsy focused on measuring POC, photosensitive, epileptic, brivaracetam, PPR, AED
Eligibility Criteria
Inclusion Criteria:
- epileptic subjects with generalized PPR
Exclusion Criteria:
- more than 2 concomitant antiepileptic drugs
Sites / Locations
Outcomes
Primary Outcome Measures
Identify lowest single oral dose producing maximal decrease or suppression of intermittent photic stimulation (IPS)photoparoxysmal response (PPR) in photosensitive epileptic subjects pre-dose
post placebo during 24h and post brivaracetam for up to 72 h
Secondary Outcome Measures
Assess relationship between plasma concentrations and changes in photosensitivity frequency range, time of onset and duration of suppressing effect
Safety
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00401648
Brief Title
Effect of Brivaracetam in Photosensitive Epileptic Subjects
Official Title
A Placebo-controlled, Single-blind, Multi-center Study to Explore the Photoparoxysmal Response in Photosensitive Epileptic Subjects After One Single Oral Dose of Brivaracetam in Capsules.
Study Type
Interventional
2. Study Status
Record Verification Date
November 2009
Overall Recruitment Status
Completed
Study Start Date
September 2002 (undefined)
Primary Completion Date
June 2003 (Actual)
Study Completion Date
June 2003 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
UCB Pharma
4. Oversight
5. Study Description
Brief Summary
to assess the effect of brivaracetam on the photoparoxysmal EEG response in photosensitive epileptic subjects
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Epilepsy
Keywords
POC, photosensitive, epileptic, brivaracetam, PPR, AED
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
Single
Allocation
Non-Randomized
Enrollment
20 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Brivaracetam
Primary Outcome Measure Information:
Title
Identify lowest single oral dose producing maximal decrease or suppression of intermittent photic stimulation (IPS)photoparoxysmal response (PPR) in photosensitive epileptic subjects pre-dose
Title
post placebo during 24h and post brivaracetam for up to 72 h
Secondary Outcome Measure Information:
Title
Assess relationship between plasma concentrations and changes in photosensitivity frequency range, time of onset and duration of suppressing effect
Title
Safety
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
epileptic subjects with generalized PPR
Exclusion Criteria:
more than 2 concomitant antiepileptic drugs
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Philipp von Rosenstiel, MD.
Organizational Affiliation
UCB Pharma
Official's Role
Study Director
Facility Information:
City
Marseille
Country
France
City
Paris
Country
France
City
Rouen
Country
France
City
Strasbourg
Country
France
City
Kork
Country
Germany
12. IPD Sharing Statement
Learn more about this trial
Effect of Brivaracetam in Photosensitive Epileptic Subjects
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