Effect of Brivaracetam in Photosensitive Epileptic Subjects

This study has been completed.
Sponsor:
Information provided by:
UCB, Inc.
ClinicalTrials.gov Identifier:
NCT00401648
First received: November 17, 2006
Last updated: November 30, 2009
Last verified: November 2009
  Purpose

to assess the effect of brivaracetam on the photoparoxysmal EEG response in photosensitive epileptic subjects


Condition Intervention Phase
Epilepsy
Drug: Brivaracetam
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Single Blind
Primary Purpose: Treatment
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.

Resource links provided by NLM:


Further study details as provided by UCB, Inc.:

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

Estimated Enrollment: 20
Study Start Date: September 2002
Study Completion Date: June 2003
Primary Completion Date: June 2003 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • epileptic subjects with generalized PPR

Exclusion Criteria:

  • more than 2 concomitant antiepileptic drugs
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00401648

Locations
France
Marseille, France
Paris, France
Rouen, France
Strasbourg, France
Germany
Kork, Germany
Sponsors and Collaborators
UCB, Inc.
Investigators
Study Director: Philipp von Rosenstiel, MD. UCB, Inc.
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00401648     History of Changes
Other Study ID Numbers: N01069, Protocol Number RPCE02D2304
Study First Received: November 17, 2006
Last Updated: November 30, 2009
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by UCB, Inc.:
POC
photosensitive
epileptic
brivaracetam
PPR
AED

Additional relevant MeSH terms:
Epilepsy
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases

ClinicalTrials.gov processed this record on August 28, 2014