We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

Effect of Brivaracetam in Photosensitive Epileptic Subjects

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00401648
First Posted: November 20, 2006
Last Update Posted: December 1, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
UCB Pharma
  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
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 Pharma:

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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • epileptic subjects with generalized PPR

Exclusion Criteria:

  • more than 2 concomitant antiepileptic drugs
  Contacts and Locations
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): NCT00401648


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

ClinicalTrials.gov Identifier: NCT00401648     History of Changes
Other Study ID Numbers: N01069
Protocol Number RPCE02D2304
First Submitted: November 17, 2006
First Posted: November 20, 2006
Last Update Posted: December 1, 2009
Last Verified: November 2009

Keywords provided by UCB Pharma:
POC
photosensitive
epileptic
brivaracetam
PPR
AED

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