NCT00401648

Brief Summary

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

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Sep 2002

Shorter than P25 for phase_2

Geographic Reach
2 countries

5 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2002

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2003

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2003

Completed
3.5 years until next milestone

First Submitted

Initial submission to the registry

November 17, 2006

Completed
3 days until next milestone

First Posted

Study publicly available on registry

November 20, 2006

Completed
Last Updated

December 1, 2009

Status Verified

November 1, 2009

Enrollment Period

9 months

First QC Date

November 17, 2006

Last Update Submit

November 30, 2009

Conditions

Epilepsy

Keywords

POCphotosensitiveepilepticbrivaracetamPPRAED

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (2)

  • Assess relationship between plasma concentrations and changes in photosensitivity frequency range, time of onset and duration of suppressing effect

  • Safety

Interventions

BrivaracetamDRUG

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • epileptic subjects with generalized PPR

You may not qualify if:

  • more than 2 concomitant antiepileptic drugs

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Unknown Facility

Marseille, France

Location

Unknown Facility

Paris, France

Location

Unknown Facility

Rouen, France

Location

Unknown Facility

Strasbourg, France

Location

Unknown Facility

Kork, Germany

Location

MeSH Terms

Conditions

Epilepsy

Interventions

brivaracetam

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System Diseases

Study Officials

  • Philipp von Rosenstiel, MD.

    UCB Pharma

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
SINGLE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

November 17, 2006

First Posted

November 20, 2006

Study Start

September 1, 2002

Primary Completion

June 1, 2003

Study Completion

June 1, 2003

Last Updated

December 1, 2009

Record last verified: 2009-11

Locations

DE(1)FR(4)