Photosensitivity Proof of Concept Trial

Status Completed

Clinical Trial Summary

The purpose of this study is to determine whether patients who usually have abnormal electrical EEG responses when shown flashing lights will show a reduction in abnormal electrical activity when they take a single dose of 2 marketed drugs (carbamazepine and levetiracetam). If so, a similar study in the future may be able to identify promising new drugs for epilepsy.

Patients who successfully complete the screening visit, will return 4 additional times and will receive either placebo (2 times) or a single oral dose of both carbamazepine 400mg and levetiracetam 1000mg in random order.

During each of the study days, several procedures and intermittent photosensitivity (IPS) assessments will be performed at 5 pre-determined times over the course of the day, one pre-dose and 4 post-dose.

Clinical Trial Description

n/a

Study Design

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

Photosensitive Epilepsy

Clinical Trial Details

NCT number	NCT00894010
Study type	Interventional
Source	The Epilepsy Study Consortium
Contact
Status	Completed
Phase	Phase 2
Start date	May 2009
Completion date	June 2011

View Details

See also
Status	Clinical Trial	Phase
Completed	`NCT03239691` - A Study to Evaluate the Effect of ACT-709478 in Photosensitive Epilepsy Patients	Phase 2
Terminated	`NCT03686033` - A Study to Evaluate the Pharmacodynamic Activity of E2082 in Adult Participants With Photosensitive Epilepsy	Phase 2
Completed	`NCT00784212` - Effect of BGG492 on EEG in Patients With Photosensitive Epilepsy	Phase 2
Completed	`NCT00579384` - A Study of the Effects of JNJ-26489112 on the Photic Induced Paroxysmal Electroencephalogram (EEG) Response in Patients With Photosensitive Epilepsy	Phase 2
Active, not recruiting	`NCT03790137` - Treatment of Sunflower Syndrome With ZX008 (Fenfluramine Hydrochloride) in Children and Young Adults (Ages 4-25).	Phase 3
Completed	`NCT03580707` - Does BRV Have Faster Onset Time & Greater Effect Than LEV in Epilepsy Pts Using PPR Pharmacodynamic Efficacy Endpoint	Phase 2/Phase 3
Terminated	`NCT03603639` - A Study to Evaluate the Pharmacodynamic Activity of E2730 in Adult Participants With Photosensitive Epilepsy	Phase 2
Completed	`NCT00609245` - Effect of Valproic Acid Concentration on Photic Response	N/A