NCT00894010

Photosensitivity Proof of Concept Trial

Assessment of Marketed AEDs in the Human Photosensitivity Proof of Concept Trial

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 6 (actual)
• Sponsor: The Epilepsy Study Consortium · Academic / Other
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Photosensitive Epilepsy

Interventions

Type	Name	Description
DRUG	carbamazepine 400mg
DRUG	levetiracetam 1000mg

Timeline

• Start date: 2009-05-01
• Primary completion: 2011-06-01
• Completion: 2011-06-01
• First posted: 2009-05-06
• Last updated: 2012-03-05

Locations

2 sites across 1 country: United States