Clinical Trial: Photosensitivity Proof of Concept Trial

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Assessment of Marketed AEDs in the Human Photosensitivity Proof of Concept Trial

Brief 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.

Detailed Summary:
Sponsor: The Epilepsy Study Consortium

Current Primary Outcome: Demonstrate the ability of carbamazepine to suppress or reduce the photosensitivity response in patients with photosensitive epilepsy. Compare the ability of carbamazepine to impact the PPR as compared with levetiracetam, which is known to suppress PPR. [ Time Frame: At the completion of each cohort. ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

Original Secondary Outcome:

Information By: The Epilepsy Study Consortium

Dates:
Date Received: May 5, 2009
Date Started: May 2009
Date Completion:
Last Updated: March 1, 2012
Last Verified: March 2012