Photosensitivity Proof of Concept Trial
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.
|Photosensitive Epilepsy||Drug: carbamazepine 400mg Drug: levetiracetam 1000mg||Phase 2|
|Study Design:||Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
|Official Title:||Assessment of Marketed AEDs in the Human Photosensitivity Proof of Concept Trial|
- 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. ]
|Study Start Date:||May 2009|
|Study Completion Date:||June 2011|
|Primary Completion Date:||June 2011 (Final data collection date for primary outcome measure)|
Drug: carbamazepine 400mg
Please refer to this study by its ClinicalTrials.gov identifier: NCT00894010
|United States, Maryland|
|Johns Hopkins Hospital, Adult Epilepsy Center|
|Baltimore, Maryland, United States, 21287|
|United States, New York|
|NYU Comprehensive Epilepsy Center|
|New York, New York, United States, 10016|
|Principal Investigator:||Jacqueline French, M.D.||NYU Comprehensive Epilepsy Center|