Photosensitivity Proof of Concept Trial
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|ClinicalTrials.gov Identifier: NCT00894010|
Recruitment Status : Completed
First Posted : May 6, 2009
Last Update Posted : March 5, 2012
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.
|Condition or disease||Intervention/treatment||Phase|
|Photosensitive Epilepsy||Drug: carbamazepine 400mg Drug: levetiracetam 1000mg||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||6 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||Assessment of Marketed AEDs in the Human Photosensitivity Proof of Concept Trial|
|Study Start Date :||May 2009|
|Actual Primary Completion Date :||June 2011|
|Actual Study Completion Date :||June 2011|
U.S. FDA Resources
Drug: carbamazepine 400mg
- 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. ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|