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| Sponsor: | The Epilepsy Study Consortium |
|---|---|
| Collaborators: |
The Epilepsy Research Foundation GlaxoSmithKline |
| Information provided by: | The Epilepsy Study Consortium |
| ClinicalTrials.gov Identifier: | NCT00894010 |
Purpose
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 | Intervention | Phase |
|---|---|---|
|
Photosensitive Epilepsy |
Drug: carbamazepine 400mg Drug: levetiracetam 1000mg |
Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator), Crossover Assignment |
| Official Title: | Assessment of Marketed AEDs in the Human Photosensitivity Proof of Concept Trial |
| Estimated Enrollment: | 6 |
| Study Start Date: | May 2009 |
| Estimated Study Completion Date: | March 2010 |
| Estimated Primary Completion Date: | March 2010 (Final data collection date for primary outcome measure) |
Eligibility| Ages Eligible for Study: | 18 Years to 60 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| United States, Maryland | |
| Johns Hopkins Hospital, Adult Epilepsy Center | Recruiting |
| Baltimore, Maryland, United States, 21287 | |
| Contact: Pamela Coe 410-502-5570 pcoe@jhmi.edu | |
| Principal Investigator: Gregory Krauss, M.D. | |
| United States, New York | |
| NYU Comprehensive Epilepsy Center | Recruiting |
| New York, New York, United States, 10016 | |
| Contact: Bree Vogelsong 646-558-0845 vogelsong.nyumc@gmail.com | |
| Principal Investigator: Jacqueline French, M.D. | |
| Principal Investigator: | Jacqueline French, M.D. | NYU Comprehensive Epilepsy Center |
More Information
| Responsible Party: | NYU Comprehensive Epilepsy Center & The Epilepsy Study Consortium ( Jacqueline French, MD ) |
| Study ID Numbers: | TESC-001 |
| Study First Received: | May 5, 2009 |
| Last Updated: | July 7, 2009 |
| ClinicalTrials.gov Identifier: | NCT00894010 History of Changes |
| Health Authority: | United States: Institutional Review Board |
|
Photosensitive epilepsy Photosensitivity Seizures Epilepsy |
|
Epilepsy, Reflex Nootropic Agents Tranquilizing Agents Nervous System Diseases Physiological Effects of Drugs Psychotropic Drugs Central Nervous System Depressants Central Nervous System Diseases Antimanic Agents Brain Diseases Protective Agents Neuroprotective Agents |
Pharmacologic Actions Carbamazepine Epilepsy Analgesics, Non-Narcotic Sensory System Agents Therapeutic Uses Piracetam Etiracetam Analgesics Peripheral Nervous System Agents Central Nervous System Agents Anticonvulsants |