|
Home
Search
Study Topics
Glossary
|
![]() |
![]() |
|
![]() |
|
![]() |
|
![]() |
![]() |
![]() |
|
![]() |
![]() |
||||||||||||||||||||||||||||||||||||
| 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: | Allocation: Randomized Intervention Model: Crossover Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment |
| 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: | July 2011 |
| Estimated Primary Completion Date: | July 2011 (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 | |
| 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 |
More Information
| Responsible Party: | Jacqueline French, MD, NYU Comprehensive Epilepsy Center & The Epilepsy Study Consortium |
| ClinicalTrials.gov Identifier: | NCT00894010 History of Changes |
| Other Study ID Numbers: | TESC-001 |
| Study First Received: | May 5, 2009 |
| Last Updated: | June 21, 2011 |
| Health Authority: | United States: Institutional Review Board |
|
Photosensitive epilepsy Photosensitivity Seizures Epilepsy |
|
Epilepsy Dermatitis, Phototoxic Epilepsy, Reflex Brain Diseases Central Nervous System Diseases Nervous System Diseases Dermatitis, Irritant Dermatitis, Contact Dermatitis Skin Diseases Photosensitivity Disorders Skin Diseases, Eczematous Carbamazepine Etiracetam Piracetam |
Analgesics, Non-Narcotic Analgesics Sensory System Agents Peripheral Nervous System Agents Physiological Effects of Drugs Pharmacologic Actions Central Nervous System Agents Therapeutic Uses Anticonvulsants Antimanic Agents Tranquilizing Agents Central Nervous System Depressants Psychotropic Drugs Nootropic Agents Neuroprotective Agents |