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| Name | Class |
|---|---|
| The Epilepsy Research Foundation | UNKNOWN |
| GlaxoSmithKline | INDUSTRY |
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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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| carbamazepine 400mg | Drug |
| ||
| levetiracetam 1000mg | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | At the completion of each cohort. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jacqueline French, M.D. | NYU Comprehensive Epilepsy Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Johns Hopkins Hospital, Adult Epilepsy Center | Baltimore | Maryland | 21287 | United States | ||
| NYU Comprehensive Epilepsy Center |
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| Label | URL |
|---|---|
| The Epilepsy Study Consortium | View source |
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| ID | Term |
|---|---|
| D020195 | Epilepsy, Reflex |
| D010787 | Photosensitivity Disorders |
| D012640 | Seizures |
| D004827 | Epilepsy |
| ID | Term |
|---|---|
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D012871 | Skin Diseases |
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| ID | Term |
|---|---|
| D002220 | Carbamazepine |
| D000077287 | Levetiracetam |
| ID | Term |
|---|---|
| D003984 | Dibenzazepines |
| D006575 | Heterocyclic Compounds, 3-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
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| New York |
| New York |
| 10016 |
| United States |
| D017437 |
| Skin and Connective Tissue Diseases |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D000081 | Acetamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000085 | Acetates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D011760 | Pyrrolidinones |
| D011759 | Pyrrolidines |
| D006573 | Heterocyclic Compounds, 1-Ring |