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| ID | Type | Description | Link |
|---|---|---|---|
| B5311005 |
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The study was terminated on September 12, 2010 per protocol following a serious adverse event that occurred with the first subject dosed at 600 mg.
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Subjects with epilepsy with a documented photoparoxysmal response to intermittent photic stimulation (IPS) will participate. Four subjects will be enrolled at each dose level and will receive a single dose of placebo and a single dose of ICA-105665 during the study, each followed by intermittent photic stimulation. The effects of ICA-105665 on the photoparoxysmal electroencephalography (EEG) response of each group will be reviewed before the dose is selected for each subsequent group of subjects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ICA-105665 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ICA-105665 | Drug | Oral tablet. Dose forms of 50 and 100 mg or placebo will be used. A single dose will be administered that can range from placebo or 100 to 600 mg. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in photosensitivity response | begin 1 hr post dose for 8 hours |
| Measure | Description | Time Frame |
|---|---|---|
| To correlate plasma concentrations of ICA-105665 with effect on the frequency range of IPS-induced PPR (Photoparoxysmal response) in subjects with photosensitive epilepsy. | 3 days | |
| To assess the safety of a single dose of ICA-105665 in subjects with photosensitive epilepsy. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pfizer Investigational Site | Little Rock | Arkansas | 72205 | United States | ||
| Pfizer Investigational Site |
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| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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| ID | Term |
|---|---|
| D004827 | Epilepsy |
| D010787 | Photosensitivity Disorders |
| D012640 | Seizures |
| ID | Term |
|---|---|
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D012871 | Skin Diseases |
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| 30 days |
| Chesterfield |
| Missouri |
| 63017 |
| United States |
| Pfizer Investigational Site | Nashville | Tennessee | 37232 | United States |
| D017437 |
| Skin and Connective Tissue Diseases |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |