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| Sponsor: | Icagen |
|---|---|
| Information provided by: | Icagen |
| ClinicalTrials.gov Identifier: | NCT00979004 |
Purpose
The purpose of this study is to determine the effects of ICA-105665 on the photoparoxysmal electroencephalography (EEG) response in photosensitive epilepsy patients exposed to intermittent photic stimulation.
| Condition | Intervention | Phase |
|---|---|---|
|
Photosensitive Epilepsy Photosensitivity Seizures Epilepsy |
Drug: ICA-105665 |
Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Single Blind (Subject), Placebo Control, Crossover Assignment, Pharmacodynamics Study |
| Official Title: | A Phase 2, Multi-Center, Single-Blind, Placebo-Controlled Pharmacodynamic Evaluation of ICA-105665 in Epilepsy Patients With a Photo-Induced Paroxysmal Electroencephalographic (EEG) Response |
| Estimated Enrollment: | 12 |
| Study Start Date: | September 2009 |
| Estimated Study Completion Date: | August 2010 |
| Estimated Primary Completion Date: | July 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| ICA-105665: Experimental |
Drug: ICA-105665
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 400 mg.
|
Subjects with epilepsy with a documented photoparoxysmal response to intermittent photic stimulation 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 EEG response of each group will be reviewed before the dose is selected for each subsequent group of subjects.
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| Contact: Elizabeth Moore, M.S. | 919 281-3955 | emoore@icagen.com |
| United States, Arkansas | |
| Recruiting | |
| Little Rock, Arkansas, United States, 72205 | |
| United States, Maryland | |
| Recruiting | |
| Baltimore, Maryland, United States, 21287 | |
| United States, Tennessee | |
| Recruiting | |
| Nashville, Tennessee, United States, 27215 | |
| Study Director: | Seth V Hetherington, MD | Icagen |
More Information
| Responsible Party: | Icagen, Inc. ( Seth Hetherington, M.D., Sr. VP Clinical and Regulatory Affairs ) |
| Study ID Numbers: | ICA-105665-04 |
| Study First Received: | September 16, 2009 |
| Last Updated: | February 3, 2010 |
| ClinicalTrials.gov Identifier: | NCT00979004 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
Photosensitivity Epilepsy Seizures |
Photosensitive epilepsy AED Photic stimulation |
|
Epilepsy, Reflex Signs and Symptoms Epilepsy Nervous System Diseases |
Seizures Neurologic Manifestations Central Nervous System Diseases Brain Diseases |