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| Sponsored by: |
Johnson & Johnson Pharmaceutical Research & Development, L.L.C. |
|---|---|
| Information provided by: | Johnson & Johnson Pharmaceutical Research & Development, L.L.C. |
| ClinicalTrials.gov Identifier: | NCT00579384 |
Purpose
The purpose of this study is to check the Effects of JNJ-26489112 on the Photic Induced Paroxysmal electroencepholgram (EEG) Response in Patients with Photosensitive Epilepsy
| Condition | Intervention | Phase |
|---|---|---|
|
Epilepsy Reflex Epilepsy, Photosensitive |
Drug: JNJ-26489112 |
Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment, Non-Randomized, Single Blind (Subject), Single Group Assignment, Safety/Efficacy Study |
| Official Title: | A Study of the Effects of JNJ-26489112 on the Photic Induced Paroxysmal Electroencephalogram Response in Patients With Photosensitive Epilepsy |
| Estimated Enrollment: | 32 |
| Estimated Study Completion Date: | May 2008 |
| Arms | Assigned Interventions |
|---|---|
| 001: Experimental |
Drug: JNJ-26489112
Single oral dose of active drug up to 3000 mg on Day 2; placebo on Days 1 and 3
|
This is a multicenter, non-randomized (participants are assigned deliberately), single-blind (patients do not know which treatment they are receiving), within patient placebo-controlled study. Up to 32 male or female patients will participate in this study. The duration of subject participation is approximately 6 weeks. Patients will receive the oral doses of study drug in the mornings of Days 1, 2, and 3. All patients will receive a single dose of placebo on Day 1, a single dose of JNJ-26489112 on Day 2, and a second single dose of placebo on Day 3. Blood samples will be taken for evaluation of JNJ-26489112 drug concentrations in plasma and blood. Blood samples will also be collected for laboratory safety assessments and measurement of antiepileptic drug concentrations. Further safety will be assessed by the reporting of adverse events, vital signs, 12-lead ECG, physical and neurological examinations. Patients will be discharged on the evening of Day 3 after the pharmacokinetic samples have been collected, and after assessment by the investigator, unless there are any ongoing adverse events which require in-house monitoring. EEG tracings, recorded during intermitent photic stimulation sessions, will be digitally recorded on a CD-ROM, coded and evaluated independently by one blinded clinical expert to determine the effects on the photosensitivity range. If complete suppression of photosensitivity or reduction of the photosensitivity range by at least 3 points on the photosensitivity scale in at least one eye condition (during closure, closed, open) is not observed in at least 3 of the 4 patients and a maximum tolerated dose has been reached, the study will be stopped. If reduction of the photosensitivity range by at least 3 points on the photosensitivity scale in at least one eye condition (during closure, closed, open) is observed in at least 3 of the 4 patients (with complete suppression in at least 2 patients) in the first cohort, the dose level of JNJ-26489112 may be reduced in subsequent cohorts until the reduction or suppression of photosensitivity is seen in fewer than 2 out of 4 patients in one cohort. Once an effective dose has been reached an additional open-label cohort may be enrolled in which no study drug (JNJ-26489112 or placebo) will be administered to patients.
Study drug (i.e., JNJ-26489112 or placebo) will be administered orally as single doses on Days 1 to 3. Placebo will be administered on Days 1 and 3, and a single dose of JNJ-26489112 will be administered on Day 2.
Eligibility| Ages Eligible for Study: | 18 Years to 60 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Patients who currently take phenobarbital, mysoline or primidone as antiepileptic therapy and test positive for barbiturates are eligible for study participation. Patients who currently take vigabatrin or frisium as antiepileptic therapy and test positive for benzodiazepines are eligible for study participation
Contacts and Locations| United States, Maryland | |
| Baltimore, Maryland, United States, 21287 | |
| United States, Tennessee | |
| Nashville, Tennessee, United States, 37232 | |
| France | |
| Marseille, France, 13385 | |
| Strasbourg, France | |
| Le Kremlin Bicetre, France, 94275 | |
| Rouen, France, 76000 | |
| Study Director: | Johnson & Johnson Pharmaceutical Research and Development, L.L.C. Clinical Trial | Johnson & Johnson Pharmaceutical Research & Development, L.L.C. |
More Information
| Responsible Party: | Johnson & Johnson Pharmaceutical Research & Development, L.L.C. ( Associate Director, Experimental Medicine ) |
| Study ID Numbers: | CR014110, 26489112NAP2001 |
| Study First Received: | December 20, 2007 |
| Last Updated: | January 29, 2009 |
| ClinicalTrials.gov Identifier: | NCT00579384 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
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JNJ-26489112 Reflex Epilepsy, photosensitive Epilepsy |
|
Epilepsy, Reflex Epilepsy Central Nervous System Diseases Photosensitive Epilepsy Brain Diseases |
|
Epilepsy, Reflex Epilepsy Nervous System Diseases Central Nervous System Diseases Brain Diseases |