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| Study 6 of 6 for search of: | "Catamenial Epilepsy" |
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| Sponsor: | Marinus Pharmaceuticals |
|---|---|
| Information provided by: | Marinus Pharmaceuticals |
| ClinicalTrials.gov Identifier: | NCT00512317 |
Purpose
To allow open-label extension to patients who have completed Protocol 1042-0600.
| Condition | Intervention | Phase |
|---|---|---|
|
Epilepsies, Partial |
Drug: ganaxolone |
Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
| Official Title: | An Open-Label Extension Study to Evaluate the Safety, Tolerability, and Efficacy of Ganaxolone as Add-on Therapy in Adult Patients With Epilepsy Consisting of Uncontrolled Partial-Onset Seizures. |
| Estimated Enrollment: | 161 |
| Study Start Date: | June 2007 |
| Estimated Study Completion Date: | June 2009 |
This is an open-label study evaluating efficacy and safety of ganaxolone treatment in adults with partial onset epilepsy with or without secondary generalizations.
The study consists of 13 visits over 108 (+or-2) weeks.
Eligibility| Ages Eligible for Study: | 18 Years to 69 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria
Contacts and Locations
Show 25 Study Locations
More Information
| Study ID Numbers: | 1042-0601, V1.6 |
| Study First Received: | August 3, 2007 |
| Last Updated: | February 3, 2009 |
| ClinicalTrials.gov Identifier: | NCT00512317 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
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partial onset epilepsy adult epilepsy partial seizures |
anticonvulsant catamenial epilepsy adult partial onset epilepsy |
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Epilepsies, Partial Epilepsy Nervous System Diseases Central Nervous System Diseases Brain Diseases |