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| Sponsored by: |
Jazz Pharmaceuticals |
|---|---|
| Information provided by: | Jazz Pharmaceuticals |
| ClinicalTrials.gov Identifier: | NCT00594945 |
Purpose
Evaluate the safety and efficacy of intranasal Clonazepam in subjects with epilepsy.
| Condition | Intervention | Phase |
|---|---|---|
|
Epilepsy |
Drug: Clonazepam |
Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment, Open Label, Uncontrolled, Single Group Assignment |
| Official Title: | A Phase 2a, Open-Label,Proof -of-Concept Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Intranasal Clonazepam in Adult Subjects With Epileptic Seizures |
| Estimated Enrollment: | 45 |
| Study Start Date: | December 2007 |
| Estimated Primary Completion Date: | December 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| 1: Experimental |
Drug: Clonazepam
1 Dose
|
Eligibility| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| United States, Maryland | |
| Mid-Atlantic Epilepsy & Sleep Center | Recruiting |
| Bethesda, Maryland, United States, 20817 | |
| Contact: Arkady Barber, RN 301-530-9744 | |
| Principal Investigator: Pavel Klein, M.B. | |
| United States, New York | |
| Columbia Comprehensive Epilepsy Center, Neurological Institute | Recruiting |
| New York, New York, United States, 10032 | |
| Contact: Alison Randall 212-305-1684 | |
| Principal Investigator: Lawrence Hirsch, MD | |
| United States, Ohio | |
| Ohio State University | Recruiting |
| Columbus, Ohio, United States, 43210 | |
| Contact: Janet Renner 614-292-1043 | |
| Principal Investigator: Bassel Shneker, MD | |
| Finland | |
| Tampere University Hospital | Recruiting |
| Tampere, Finland, 33521 | |
| Contact: Mervi Mattila 358 40 586 8471 | |
| Principal Investigator: Jukka Petola, MD | |
More Information
| Responsible Party: | Jazz Pharmaceuticals ( Director, Transitional Medicine ) |
| Study ID Numbers: | 07-001 |
| Study First Received: | January 7, 2008 |
| Last Updated: | September 16, 2008 |
| ClinicalTrials.gov Identifier: | NCT00594945 |
| Health Authority: | United States: Food and Drug Administration |
|
Epilepsy Clonazepam Seizures Central Nervous System Diseases Brain Diseases |
|
Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action GABA Modulators Therapeutic Uses Physiological Effects of Drugs |
Nervous System Diseases GABA Agents Central Nervous System Agents Pharmacologic Actions Anticonvulsants |
