Study of Intranasal Clonazepam in Adult Subjects With Epileptic Seizures
Evaluate the safety and efficacy of intranasal Clonazepam in subjects with epilepsy...
Brief Summary
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”
Evaluate the safety and efficacy of intranasal Clonazepam in subjects with epilepsy.
- Study Type: Interventional
- Study Design: Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
- Study Primary Completion Date: December 2008
Intervention(s) in this Clinical Trial
- Drug: Clonazepam
- 1 Dose
Arms, Groups and Cohorts in this Clinical Trial
- Experimental: 1
Outcome Measures for this Clinical Trial
Primary Measures
- EEG
- Time Frame: 1 Day
Safety Issue?: No
- Time Frame: 1 Day
Secondary Measures
- Safety
- Time Frame: 1 Day
Safety Issue?: Yes
- Time Frame: 1 Day
Criteria for Participation in this Clinical Trial
Inclusion Criteria:
- Diagnosis of refractory epilepsy
- No Nasal conditions that would preclude the use of intranasal product
Exclusion Criteria:
- Subject with a clinical significant unstable medical abnormality
- Subject currently or regularly taking Clonazepam
Gender Eligibility for this Clinical Trial: Both
Minimum Age for this Clinical Trial: 18 Years
Maximum Age for this Clinical Trial: 65 Years
Are Healthy Volunteers Accepted for this Clinical Trial?: No
Clinical Trial Investigator Information
Lead Investigator: Jazz Pharmaceuticals Industry
Overall Clinical Trial Officials and Contacts
Beverly Benson, PhD Study Director Jazz Pharmaceuticals
Additional Information
Information obtained from ClinicalTrials.gov on February 02, 2012
Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00594945
Study ID Number: 07-001
ClinicalTrials.gov Identifier: NCT00594945
Health Authority: United States: Food and Drug Administration
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The URL of this page is:
http://clinicaltrialsfeeds.org/clinical-trials/show/NCT00594945
