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: Treatment, Open Label, Uncontrolled, Single Group Assignment

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

Primary Measures

• EEG
  • Time Frame: 1 Day
    Safety Issue?: No

Secondary Measures

• Safety
  • Time Frame: 1 Day
    Safety Issue?: Yes

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

Lead Sponsor: Jazz Pharmaceuticals

Overall Clinical Trial Officials and Contacts

Beverly Benson, PhD Study Director Jazz Pharmaceuticals  

Information obtained from ClinicalTrials.gov on July 02, 2009

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