Study of Intranasal Clonazepam in Adult Subjects With Epileptic Seizures

Epilepsy Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00594945
• Other study ID #: 07-001
• Status: Completed
• Phase: Phase 2
• First received: January 7, 2008
• Last updated: May 29, 2014
• Start date: December 2007
• Est. completion date: June 2009

Study information

• Verified date: May 2014
• Source: Jazz Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

Evaluate the safety and efficacy of intranasal Clonazepam in subjects with epilepsy.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 45
• Est. completion date: June 2009
• Est. primary completion date: December 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Study Design

Allocation: Non-Randomized, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Epilepsy

Intervention

Drug:
• Clonazepam
1 Dose

Locations

Country	Name	City	State
Finland	Tampere University Hospital	Tampere
United States	Mid-Atlantic Epilepsy & Sleep Center	Bethesda	Maryland
United States	Ohio State University	Columbus	Ohio
United States	Neurological Clinic of Texas, PA	Dallas	Texas
United States	Clinical Trials. inc.	Little Rock	Arkansas
United States	Columbia Comprehensive Epilepsy Center, Neurological Institute	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Jazz Pharmaceuticals

Countries where clinical trial is conducted

United States,  Finland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Spikes and Sharp Waves, Relative Change From Baseline to Treatment Day (%).	Summary of video EEG number of spikes and sharp waves. Over a 24 hour period.	Change from baseline to treatment day	No