Study of Intranasal Clonazepam in Adult Subjects With Epileptic Seizures

Phase 2

Completed

• Conditions: Epilepsy
• Interventions: Drug: Clonazepam

• Registration Number: NCT00594945
• Lead Sponsor: Jazz Pharmaceuticals

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2007-12
• Study First Submitted: 2008-01-07
• Study First Submitted QC: 2008-01-07
• Study First Posted: 2008-01-16
• Primary Completion: 2008-12
• Study Completion: 2009-06
• Results First Submitted: 2013-06-26
• Status Verified: 2014-05
• Results First Submitted QC: 2014-05-29
• Last Update Submitted: 2014-05-29
• Results First Posted: 2014-07-01
• Last Update Posted: 2014-07-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 45

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

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Intranasal Clonazepam both Dose Groups 2 mg & 3 mg	Clonazepam	-
Intranasal Clonazepam 2 mg	Clonazepam	-
Intranasal Clonazepam 3 mg	Clonazepam	-

Primary Outcome Measures

Name	Time	Method
Number of Spikes and Sharp Waves, Relative Change From Baseline to Treatment Day (%).	Change from baseline to treatment day	Summary of video EEG number of spikes and sharp waves. Over a 24 hour period.

Trial Locations

Locations (6)

Clinical Trials. inc.; 🇺🇸 Little Rock, Arkansas, United States

Ohio State University; 🇺🇸 Columbus, Ohio, United States

Columbia Comprehensive Epilepsy Center, Neurological Institute; 🇺🇸 New York, New York, United States

Mid-Atlantic Epilepsy & Sleep Center; 🇺🇸 Bethesda, Maryland, United States

Neurological Clinic of Texas, PA; 🇺🇸 Dallas, Texas, United States

Tampere University Hospital; 🇫🇮 Tampere, Finland