Study of Intranasal Clonazepam in Adult Subjects With Epileptic Seizures

This study has been completed.

First Received: January 7, 2008 Last Updated: June 4, 2009 History of Changes

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

Resource links provided by NLM:

Genetics Home Reference related topics: pyridoxal 5'-phosphate-dependent epilepsy pyridoxine-dependent epilepsy

MedlinePlus related topics: Epilepsy Seizures

Drug Information available for: Clonazepam

U.S. FDA Resources

Further study details as provided by Jazz Pharmaceuticals:

Primary Outcome Measures:

EEG [ Time Frame: 1 Day ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Safety [ Time Frame: 1 Day ] [ Designated as safety issue: Yes ]

Enrollment:	45
Study Start Date:	December 2007
Study Completion Date:	June 2009
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

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00594945

Locations

United States, Maryland
Mid-Atlantic Epilepsy & Sleep Center
Bethesda, Maryland, United States, 20817
United States, New York
Columbia Comprehensive Epilepsy Center, Neurological Institute
New York, New York, United States, 10032
United States, Ohio
Ohio State University
Columbus, Ohio, United States, 43210
Finland
Tampere University Hospital
Tampere, Finland, 33521

Sponsors and Collaborators

Jazz Pharmaceuticals

Investigators

Study Director:

Beverly Benson, PhD

Jazz Pharmaceuticals

More Information

No publications provided

Responsible Party:	Jazz Pharmaceuticals ( Director, Transitional Medicine )
Study ID Numbers:	07-001
Study First Received:	January 7, 2008
Last Updated:	June 4, 2009
ClinicalTrials.gov Identifier:	NCT00594945 History of Changes
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Neurotransmitter Agents
Epilepsy
Clonazepam
Seizures

Central Nervous System Diseases
Brain Diseases
Anticonvulsants

Additional relevant MeSH terms:

Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
GABA Modulators
Physiological Effects of Drugs
Nervous System Diseases
Central Nervous System Diseases
Brain Diseases

Pharmacologic Actions
Epilepsy
Therapeutic Uses
Clonazepam
GABA Agents
Central Nervous System Agents
Anticonvulsants

ClinicalTrials.gov processed this record on July 02, 2009