Study of Intranasal Clonazepam in Adult Subjects With Epileptic Seizures

This study is currently recruiting participants.

Verified by Jazz Pharmaceuticals, September 2008

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

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

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

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 ]

Estimated Enrollment:

Study Start Date:

December 2007

Estimated 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:

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	Recruiting
Bethesda, Maryland, United States, 20817
Contact: Arkady Barber, RN 301-530-9744
Principal Investigator: Pavel Klein, M.B.
United States, New York
Columbia Comprehensive Epilepsy Center, Neurological Institute	Recruiting
New York, New York, United States, 10032
Contact: Alison Randall 212-305-1684
Principal Investigator: Lawrence Hirsch, MD
United States, Ohio
Ohio State University	Recruiting
Columbus, Ohio, United States, 43210
Contact: Janet Renner 614-292-1043
Principal Investigator: Bassel Shneker, MD
Finland
Tampere University Hospital	Recruiting
Tampere, Finland, 33521
Contact: Mervi Mattila 358 40 586 8471
Principal Investigator: Jukka Petola, MD

Sponsors and Collaborators

Jazz Pharmaceuticals

More Information

Responsible Party:

Jazz Pharmaceuticals ( Director, Transitional Medicine )

Study ID Numbers:

07-001

First Received:

January 7, 2008

Last Updated:

September 16, 2008

ClinicalTrials.gov Identifier:

NCT00594945

Health Authority:

United States: Food and Drug Administration

Study placed in the following topic categories:

Epilepsy
Clonazepam
Seizures
Central Nervous System Diseases
Brain Diseases

Additional relevant MeSH terms:

Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
GABA Modulators
Therapeutic Uses
Physiological Effects of Drugs

Nervous System Diseases
GABA Agents
Central Nervous System Agents
Pharmacologic Actions
Anticonvulsants

ClinicalTrials.gov processed this record on January 07, 2009