Study of Intranasal Clonazepam in Adult Subjects With Epileptic Seizures - Full Text View

Study of Intranasal Clonazepam in Adult Subjects With Epileptic Seizures

This study is currently recruiting participants.
Verified by Jazz Pharmaceuticals, June 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

MedlinePlus related topics:

Epilepsy Seizures

ChemIDplus related topics:

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:	45
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:	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	Recruiting
	Bethesda, Maryland, United States, 20817
	Contact: Arkady Barber, RN 301-530-9744
	Principal Investigator: Pavel Klein, M.B.
	Mid-Atlantic Epilepsy & Sleep Center	Recruiting
	Bethesda, Maryland, United States, 20817
	Contact: Arkady Barber 301-530-9744
	Principal Investigator: Pavel Klein, MB, B. Chir

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:	June 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 August 21, 2008