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

Tracking Information

First Received Date ^ICMJE

January 7, 2008

Last Updated Date

June 4, 2009

Start Date ^ICMJE

December 2007

Primary Completion Date

December 2008 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00594945 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

Study of Intranasal Clonazepam in Adult Subjects With Epileptic Seizures

Official Title ^ICMJE

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

Brief Summary

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

Detailed Description

Study Phase

Phase II

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Open Label, Uncontrolled, Single Group Assignment

Condition ^ICMJE

Epilepsy

Intervention ^ICMJE

Drug: Clonazepam

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

June 2009

Primary Completion Date

December 2008 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years to 65 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States, Finland

Administrative Information

NCT ID ^ICMJE

NCT00594945

Responsible Party

Director, Transitional Medicine, Jazz Pharmaceuticals

Study ID Numbers ^ICMJE

07-001

Study Sponsor ^ICMJE

Jazz Pharmaceuticals

Collaborators ^ICMJE

Investigators ^ICMJE

Study Director:

Beverly Benson, PhD

Jazz Pharmaceuticals

Information Provided By

Jazz Pharmaceuticals

Verification Date

June 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP