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Study of Intranasal Clonazepam in Adult Subjects With Epileptic Seizures

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Jazz Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00594945
First received: January 7, 2008
Last updated: March 28, 2012
Last verified: March 2012
History of Changes
  Purpose

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


Condition Intervention Phase
Epilepsy
 Drug: Clonazepam
 Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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:

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
Experimental: 1 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, Arkansas
Clinical Trials. inc.
Little Rock, Arkansas, United States, 72205
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
United States, Texas
Neurological Clinic of Texas, PA
Dallas, Texas, United States, 75232
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
ClinicalTrials.gov Identifier: NCT00594945     History of Changes
Other Study ID Numbers: 07-001
Study First Received: January 7, 2008
Last Updated: March 28, 2012
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Epilepsy
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Clonazepam
Anticonvulsants
Central Nervous System Agents
 Therapeutic Uses
Pharmacologic Actions
GABA Modulators
GABA Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on May 19, 2013