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Study of Intranasal Clonazepam in Adult Subjects With Epileptic Seizures

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ClinicalTrials.gov Identifier: NCT00594945
Recruitment Status : Completed
First Posted : January 16, 2008
Results First Posted : July 1, 2014
Last Update Posted : July 1, 2014
Sponsor:
Information provided by (Responsible Party):
Jazz Pharmaceuticals

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

Condition or disease Intervention/treatment Phase
Epilepsy Drug: Clonazepam Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 45 participants
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: None (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
Study Start Date : December 2007
Actual Primary Completion Date : December 2008
Actual Study Completion Date : June 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Epilepsy Seizures
Drug Information available for: Clonazepam
U.S. FDA Resources

Arm Intervention/treatment
Experimental: Intranasal Clonazepam 2 mg Drug: Clonazepam
1 Dose
Experimental: Intranasal Clonazepam 3 mg Drug: Clonazepam
1 Dose
Experimental: Intranasal Clonazepam both Dose Groups 2 mg & 3 mg Drug: Clonazepam
1 Dose



Primary Outcome Measures :
  1. Number of Spikes and Sharp Waves, Relative Change From Baseline to Treatment Day (%). [ Time Frame: Change from baseline to treatment day ]
    Summary of video EEG number of spikes and sharp waves. Over a 24 hour period.



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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Jazz Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00594945     History of Changes
Other Study ID Numbers: 07-001
First Posted: January 16, 2008    Key Record Dates
Results First Posted: July 1, 2014
Last Update Posted: July 1, 2014
Last Verified: May 2014

Additional relevant MeSH terms:
Seizures
Epilepsy
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms
Clonazepam
Anticonvulsants
GABA Modulators
GABA Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs