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: May 29, 2014
Last verified: May 2014
  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: Allocation: Non-Randomized
Intervention Model: Crossover 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:


Further study details as provided by Jazz Pharmaceuticals:

Primary Outcome Measures:
  • Number of Spikes and Sharp Waves, Relative Change From Baseline to Treatment Day (%). [ Time Frame: Change from baseline to treatment day ] [ Designated as safety issue: No ]
    Summary of video EEG number of spikes and sharp waves. Over a 24 hour period.


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: 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

  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Results First Received: June 26, 2013
Last Updated: May 29, 2014
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 September 18, 2014