Back to resultsStudy of Intranasal Clonazepam in Adult Subjects With Epileptic Seizures
Primary Purpose
Epilepsy
Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Clonazepam
Sponsored by
About this trial
This is an interventional treatment trial for Epilepsy
Eligibility 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
Sites / Locations
- Clinical Trials. inc.
- Mid-Atlantic Epilepsy & Sleep Center
- Columbia Comprehensive Epilepsy Center, Neurological Institute
- Ohio State University
- Neurological Clinic of Texas, PA
- Tampere University Hospital
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Experimental
Arm Label
Intranasal Clonazepam 2 mg
Intranasal Clonazepam 3 mg
Intranasal Clonazepam both Dose Groups 2 mg & 3 mg
Arm Description
Outcomes
Primary Outcome Measures
Number of Spikes and Sharp Waves, Relative Change From Baseline to Treatment Day (%).
Summary of video EEG number of spikes and sharp waves. Over a 24 hour period.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00594945
Brief Title
Study of Intranasal Clonazepam in Adult Subjects With Epileptic Seizures
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 Type
Interventional
2. Study Status
Record Verification Date
May 2014
Overall Recruitment Status
Completed
Study Start Date
December 2007 (undefined)
Primary Completion Date
December 2008 (Actual)
Study Completion Date
June 2009 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Jazz Pharmaceuticals
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Evaluate the safety and efficacy of intranasal Clonazepam in subjects with epilepsy.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Epilepsy
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
45 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Intranasal Clonazepam 2 mg
Arm Type
Experimental
Arm Title
Intranasal Clonazepam 3 mg
Arm Type
Experimental
Arm Title
Intranasal Clonazepam both Dose Groups 2 mg & 3 mg
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Clonazepam
Intervention Description
1 Dose
Primary Outcome Measure Information:
Title
Number of Spikes and Sharp Waves, Relative Change From Baseline to Treatment Day (%).
Description
Summary of video EEG number of spikes and sharp waves. Over a 24 hour period.
Time Frame
Change from baseline to treatment day
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Beverly Benson, PhD
Organizational Affiliation
Jazz Pharmaceuticals
Official's Role
Study Director
Facility Information:
Facility Name
Clinical Trials. inc.
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72205
Country
United States
Facility Name
Mid-Atlantic Epilepsy & Sleep Center
City
Bethesda
State/Province
Maryland
ZIP/Postal Code
20817
Country
United States
Facility Name
Columbia Comprehensive Epilepsy Center, Neurological Institute
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Facility Name
Ohio State University
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
Facility Name
Neurological Clinic of Texas, PA
City
Dallas
State/Province
Texas
ZIP/Postal Code
75232
Country
United States
Facility Name
Tampere University Hospital
City
Tampere
ZIP/Postal Code
33521
Country
Finland
12. IPD Sharing Statement
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Study of Intranasal Clonazepam in Adult Subjects With Epileptic Seizures
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