Study of Intranasal Clonazepam in Adult Subjects With Epileptic Seizures
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
1 other identifier
interventional
45
2 countries
6
Brief Summary
Evaluate the safety and efficacy of intranasal Clonazepam in subjects with epilepsy.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Dec 2007
Shorter than P25 for phase_2
6 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2007
CompletedFirst Submitted
Initial submission to the registry
January 7, 2008
CompletedFirst Posted
Study publicly available on registry
January 16, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2009
CompletedResults Posted
Study results publicly available
July 1, 2014
CompletedJuly 1, 2014
May 1, 2014
1 year
January 7, 2008
June 26, 2013
May 29, 2014
Conditions
Outcome Measures
Primary Outcomes (1)
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.
Change from baseline to treatment day
Study Arms (3)
Intranasal Clonazepam 2 mg
EXPERIMENTALIntranasal Clonazepam 3 mg
EXPERIMENTALIntranasal Clonazepam both Dose Groups 2 mg & 3 mg
EXPERIMENTALInterventions
1 Dose
Eligibility Criteria
You may qualify if:
- Diagnosis of refractory epilepsy
- No Nasal conditions that would preclude the use of intranasal product
You may not qualify if:
- Subject with a clinical significant unstable medical abnormality
- Subject currently or regularly taking Clonazepam
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (6)
Clinical Trials. inc.
Little Rock, Arkansas, 72205, United States
Mid-Atlantic Epilepsy & Sleep Center
Bethesda, Maryland, 20817, United States
Columbia Comprehensive Epilepsy Center, Neurological Institute
New York, New York, 10032, United States
Ohio State University
Columbus, Ohio, 43210, United States
Neurological Clinic of Texas, PA
Dallas, Texas, 75232, United States
Tampere University Hospital
Tampere, 33521, Finland
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Executive Director, Clinical Development
- Organization
- Jazz Pharmaceuticals, Inc.
Study Officials
- STUDY DIRECTOR
Beverly Benson, PhD
Jazz Pharmaceuticals
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 7, 2008
First Posted
January 16, 2008
Study Start
December 1, 2007
Primary Completion
December 1, 2008
Study Completion
June 1, 2009
Last Updated
July 1, 2014
Results First Posted
July 1, 2014
Record last verified: 2014-05