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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

Tracking Information
First Submitted Date  ICMJE January 7, 2008
First Posted Date  ICMJE January 16, 2008
Results First Submitted Date  ICMJE June 26, 2013
Results First Posted Date  ICMJE July 1, 2014
Last Update Posted Date July 1, 2014
Study Start Date  ICMJE December 2007
Actual Primary Completion Date December 2008   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 29, 2014)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: January 7, 2008)
EEG [ Time Frame: 1 Day ]
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE
 (submitted: January 7, 2008)
Safety [ Time Frame: 1 Day ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study of Intranasal Clonazepam in Adult Subjects With Epileptic Seizures
Official Title  ICMJE 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
Brief Summary Evaluate the safety and efficacy of intranasal Clonazepam in subjects with epilepsy.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Epilepsy
Intervention  ICMJE Drug: Clonazepam
1 Dose
Study Arms  ICMJE
  • Experimental: Intranasal Clonazepam 2 mg
    Intervention: Drug: Clonazepam
  • Experimental: Intranasal Clonazepam 3 mg
    Intervention: Drug: Clonazepam
  • Experimental: Intranasal Clonazepam both Dose Groups 2 mg & 3 mg
    Intervention: Drug: Clonazepam
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 7, 2008)
45
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE June 2009
Actual Primary Completion Date December 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Finland,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00594945
Other Study ID Numbers  ICMJE 07-001
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Jazz Pharmaceuticals
Study Sponsor  ICMJE Jazz Pharmaceuticals
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Beverly Benson, PhD Jazz Pharmaceuticals
PRS Account Jazz Pharmaceuticals
Verification Date May 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP