Study of Intranasal Clonazepam in Adult Subjects With Epileptic Seizures

May 29, 2014 updated by: Jazz Pharmaceuticals

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

45

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Finland
      • Tampere, Finland, 33521
        • Tampere University Hospital
  • United States
    • Arkansas
      • Little Rock, Arkansas, United States, 72205
        • Clinical Trials. inc.
    • Maryland
      • Bethesda, Maryland, United States, 20817
        • Mid-Atlantic Epilepsy & Sleep Center
    • New York
      • New York, New York, United States, 10032
        • Columbia Comprehensive Epilepsy Center, Neurological Institute
    • Ohio
      • Columbus, Ohio, United States, 43210
        • Ohio State University
    • Texas
      • Dallas, Texas, United States, 75232
        • Neurological Clinic of Texas, PA

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Change from baseline to treatment day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Jazz Pharmaceuticals

Investigators

  • Study Director: Beverly Benson, PhD, Jazz Pharmaceuticals

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2007

Primary Completion (Actual)

December 1, 2008

Study Completion (Actual)

June 1, 2009

Study Registration Dates

First Submitted

January 7, 2008

First Submitted That Met QC Criteria

January 7, 2008

First Posted (Estimate)

January 16, 2008

Study Record Updates

Last Update Posted (Estimate)

July 1, 2014

Last Update Submitted That Met QC Criteria

May 29, 2014

Last Verified

May 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 07-001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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