Study of Intranasal Clonazepam in Adult Subjects With Epileptic Seizures

NCT ID: NCT00594945

Last Updated: 2014-07-01

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

45 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-12-31

Study Completion Date

2009-06-30

Brief Summary

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

Detailed Description

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Conditions

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Epilepsy

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Intranasal Clonazepam 2 mg

Group Type EXPERIMENTAL

Clonazepam

Intervention Type DRUG

1 Dose

Intranasal Clonazepam 3 mg

Group Type EXPERIMENTAL

Clonazepam

Intervention Type DRUG

1 Dose

Intranasal Clonazepam both Dose Groups 2 mg & 3 mg

Group Type EXPERIMENTAL

Clonazepam

Intervention Type DRUG

1 Dose

Interventions

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Clonazepam

1 Dose

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Jazz Pharmaceuticals

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Beverly Benson, PhD

Role: STUDY_DIRECTOR

Jazz Pharmaceuticals

Locations

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Clinical Trials. inc.

Little Rock, Arkansas, United States

Site Status

Mid-Atlantic Epilepsy & Sleep Center

Bethesda, Maryland, United States

Site Status

Columbia Comprehensive Epilepsy Center, Neurological Institute

New York, New York, United States

Site Status

Ohio State University

Columbus, Ohio, United States

Site Status

Neurological Clinic of Texas, PA

Dallas, Texas, United States

Site Status

Tampere University Hospital

Tampere, , Finland

Site Status

Countries

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United States Finland

Other Identifiers

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07-001

Identifier Type: -

Identifier Source: org_study_id

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