Study of Intranasal Clonazepam in Adult Subjects With Epileptic Seizures

Phase 2CompletedNCT00594945

Jazz Pharmaceuticals45 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Epilepsy

Interventions

ClonazepamDRUG

1 Dose

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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

Locations (6)

Clinical Trials. inc.

Little Rock, Arkansas, United States

Mid-Atlantic Epilepsy & Sleep Center

Bethesda, Maryland, United States

Columbia Comprehensive Epilepsy Center, Neurological Institute

New York, New York, United States

Ohio State University

Columbus, Ohio, United States

Outcomes

Primary Outcomes

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.

Time frame: Change from baseline to treatment day

Data from ClinicalTrials.gov

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