Study to Evaluate the Safety and Efficacy of GABITRIL Treatment in Adults With Generalized Anxiety Disorder.

NCT ID: NCT00214994

Last Updated: 2014-05-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Study Classification

INTERVENTIONAL

Study Start Date

2005-01-31

Study Completion Date

2006-12-31

Brief Summary

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A 12-Month, Open-Label, Flexible-Dosage Study to Evaluate the Safety and Efficacy of GABITRIL Treatment in Adults with Generalized Anxiety Disorder.

Detailed Description

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Conditions

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Anxiety Disorders

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Gabitril

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

Subjects who have completed 10 weeks of double-blind treatment and the subsequent taper period in 1 of the 3 previous double-blind studies (studies C6671/3030/AX/US, C6671/3031/AX/US, or C6671/3032/AX/US).
Minimum Eligible Age

18 Years

Maximum Eligible Age

64 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Cephalon

INDUSTRY

Sponsor Role lead

Locations

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Birmingham Research Group

Birmingham, Alabama, United States

Site Status

Pivotal Research Center

Mesa, Arizona, United States

Site Status

Pivotal Research

Peoria, Arizona, United States

Site Status

Southwestern Research

Beverly Hills, California, United States

Site Status

Valley Clinical Research

El Centro, California, United States

Site Status

Irvine Center for Clinical Res

Irvine, California, United States

Site Status

Pharmacology Research Institute

Los Alamitos, California, United States

Site Status

Pacific Institue for Medical

Los Angeles, California, United States

Site Status

Pharmacology Research Institute

Newport Beach, California, United States

Site Status

Pacific Clinical Research Medi

Orange, California, United States

Site Status

Pharmacology Research Institute

Riverside, California, United States

Site Status

Affiliated Research Institute

San Diego, California, United States

Site Status

HealthQuest Clinical Trials

San Diego, California, United States

Site Status

Clinical Innovations Inc.

Santa Ana, California, United States

Site Status

Radiant Research Denver

Denver, Colorado, United States

Site Status

University of Connecticut

Farmington, Connecticut, United States

Site Status

University of Florida

Jacksonville, Florida, United States

Site Status

Miami Research Associates

Miami, Florida, United States

Site Status

Medicial Research Group of Central Florida

Orange City, Florida, United States

Site Status

Clinical Neuroscience Solution

Orlando, Florida, United States

Site Status

Roskamp Institute

Sarasota, Florida, United States

Site Status

Stedman Clinical Trials

Tampa, Florida, United States

Site Status

Clinical Neuroscience Solution

West Palm Beach, Florida, United States

Site Status

Atlanta Institue of Medicaine

Atlanta, Georgia, United States

Site Status

Emory University

Atlanta, Georgia, United States

Site Status

Carman Research

Smyrna, Georgia, United States

Site Status

Hawaii Clinical Research

Honolulu, Hawaii, United States

Site Status

American Medical Research

Aurora, Illinois, United States

Site Status

Cunningham Clinical Research

Edwardsville, Illinois, United States

Site Status

Henry Lahmeyer, MD

Northfield, Illinois, United States

Site Status

Midwest Center for Neurobehavi

Oakbrook Terrace, Illinois, United States

Site Status

Indiana University

Indianapolis, Indiana, United States

Site Status

Vince and Associates Clinical

Overland Park, Kansas, United States

Site Status

Hartford Research Ltd

Florence, Kentucky, United States

Site Status

Pedia Research, LLC

Owensboro, Kentucky, United States

Site Status

Four Rivers Clinical Research

Paducah, Kentucky, United States

Site Status

LSUHSC New Orleans

New Orleans, Louisiana, United States

Site Status

LSUHSC in Shreveport

Shreveport, Louisiana, United States

Site Status

Capital Clinical Research Asso

Rockville, Maryland, United States

Site Status

Dupont Clinical Research

Rockville, Maryland, United States

Site Status

University of Massachusetts

Worcester, Massachusetts, United States

Site Status

Wayne State University

Detroit, Michigan, United States

Site Status

Summit Research Network Farmin

Farmington Hills, Michigan, United States

Site Status

Summit Research Network Michig

Okemos, Michigan, United States

Site Status

Regions Hospital

Saint Paul, Minnesota, United States

Site Status

Radiant Research Las Vegas

Las Vegas, Nevada, United States

Site Status

CNS Research Institute

Clementon, New Jersey, United States

Site Status

Center for Emotional Fitness

Moorestown, New Jersey, United States

Site Status

University of New Mexico

Albuquerque, New Mexico, United States

Site Status

Social Psychiatry Research Ins

Brooklyn, New York, United States

Site Status

Neurobehavioral Research, Inc.

Lawrence, New York, United States

Site Status

Eastside Comprehensive Medical

New York, New York, United States

Site Status

Fieve Clinical Services, Inc.

New York, New York, United States

Site Status

Medical and Behavioral

New York, New York, United States

Site Status

Medical Research Network

New York, New York, United States

Site Status

Behavioral Medical Research

Staten Island, New York, United States

Site Status

Medark Clinical Trials and Research

Morganton, North Carolina, United States

Site Status

Richard Weisler, MD and Assoc

Raleigh, North Carolina, United States

Site Status

Wake Research Associates

Raleigh, North Carolina, United States

Site Status

North Coast Clinical Trials

Beechwood, Ohio, United States

Site Status

Hartford Research Group

Cincinnati, Ohio, United States

Site Status

Midwest Clinical Research Ctr

Dayton, Ohio, United States

Site Status

University of Oklahoma

Oklahoma City, Oklahoma, United States

Site Status

Pahl Pharmaceutical Research

Oklahoma City, Oklahoma, United States

Site Status

OCCI Eugene

Eugene, Oregon, United States

Site Status

Summit Research Network Inc.

Portland, Oregon, United States

Site Status

OCCI, Inc.

Salem, Oregon, United States

Site Status

Keystone Clinical Studies LLC

Norristown, Pennsylvania, United States

Site Status

University of Pennsylvania

Philadelphia, Pennsylvania, United States

Site Status

CNS Research Institute PC

Philadelphia, Pennsylvania, United States

Site Status

South East Health Consultants

Charleston, South Carolina, United States

Site Status

Carolina Clinical Research Ser

Columbia, South Carolina, United States

Site Status

Clinical Neuroscience Solution

Memphis, Tennessee, United States

Site Status

FutureSearch Trials

Austin, Texas, United States

Site Status

Claghorn-Lesem Research

Bellaire, Texas, United States

Site Status

UT Southwestern Medical Center

Dallas, Texas, United States

Site Status

Fabre Research Clinics, Inc.

Houston, Texas, United States

Site Status

R D Clinical Research

Lake Jackson, Texas, United States

Site Status

Croft Group Research Center

San Antonio, Texas, United States

Site Status

Radiant Research Salt Lake

Salt Lake City, Utah, United States

Site Status

University of Utah

Salt Lake City, Utah, United States

Site Status

Comprehensive Neuroscience Of

Arlington, Virginia, United States

Site Status

Northwest Clinical Research

Bellevue, Washington, United States

Site Status

Summit Seattle Boren

Seattle, Washington, United States

Site Status

Northbrook Research Center

Brown Deer, Wisconsin, United States

Site Status

Dean Foundation

Middleton, Wisconsin, United States

Site Status

University of Alberta

Edmonton, Alberta, Canada

Site Status

University of British Columbia

Vancouver, British Columbia, Canada

Site Status

St. Boniface General Hospital

Winnipeg, Manitoba, Canada

Site Status

McMaster University Medical Ce

Hamilton, Ontario, Canada

Site Status

Center for Addiction and Mental Health, Mood and Anxiety Program

Toronto, Ontario, Canada

Site Status

Mood & Anxiety Disorders Ctr

Toronto, Ontario, Canada

Site Status

Clinique Marie-Fitzbach

Québec, Quebec, Canada

Site Status

Countries

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United States Canada

Other Identifiers

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C6671/3033/AX/US

Identifier Type: -

Identifier Source: org_study_id

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