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

May 8, 2014 updated by: Cephalon

A 12-Month, Open-Label, Flexible-Dosage Study to Evaluate the Safety and Efficacy of GABITRIL Treatment (up to 16 mg/Day) in Adults With Generalized Anxiety Disorder.

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Phase 3

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

  • Canada
      • Quebec, Canada, G1R 2W8
        • Clinique Marie-Fitzbach
    • Alberta
      • Edmonton, Alberta, Canada, T6G 2C8
        • University of Alberta
    • British Columbia
      • Vancouver, British Columbia, Canada, V6T 2A1
        • University of British Columbia
    • Manitoba
      • Winnipeg, Manitoba, Canada, R2H 2A6
        • St. Boniface General Hospital
    • Ontario
      • Hamilton, Ontario, Canada, L8N 3Z5
        • McMaster University Medical Ce
      • Toronto, Ontario, Canada, M5t 1R8
        • Center for Addiction and Mental Health, Mood and Anxiety Program
      • Toronto, Ontario, Canada, M5T 1R8
        • Mood & Anxiety Disorders Ctr
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35216
        • Birmingham Research Group
    • Arizona
      • Mesa, Arizona, United States, 85210
        • Pivotal Research Center
      • Peoria, Arizona, United States, 85381
        • Pivotal Research
    • California
      • Beverly Hills, California, United States, 90210
        • Southwestern Research
      • El Centro, California, United States, 92243
        • Valley Clinical Research
      • Irvine, California, United States, 92618
        • Irvine Center for Clinical Res
      • Los Alamitos, California, United States, 90720
        • Pharmacology Research Institute
      • Los Angeles, California, United States, 90024
        • Pacific Institue for Medical
      • Newport Beach, California, United States, 92660
        • Pharmacology Research Institute
      • Orange, California, United States, 92868
        • Pacific Clinical Research Medi
      • Riverside, California, United States, 92506
        • Pharmacology Research Institute
      • San Diego, California, United States, 92108
        • Affiliated Research Institute
      • San Diego, California, United States, 92123
        • HealthQuest Clinical Trials
      • Santa Ana, California, United States, 92705
        • Clinical Innovations Inc.
    • Colorado
      • Denver, Colorado, United States, 80212
        • Radiant Research Denver
    • Connecticut
      • Farmington, Connecticut, United States, 06030
        • University of Connecticut
    • Florida
      • Jacksonville, Florida, United States, 32257
        • University of Florida
      • Miami, Florida, United States, 33173
        • Miami Research Associates
      • Orange City, Florida, United States, 32763
        • Medicial Research Group of Central Florida
      • Orlando, Florida, United States, 32806
        • Clinical Neuroscience Solution
      • Sarasota, Florida, United States, 34243
        • Roskamp Institute
      • Tampa, Florida, United States, 33613
        • Stedman Clinical Trials
      • West Palm Beach, Florida, United States, 33407
        • Clinical Neuroscience Solution
    • Georgia
      • Atlanta, Georgia, United States, 30329
        • Emory University
      • Atlanta, Georgia, United States, 30328
        • Atlanta Institue of Medicaine
      • Smyrna, Georgia, United States, 30080
        • Carman Research
    • Hawaii
      • Honolulu, Hawaii, United States, 96826
        • Hawaii Clinical Research
    • Illinois
      • Aurora, Illinois, United States, 60506
        • American Medical Research
      • Edwardsville, Illinois, United States, 62025
        • Cunningham Clinical Research
      • Northfield, Illinois, United States, 60093
        • Henry Lahmeyer, MD
      • Oakbrook Terrace, Illinois, United States, 60181
        • Midwest Center for Neurobehavi
    • Indiana
      • Indianapolis, Indiana, United States, 46202
        • Indiana University
    • Kansas
      • Overland Park, Kansas, United States, 66211
        • Vince and Associates Clinical
    • Kentucky
      • Florence, Kentucky, United States, 41042
        • Hartford Research Ltd
      • Owensboro, Kentucky, United States, 42301
        • Pedia Research, LLC
      • Paducah, Kentucky, United States, 42003
        • Four Rivers Clinical Research
    • Louisiana
      • New Orleans, Louisiana, United States, 70115
        • LSUHSC New Orleans
      • Shreveport, Louisiana, United States, 71130-3932
        • LSUHSC in Shreveport
    • Maryland
      • Rockville, Maryland, United States, 20852
        • Dupont Clinical Research
      • Rockville, Maryland, United States, 20852
        • Capital Clinical Research Asso
    • Massachusetts
      • Worcester, Massachusetts, United States, 01655
        • University of Massachusetts
    • Michigan
      • Detroit, Michigan, United States, 48207
        • Wayne State University
      • Farmington Hills, Michigan, United States, 48336
        • Summit Research Network Farmin
      • Okemos, Michigan, United States, 48864
        • Summit Research Network Michig
    • Minnesota
      • St. Paul, Minnesota, United States, 55101
        • Regions Hospital
    • Nevada
      • Las Vegas, Nevada, United States, 89146-5611
        • Radiant Research Las Vegas
    • New Jersey
      • Clementon, New Jersey, United States, 08021
        • CNS Research Institute
      • Moorestown, New Jersey, United States, 08057
        • Center for Emotional Fitness
    • New Mexico
      • Albuquerque, New Mexico, United States, 87131-5311
        • University of New Mexico
    • New York
      • Brooklyn, New York, United States, 11235
        • Social Psychiatry Research Ins
      • Lawrence, New York, United States, 11559
        • Neurobehavioral Research, Inc.
      • New York, New York, United States, 10021
        • Fieve Clinical Services, Inc.
      • New York, New York, United States, 10021
        • Eastside Comprehensive Medical
      • New York, New York, United States, 10023
        • Medical and Behavioral
      • New York, New York, United States, 10024
        • Medical Research Network
      • Staten Island, New York, United States, 10305
        • Behavioral Medical Research
    • North Carolina
      • Morganton, North Carolina, United States, 28655
        • Medark Clinical Trials and Research
      • Raleigh, North Carolina, United States, 27612
        • Wake Research Associates
      • Raleigh, North Carolina, United States, 27609
        • Richard Weisler, MD and Assoc
    • Ohio
      • Beechwood, Ohio, United States, 44122
        • North Coast Clinical Trials
      • Cincinnati, Ohio, United States, 45242
        • Hartford Research Group
      • Dayton, Ohio, United States, 45408
        • Midwest Clinical Research Ctr
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73104
        • University of Oklahoma
      • Oklahoma City, Oklahoma, United States, 73118
        • Pahl Pharmaceutical Research
    • Oregon
      • Eugene, Oregon, United States, 97401
        • OCCI Eugene
      • Portland, Oregon, United States, 97210
        • Summit Research Network Inc.
      • Salem, Oregon, United States, 97309
        • OCCI, Inc.
    • Pennsylvania
      • Norristown, Pennsylvania, United States, 19401
        • Keystone Clinical Studies LLC
      • Philadelphia, Pennsylvania, United States, 19104
        • University of Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19149
        • CNS Research Institute PC
    • South Carolina
      • Charleston, South Carolina, United States, 29407
        • South East Health Consultants
      • Columbia, South Carolina, United States, 29201
        • Carolina Clinical Research Ser
    • Tennessee
      • Memphis, Tennessee, United States, 38119
        • Clinical Neuroscience Solution
    • Texas
      • Austin, Texas, United States, 78703
        • FutureSearch Trials
      • Bellaire, Texas, United States, 77401
        • Claghorn-Lesem Research
      • Dallas, Texas, United States, 75235
        • UT Southwestern Medical Center
      • Houston, Texas, United States, 77004
        • Fabre Research Clinics, Inc.
      • Lake Jackson, Texas, United States, 77566
        • R D Clinical Research
      • San Antonio, Texas, United States, 78229
        • Croft Group Research Center
    • Utah
      • Salt Lake City, Utah, United States, 84132
        • University of Utah
      • Salt Lake City, Utah, United States, 84107
        • Radiant Research Salt Lake
    • Virginia
      • Arlington, Virginia, United States, 22201
        • Comprehensive Neuroscience Of
    • Washington
      • Bellevue, Washington, United States, 98004
        • Northwest Clinical Research
      • Seattle, Washington, United States, 98104
        • Summit Seattle Boren
    • Wisconsin
      • Brown Deer, Wisconsin, United States, 53223
        • Northbrook Research Center
      • Middleton, Wisconsin, United States, 53562
        • Dean Foundation

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 64 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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).

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: Single Group Assignment
  • Masking: None (Open Label)

Collaborators and Investigators

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

Sponsor

Cephalon

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

January 1, 2005

Study Completion

December 1, 2006

Study Registration Dates

First Submitted

September 14, 2005

First Submitted That Met QC Criteria

September 21, 2005

First Posted (Estimate)

September 22, 2005

Study Record Updates

Last Update Posted (Estimate)

May 9, 2014

Last Update Submitted That Met QC Criteria

May 8, 2014

Last Verified

May 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • C6671/3033/AX/US

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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3
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