Evaluate the Safety of GABITRIL in Adults With Generalized Anxiety Disorder

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00233675
Recruitment Status : Completed
First Posted : October 6, 2005
Last Update Posted : May 9, 2014
Information provided by (Responsible Party):
Teva Pharmaceutical Industries ( Cephalon )

Brief Summary:
To assess the long-term safety and tolerability of tiagabine treatment in patients with generalized anxiety disorder (GAD).

Condition or disease Intervention/treatment Phase
General Anxiety Disorder Drug: GABITRIL (tiagabine hydrochloride; CEP-6671) Phase 3

Study Type : Interventional  (Clinical Trial)
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A 12-Month, Open-Label, Flexible-Dosage Study to Evaluate the Safety of GABITRIL at Dosages up to 16mg/Day in Adults With Generalized Anxiety Disorder
Study Start Date : August 2003
Actual Primary Completion Date : February 2005

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety
U.S. FDA Resources

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior

Information from the National Library of Medicine

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Please refer to this study by its identifier (NCT number): NCT00233675

  Hide Study Locations
United States, Arizona
Pivotal Research Center
Mesa, Arizona, United States, 85210
United States, California
Southwestern Research
Beverly Hills, California, United States, 90210
Pharmacology Research Institut
Newport Beach, California, United States, 92660
Pharmacology Research Institut
Northridge, California, United States, 91324
Pacific Clinical Research Medi
Orange, California, United States, 92868
Radiant Research San Diego
San Diego, California, United States, 92103
Affiliated Research Institute
San Diego, California, United States, 92108
United States, Colorado
Radiant Research Denver
Denver, Colorado, United States, 80212
United States, Connecticut
University of Connecticut
Farmington, Connecticut, United States, 06030
United States, Florida
Clinical Neuroscience Solution
Jacksonville, Florida, United States, 32216
Clinical Neuroscience Solution
West Palm Beach, Florida, United States, 33407
United States, Georgia
Carman Research
Smyrna, Georgia, United States, 30080
United States, Illinois
Cunningham Clinical Research
Edwardsville, Illinois, United States, 62025
United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
United States, Michigan
Summit Research Network Farmin
Farmington Hills, Michigan, United States, 48336
United States, New Jersey
CNS Research Institute
Clementon, New Jersey, United States, 08021
United States, New York
Social Psychiatry Research Ins
Brooklyn, New York, United States, 11235
Fieve Clinical Services, Inc.
New York, New York, United States, 10021
Medical and Behavioral
New York, New York, United States, 10023
Medical Research Network
New York, New York, United States, 10024
United States, North Carolina
Richard Weisler, MD and Assoc
Raleigh, North Carolina, United States, 27609
United States, Oregon
Summit Research Network Inc.
Portland, Oregon, United States, 97210
United States, Pennsylvania
University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
United States, South Carolina
South East Health Consultants
Charleston, South Carolina, United States, 29407
United States, Texas
Claghorn-Lesem Research
Bellaire, Texas, United States, 77401
United States, Utah
Radiant Research Salt Lake
Salt Lake City, Utah, United States, 84107
United States, Virginia
Comprehensive Neuroscience Of
Falls Church, Virginia, United States, 22041
United States, Washington
Summit Seattle Boren
Seattle, Washington, United States, 98104
Sponsors and Collaborators
Study Director: Charles Brown, MD Cephalon

Responsible Party: Cephalon Identifier: NCT00233675     History of Changes
Other Study ID Numbers: C6671A/301/AX/US
First Posted: October 6, 2005    Key Record Dates
Last Update Posted: May 9, 2014
Last Verified: May 2014

Additional relevant MeSH terms:
Anxiety Disorders
Pathologic Processes
Mental Disorders
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Physiological Effects of Drugs
GABA Agonists
GABA Agents