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Evaluate the Safety of GABITRIL in Adults With Generalized Anxiety Disorder

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Teva Pharmaceutical Industries ( Cephalon )
ClinicalTrials.gov Identifier:
NCT00233675
First received: September 27, 2005
Last updated: May 8, 2014
Last verified: May 2014
  Purpose

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


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

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Teva Pharmaceutical Industries:

Study Start Date: August 2003
Primary Completion Date: February 2005 (Final data collection date for primary outcome measure)
  Eligibility

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00233675

  Hide Study Locations
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
Affiliated Research Institute
San Diego, California, United States, 92108
Radiant Research San Diego
San Diego, California, United States, 92103
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
Cephalon
Investigators
Study Director: Charles Brown, MD Cephalon
  More Information

No publications provided

Responsible Party: Teva Pharmaceutical Industries ( Cephalon )
ClinicalTrials.gov Identifier: NCT00233675     History of Changes
Other Study ID Numbers: C6671A/301/AX/US
Study First Received: September 27, 2005
Last Updated: May 8, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Anxiety Disorders
Disease
Mental Disorders
Pathologic Processes
Tiagabine
Anticonvulsants
Central Nervous System Agents
GABA Agents
GABA Agonists
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Neurotransmitter Uptake Inhibitors
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on November 25, 2014