Evaluate the Safety of GABITRIL in Adults With Generalized Anxiety Disorder

April 11, 2023 updated by: Cephalon

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

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

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

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

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

  • Adult

Accepts Healthy Volunteers

No

Description

Not available at time of registration

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

Investigators

  • Study Director: Charles Brown, MD, 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

August 1, 2003

Primary Completion (Actual)

February 1, 2005

Study Registration Dates

First Submitted

September 27, 2005

First Submitted That Met QC Criteria

September 27, 2005

First Posted (Estimate)

October 6, 2005

Study Record Updates

Last Update Posted (Actual)

April 12, 2023

Last Update Submitted That Met QC Criteria

April 11, 2023

Last Verified

April 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • C6671A/301/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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