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

This study has been completed.
Sponsor:
Information provided by:
Cephalon
ClinicalTrials.gov Identifier:
NCT00214994
First received: September 14, 2005
Last updated: September 7, 2007
Last verified: September 2007
History of Changes
  Purpose

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


Condition Intervention Phase
Anxiety Disorders
 Drug: Gabitril
 Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
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 and Efficacy of GABITRIL Treatment (up to 16 mg/Day) in Adults With Generalized Anxiety Disorder.

Resource links provided by NLM:

MedlinePlus related topics: Anxiety
U.S. FDA Resources

Further study details as provided by Cephalon:

Study Start Date: January 2005
Estimated Study Completion Date: December 2006
  Eligibility

Ages Eligible for Study:   18 Years to 64 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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).

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00214994

  Show 93 Study Locations
Sponsors and Collaborators
Cephalon
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00214994     History of Changes
Other Study ID Numbers: C6671/3033/AX/US
Study First Received: September 14, 2005
Last Updated: September 7, 2007
Health Authority: United States: Food and Drug Administration
Canada: Health Canada

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

ClinicalTrials.gov processed this record on June 18, 2013