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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:
Teva Pharmaceutical Industries
ClinicalTrials.gov Identifier:
NCT00214994
First received: September 14, 2005
Last updated: May 8, 2014
Last verified: May 2014
  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:


Further study details as provided by Teva Pharmaceutical Industries:

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

Ages Eligible for Study:   18 Years to 64 Years   (Adult)
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
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: NCT00214994

  Show 93 Study Locations
Sponsors and Collaborators
Cephalon
  More Information

ClinicalTrials.gov Identifier: NCT00214994     History of Changes
Other Study ID Numbers: C6671/3033/AX/US 
Study First Received: September 14, 2005
Last Updated: May 8, 2014
Health Authority: United States: Food and Drug Administration
Canada: Health Canada

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

ClinicalTrials.gov processed this record on September 26, 2016