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GABITRIL

Phase 3

General Anxiety Disorder | Small molecule | Psychiatry |Teva Pharmaceutical Industries Limited|Last Updated: Apr 12, 2023

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLED
Total Trials1
Total Enrollment -

FDA Designations

No designations recorded

Clinical trial landscape

GABITRIL · 5 trials · 4 indications

Phase 3 5
NCT00214994Study to Evaluate the Safety and Efficacy of GABITRIL Treatment in Adults With Generalized Anxiety Disorder.Anxiety Disorders
COMPLETED- Analytics
NCT00236015A 10-Week Efficacy and Safety Study of Gabitril in the Treatment of Adults With Generalized Anxiety DisorderAnxiety Disorder
COMPLETED880 Analytics
NCT00236054A 10-Week Efficacy and Safety Study for of Gabitril in the Treatment of Adults With Generalized Anxiety DisorderGeneralized Anxiety Disorder
COMPLETED440 Analytics
NCT00236067A 10-Week Study for Efficacy and Safety Study of Gabitril in the Treatment of Adults With Generalized Anxiety DisorderGeneralized Anxiety Disorder
COMPLETED440 Analytics
NCT00233675Evaluate the Safety of GABITRIL in Adults With Generalized Anxiety DisorderGeneral Anxiety Disorder
COMPLETED- Analytics
PHASE3COMPLETED
Study to Evaluate the Safety and Efficacy of GABITRIL Treatment in Adults With Generalized Anxiety Disorder.
Anxiety DisordersUnlock trial analytics
PHASE3COMPLETED
A 10-Week Efficacy and Safety Study of Gabitril in the Treatment of Adults With Generalized Anxiety Disorder
Anxiety DisorderUnlock trial analytics
PHASE3COMPLETED
A 10-Week Efficacy and Safety Study for of Gabitril in the Treatment of Adults With Generalized Anxiety Disorder
Generalized Anxiety DisorderUnlock trial analytics
PHASE3COMPLETED
A 10-Week Study for Efficacy and Safety Study of Gabitril in the Treatment of Adults With Generalized Anxiety Disorder
Generalized Anxiety DisorderUnlock trial analytics
PHASE3COMPLETED
Evaluate the Safety of GABITRIL in Adults With Generalized Anxiety Disorder
General Anxiety DisorderUnlock trial analytics

Study Endpoints

Primary Endpoints

Reduction of symptomatology associated with Generalized Anxiety Disorder as assessed by the change from baseline to end point in the total score of the HAM-A scale.
Reduction of symptomatology associated with Generalized Anxiety Disorder as assessed by the change from baseline to endpoint in the total score of the HAM-A scale.

Secondary Endpoints

Assessment of proportion of responders and patients in remission according to HAM-A scores and CGI ratings by visit, assessment of the safety and tolerability in patients with GAD
Assessment of proportion of responders and
patients in remission according to HAM-A scores and CGI ratings by
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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Interventions

NameTypeDescription
GabitrilDRUG -
GABITRIL (tiagabine hydrochloride; CEP-6671)DRUG -
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Eligibility Criteria

Age Range18 Years to 64 Years
SexALL
Healthy VolunteersNo
Study Sites93

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).

Countries:United StatesCanada
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Frequently asked questions about GABITRIL

What is GABITRIL used for?

GABITRIL is a small molecule being studied for the treatment of generalized anxiety disorder in adults. It is an investigational drug in Phase 3 clinical development and has not been approved by the FDA. Clinical trials have evaluated its safety and efficacy in patients with generalized anxiety disorder.

Who makes GABITRIL?

GABITRIL is being developed by Teva Pharmaceutical Industries Limited, a company publicly traded under the ticker TEVA. The drug is currently in Phase 3 clinical trials for generalized anxiety disorder, with studies conducted in the United States and Canada.

What phase is GABITRIL in?

GABITRIL is in Phase 3 clinical development for the treatment of generalized anxiety disorder. It is an investigational drug, meaning it has not received FDA approval. Several Phase 3 trials have been completed to evaluate its safety and efficacy in adult patients.

What clinical trials has GABITRIL been in?

GABITRIL has been studied in multiple Phase 3 clinical trials, including NCT00233675, NCT00236015, NCT00236054, and NCT00236067. These trials evaluated the safety and efficacy of GABITRIL in adults with generalized anxiety disorder. All trials have been completed, with total enrollment across studies reaching 880 participants.

Is GABITRIL FDA approved?

GABITRIL is not FDA approved. It is an investigational drug currently in Phase 3 clinical trials for generalized anxiety disorder. The completed trials have assessed its safety and efficacy, but regulatory approval has not been granted.