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Gabitril

Phase 3

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

Gabitril development status

Highest phase Phase 3
Registered trials 4 across 1 sponsor since Sep 2001

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindUNCONTROLLED
Total Trials5
Total Enrollment1,760

FDA Designations

No designations recorded

Gabitril clinical trials

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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Competitive Landscape -Anxiety Disorders 40 trials (matched to "Anxiety Disorder")

Frequently asked questions about Gabitril

What is Gabitril?

Gabitril is a small molecule drug developed by Teva Pharmaceutical Industries Limited, which trades under the ticker TEVA. It is being studied as a treatment for anxiety disorders, including generalized anxiety disorder. Gabitril is also known by the chemical name tiagabine hydrochloride and by the development code CEP-6671.

What is Gabitril used for in generalized anxiety disorder?

Gabitril is being evaluated for the treatment of generalized anxiety disorder in adults. Its clinical program includes Phase 3 trials in this indication, with studies enrolling adults aged 18 years and older. The trials were conducted in the United States and Canada and have been completed.

Who makes Gabitril?

Gabitril is developed by Teva Pharmaceutical Industries Limited, which is listed under the ticker symbol TEVA. Teva is the sponsor of the clinical development program evaluating Gabitril in anxiety disorders, including generalized anxiety disorder.

What phase is Gabitril in?

Gabitril is in Phase 3 clinical development for anxiety disorders, including generalized anxiety disorder. The completed Phase 3 studies were randomized and double blind, and enrolled adults aged 18 years and older. Gabitril remains an investigational treatment in this development program.

What clinical trials is Gabitril in?

Gabitril has been studied in completed Phase 3 trials, including NCT00236067, NCT00236054, NCT00236015, and NCT00233675. These trials evaluated Gabitril in adults with generalized anxiety disorder or anxiety disorder, with enrollment of 440 or 880 participants in the individual studies. The studies took place in the United States and Canada.

Is Gabitril the same as tiagabine hydrochloride?

Yes, Gabitril is the brand name for tiagabine hydrochloride, which is also identified by the development code CEP-6671. These names refer to the same small molecule drug developed by Teva Pharmaceutical Industries Limited for anxiety disorders, including generalized anxiety disorder.