CLINICAL TRIALS PROFILE FOR GABITRIL

All Clinical Trials for GABITRIL

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00214994 ↗	Study to Evaluate the Safety and Efficacy of GABITRIL Treatment in Adults With Generalized Anxiety Disorder.	Completed	Cephalon	Phase 3	2005-01-01	A 12-Month, Open-Label, Flexible-Dosage Study to Evaluate the Safety and Efficacy of GABITRIL Treatment in Adults with Generalized Anxiety Disorder.
NCT00174850 ↗	Switching From an SSRI to Tiagabine(GABITRIL) in Order to Alleviate SSRI Induced Sexual Dysfunction	Completed	State University of New York - Upstate Medical University	Phase 4	2004-07-01	Anxious patients are now treated with Selective Serotonin Reuptake Inhibitor medications (common antidepressants) which elevate serotonin and thus alleviate anxiety. These medications have clearly proven efficacy upwards of 70% for many anxiety disorders. In regards to tolerability, they have a major problem in that they often produce sexual dysfunction in men and women (ie. decreased libido, anorgasmia, impotence) upwards of 30% of the time. Benzodiazepine anxiolytics are also FDA approved to treat anxiety with equal efficacy and greater tolerability (very little, if any sexual dysfunction). They do, however, carry a substantial risk for addiction. Tiagabine is a Selective GABA Reuptake Inhibitor (SGRI) that is FDA approved to treat certain types of epilepsy. Like benzodiazepines, Tiagabine also increases the neurotransmitter, GABA, in the brain and is thought to alleviate anxiety (see references below) this way too, but without any addiction risk common to Valium-type drugs. The safety profile of Tiagabine is thought to be much safer. Two double blind studies are ongoing which are looking at Tiagabine's effectiveness in PTSD and GAD. There are many open label studies showing anxiety reduction and many psychiatrists in clinical practice are utilizing this agent as an anxiety treatment in an off-label manner. This study is designed to evaluate anxious patients who are taking SSRI medication, have had a reasonable response, but are experiencing significant sexual side effects which are pushing them towards noncompliance and possible relapse into anxiety. 30 subjects (15 men and 15 women) will be asked to join the study and be placed on Tiagabine as well as their current SSRI. Once an acceptable dose of Tiagabine is reached in the first four weeks, the subjects' SSRIs will be slowly stopped. Two weeks after enrollment, all subjects will be called in order to check for any side effects to the study drug and to insure that each subject is titrating to the proper dose of study drug according to the study protocol. An open-label, non-placebo prospective 10 week follow up will occur, where the now Tiagabine monotherapy subjects will be followed to see primarily if their sexual dysfunction improves and if there anxiety remains controlled.
NCT00179465 ↗	Treating Schizophrenia by Correcting Abnormal Brain Development	Active, not recruiting	Dartmouth-Hitchcock Medical Center	Phase 3	2003-11-01	The purpose of this study is to determine whether treatment with tiagabine (Gabitril) during the early course of schizophrenia can fundamentally correct the brain deficits associated with the disease. This study is funded by the National Institutes of Health.
NCT00179465 ↗	Treating Schizophrenia by Correcting Abnormal Brain Development	Active, not recruiting	Beth Israel Deaconess Medical Center	Phase 3	2003-11-01	The purpose of this study is to determine whether treatment with tiagabine (Gabitril) during the early course of schizophrenia can fundamentally correct the brain deficits associated with the disease. This study is funded by the National Institutes of Health.
NCT00233675 ↗	Evaluate the Safety of GABITRIL in Adults With Generalized Anxiety Disorder	Completed	Cephalon	Phase 3	2003-08-01	To assess the long-term safety and tolerability of tiagabine treatment in patients with generalized anxiety disorder (GAD).
NCT00208741 ↗	Study To Evaluate The Effects Of Gabitril™ In Patients With Social Anxiety Disorder	Completed	Cephalon	Phase 4	2002-06-01	The main purpose of this study is to determine how safe and effective Gabitril is for outpatients with Social Anxiety Disorder (SAD).
NCT00208741 ↗	Study To Evaluate The Effects Of Gabitril™ In Patients With Social Anxiety Disorder	Completed	Emory University	Phase 4	2002-06-01	The main purpose of this study is to determine how safe and effective Gabitril is for outpatients with Social Anxiety Disorder (SAD).

Clinical Trial Conditions for GABITRIL

Condition Name

Condition Name for GABITRIL
Intervention	Trials
Generalized Anxiety Disorder	2
Social Anxiety Disorder	1
Alcoholism	1
Anxiety	1

Condition MeSH

Condition MeSH for GABITRIL
Intervention	Trials
Anxiety Disorders	7
Disease	6
Phobia, Social	1
Sleep Apnea, Obstructive	1

Clinical Trial Locations for GABITRIL

Trials by Country

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Trials by Country for GABITRIL
Location	Trials
United States	113
Canada	10

Trials by US State

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Trials by US State for GABITRIL
Location	Trials
New York	7
Georgia	6
California	5
Massachusetts	5
Pennsylvania	5

Clinical Trial Progress for GABITRIL

Clinical Trial Phase

Clinical Trial Phase for GABITRIL
Clinical Trial Phase	Trials
Phase 4	2
Phase 3	6
Phase 2	1

Clinical Trial Status

Clinical Trial Status for GABITRIL
Clinical Trial Phase	Trials
Completed	9
Active, not recruiting	1

Clinical Trial Sponsors for GABITRIL

Sponsor Name

Sponsor Name for GABITRIL
Sponsor	Trials
Cephalon	6
Brigham and Women's Hospital	1
State University of New York - Upstate Medical University	1

Sponsor Type

Sponsor Type for GABITRIL
Sponsor	Trials
Other	6
Industry	6

Gabitril (Tiagabine): Clinical Trials, Market Analysis, and Projections

Introduction to Gabitril

Gabitril, also known as tiagabine, is an antiepileptic drug (AED) that inhibits the uptake of γ-aminobutyric acid (GABA) into glial and neuronal elements. This mechanism of action makes it a unique and effective treatment for certain types of seizures.

Clinical Trials Overview

Design and Setting

Clinical trials for Gabitril have been extensive and well-structured. One notable study was a randomized, double-blind, placebo-controlled trial conducted across 21 US medical centers. This study involved patients aged 12 to 77 years who had complex partial seizures (CPS) and were already on stable regimens of other AEDs[1].

Patient Population and Interventions

The trial included 297 patients who were randomized to receive either placebo or tiagabine at doses of 16 mg, 32 mg, or 56 mg per day. The study had a 12-week unblinded baseline phase followed by a 20-week double-blind treatment phase. During the first 4 weeks of the treatment phase, the tiagabine dose was titrated to the assigned level, and patients were monitored for adverse events and compliance[1].

Efficacy and Tolerability

The primary outcome variable was the change in 4-week median CPS frequency from the baseline phase to the double-blind treatment phase. The results showed that tiagabine significantly reduced the frequency of CPS, particularly at doses of 32 mg and 56 mg per day. Between 24% and 50% of patients experienced a reduction in seizure rates of 50% or more, depending on the type of partial seizure[1][3].

Adverse Events

Adverse events associated with Gabitril were generally mild or moderate and transient, occurring mainly during the dose titration period. Common adverse events included dizziness, asthenia, somnolence, nausea, nervousness, tremor, and abdominal pain. Approximately 21% of patients discontinued treatment due to adverse events, with dizziness, somnolence, and depression being the most common reasons[1][4].

Market Analysis

Global Antiepileptic Drugs Market

The global antiepileptic drugs (AED) market, which includes Gabitril, is projected to grow from $17.13 billion in 2024 to $24.85 billion by 2032, at a CAGR of 4.8%. North America, particularly the U.S., dominates this market, driven by the increasing prevalence of epilepsy and significant FDA approvals[5].

Specific Market Trends for Gabitril

While Gabitril is not as widely used as some other AEDs like gabapentin, it holds a niche position due to its unique mechanism of action. The market for Gabitril is influenced by the overall demand for AEDs, especially in regions with high prevalence rates of epilepsy.

Regional Market Insights

• North America: This region, led by the U.S., is a significant market for AEDs, including Gabitril. The U.S. market is expected to grow substantially due to increasing epilepsy prevalence and FDA approvals[5].
• Europe: Europe also represents a substantial market share, driven by an aging demographic and heightened awareness of neurological disorders. Countries like Germany are expected to see rapid growth in the AED market, including Gabitril[2].
• Asia Pacific: This region is expected to register the fastest CAGR, driven by increasing healthcare expenditures and a growing population, especially in countries like India and China[2].

Market Projections

Growth Drivers

• Increasing Prevalence of Epilepsy: The rising number of epilepsy cases globally is a key driver for the AED market, including Gabitril.
• Aging Population: The geriatric population is more susceptible to neurological disorders, leading to increased demand for AEDs.
• Generic Formulations: The increasing demand for generic formulations, particularly in developing regions, is expected to boost the market for AEDs like Gabitril[2].

Challenges and Opportunities

• Competition: The AED market is highly competitive, with many established drugs. However, Gabitril's unique mechanism of action provides it with a niche market.
• Regulatory Approvals: Continuous regulatory approvals and investments in R&D for improved formulations are expected to drive market growth.
• Emerging Markets: The Asia Pacific region, especially countries like India, offers significant growth opportunities due to increasing healthcare spending and awareness of neurological treatments[2][5].

Key Takeaways

• Clinical Efficacy: Gabitril has demonstrated significant efficacy in reducing the frequency of complex partial seizures in clinical trials.
• Market Growth: The global AED market, including Gabitril, is projected to grow at a CAGR of 4.8% from 2024 to 2032.
• Regional Insights: North America, Europe, and the Asia Pacific are key regions driving the market growth for AEDs.
• Growth Drivers: Increasing epilepsy prevalence, an aging population, and the demand for generic formulations are major growth drivers.

FAQs

What is Gabitril used for?

Gabitril (tiagabine) is used as an adjunctive therapy for the treatment of complex partial seizures in patients with epilepsy.

What is the mechanism of action of Gabitril?

Gabitril inhibits the uptake of γ-aminobutyric acid (GABA) into glial and neuronal elements, thereby increasing the concentration of GABA in the synaptic cleft.

What are the common adverse events associated with Gabitril?

Common adverse events include dizziness, asthenia, somnolence, nausea, nervousness, tremor, and abdominal pain.

How does the market for Gabitril compare to other AEDs?

While Gabitril is not as widely used as some other AEDs like gabapentin, it holds a niche position due to its unique mechanism of action and is part of a growing global AED market.

What are the key regions driving the growth of the AED market?

North America, Europe, and the Asia Pacific are the key regions driving the growth of the AED market, including Gabitril.

Sources

1. Tiagabine for Complex Partial Seizures: A Randomized, Add-on Trial - JAMA Network
2. Gabapentin Market Size And Share | Industry Report, 2030 - Grand View Research
3. Review of controlled trials of gabitril (tiagabine): a clinician's viewpoint - PubMed
4. Gabitril (Tiagabine Hydrochloride): Side Effects, Uses - RxList
5. Antiepileptic Drugs [AED] Market Size, Trends | Forecast, 2032 - Fortune Business Insights