CLINICAL TRIALS PROFILE FOR TETRABENAZINE

All Clinical Trials for Tetrabenazine

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00219804 ↗	Efficacy and Safety of Tetrabenazine in Chorea	Completed	Prestwick Pharmaceuticals	Phase 3	1969-12-31	The primary objective of this study was to establish the absolute reduction of chorea in participants with Huntington's disease(HD) treated with tetrabenazine or placebo
NCT00362804 ↗	Tetrabenazine for Partial Responders	Completed	Stanley Medical Research Institute	N/A	2002-02-01	Purpose of Study: A) To improve outcome in large population of antipsychotic patients with schizophrenia or schizoaffective who are only partial responders B) To increase understanding of pharmacology and mechanisms of action underlying antipsychotic effect Hypothesis/Objectives of the Study: Tetrabenazine, through its pre-synaptic action, should augment the post-synaptic effects of an antipsychotic. Background and Rationale for the study: Preliminary evidence that other amine-depleting agents e.g., reserpine, can induce such an effect
NCT00362804 ↗	Tetrabenazine for Partial Responders	Completed	Centre for Addiction and Mental Health	N/A	2002-02-01	Purpose of Study: A) To improve outcome in large population of antipsychotic patients with schizophrenia or schizoaffective who are only partial responders B) To increase understanding of pharmacology and mechanisms of action underlying antipsychotic effect Hypothesis/Objectives of the Study: Tetrabenazine, through its pre-synaptic action, should augment the post-synaptic effects of an antipsychotic. Background and Rationale for the study: Preliminary evidence that other amine-depleting agents e.g., reserpine, can induce such an effect
NCT00632645 ↗	Neuroleptic and Huntington Disease Comparison of : Olanzapine, la Tetrabenazine and Tiapride	Completed	Assistance Publique - Hôpitaux de Paris	Phase 3	2009-04-01	Huntington's disease (HD) is autosomal dominant neurodegenerative disease, starting in average (with high variability) in the fourth decade. The disease progression is classically characterized by a cognitive deterioration (cortical-frontal dementia), motor disorders (associating chorea, dystonia and bradykinesia), psychiatric disturbances (combining depression and irritability) and metabolic disorder (cachexia). The disease is fatal within 15 to 20 years in most patients. HD has no cure. Neuroleptics are the main drug used and the only to demonstrate its efficacy on chorea in clinical trials. But neuroleptics have also beneficial and adverse effects on other disease characteristics (motor, psychiatric, cognitive or metabolic). Their profile between beneficial and adverse effects could be different according the neuroleptics and their classification. The aim of this study is to compare beneficial and adverse effects of 3 different neuroleptics in HD.

Clinical Trial Conditions for Tetrabenazine

Condition Name

Condition Name for Tetrabenazine
Intervention	Trials
Healthy	2
Huntington Disease	2
Huntington's Disease	2
Schizoaffective Disorder	2

Condition MeSH

Condition MeSH for Tetrabenazine
Intervention	Trials
Huntington Disease	5
Movement Disorders	2
Schizophrenia	2
Psychotic Disorders	2

Clinical Trial Locations for Tetrabenazine

Trials by Country

Trials by Country for Tetrabenazine
Location	Trials
United States	29
France	3
Canada	3
India	2
Australia	1

Trials by US State

Trials by US State for Tetrabenazine
Location	Trials
Texas	2
New York	2
Wisconsin	1
Washington	1
Vermont	1

Clinical Trial Progress for Tetrabenazine

Clinical Trial Phase

Clinical Trial Phase for Tetrabenazine
Clinical Trial Phase	Trials
Phase 4	2
Phase 3	4
Phase 2	1

Clinical Trial Status

Clinical Trial Status for Tetrabenazine
Clinical Trial Phase	Trials
Completed	10
Recruiting	1
Withdrawn	1

Clinical Trial Sponsors for Tetrabenazine

Sponsor Name

Sponsor Name for Tetrabenazine
Sponsor	Trials
Dr. Reddy's Laboratories Limited	2
William Ondo, MD	1
Assistance Publique - Hôpitaux de Paris	1

Sponsor Type

Sponsor Type for Tetrabenazine
Sponsor	Trials
Other	14
Industry	7

Tetrabenazine: Clinical Trials, Market Analysis, and Projections

Introduction to Tetrabenazine

Tetrabenazine, marketed under the brand name Xenazine, is a significant medication in the treatment of Huntington's disease (HD), particularly for managing chorea, a hallmark symptom of the condition. Here, we will delve into the current clinical trials, market analysis, and future projections for tetrabenazine.

Clinical Trials and Efficacy

Phase 3 Clinical Trials

The efficacy of tetrabenazine was prominently demonstrated in the pivotal phase 3 clinical trial, Efficacy and Safety of Tetrabenzine in Chorea (TETRA-HD, NCT00219804). This multicenter, prospective, double-blind, placebo-controlled trial involved 84 patients, with 54 receiving tetrabenazine and 30 receiving a placebo for 12 weeks. The trial showed that tetrabenazine significantly reduced the severity of chorea, as indicated by a decrease of 5 units on the Total Maximal Chorea (TMC) score of the Unified Huntington’s Disease Rating Scale (UHDRS), compared to a 1.5-unit decrease in the placebo group[1].

Long-Term Safety and Efficacy

A subsequent open-label study evaluated the long-term safety and efficacy of tetrabenazine over 80 weeks. This study included patients who had completed the 12-week phase 3 trial and showed that tetrabenazine continued to suppress chorea related to HD. However, patients were monitored for potential adverse effects such as parkinsonism, dysphagia, sleep disturbances, depression, anxiety, and akathisia[1].

Ongoing Clinical Trials

Currently, a phase 4 clinical trial is ongoing to assess whether tetrabenazine can reduce impulsivity in patients with HD, as well as its effects on mood and thinking. This trial involves evaluating patients with tests for suicidal ideation, depression, and impulsivity before and during treatment[1].

Market Analysis

Market Dominance

Tetrabenazine has been the leading drug in the global Huntington’s disease treatment market. It was the first FDA-approved drug for treating chorea associated with HD, which has driven its widespread adoption. The availability of generic versions of tetrabenazine has further boosted its market share[2][3][5].

Regional Market Performance

The North American market has been a significant contributor to the global Huntington’s disease treatment market, with the region expected to continue dominating during the forecast period. Other regions, such as Latin America and the Middle East & Africa, are expected to experience slower growth due to lower prevalence rates and lower adoption rates, although there is potential for growth as awareness and reimbursement policies improve[2][5].

Competitive Landscape

Teva Pharmaceutical Industries Ltd. is a major player in the market, particularly with its drug AUSTEDO (deutetrabenazine), which has seen steady adoption since its FDA approval in 2017. Other key players include H. Lundbeck A/S, Bausch Health Companies Inc., Sun Pharmaceutical Industries, Inc., Lupin, Dr. Reddy’s Laboratories Ltd., and Hikma Pharmaceuticals PLC, which are primarily generic manufacturers of tetrabenazine[2].

Market Projections

Growth Rate and Market Size

The global Huntington’s disease treatment market is projected to grow at a CAGR of 11.7% from 2024 to 2032, with the market size expected to reach USD 2.932 billion by 2030. The tetrabenazine segment is anticipated to continue experiencing robust demand due to its efficacy and the availability of generic versions[2][5].

Driving Factors

The increasing prevalence of Huntington’s disease globally, along with growing government support for awareness and treatment, are key factors driving market growth. Early diagnosis and timely treatment also contribute to the demand for tetrabenazine and other HD therapeutics[2][5].

Distribution Channels

Hospital pharmacies are expected to capture the largest share of the Huntington’s disease treatment market in the coming years due to the easy availability of these medications in these settings[5].

Adverse Effects and Safety Considerations

Tetrabenazine, while effective, comes with significant adverse effects that need careful monitoring. These include suicidal thoughts and behavior, depression, restlessness, complicated falls, breast cancer, and withdrawal symptoms. Patients must be screened carefully before initiating treatment, and ongoing monitoring is essential to manage these risks[1][2].

Key Takeaways

• Clinical Efficacy: Tetrabenazine has demonstrated significant efficacy in reducing chorea symptoms in HD patients through various clinical trials.
• Market Dominance: It remains the leading drug in the global Huntington’s disease treatment market due to its FDA approval and availability of generic versions.
• Growth Projections: The market is expected to grow at a CAGR of 11.7% from 2024 to 2032, driven by increasing prevalence and government support.
• Safety Considerations: Careful patient screening and ongoing monitoring are crucial due to potential adverse effects.

FAQs

What is the primary use of tetrabenazine in medical treatment?

Tetrabenazine is primarily used to treat chorea, a symptom associated with Huntington’s disease.

What were the key findings of the TETRA-HD clinical trial?

The TETRA-HD trial showed that tetrabenazine significantly reduced chorea severity in HD patients, with a 5-unit decrease in the TMC score of the UHDRS compared to a 1.5-unit decrease in the placebo group[1].

What are the common adverse effects associated with tetrabenazine?

Common adverse effects include suicidal thoughts and behavior, depression, restlessness, complicated falls, breast cancer, and withdrawal symptoms[1][2].

Which region is expected to dominate the Huntington’s disease treatment market?

North America is expected to continue dominating the market during the forecast period due to high prevalence rates and strong healthcare infrastructure[2][5].

What is the projected growth rate of the global Huntington’s disease treatment market?

The market is projected to grow at a CAGR of 11.7% from 2024 to 2032[2][5].

References

1. Rare Disease Advisor: Xenazine (Tetrabenazine) - Rare Disease Advisor.
2. Fortune Business Insights: Huntington's Disease Treatment Market Size, Share [2032].
3. Maximize Market Research: Huntington's Disease Treatment Market: Global Industry Analysis.
4. JAMA Network: Effect of Deutetrabenazine on Chorea Among Patients With Huntington Disease.
5. GlobeNewswire: Huntington's Disease Treatment Market Size to Hit USD 2.932 Billion By 2030 at a CAGR of 17.5%.