Efficacy and Safety of Tetrabenazine in Chorea

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Study Classification

INTERVENTIONAL

Brief Summary

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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

Detailed Description

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Conditions

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Huntington's Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

DOUBLE

Interventions

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tetrabenazine or placebo

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* 18 years of age or older
* suffer from manifest HD as confirmed by genetic testing
* Meet chorea and total functional capacity scores on Unified Huntington's Disease Rating Scale
* Meet criteria on Hamilton Depression Rating Scale, Unified Parkinson's Disease Rating Scale dysphagia and dysarthria scale
* Independently ambulatory

Exclusion Criteria

* previous treatment with tetrabenazine
* unstable or serious medical or psychiatric illness
* concomitant use identified drugs
* untreated depression
* lack of caregiver

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Principal Investigators

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Fred Marshall, M.D.

Role: PRINCIPAL_INVESTIGATOR

Huntington's Study Group

References

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Claassen DO, Carroll B, De Boer LM, Wu E, Ayyagari R, Gandhi S, Stamler D. Indirect tolerability comparison of Deutetrabenazine and Tetrabenazine for Huntington disease. J Clin Mov Disord. 2017 Mar 1;4:3. doi: 10.1186/s40734-017-0051-5. eCollection 2017.

Reference Type DERIVED

PMID: 28265459 (View on PubMed)

Frank S. Tetrabenazine as anti-chorea therapy in Huntington disease: an open-label continuation study. Huntington Study Group/TETRA-HD Investigators. BMC Neurol. 2009 Dec 18;9:62. doi: 10.1186/1471-2377-9-62.