Clinical Trials Logo
  1. Home
  2. Huntington's Disease
  3. NCT00219804
  4. Details
NCT00219804 Clinical Trial

Efficacy and Safety of Tetrabenazine in Chorea

Huntington's Disease Clinical Trial

Official title:
A Randomized, Double-Blind, Placebo-Controlled Study of Tetrabenazine for the Treatment of Huntington's Chorea

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00219804
Other study ID # 103,004
Secondary ID
Status Completed
Phase Phase 3
First received September 14, 2005
Last updated September 14, 2005

Study information
Verified date September 2005
Source Prestwick Pharmaceuticals
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

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

Recruitment information / eligibility
Status Completed
Enrollment 0
Est. completion date
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double-Blind

Related Conditions & MeSH terms

Intervention

Drug:
• tetrabenazine or placebo

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Prestwick Pharmaceuticals
See also
  Status Clinical Trial Phase
Recruiting NCT04120493 - Safety and Proof-of-Concept (POC) Study With AMT-130 in Adults With Early Manifest Huntington's Disease Phase 1/Phase 2
Completed NCT02956148 - Follow-up Measurement of Brain PDE10A Enzyme Levels in Huntington´s Disease Gene Expansion Carriers Early Phase 1
Terminated NCT02494778 - A Study Evaluating if Pridopidine is Safe, Efficacious, and Tolerable in Patients With Huntington's Disease Phase 2
Completed NCT02197130 - Randomized, Placebo Controlled Study Of The Efficacy And Safety Of PF-02545920 In Subjects With Huntington's Disease Phase 2
Completed NCT02216474 - Brain Stimulation in Movement Disorders N/A
Completed NCT02208934 - Study To Assess the Safety and Tolerability of Single Ascending Oral Doses of PBF-999 in Healthy Young Male Volunteers Phase 1
Completed NCT01806896 - Study Evaluating The Safety, Tolerability And Brain Function Of 2 Doses Of PF-0254920 In Subjects With Early Huntington's Disease Phase 2
Completed NCT01502046 - Neuroprotection by Cannabinoids in Huntington's Disease Phase 2
Terminated NCT00712426 - Creatine Safety, Tolerability, & Efficacy in Huntington's Disease (CREST-E) Phase 3
Completed NCT00670709 - Examination of Quantitative Electroencephalographic (QEEG) Biomarkers in Huntington's Disease
Completed NCT00029874 - Minocycline in Patients With Huntington's Disease Phase 1/Phase 2
Terminated NCT02231580 - Study Exploring Safety, Pharmacokinetic and Pharmacodynamic of BN82451 in Male Huntington's Disease Patients Phase 2
Completed NCT02215616 - A Clinical Study in Participants With Huntington's Disease (HD) to Assess Efficacy and Safety of Three Oral Doses of Laquinimod Phase 2
Not yet recruiting NCT02551705 - Functional Imaging of Social Cognition in Premanifest Huntington's Disease N/A
Active, not recruiting NCT02101957 - Multicentric Trial of the Treatment of Huntington's Disease by Cysteamine (RP103) Phase 2/Phase 3
Completed NCT00975481 - A Study To Evaluate The Abuse Potential Of Single Oral Doses Of Dimebon (Latrepirdine) In Healthy Recreational Polydrug Users Phase 1
Completed NCT00990613 - A Study Evaluating The Absorption Of Dimebon Into The Body From A Dimebon Solution Applied To The Skin Phase 1
Completed NCT01521832 - Escalating Dose Study in Healthy Volunteers With SEN0014196 Phase 1
Completed NCT00387270 - Safety Study of the Novel Drug Dimebon to Treat Patients With Huntington's Disease Phase 1/Phase 2
Completed NCT00095355 - Effects of Lithium and Divalproex`on Brain-Derived Neurotrophic Factor in Huntington's Disease Phase 2