A randomised phase II multicentre, double blind, parallel group, placebo controlled study of ACR16 50 mg once daily for the symptomatic treatment of Huntington disease

• Conditions: ACR16 belongs to a new class of CNS active agents called dopaminergic stabilizers. Dopaminergic stabilizers are compounds that can both enhance and counteract dopamine dependent functions in the CNS, depending on the initial level of dopaminergic activity. The stabilizing feature of such compounds is illustrated by their interaction with dopaminergic agonists.

• Registration Number: EUCTR2004-000394-60-DK
• Lead Sponsor: A. Carlsson Research AB

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2004-08-17
• Last Update Posted: 7 January 2013

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

Huntington disease diagnosed with the aid of clinical features and the presence of > 35 CAG repeats in the Huntington gene.

Ambulatory and willing and able to comply with the study specific procedures.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Second or third degree AV block or sick sinus syndrome; resting heart rate below 50 beats per minute; congestive heart failure classified as functional Class III or IV by the New York Heart Association; myocardial infarction within six months of baseline; a prolonged QTc interval at screen or pre-treatment (defined as a QTc interval of > 450 msec for males or > 470 msec for females); other clinically significant heart conditions which would negatively impact on the patient completing the study.

Serum creatinine concentrations above 200 mmol/l.

Any other clinically significant condition or laboratory assay abnormality that would interfere with the patient’s ability to participate in the study.

Female of childbearing potential.

Antichoreic medication, with exception of Risperidon, within 30 days before inclusion. If Risperidon has been taken the dose should have been kept stable for 30 days before inclusion and should remain stable throughout the study.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified