HART - ACR16, a dopamine stabilizer
HART is a multi-center, North American, randomized, double-blind, parallel group study comparing three doses of ACR16 versus placebo for the symptomatic treatment of Huntington Disease.
The Huntington Study Group (HSG) is conducting a study of the research medication ACR16 in persons 30 years of age and older who have clinical features of Huntington Disease (HD). HART is designed to determine the general safety and tolerability and an effective dose of ACR16 as well as the effect of ACR16 on motor (movement) and cognitive (thinking) abilities in subjects with HD. Approximately 35 research centers in North America will enroll up to 220 subjects for 16 weeks each. Enrollment began in October 2008. This Phase IIB study is sponsored by NeuroSearch Sweden AB.
ACR16 belongs to a novel class of agents called dopaminergic stabilizers, which have the ability to either enhance or inhibit dopamine controlled functions depending upon the initial level of dopaminergic activity. ACR16 was previously evaluated in four clinical Phase I/II studies for Huntington's Disease, Parkinson's Disease and psychosis and demonstrated a good safety and tolerability profile. In a Phase II study with Huntington's Disease, the results showed that 28 days of treatment with ACR16 led to an improvement in the patients' voluntary movements, including Parkinsonism and gait.
Links for more information
eligibility and other information about the trial:
Clinicaltrials.gov information
about participating sites and contact people:
Huntington Study Group list of participating sites