Trial status: This Phase III trial began April 2008 in Europe and the U.K., coordinated by the European Huntington Disease Network (EHDN). The U.S. Phase II trial, coordinated by the Huntington Study Group began recruitment in North America at first sites in October 2008.

FDA phase: Phase III trial in Europe. Phase II trial in the U.S.

Sponsor: NeuroSearch

Trial design: The European Trial (MermaHD) is a randomized, double-blind, placebo controlled trial of ACR-16 using 2 different doses for six months. This trial has completed enrollment of 420 participants. The North American trial (HART) is also a randomized, double-blind, placebo controlled trial lasting 3 months using 3 different doses of ACR-16. This trial continues to enroll, and will need 220 participants.

Outcome measures: Comparison of motor, cognitive, behavioral, and functional capacity scores before and after 6 months of treatment with ACR-16 (in Europe), or 3 months of treatment (in North America). Voluntary motor function will be the primary outcome measure.

Location: Sites in in Europe and the U.K, and Sites in North America and trial descriptions can be found on the ClinicalTrials.gov web source. The trials will be performed with the assistance of the Huntington Study Group and European Huntington's Disease Association.