Trial Status: Active. But no longer enrolling.

Trial name: First-HD

FDA phase: Phase III

Sponsor: Auspex Pharmaceuticals, Inc.

Trial design: A Phase 3 clinical trial testing the effectiveness and tolerability of SD-809 ER, a chemically modified formulation of tetrabenazine (Xenazine®, Nitoman®), in Huntington’s individuals for the treatment of chorea. It is hoped that this new formulation will be equally effective, but have fewer sided effects than the tetrabenazine drug now available.

This trial is approximately 4 months long and requires 8 in-person visits and a care-partner. Travel and lodging reimbursement is available. The participant must not have recently received tetrabenazine, and must be off all antipsychotic drugs at least 1 month prior to enrollment.

If requirements are met, the participant (whether on placebo or active drug in First-HD), will be offered active drug in ARC-HD, a year long follow-up study.

Outcome measures: Total maximal chorea score is the primary measure. Other measures include the impression of treatment benefit felt by (1) the participant and (2) the physician investigator. Change in a measurement of balance is another outcome measure.

Location: Recruiting will be ongoing at approximately thirty Huntington Study Group Centers listed on the ClinicalTrials.gov page for the trial.