Design:

A global Phase 3, randomized, placebo-controlled, double-blind safety and efficacy trial of oral dimebon (latrepirdine) in patients with Huntington disease (HD).

Please call the Huntington Study Group toll-free in North America at 800-487-7671 for additional information regarding this trial.

Locations:

Approximately 50 centers are located in the United States, Canada, Europe, and Australia. View trial locations.

Primary objectives

• Determine the effect of dimebon (latrepirdine) on cognition
• Determine the effect of dimebon on global function

Secondary objectives

• Determine the effect of dimebon (latrepirdine) on behavior
• Determine the effect of dimebon on self-care and daily function
• Determine the effect of dimebon on motor symptoms
• Determine the safety of treatment with dimebon

Trial design

• Randomized, placebo-controlled, double-blind safety and efficacy trial of oral dimebon (latrepirdine) in patients with Huntington disease
• 350 patients randomized into 2 equal groups
  • — Dimebon 20 mg 3 times a day (TID)
  • — Placebo
• Patients are required to participate in the trial with a caregiver who can assist at least 5 days a week for 3 hours a day
• Efficacy assessments to be performed at baseline and weeks 13 and 26
• Patients will receive 26 weeks of treatment; those who complete the 26-week trial (placebo and dimebon groups) may then choose to participate in an open-label extension trial in which all patients receive dimebon until dimebon is approved for sale

Key inclusion criteria

• Aged ≥ 30 years
• Clinical features of HD and a CAG polyglutamate repeat expansion ≥ 36
• Cognitive impairment according to:
  • — Screening Mini-Mental State Examination (MMSE) and a baseline (predose) MMSE score
    — between 10 and 26 (inclusive); and
  • — Subjective assessment of cognitive impairment by investigator, with decline from
    — pre-HD levels
• Ability to give informed consent or to have a legally authorized representative provide consent
• A guardian or caregiver who assists the subject at least 5 days per week for at least 3 hours per day and who has knowledge of the subject's personal care and cognitive, functional, and emotional states

Key exclusion criteria

• Onset of HD symptoms prior to age 18 years
• Any major medical illness or unstable medical condition within 180 days of screening that may interfere with the patient's ability to comply with trial procedures and abide by trial restrictions, or with the investigator's ability to interpret safety data