Medivation reports positive results from Phase II Huntington’s disease study

Cognitive function was significantly improved over placebo (p=0.03) as measured by the mini-mental state examination (MMSE), the cognition scale most widely used by clinicians to assess patients with neurodegenerative diseases.

Dimebon-treated patients also demonstrated favorable results on the behavioral component of the United Huntington’s disease rating scale (UHDRS), a composite scale measuring several components of Huntington’s disease (HD), but these results did not reach statistical significance. However, Dimebon was very well tolerated in this trial.

The overall incidence of adverse events was lower in the Dimebon group than in the placebo group, an unusual finding in a clinical study of any drug. Of particular note, Huntington’s disease patients treated with Dimebon had fewer falls (9%), a common problem in this patient population that often results in injury and associated health care costs, than did patients on placebo (16%).

The randomized, double-blinded, placebo-controlled Phase II trial was conducted at 16 centers in the US and the UK in collaboration with the Huntington Study Group. The trial enrolled 90 HD patients, with half randomized to Dimebon and the other half to placebo for a three-month dosing period.

The primary endpoint of the trial was safety and tolerability. The secondary endpoint was efficacy, as measured by the MMSE, the UHDRS and the Alzheimer’s disease assessment scale-cognitive subscale, a cognition scale generally used in Alzheimer’s disease clinical trials.