(April 2009) The phase II clinical trial of minocycline in Huntington disease (HD) is complete. Preliminary results were shared by conference call with the participants in the study and with the physicians and clinical research staff at the trial sites. Final study results will be presented June 8th, 2009 at the 13th International Congress of Parkinson's Disease and Movement Disorders. The study, led by the Huntington Study Group, was funded by the Orphan Products Division of the FDA. This was a phase II futility design clinical trial to assess whether minocycline should be tested in an advanced phase trial and to assess its safety and tolerability over 18 months.
The randomized, double-blind study of minocycline was conducted at 12 centers.One hundred fourteen research participants with HD participated in the study. Comparisons were made to data obtained from a historical database. HD progression was measured by the change in Total Functional Capacity (TFC) score
from baseline to Month 18. Although minocycline at 200 mg/day was well tolerated and safe over 18 months of treatment in participants with HD, the overall trial results suggest that minocycline is not associated with a meaningful slowing of the rate of functional decline and that further study of minocycline 200 mg/day in HD is not warranted.
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