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news.Medicure, a biopharmaceutical company, has received the Health Canada, Therapeutic Products Directorate approval for a Phase II clinical study of Avastrem for the treatment of tardive dyskinesia. The company anticipates enrollment to begin in March 2009.
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This 12-week, randomized, double-blind, placebo-controlled, parallel group comparative study will evaluate the safety and efficacy of Avastrem in the treatment of tardive dyskinesia (TD).
The primary objective of the Phase II study is to assess the beneficial effect of Avastrem on the reduction of expressed symptoms of TD compared to placebo.
The abnormal involuntary movement scale will be used to assess the improvement in symptoms after treatment from baseline through to week 12. The study will enroll approximately 140 patients with a planned interim analysis about mid way.