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Medicure Inc provides update on Tardoxal and TEND-TD Study


Wednesday, 13 Aug 2014 12:23pm EDT 

Medicure Inc:Announces that preliminary results of its Phase IIa Clinical Trial, Tardoxal for treatment of Tardive Dyskinesia (TEND-TD) showed non-statistically significant improvement in primary efficacy endpoint in patients treated with Tardoxal.Medicure views these preliminary results as supportive of continuing program and developing modified formulation as prelude to larger, confirmatory Phase II study.TEND-TD was planned as 140 patient Phase II clinical trial to evaluate efficacy and safety of Tardoxal for treatment of Tardive Dyskinesia (TD), with pre-planned interim analysis after about 40 patients were enrolled.Says primary efficacy endpoint for study was decrease in involuntary movements as measured by Abnormal Involuntary Movement Scale (AIMS), standardized test used to detect and monitor TD and other movement disorders.Results from all 37 patients who completed 12 week treatment period showed trend to greater improvement in AIMS score from baseline to completion of study in Tardoxal group versus placebo.Study was not adequately powered to assess efficacy and improvement noted was not statistically significant. 

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