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AVANIR Pharmaceuticals (AVNR) has completed targeted enrollment of patients into the STAR trial, a confirmatory Phase III trial of Zenvia(TM) (dextromethorphan/quinidine [DM/Q]) in patients exhibiting signs and symptoms of pseudobulbar affect (PBA). The randomized, multi-center, international STAR trial is designed to compare the effects of Zenvia 30/10 mg, Zenvia 20/10 mg and placebo on involuntary crying/laughing episodes rates.
The STAR trial had a targeted enrollment of 120 patients with multiple sclerosis (MS) and 180 patients with amyotrophic lateral sclerosis (ALS) who exhibit signs and symptoms of PBA at approximately 50 sites in the U.S. and Latin America. The primary efficacy analysis is based on the changes in crying/laughing episode rates recorded in patient diaries.
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