Avanir completes enrollment in Phase III pseudobulbar affect trial

The randomized, multi-center, international Star trial is designed to compare the effects of Zenvia 30/10mg, Zenvia 20/10mg 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 who exhibit signs and symptoms of pseudobulbar affect at approximately 50 sites in the US and Latin America. The primary efficacy analysis is based on the changes in crying/laughing episode rates recorded in patient diaries.

Secondary endpoints for this clinical trial include: center for neurologic study-lability scale score; neuropsychiatric inventory questionnaire; SF-36 health survey; beck depression inventory; and pain rating scale score (MS patients only). Safety and tolerability of Zenvia are determined by reporting adverse events, physical exam, vital signs, electrocardiogram, respiratory function tests and clinical assessment of clinical laboratory variables.

Randall Kaye, chief medical officer of Avanir, said: “The completion of patient enrollment into the Star trial is an important clinical milestone for Avanir. We look forward to unblinding the data in the third calendar quarter of this year and plan to submit our complete response to the approvable letter in the first half of 2010.”