Neurana Pharmaceuticals has enrolled its first patient in the "STAR Study," a Phase 2 dose ranging study of tolperisone in acute muscle spasms of the back.
The STAR Study is a double-blind, randomized, placebo-controlled, parallel group study of the efficacy and safety of tolperisone or placebo administered as multiple doses three times a day (TID) in approximately 400 male and female subjects experiencing back pain due to or associated with muscle spasm. The primary endpoint is subject-rated pain due to acute back spasm using a Numerical Rating Scale (NRS; 0-10 scale, from no pain to worst possible pain). The study will be conducted across approximately 45 sites in the U.S.
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"We are very excited to announce the first patient enrolled in the STAR Study," said Craig Thompson, President and Chief Executive Officer of Neurana. "This marks an important achievement in the U.S. clinical development of tolperisone and furthers our aim of providing patients suffering from acute back pain a novel, non-sedating, non-drowsy, non-opioid therapy."