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Neurana Pharmaceuticals announces first patient enrolled in phase III RESUME-1 study of of tolperisone for muscle spasms of the back.

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Published:9th Jan 2021
Neurana Pharmaceuticals, has announced that the first patient has been enrolled in the Phase III, RESUME-1, clinical study of tolperisone , a novel, non-opioid, centrally acting muscle relaxant in clinical development for the treatment of symptoms associated with acute and painful muscles spasms of the back. The RESUME-1 Study is a 14 day, double-blind, randomized, placebo-controlled Phase III study designed to assess the safety and efficacy of tolperisone in 1,000 male and female patients experiencing back pain due to or associated with muscle spasm of acute onset. The tolperisone group will receive 50 mg, 100 mg or 200 mg doses administered three times per day (TID) for a total daily dose of 150 mg, 300 mg or 600 mg. The tolperisone doses selected for the RESUME-1 Study are based on positive safety and efficacy results from the Phase II STAR Study (CLN-201), in combination with feedback from the FDA at Neurana’s End-of-Phase II Meeting. The primary endpoint is subject-rated pain “right now” due to acute back spasm using a Numerical Rating Scale (NRS) (0 to 10 scale, from no pain to worst pain imaginable) on Day 14. The study will enroll patients across 70 clinical sites in the United States. Neurana anticipates reporting top-line data from the Phase III RESUME-1 Study in the fourth quarter of 2021.
Condition: Pain:Chronic Muscoskeletal
Type: drug

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