Phase 3 Study of Tolperisone for Muscle Spasms Completes Enrollment 

Enrollment of 1,000 participants is complete for the phase 3 RESUME-1 study (NCT04671082) of tolperisone (Mydocalm; Neurana Pharmaceuticals, San Diego, CA) for muscle spasms associated with acute, painful musculoskeletal conditions. 

Tolperisone works as a centrally active muscle relaxant and has been formally tested for effects on driving ability and cognitive function, which were not observed.

Randall Kaye, MD, chief medical officer of Neurana, commented, "We are very pleased to accomplish this significant clinical milestone and look forward to releasing topline data in the coming months. This phase 3 study is a vital component of the clinical program for tolperisone and we extend our sincere gratitude to the individuals, physicians, site investigators and other personnel who participated in the study."

The phase 3 RESUME-1 study launched in December 2020. The participants have been randomly assigned to receive placebo or tolperisone at doses of 50, 100, or 200 mg 3 times per day for 14 days. Participant-reported pain due to acute back spasm at day 14 will be measured by the Numerical Rating Scale, which uses a scale of 0 to 10, where 0 equals no pain and 10 equals worst pain imaginable. Time to onset of action, Clinician Global Impression of Change (CGI-C), and Patient Global Impression of Change (PGI-C) will also be assessed.