Phase 3 Study of Tolperisone for Muscle Spasms Reaches 50% Enrollment 

For the phase 3 RESUME-1 clinical study (NCT04671082) of tolperisone (Mydocalm; Neurana Pharmaceuticals, San Diego, CA), 500 of the planned 1,000 participants have enrolled. Tolperisone works as a centrally active muscle relaxant for treatment of acute and painful muscles spasms of the back.

Participants will receive placebo or 150, 300 or 600 mg/day in three divided doses daily for 14 days. The Numerical Rating Scale (NRS) (0 to 10 scale, from no pain to worst pain imaginable) will be used to rate participants’ pain "right now" due to acute back spasm on Day 14. Participants are being enrolled for the study across approximately 70 clinical sites throughout the US.

Randall Kaye, MD, chief medical officer of Neurana, stated, "We are very pleased with the pace and cadence of enrollment, particularly considering the challenges of the COVID-19 environment. RESUME-1 is the largest clinical study ever conducted in patients with acute and painful muscle spasms of the back, and to initiate such a study during the unparalleled challenges of COVID-19, is not only a testament to the entire team involved, but also to this painful condition, which impacts so many people. Enrolling half of the projected subjects brings us 1 step closer to potentially providing a novel solution for patients to manage their acute and painful muscle spasms without the drowsiness associated with commonly prescribed medicines."