Neurana Pharmaceuticals has concluded subject enrolment in a Phase III RESUME-1 clinical trial of its therapy, tolperisone, to treat muscle spasms linked to acute, painful musculoskeletal conditions.
The company has enrolled a total of 1,000 subjects in the trial of tolperisone, a new non-opioid centrally acting muscle relaxant.
Initiated in December 2020, the randomised, double-blind, placebo-controlled trial is evaluating the safety and efficacy of tolperisone to treat muscle spasms.
Individuals who were part of the trial had acute back pain below the neck and above the inferior gluteal folds caused by acute and severe muscle spasms commencing within seven days before admission into the trial and a minimum of eight weeks after the previous acute back pain episode.
Participants were categorised to receive either thrice daily doses of 50mg, 100mg or 200mg tolperisone or a placebo for 14 days.
The doses of tolperisone for the trial were selected based on favourable safety and efficacy data from the Phase II STAR trial and the US Food and Drug Administration feedback.
Subject-reported pain at day 14 due to acute back spasm as assessed using the numerical rating scale is the trial’s primary goal.
Evaluating time to action onset, clinician global impression of change, and patient global impression of change comprise the secondary goals.
Neurana Pharmaceuticals chief medical officer Randall Kaye said: “We are very pleased to accomplish this significant clinical milestone and look forward to releasing topline data in the coming months.
“This Phase III study is a vital component of the clinical programme for tolperisone and we extend our sincere gratitude to the individuals, physicians, site investigators and other personnel who participated in the study.”
The company plans to report topline results from the trial in the first quarter of next year.
In February 2019, Neurana enrolled the first subject in the Phase II STAR study for evaluating tolperisone to treat acute back muscle spasms.