Receive our newsletter – data, insights and analysis delivered to you
  1. News
November 30, 2021

Neurana concludes subject enrolment in trial of muscle spasm therapy

Subject-reported pain at day 14 due to acute back spasm is the primary goal of the trial. 

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.

Content from our partners
The importance of reference products in biosimilar trials, and how to source them
Africa’s last mile: Building viable vaccine supply chains
Why this global life sciences COO believes relocation to Charleston, SC, was key to achieving next-level success

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.

Related Companies

NEWSLETTER Sign up Tick the boxes of the newsletters you would like to receive. Key drug pipeline and competitive landscape changes based on the latest clinical activity, sent every Tuesday. Curated analysis and data-driven insights on clinical trials strategy and operations, sent every Thursday. The pharmaceutical industry's most comprehensive news and information delivered every month.
I consent to GlobalData UK Limited collecting my details provided via this form in accordance with the Privacy Policy
SUBSCRIBED

THANK YOU