RESUME-1: A Phase III Study of Tolperisone in the Treatment of Painful, Acute Muscle Spasms of the Back

Abstract

Tolperisone is a nonopioid, centrally acting muscle relaxant in clinical development in the USA for the treatment of symptoms associated with acute, painful muscles spasms of the back. CLN-301, RESUME-1, is a 14-day double-blind, randomized, placebo-controlled, parallel-group Phase III study of the efficacy and safety of tolperisone administered orally three-times daily in 1000 male and female subjects at approximately 70 clinical sites in the USA experiencing back pain due to or associated with muscle spasm of acute onset. Tolperisone is a promising therapeutic for managing acute, painful muscle spasms of the back as it appears to lack the off-target CNS effects often seen with conventional skeletal muscle relaxants.

Clinical Trials registration number: NCT04671082

Infographic

Infographic: A PDF version of this infographic is available as supplemental material.

Keywords::

• acute back pain
• acute muscle spasm
• acute pain
• back pain
• back strain
• low-back pain
• muscle spasm
• skeletal muscle relaxant

Supplementary data

An infographic accompanies this paper and is included at the end of the references section in the PDF version. To view or download this infographic in your browser please click here: www.tandfonline.com/doi/suppl/10.2217/pmt-2021-0041

Financial & competing interests disclosure

SA Vaughan, K Torres and R Kaye are employees of Neurana Pharmaceuticals, which provided financial support for this study. The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed.

No writing assistance was utilized in the production of this manuscript.

Additional information

Funding

SA Vaughan, K Torres and R Kaye are employees of Neurana Pharmaceuticals, which provided financial support for this study. The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed. No writing assistance was utilized in the production of this manuscript.