NCT03802565

Tolperisone in Acute Muscle Spasm of the Back

Dose Ranging Study of Tolperisone in Acute Muscle Spasm of the Back

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 415 (actual)
• Sponsor: Neurana Pharmaceuticals, Inc. · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

This is a double-blind, randomized, placebo-controlled, parallel group study of the efficacy and safety of tolperisone (a non-opioid) or placebo administered as multiple doses three times a day (TID) in approximately 400 male and female subjects experiencing back pain due to or associated with muscle spasm.

Conditions

• Back Pain
• Acute Pain
• Back Spasm Upper Back
• Back Strain
• Muscle Cramp
• Muscle Spasm
• Low Back Pain

Interventions

Type	Name	Description
DRUG	Tolperisone	TID
DRUG	Placebo	Placebo

Timeline

• Start date: 2019-02-01
• Primary completion: 2019-06-28
• Completion: 2019-07-12
• First posted: 2019-01-14
• Last updated: 2022-02-01
• Results posted: 2020-11-10

Locations

43 sites across 1 country: United States

Regulatory

• FDA-regulated drug study