CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 415 enrolled
Drug / intervention
Tolperisone +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03802565
NCT03802565Phase 2Completed
CompareCT.gov

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

Neurana Pharmaceuticals, Inc.·interventional·Posted Jan 14, 2019·Updated Feb 1, 2022

In Brief

A Phase 2 clinical trial evaluating Tolperisone and Placebo for Back Pain and 6 related conditions. Completed, enrolled 415 participants across 43 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsBack Pain, Acute Pain, Back Spasm Upper Back, Back Strain, Muscle Cramp, Muscle Spasm, Low Back Pain
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
20192020202120222023202420252026
First PostedJan 14, 2019
Enrollment StartFeb 1, 2019
Primary CompletionJun 28, 2019
Study CompletionJul 12, 2019
TodayJul 2, 2026
Enrollment to primary: 5 monthsPosted 7.5 years ago

Interventions

Tolperisonedrug

TID

Placebodrug

Placebo