Trial · NCT03802565

Tolperisone in Acute Muscle Spasm of the Back

NCT03802565, Phase 2, Completed, Neurana Pharmaceuticals, Inc.; results first posted 2020-11-10

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Tolperisone in Acute Muscle Spasm of the Back. Trials, record NCT03802565. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03802565

On this page

Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Tolperisone in Acute Muscle Spasm of the Back
NCT number: NCT03802565
Status: Completed
Phases: Phase 2
Enrollment: 415 participants, actual
Lead sponsor: Neurana Pharmaceuticals, Inc.
Conditions: Back Pain, Acute Pain, Back Spasm Upper Back, Back Strain, Muscle Cramp, Muscle Spasm, Low Back Pain
Interventions: Tolperisone, Placebo
First posted: 2019-01-14
Last updated: 2022-02-01
Results first posted: 2020-11-10

Source ClinicalTrials.gov

Registered outcomes1

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Mean Effect Size in Subjected-Rated Pain	Day 1 to Day 14	Mean effect size between Tolperisone and Placebo of subject-rated pain due to acute back spasm using a Numerical Rating Scale (NRS; 0-10 scale, from no pain to worst possible pain) on Day 14 "right now."

Source ClinicalTrials.gov

Outcomes1

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Mean Effect Size in Subjected-Rated Pain	Day 1 to Day 14		score on a scale	MEAN

Source ClinicalTrials.gov

Results by group5

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Spread	Units
Mean Effect Size in Subjected-Rated Pain	Tolperisone 50 mg	-4.2	95% Confidence Interval -9 to 1	score on a scale
Mean Effect Size in Subjected-Rated Pain	Tolperisone 100 mg	-4.0	95% Confidence Interval -10 to 2	score on a scale
Mean Effect Size in Subjected-Rated Pain	Tolperisone 150 mg	-3.7	95% Confidence Interval -8 to 1	score on a scale
Mean Effect Size in Subjected-Rated Pain	Tolperisone 200 mg	-4.4	95% Confidence Interval -10 to 1	score on a scale
Mean Effect Size in Subjected-Rated Pain	Placebo	-3.5	95% Confidence Interval -8 to 1	score on a scale

Source ClinicalTrials.gov

Participant flow15

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Tolperisone 50 mg	82
Overall Study	STARTED	Tolperisone 100 mg	87
Overall Study	STARTED	Tolperisone 150 mg	83
Overall Study	STARTED	Tolperisone 200 mg	85
Overall Study	STARTED	Placebo	78
Overall Study	COMPLETED	Tolperisone 50 mg	77
Overall Study	COMPLETED	Tolperisone 100 mg	83
Overall Study	COMPLETED	Tolperisone 150 mg	74
Overall Study	COMPLETED	Tolperisone 200 mg	77
Overall Study	COMPLETED	Placebo	72

1 to 10 of 15Source ClinicalTrials.gov

See all 15 participant flow

Adverse events25

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk
other	Headache	Nervous system disorders	Tolperisone 50 mg	3	82
other	Headache	Nervous system disorders	Tolperisone 100 mg	5	87
other	Headache	Nervous system disorders	Tolperisone 150 mg	8	83
other	Headache	Nervous system disorders	Tolperisone 200 mg	8	85
other	Headache	Nervous system disorders	Placebo	3	78
other	Dizziness	Nervous system disorders	Tolperisone 50 mg	1	82
other	Dizziness	Nervous system disorders	Tolperisone 100 mg	2	87
other	Dizziness	Nervous system disorders	Tolperisone 150 mg	0	83
other	Dizziness	Nervous system disorders	Tolperisone 200 mg	2	85
other	Dizziness	Nervous system disorders	Placebo	0	78

1 to 10 of 25Source ClinicalTrials.gov

See all 25 adverse events

Adverse event totals15

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Tolperisone 50 mg	0	82
Total, all-cause mortality	Tolperisone 100 mg	0	87
Total, all-cause mortality	Tolperisone 150 mg	0	83
Total, all-cause mortality	Tolperisone 200 mg	0	85
Total, all-cause mortality	Placebo	0	78
Total, other adverse events	Tolperisone 50 mg	7	82
Total, other adverse events	Tolperisone 100 mg	13	87
Total, other adverse events	Tolperisone 150 mg	12	83
Total, other adverse events	Tolperisone 200 mg	14	85
Total, other adverse events	Placebo	5	78

1 to 10 of 15Source ClinicalTrials.gov

See all 15 adverse event totals

Papers0

The papers the trial lists on ClinicalTrials.gov.

None in this release.

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons0

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

None in this release.

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT03802565

GET https://conductscience.org/api/trials/v1/NCT03802565/events?page=2

API reference For AI assistants