Tolperisone in Acute Muscle Spasm of the Back

Low Back Pain Clinical Trial

— STAR  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03802565
• Other study ID #: 201
• Status: Completed
• Phase: Phase 2
• Start date: February 1, 2019
• Est. completion date: July 12, 2019

Study information

• Verified date: January 2022
• Source: Neurana Pharmaceuticals, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 415
• Est. completion date: July 12, 2019
• Est. primary completion date: June 28, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Ambulatory
• Current acute back pain and/or stiffness due to acute and painful muscle spasm starting within 7 days prior to study entry and more than 8 weeks after the last episode of acute back pain.
• Pain of 4 or more on the subject "right now" rating of pain intensity Numeric Rating Scale (NRS) scale of 0-10.
• Willing to discontinue all medication used for the treatment of pain or muscle spasm on study entry.
• Pain localized below the neck and above the inferior gluteal folds.
• Body mass index ranging between 18 and 35 kg/m².

Exclusion Criteria:

• Unwillingness to stop taking pain or antispasmodic medication other than the study medication (specifically opioid use [e.g., Vicodin], barbiturates, and cannabis).
• Chronic pain for the previous 3 months or longer, on more days than not.
• Radicular pain in the lower extremity (i.e. pain radiating below the knee), sciatica pain down the leg, or pain below the knee (indicating a lumber radiculopathy); radicular pain in the upper extremity, radiating into the forearm or hand (indicating a cervical radiculopathy).
• Concomitant severe pain in a region other than the back.
• Spinal surgery within 1 year of study entry.
• Back pain due to major trauma (e.g., motor vehicle accident, fracture of bone) unless resolved for more than 1 year.
• Treatment of back pain ongoing with non-pharmacological therapy (e.g., acupuncture, chiropractic adjustment, massage, Transcutaneous Electrical Nerve Stimulation [TENS], physiotherapy).
• Subjects who test positive for alcohol by breathalyzer test.
• Unwilling to stop taking moderate to potent inhibitors of cytochrome P450 (CYP) isozymes CYP2D6 and CYP2C19, which are likely to cause drug interactions with tolperisone HCl (e.g., medications such as paroxetine and fluvoxamine).

Related Conditions & MeSH terms

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

Intervention

Drug:
• Tolperisone
TID
• Placebo
Placebo

Locations

Country	Name	City	State
United States	Albuquerque Clinical Trials, Inc.	Albuquerque	New Mexico
United States	Michigan Head Pain and Neurological	Ann Arbor	Michigan
United States	NeuroTrials Research, Inc.	Atlanta	Georgia
United States	Inquest Clinical Research	Baytown	Texas
United States	DiscoveResearch, Inc.	Bryan	Texas
United States	Sterling Research Group- Springdale	Cincinnati	Ohio
United States	Cleveland Clinic	Cleveland	Ohio
United States	Center for Providence Health Partners	Dayton	Ohio
United States	Riverside Clinical Research	Edgewater	Florida
United States	Otrimed Clinical Research	Edgewood	Kentucky
United States	Williamette Valley Clinical Studies	Eugene	Oregon
United States	MediSphere Medical Research Center	Evansville	Indiana
United States	Research Center of Fresno	Fresno	California
United States	Empirical Research Group	Gainesville	Florida
United States	HD Research Corp	Houston	Texas
United States	Tennessee Valley Pain Consultants	Huntsville	Alabama
United States	Centex Studies, Inc.	Lake Charles	Louisiana
United States	Jubilee Clinical Research	Las Vegas	Nevada
United States	Center of Applied Research	Little Rock	Arkansas
United States	Long Beach Clinical Trials Services, Inc.	Long Beach	California
United States	Georgia Institute for Clinical Research	Marietta	Georgia
United States	Centex Studies, Inc.	McAllen	Texas
United States	LLC Medical Research	Miami	Florida
United States	Savin Medical Group	Miami Lakes	Florida
United States	Health Research of Hampton Roads, Inc.	Newport News	Virginia
United States	IPS Research	Oklahoma City	Oklahoma
United States	Avail Clinical Research	Orange City	Florida
United States	ClinRX Research Joseph, Inc.	Plano	Texas
United States	Private Practice	Plantation	Florida
United States	Health Concepts	Rapid City	South Dakota
United States	Northern California Research	Sacramento	California
United States	Sundance Clinical Research	Saint Louis	Missouri
United States	Highland Clinical Research	Salt Lake City	Utah
United States	Pacific Research Network, LLC	San Diego	California
United States	San Diego Sports Medicine	San Diego	California
United States	CITrials	Santa Ana	California
United States	Frontier Clinical Research, Inc.	Smithfield	Pennsylvania
United States	Georgia Clinical Research	Snellville	Georgia
United States	Fiel Family and Sports Medicine	Tempe	Arizona
United States	Omega Medical Research	Warwick	Rhode Island
United States	Center for Rheumatology and Bone	Wheaton	Maryland
United States	Upstate Clinical Research Associates	Williamsville	New York
United States	Clinical Trials of America	Winston-Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Neurana Pharmaceuticals, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean Effect Size in Subjected-Rated Pain	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."	Day 1 to Day 14