Tolperisone in Acute Muscle Spasm of the Back (STAR)

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

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 Overview

• Status: Completed
• Conditions: Back Pain; Low Back Pain; Acute Pain; Muscle Cramp; Back Strain; Muscle Spasm; Back Spasm Upper Back
• Intervention / Treatment: Drug: Placebo; Drug: Tolperisone

• Study Type: Interventional
• Enrollment (Actual): 415
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Huntsville, Alabama, United States, 35801
      • Tennessee Valley Pain Consultants
  • Arizona
    • Tempe, Arizona, United States, 85283
      • Fiel Family and Sports Medicine
  • Arkansas
    • Little Rock, Arkansas, United States, 72212
      • Center of Applied Research
  • California
    • Fresno, California, United States, 93702
      • Research Center of Fresno
    • Long Beach, California, United States, 90806
      • Long Beach Clinical Trials Services, Inc.
    • Sacramento, California, United States, 95628
      • Northern California Research
    • San Diego, California, United States, 92103
      • Pacific Research Network, LLC
    • San Diego, California, United States, 92120
      • San Diego Sports Medicine
    • Santa Ana, California, United States, 92705
      • CiTrials
  • Florida
    • Edgewater, Florida, United States, 32132
      • Riverside Clinical Research
    • Gainesville, Florida, United States, 32653
      • Empirical Research Group
    • Miami, Florida, United States, 33126
      • LLC Medical Research
    • Miami Lakes, Florida, United States, 33014
      • Savin Medical Group
    • Orange City, Florida, United States, 32763
      • Avail Clinical Research
    • Plantation, Florida, United States, 33313
      • Private Practice
  • Georgia
    • Atlanta, Georgia, United States, 30342
      • NeuroTrials Research, Inc.
    • Marietta, Georgia, United States, 30060
      • Georgia Institute for Clinical Research
    • Snellville, Georgia, United States, 30078
      • Georgia Clinical Research
  • Indiana
    • Evansville, Indiana, United States, 47714
      • Medisphere Medical Research Center
  • Kentucky
    • Edgewood, Kentucky, United States, 41017
      • Otrimed Clinical Research
  • Louisiana
    • Lake Charles, Louisiana, United States, 70601
      • Centex Studies, Inc.
  • Maryland
    • Wheaton, Maryland, United States, 20902
      • Center for Rheumatology and Bone
  • Michigan
    • Ann Arbor, Michigan, United States, 48104
      • Michigan Head Pain and Neurological
  • Missouri
    • Saint Louis, Missouri, United States, 63141
      • Sundance Clinical Research
  • Nevada
    • Las Vegas, Nevada, United States, 89106
      • Jubilee Clinical Research
  • New Mexico
    • Albuquerque, New Mexico, United States, 87102
      • Albuquerque Clinical Trials, Inc.
  • New York
    • Williamsville, New York, United States, 14221
      • Upstate Clinical Research Associates
  • North Carolina
    • Winston-Salem, North Carolina, United States, 27103
      • Clinical Trials of America
  • Ohio
    • Cincinnati, Ohio, United States, 45246
      • Sterling Research Group- Springdale
    • Cleveland, Ohio, United States, 44195
      • Cleveland Clinic
    • Dayton, Ohio, United States, 45439
      • Center for Providence Health Partners
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73103
      • IPS Research
  • Oregon
    • Eugene, Oregon, United States, 97404
      • Williamette Valley Clinical Studies
  • Pennsylvania
    • Smithfield, Pennsylvania, United States, 15478
      • Frontier Clinical Research, Inc.
  • Rhode Island
    • Warwick, Rhode Island, United States, 02886
      • Omega Medical Research
  • South Dakota
    • Rapid City, South Dakota, United States, 57702
      • Health Concepts
  • Texas
    • Baytown, Texas, United States, 77521
      • Inquest Clinical Research
    • Bryan, Texas, United States, 77802
      • DiscoveResearch, Inc.
    • Houston, Texas, United States, 77004
      • HD Research Corp
    • McAllen, Texas, United States, 78504
      • Centex Studies, Inc.
    • Plano, Texas, United States, 75007
      • ClinRX Research Joseph, Inc.
  • Utah
    • Salt Lake City, Utah, United States, 84124
      • Highland Clinical Research
  • Virginia
    • Newport News, Virginia, United States, 23606
      • Health Research of Hampton Roads, Inc.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

5

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Tolperisone 50 mg; TID (150 mg/day)	Drug: Tolperisone; TID
Experimental: Tolperisone 100 mg; TID (300 mg/day)	Drug: Tolperisone; TID
Experimental: Tolperisone 150 mg; TID (450 mg/day)	Drug: Tolperisone; TID
Experimental: Tolperisone 200 mg; TID (600 mg/day)	Drug: Tolperisone; TID
Placebo Comparator: Placebo; TID	Drug: Placebo; Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Neurana Pharmaceuticals, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2019
• Primary Completion (Actual): June 28, 2019
• Study Completion (Actual): July 12, 2019

Study Registration Dates

• First Submitted: January 10, 2019
• First Submitted That Met QC Criteria: January 11, 2019
• First Posted (Actual): January 14, 2019

Study Record Updates

• Last Update Posted (Actual): February 1, 2022
• Last Update Submitted That Met QC Criteria: January 28, 2022
• Last Verified: January 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Pain; Neurologic Manifestations; Musculoskeletal Diseases; Muscular Diseases; Neuromuscular Manifestations; Dyskinesias; Back Pain; Low Back Pain; Acute Pain; Hyperkinesis; Spasm; Muscle Cramp; Physiological Effects of Drugs; Peripheral Nervous System Agents; Neuromuscular Agents; Muscle Relaxants, Central; Tolperisone
• Other Study ID Numbers: 201

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No