Tolperisone in Acute Muscle Spasm of the Back
STAR
Dose Ranging Study of Tolperisone in Acute Muscle Spasm of the Back
1 other identifier
interventional
415
1 country
43
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Feb 2019
Shorter than P25 for phase_2
43 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 10, 2019
CompletedFirst Posted
Study publicly available on registry
January 14, 2019
CompletedStudy Start
First participant enrolled
February 1, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 28, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
July 12, 2019
CompletedResults Posted
Study results publicly available
November 10, 2020
CompletedFebruary 1, 2022
January 1, 2022
5 months
January 10, 2019
October 19, 2020
January 28, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
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
Study Arms (5)
Tolperisone 50 mg
EXPERIMENTALTID (150 mg/day)
Tolperisone 100 mg
EXPERIMENTALTID (300 mg/day)
Tolperisone 150 mg
EXPERIMENTALTID (450 mg/day)
Tolperisone 200 mg
EXPERIMENTALTID (600 mg/day)
Placebo
PLACEBO COMPARATORTID
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (43)
Tennessee Valley Pain Consultants
Huntsville, Alabama, 35801, United States
Fiel Family and Sports Medicine
Tempe, Arizona, 85283, United States
Center of Applied Research
Little Rock, Arkansas, 72212, United States
Research Center of Fresno
Fresno, California, 93702, United States
Long Beach Clinical Trials Services, Inc.
Long Beach, California, 90806, United States
Northern California Research
Sacramento, California, 95628, United States
Pacific Research Network, LLC
San Diego, California, 92103, United States
San Diego Sports Medicine
San Diego, California, 92120, United States
CITrials
Santa Ana, California, 92705, United States
Riverside Clinical Research
Edgewater, Florida, 32132, United States
Empirical Research Group
Gainesville, Florida, 32653, United States
LLC Medical Research
Miami, Florida, 33126, United States
Savin Medical Group
Miami Lakes, Florida, 33014, United States
Avail Clinical Research
Orange City, Florida, 32763, United States
Private Practice
Plantation, Florida, 33313, United States
NeuroTrials Research, Inc.
Atlanta, Georgia, 30342, United States
Georgia Institute for Clinical Research
Marietta, Georgia, 30060, United States
Georgia Clinical Research
Snellville, Georgia, 30078, United States
MediSphere Medical Research Center
Evansville, Indiana, 47714, United States
Otrimed Clinical Research
Edgewood, Kentucky, 41017, United States
Centex Studies, Inc.
Lake Charles, Louisiana, 70601, United States
Center for Rheumatology and Bone
Wheaton, Maryland, 20902, United States
Michigan Head Pain and Neurological
Ann Arbor, Michigan, 48104, United States
Sundance Clinical Research
St Louis, Missouri, 63141, United States
Jubilee Clinical Research
Las Vegas, Nevada, 89106, United States
Albuquerque Clinical Trials, Inc.
Albuquerque, New Mexico, 87102, United States
Upstate Clinical Research Associates
Williamsville, New York, 14221, United States
Clinical Trials of America
Winston-Salem, North Carolina, 27103, United States
Sterling Research Group- Springdale
Cincinnati, Ohio, 45246, United States
Cleveland Clinic
Cleveland, Ohio, 44195, United States
Center for Providence Health Partners
Dayton, Ohio, 45439, United States
IPS Research
Oklahoma City, Oklahoma, 73103, United States
Williamette Valley Clinical Studies
Eugene, Oregon, 97404, United States
Frontier Clinical Research, Inc.
Smithfield, Pennsylvania, 15478, United States
Omega Medical Research
Warwick, Rhode Island, 02886, United States
Health Concepts
Rapid City, South Dakota, 57702, United States
Inquest Clinical Research
Baytown, Texas, 77521, United States
DiscoveResearch, Inc.
Bryan, Texas, 77802, United States
HD Research Corp
Houston, Texas, 77004, United States
Centex Studies, Inc.
McAllen, Texas, 78504, United States
ClinRX Research Joseph, Inc.
Plano, Texas, 75007, United States
Highland Clinical Research
Salt Lake City, Utah, 84124, United States
Health Research of Hampton Roads, Inc.
Newport News, Virginia, 23606, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Randall Kaye, MD - Chief Medical Officer
- Organization
- Neurana Pharmaceuticals, Inc.
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 10, 2019
First Posted
January 14, 2019
Study Start
February 1, 2019
Primary Completion
June 28, 2019
Study Completion
July 12, 2019
Last Updated
February 1, 2022
Results First Posted
November 10, 2020
Record last verified: 2022-01
Data Sharing
- IPD Sharing
- Will not share