Efficacy and Safety of Tolperisone in Subjects With Pain Due to Acute Back Muscle Spasm
RESUME-1
A Phase 3, 14-Day, Double-blind, Randomized, Placebo-Controlled, Multicenter Study of the Efficacy and Safety of Tolperisone in Subjects With Pain Due to Acute Back Muscle Spasm
2 other identifiers
interventional
1,004
1 country
56
Brief Summary
This is a double-blind, randomized, placebo-controlled, multicenter study of the efficacy and safety of tolperisone (a non-opioid) or placebo administered in subjects with pain due to acute back muscle spasm.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Dec 2020
Shorter than P25 for phase_3
56 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
December 10, 2020
CompletedStudy Start
First participant enrolled
December 15, 2020
CompletedFirst Posted
Study publicly available on registry
December 17, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 13, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
March 21, 2022
CompletedMarch 22, 2022
March 1, 2022
12 months
December 10, 2020
March 21, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
Numerical rating scale (NRS)
Numerical rating scale (NRS), a 0-10 scale, from no pain to worst possible pain - Subject-rated pain "right now" due to acute back spasm.
Day 1 to Day 14
Study Arms (4)
Tolperisone 50 mg
EXPERIMENTALTolperisone 50 mg
Tolpersione 100 mg
EXPERIMENTALTolperisone 100 mg
Tolperisone 200 mg
EXPERIMENTALTolperisone 200 mg
Placebo
PLACEBO COMPARATORPlacebo
Interventions
TID
Eligibility Criteria
You may qualify if:
- Ambulatory
- Current acute back pain due to acute muscle spasm starting within 7 days prior to study entry (Day 1) and at least 8 weeks following resolution of the last episode of acute back pain.
- Willingness to discontinue all previous or ongoing treatment of pain or muscle spasm on study entry at Day 1 through the end of treatment including medication, acupuncture, chiropractic adjustment, massage, transcutaneous electrical nerve stimulation \[TENS\], or physiotherapy.
- Pain must be localized from the neck (C-3 or lower) to the inferior gluteal folds and spasm assessed during the Screening physical examination.
- Body mass index range between 18 and 35 kg/m², inclusive.
You may not qualify if:
- Presence of acute or chronic back pain for the previous 8 days or longer, where back pain is present on more days than not.
- Presence of pain anywhere other than the target back pain that is bothersome, interferes with activity, or for which pain relief is taken.
- History of any neck, back, or pelvic surgery.
- History within the previous 3 years of: spinal fracture or spinal infection; inflammatory arthritis; degenerative spine disease; or any other back or spine condition that may reasonably contribute to current back pain.
- Subjects who test positive for alcohol by breathalyzer test or have a positive urine drug screen for drugs of abuse (e.g. amphetamines, methamphetamines, barbiturates, benzodiazepines, cocaine, cannabinoids, oxycodone, opiates), including cannabis even where legal, at Screening.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (56)
Clinical Research Institute of Arizona, LLC
Surprise, Arizona, 85374, United States
Applied Research Center of Arkansas
Little Rock, Arkansas, 72212, United States
Alliance Research Institute
Canoga Park, California, 91304, United States
Long Beach Clinical Trials Services, Inc
Long Beach, California, 90806, United States
Northern California Research
Sacramento, California, 95821, United States
Collaborative Neuroscience Research, LLC
Torrance, California, 90502, United States
Lynn Institute of Denver
Aurora, Colorado, 80012, United States
Emerson Clinical Research Institute
Washington D.C., District of Columbia, 20011, United States
Multi-Specialty Research Associates, Inc.
Lake City, Florida, 32055, United States
LCC Medical Research Institute, LLC
Miami, Florida, 33126, United States
Savin Medical Group
Miami Lakes, Florida, 33014, United States
Accel Research Sites
Orange City, Florida, 32763, United States
Combined Research Orlando
Orlando, Florida, 32807, United States
iResearch Atlanta
Decatur, Georgia, 30030, United States
Georgia Clinical Research LLC
Lawrenceville, Georgia, 30044, United States
IMA Clinical Research, PC
Chicago, Illinois, 60602, United States
Evanston Premier Healthcare Research LLC
Evanston, Illinois, 60201, United States
Investigators Research Group
Brownsburg, Indiana, 46112, United States
Professional Research Network of Kansas, LLC
Wichita, Kansas, 67205, United States
Research Integrity, LLC
Owensboro, Kentucky, 42303, United States
DelRicht Research
New Orleans, Louisiana, 70124, United States
DelRicht Research
Prairieville, Louisiana, 70769, United States
Michigan Head Pain and Neurological Institute
Ann Arbor, Michigan, 48104, United States
Onyx Clinical Research
Rochester Hills, Michigan, 48307, United States
Quinn Healthcare/SKYCRNG
Ridgeland, Mississippi, 39157, United States
IMA Clinical Research
St Louis, Missouri, 63117, United States
Pioneer Clinical Research, LLC
Bellevue, Nebraska, 68005, United States
Skyline Medical Center, PC
Elkhorn, Nebraska, 68022, United States
Jubilee Clinical Research, Inc.
Las Vegas, Nevada, 89106, United States
Albuquerque Clinical Trials, Inc.
Albuquerque, New Mexico, 87102, United States
Integrative Clinical Trials, LLC
Brooklyn, New York, 11229, United States
Drug Trials America
Hartsdale, New York, 10530, United States
Manhattan Behavioral Medicine PLLC
New York, New York, 10036, United States
Advanced Research Solutions, LLC
Staten Island, New York, 10302, United States
Upstate ClinicalResearch Associates LLC
Williamsville, New York, 14221, United States
Carolina Research Center, Inc.
Shelby, North Carolina, 28150, United States
Progressive Medicine of the Triad, LLC
Winston-Salem, North Carolina, 27103, United States
Hometown Urgent Care and Research
Cincinnati, Ohio, 45215, United States
Hometown Urgent Care and Research
Columbus, Ohio, 43214, United States
Hometown Urgent Care and Research
Dayton, Ohio, 45424, United States
Onyx Clinical Research
Youngstown, Ohio, 44505, United States
Today Clinical Research
Oklahoma City, Oklahoma, 73129, United States
DelRicht Research
Tulsa, Oklahoma, 74133, United States
Frontier Clinical Research, LLC
Smithfield, Pennsylvania, 15478, United States
PCPMG Clinical Research Unit, LLC
Anderson, South Carolina, 29651, United States
New Phase Research & Development, LLC
Knoxville, Tennessee, 37909, United States
Central Texas Clinical Research
Austin, Texas, 78705, United States
Premier Family Physicians
Austin, Texas, 78735, United States
ClinRx Research Joseph INC
Carrollton, Texas, 75007, United States
Centex Studies, Inc.
Houston, Texas, 77058, United States
Centex Studies, Inc.
Houston, Texas, 77090, United States
R & H Clinical Research
Katy, Texas, 77494, United States
Village Health Partners
Plano, Texas, 75024, United States
Sun Research Institute
San Antonio, Texas, 78215, United States
Spectrum Medical, Inc.
Danville, Virginia, 24541, United States
Health Research of Hampton Roads, Inc.
Newport News, Virginia, 23606, United States
Related Publications (1)
Vaughan SA, Torres K, Kaye R. RESUME-1: a Phase III study of tolperisone in the treatment of painful, acute muscle spasms of the back. Pain Manag. 2022 Jan;12(1):25-33. doi: 10.2217/pmt-2021-0041. Epub 2021 Jul 1.
PMID: 34192885DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 10, 2020
First Posted
December 17, 2020
Study Start
December 15, 2020
Primary Completion
December 13, 2021
Study Completion
March 21, 2022
Last Updated
March 22, 2022
Record last verified: 2022-03
Data Sharing
- IPD Sharing
- Will not share