Efficacy and Safety of Tolperisone in Subjects With Pain Due to Acute Back Muscle Spasm
- Conditions
- Back Muscle SpasmBack Spasm UpperBack StrainBack PainMuscle SpasmAcute Pain
- Interventions
- Drug: Placebo
- Registration Number
- NCT04671082
- Lead Sponsor
- Neurana Pharmaceuticals, Inc.
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 1004
- 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.
- 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 neurogenic pain in the back, neck, upper or lower extremities, including pain from (or suspected from) nerve root compression or injury (radicular pain or "pinched nerve") or neuropathic pain. Evidence of these types of exclusionary pain includes radiation of pain that radiates beyond the back, chronic pain, and pain associated with abnormal sensation or loss of sensation in the back or extremities.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Tolperisone 200 mg Tolperisone Hydrochloride Tolperisone 200 mg Tolperisone 50 mg Tolperisone Hydrochloride Tolperisone 50 mg Tolpersione 100 mg Tolperisone Hydrochloride Tolperisone 100 mg Placebo Placebo Placebo
- Primary Outcome Measures
Name Time Method Numerical rating scale (NRS) Day 1 to Day 14 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.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (50)
Clinical Research Institute of Arizona, LLC
🇺🇸Surprise, Arizona, United States
Alliance Research Institute
🇺🇸Canoga Park, California, United States
Long Beach Clinical Trials Services, Inc
🇺🇸Long Beach, California, United States
Collaborative Neuroscience Research, LLC
🇺🇸Torrance, California, United States
Savin Medical Group
🇺🇸Miami Lakes, Florida, United States
Multi-Specialty Research Associates, Inc.
🇺🇸Lake City, Florida, United States
Evanston Premier Healthcare Research LLC
🇺🇸Evanston, Illinois, United States
iResearch Atlanta
🇺🇸Decatur, Georgia, United States
Accel Research Sites
🇺🇸Orange City, Florida, United States
Investigators Research Group
🇺🇸Brownsburg, Indiana, United States
Georgia Clinical Research LLC
🇺🇸Lawrenceville, Georgia, United States
Research Integrity, LLC
🇺🇸Owensboro, Kentucky, United States
Onyx Clinical Research
🇺🇸Youngstown, Ohio, United States
IMA Clinical Research
🇺🇸Saint Louis, Missouri, United States
DelRicht Research
🇺🇸Tulsa, Oklahoma, United States
Albuquerque Clinical Trials, Inc.
🇺🇸Albuquerque, New Mexico, United States
Integrative Clinical Trials, LLC
🇺🇸Brooklyn, New York, United States
Drug Trials America
🇺🇸Hartsdale, New York, United States
Advanced Research Solutions, LLC
🇺🇸Staten Island, New York, United States
Manhattan Behavioral Medicine PLLC
🇺🇸New York, New York, United States
Upstate ClinicalResearch Associates LLC
🇺🇸Williamsville, New York, United States
Hometown Urgent Care and Research
🇺🇸Dayton, Ohio, United States
Carolina Research Center, Inc.
🇺🇸Shelby, North Carolina, United States
Frontier Clinical Research, LLC
🇺🇸Smithfield, Pennsylvania, United States
PCPMG Clinical Research Unit, LLC
🇺🇸Anderson, South Carolina, United States
ClinRx Research Joseph INC
🇺🇸Carrollton, Texas, United States
New Phase Research & Development, LLC
🇺🇸Knoxville, Tennessee, United States
R & H Clinical Research
🇺🇸Katy, Texas, United States
Village Health Partners
🇺🇸Plano, Texas, United States
Spectrum Medical, Inc.
🇺🇸Danville, Virginia, United States
Health Research of Hampton Roads, Inc.
🇺🇸Newport News, Virginia, United States
LCC Medical Research Institute, LLC
🇺🇸Miami, Florida, United States
IMA Clinical Research, PC
🇺🇸Chicago, Illinois, United States
Jubilee Clinical Research, Inc.
🇺🇸Las Vegas, Nevada, United States
Centex Studies, Inc.
🇺🇸Houston, Texas, United States
Professional Research Network of Kansas, LLC
🇺🇸Wichita, Kansas, United States
Sun Research Institute
🇺🇸San Antonio, Texas, United States
Today Clinical Research
🇺🇸Oklahoma City, Oklahoma, United States
Quinn Healthcare/SKYCRNG
🇺🇸Ridgeland, Mississippi, United States
Applied Research Center of Arkansas
🇺🇸Little Rock, Arkansas, United States
Emerson Clinical Research Institute
🇺🇸Washington, District of Columbia, United States
Northern California Research
🇺🇸Sacramento, California, United States
Lynn Institute of Denver
🇺🇸Aurora, Colorado, United States
Combined Research Orlando
🇺🇸Orlando, Florida, United States
Michigan Head Pain and Neurological Institute
🇺🇸Ann Arbor, Michigan, United States
Progressive Medicine of the Triad, LLC
🇺🇸Winston-Salem, North Carolina, United States
Central Texas Clinical Research
🇺🇸Austin, Texas, United States
Premier Family Physicians
🇺🇸Austin, Texas, United States
Pioneer Clinical Research, LLC
🇺🇸Bellevue, Nebraska, United States
Skyline Medical Center, PC
🇺🇸Elkhorn, Nebraska, United States