Clinical trial NCT04671082: Efficacy and Safety of Tolperisone in Subjects With Pain Due to Acute Back Muscle Spasm
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Back Muscle Spasm
Back Pain
Back Strain
Back Spasm Upper
Muscle Spasm
Acute Pain
Lead sponsor: Neurana Pharmaceuticals, Inc.
Sponsor class: INDUSTRY
First posted: 2020-12-17
Enrollment: 1004
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Numerical rating scale (NRS)
timeFrame: Day 1 to Day 14
Secondary outcomes:
Other outcomes:
Locations:
city: Surprise
country: United States
facility: Clinical Research Institute of Arizona, LLC
state: Arizona
city: Little Rock
country: United States
facility: Applied Research Center of Arkansas
state: Arkansas
city: Canoga Park
country: United States
facility: Alliance Research Institute
state: California
city: Long Beach
country: United States
facility: Long Beach Clinical Trials Services, Inc
state: California
city: Sacramento
country: United States
facility: Northern California Research
state: California
city: Torrance
country: United States
facility: Collaborative Neuroscience Research, LLC
state: California
city: Aurora
country: United States
facility: Lynn Institute of Denver
state: Colorado
city: Washington
country: United States
facility: Emerson Clinical Research Institute
state: District of Columbia
city: Lake City
country: United States
facility: Multi-Specialty Research Associates, Inc.
state: Florida
city: Miami Lakes
country: United States
facility: Savin Medical Group
state: Florida
city: Miami
country: United States
facility: LCC Medical Research Institute, LLC
state: Florida
city: Orange City
country: United States
facility: Accel Research Sites
state: Florida
city: Orlando
country: United States
facility: Combined Research Orlando
state: Florida
city: Decatur
country: United States
facility: iResearch Atlanta
state: Georgia
city: Lawrenceville
country: United States
facility: Georgia Clinical Research LLC
state: Georgia
city: Chicago
country: United States
facility: IMA Clinical Research, PC
state: Illinois
city: Evanston
country: United States
facility: Evanston Premier Healthcare Research LLC
state: Illinois
city: Brownsburg
country: United States
facility: Investigators Research Group
state: Indiana
city: Wichita
country: United States
facility: Professional Research Network of Kansas, LLC
state: Kansas
city: Owensboro
country: United States
facility: Research Integrity, LLC
state: Kentucky
city: New Orleans
country: United States
facility: DelRicht Research
state: Louisiana
city: Prairieville
country: United States
facility: DelRicht Research
state: Louisiana
city: Ann Arbor
country: United States
facility: Michigan Head Pain and Neurological Institute
state: Michigan
city: Rochester Hills
country: United States
facility: Onyx Clinical Research
state: Michigan
city: Ridgeland
country: United States
facility: Quinn Healthcare/SKYCRNG
state: Mississippi
city: Saint Louis
country: United States
facility: IMA Clinical Research
state: Missouri
city: Bellevue
country: United States
facility: Pioneer Clinical Research, LLC
state: Nebraska
city: Elkhorn
country: United States
facility: Skyline Medical Center, PC
state: Nebraska
city: Las Vegas
country: United States
facility: Jubilee Clinical Research, Inc.
state: Nevada
city: Albuquerque
country: United States
facility: Albuquerque Clinical Trials, Inc.
state: New Mexico
city: Brooklyn
country: United States
facility: Integrative Clinical Trials, LLC
state: New York
city: Hartsdale
country: United States
facility: Drug Trials America
state: New York
city: New York
country: United States
facility: Manhattan Behavioral Medicine PLLC
state: New York
city: Staten Island
country: United States
facility: Advanced Research Solutions, LLC
state: New York
city: Williamsville
country: United States
facility: Upstate ClinicalResearch Associates LLC
state: New York
city: Shelby
country: United States
facility: Carolina Research Center, Inc.
state: North Carolina
city: Winston-Salem
country: United States
facility: Progressive Medicine of the Triad, LLC
state: North Carolina
city: Cincinnati
country: United States
facility: Hometown Urgent Care and Research
state: Ohio
city: Columbus
country: United States
facility: Hometown Urgent Care and Research
state: Ohio
city: Dayton
country: United States
facility: Hometown Urgent Care and Research
state: Ohio
city: Youngstown
country: United States
facility: Onyx Clinical Research
state: Ohio
city: Oklahoma City
country: United States
facility: Today Clinical Research
state: Oklahoma
city: Tulsa
country: United States
facility: DelRicht Research
state: Oklahoma
city: Smithfield
country: United States
facility: Frontier Clinical Research, LLC
state: Pennsylvania
city: Anderson
country: United States
facility: PCPMG Clinical Research Unit, LLC
state: South Carolina
city: Knoxville
country: United States
facility: New Phase Research & Development, LLC
state: Tennessee
city: Austin
country: United States
facility: Central Texas Clinical Research
state: Texas
city: Austin
country: United States
facility: Premier Family Physicians
state: Texas
city: Carrollton
country: United States
facility: ClinRx Research Joseph INC
state: Texas
city: Houston
country: United States
facility: Centex Studies, Inc.
state: Texas
city: Houston
country: United States
facility: Centex Studies, Inc.
state: Texas
city: Katy
country: United States
facility: R & H Clinical Research
state: Texas
city: Plano
country: United States
facility: Village Health Partners
state: Texas
city: San Antonio
country: United States
facility: Sun Research Institute
state: Texas
city: Danville
country: United States
facility: Spectrum Medical, Inc.
state: Virginia
city: Newport News
country: United States
facility: Health Research of Hampton Roads, Inc.
state: Virginia
Study officials:
References:
citation: 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.