Efficacy and Safety of Tolperisone in Subjects With Pain Due to Acute Back Muscle Spasm

Completed · Phase 3 · Has a placebo group

Conditions studied: Back Muscle Spasm, Back Pain, Back Strain, Back Spasm Upper, Muscle Spasm, Acute Pain

In brief

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.

Key facts

Study ID

NCT04671082

Run by

Neurana Pharmaceuticals, Inc.

People needed

1004

Starts

2020-12-15

Expected to finish

2022-03-21

Last updated by the study team

2022-03-22

Who can join

Age: 18 and older, up to 64. Sex: any. Healthy volunteers: not accepted.

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 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.

Where it is running

• Applied Research Center of Arkansas — Little Rock, Arkansas, United States
• Alliance Research Institute — Canoga Park, California, United States
• Long Beach Clinical Trials Services, Inc — Long Beach, California, United States
• Northern California Research — Sacramento, California, United States
• Collaborative Neuroscience Research, LLC — Torrance, California, United States
• Lynn Institute of Denver — Aurora, Colorado, United States
• Emerson Clinical Research Institute — Washington D.C., District of Columbia, United States
• Multi-Specialty Research Associates, Inc. — Lake City, Florida, United States
• LCC Medical Research Institute, LLC — Miami, Florida, United States
• Savin Medical Group — Miami Lakes, Florida, United States
• Accel Research Sites — Orange City, Florida, United States
• Combined Research Orlando — Orlando, Florida, United States
• iResearch Atlanta — Decatur, Georgia, United States
• Georgia Clinical Research LLC — Lawrenceville, Georgia, United States
• IMA Clinical Research, PC — Chicago, Illinois, United States
• Evanston Premier Healthcare Research LLC — Evanston, Illinois, United States
• Investigators Research Group — Brownsburg, Indiana, United States
• Professional Research Network of Kansas, LLC — Wichita, Kansas, United States
• Research Integrity, LLC — Owensboro, Kentucky, United States
• DelRicht Research — New Orleans, Louisiana, United States
• DelRicht Research — Prairieville, Louisiana, United States
• Michigan Head Pain and Neurological Institute — Ann Arbor, Michigan, United States
• Onyx Clinical Research — Rochester Hills, Michigan, United States
• Quinn Healthcare/SKYCRNG — Ridgeland, Mississippi, United States
• Clinical Research Institute of Arizona, LLC — Surprise, Arizona, United States

Full record on ClinicalTrials.gov

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