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
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, District of Columbia, United States
Multi-Specialty Research Associates, Inc.
🇺🇸Lake City, Florida, United States
Savin Medical Group
🇺🇸Miami Lakes, Florida, United States
Scroll for more (40 remaining)Clinical Research Institute of Arizona, LLC🇺🇸Surprise, Arizona, United States