Tolperisone in Acute Muscle Spasm of the Back

Phase 2

Completed

Conditions: Acute Pain
Muscle Spasm
Low Back Pain
Back Spasm Upper Back
Back Strain
Muscle Cramp
Back Pain

Interventions: Drug: Tolperisone
Drug: Placebo

Registration Number: NCT03802565

Lead Sponsor: Neurana Pharmaceuticals, Inc.

Brief Summary: This is a double-blind, randomized, placebo-controlled, parallel group study of the efficacy and safety of tolperisone (a non-opioid) or placebo administered as multiple doses three times a day (TID) in approximately 400 male and female subjects experiencing back pain due to or associated with muscle spasm.

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 415

Inclusion Criteria

Ambulatory
Current acute back pain and/or stiffness due to acute and painful muscle spasm starting within 7 days prior to study entry and more than 8 weeks after the last episode of acute back pain.
Pain of 4 or more on the subject "right now" rating of pain intensity Numeric Rating Scale (NRS) scale of 0-10.
Willing to discontinue all medication used for the treatment of pain or muscle spasm on study entry.
Pain localized below the neck and above the inferior gluteal folds.
Body mass index ranging between 18 and 35 kg/m².

Exclusion Criteria

Unwillingness to stop taking pain or antispasmodic medication other than the study medication (specifically opioid use [e.g., Vicodin], barbiturates, and cannabis).
Chronic pain for the previous 3 months or longer, on more days than not.
Radicular pain in the lower extremity (i.e. pain radiating below the knee), sciatica pain down the leg, or pain below the knee (indicating a lumber radiculopathy); radicular pain in the upper extremity, radiating into the forearm or hand (indicating a cervical radiculopathy).
Concomitant severe pain in a region other than the back.
Spinal surgery within 1 year of study entry.
Back pain due to major trauma (e.g., motor vehicle accident, fracture of bone) unless resolved for more than 1 year.
Treatment of back pain ongoing with non-pharmacological therapy (e.g., acupuncture, chiropractic adjustment, massage, Transcutaneous Electrical Nerve Stimulation [TENS], physiotherapy).
Subjects who test positive for alcohol by breathalyzer test.
Unwilling to stop taking moderate to potent inhibitors of cytochrome P450 (CYP) isozymes CYP2D6 and CYP2C19, which are likely to cause drug interactions with tolperisone HCl (e.g., medications such as paroxetine and fluvoxamine).

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Tolperisone 150 mg	Tolperisone	TID (450 mg/day)
Placebo	Placebo	TID
Tolperisone 50 mg	Tolperisone	TID (150 mg/day)
Tolperisone 100 mg	Tolperisone	TID (300 mg/day)
Tolperisone 200 mg	Tolperisone	TID (600 mg/day)

Primary Outcome Measures

Name	Time	Method
Mean Effect Size in Subjected-Rated Pain	Day 1 to Day 14	Mean effect size between Tolperisone and Placebo of subject-rated pain due to acute back spasm using a Numerical Rating Scale (NRS; 0-10 scale, from no pain to worst possible pain) on Day 14 "right now."

Secondary Outcome Measures

Name	Time	Method

Trial Locations

Locations (42): CITrials
🇺🇸
Santa Ana, California, United States
Private Practice
🇺🇸
Plantation, Florida, United States
Cleveland Clinic
🇺🇸
Cleveland, Ohio, United States
Tennessee Valley Pain Consultants
🇺🇸
Huntsville, Alabama, United States
Research Center of Fresno
🇺🇸
Fresno, California, United States
Long Beach Clinical Trials Services, Inc.
🇺🇸
Long Beach, California, United States
Riverside Clinical Research
🇺🇸
Edgewater, Florida, United States
Savin Medical Group
🇺🇸
Miami Lakes, Florida, United States
NeuroTrials Research, Inc.
🇺🇸
Atlanta, Georgia, United States
Georgia Institute for Clinical Research
🇺🇸
Marietta, Georgia, United States
MediSphere Medical Research Center
🇺🇸
Evansville, Indiana, United States
Omega Medical Research
🇺🇸
Warwick, Rhode Island, United States
Williamette Valley Clinical Studies
🇺🇸
Eugene, Oregon, United States
Health Concepts
🇺🇸
Rapid City, South Dakota, United States
Inquest Clinical Research
🇺🇸
Baytown, Texas, United States
Sundance Clinical Research
🇺🇸
Saint Louis, Missouri, United States
Centex Studies, Inc.
🇺🇸
McAllen, Texas, United States
Georgia Clinical Research
🇺🇸
Snellville, Georgia, United States
Albuquerque Clinical Trials, Inc.
🇺🇸
Albuquerque, New Mexico, United States
Otrimed Clinical Research
🇺🇸
Edgewood, Kentucky, United States
Upstate Clinical Research Associates
🇺🇸
Williamsville, New York, United States
Center for Providence Health Partners
🇺🇸
Dayton, Ohio, United States
Frontier Clinical Research, Inc.
🇺🇸
Smithfield, Pennsylvania, United States
DiscoveResearch, Inc.
🇺🇸
Bryan, Texas, United States
ClinRX Research Joseph, Inc.
🇺🇸
Plano, Texas, United States
Health Research of Hampton Roads, Inc.
🇺🇸
Newport News, Virginia, United States
Pacific Research Network, LLC
🇺🇸
San Diego, California, United States
San Diego Sports Medicine
🇺🇸
San Diego, California, United States
LLC Medical Research
🇺🇸
Miami, Florida, United States
Jubilee Clinical Research
🇺🇸
Las Vegas, Nevada, United States
HD Research Corp
🇺🇸
Houston, Texas, United States
Sterling Research Group- Springdale
🇺🇸
Cincinnati, Ohio, United States
Highland Clinical Research
🇺🇸
Salt Lake City, Utah, United States
Center of Applied Research
🇺🇸
Little Rock, Arkansas, United States
Fiel Family and Sports Medicine
🇺🇸
Tempe, Arizona, United States
Avail Clinical Research
🇺🇸
Orange City, Florida, United States
Michigan Head Pain and Neurological
🇺🇸
Ann Arbor, Michigan, United States
Clinical Trials of America
🇺🇸
Winston-Salem, North Carolina, United States
Northern California Research
🇺🇸
Sacramento, California, United States
IPS Research
🇺🇸
Oklahoma City, Oklahoma, United States
Empirical Research Group
🇺🇸
Gainesville, Florida, United States
Center for Rheumatology and Bone
🇺🇸
Wheaton, Maryland, United States