Tolperisone in Acute Muscle Spasm of the Back

Completed · Phase 2 · Has a placebo group

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

In brief

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.

Key facts

Study ID

NCT03802565

Run by

Neurana Pharmaceuticals, Inc.

People needed

415

Starts

2019-02-01

Expected to finish

2019-07-12

Last updated by the study team

2022-02-01

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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).

Where it is running

• Tennessee Valley Pain Consultants — Huntsville, Alabama, United States
• Fiel Family and Sports Medicine — Tempe, Arizona, United States
• Center of Applied Research — Little Rock, Arkansas, United States
• Research Center of Fresno — Fresno, California, United States
• Long Beach Clinical Trials Services, Inc. — Long Beach, California, United States
• Northern California Research — Sacramento, California, United States
• Pacific Research Network, LLC — San Diego, California, United States
• San Diego Sports Medicine — San Diego, California, United States
• CITrials — Santa Ana, California, United States
• Riverside Clinical Research — Edgewater, Florida, United States
• Empirical Research Group — Gainesville, Florida, United States
• LLC Medical Research — Miami, Florida, United States
• Savin Medical Group — Miami Lakes, Florida, United States
• Avail Clinical Research — Orange City, Florida, United States
• Private Practice — Plantation, Florida, United States
• NeuroTrials Research, Inc. — Atlanta, Georgia, United States
• Georgia Institute for Clinical Research — Marietta, Georgia, United States
• Georgia Clinical Research — Snellville, Georgia, United States
• MediSphere Medical Research Center — Evansville, Indiana, United States
• Otrimed Clinical Research — Edgewood, Kentucky, United States
• Centex Studies, Inc. — Lake Charles, Louisiana, United States
• Center for Rheumatology and Bone — Wheaton, Maryland, United States
• Michigan Head Pain and Neurological — Ann Arbor, Michigan, United States
• Sundance Clinical Research — St Louis, Missouri, United States
• Jubilee Clinical Research — Las Vegas, Nevada, United States

Full record on ClinicalTrials.gov

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