Tolperisone in Acute Muscle Spasm of the Back



Status:Recruiting
Conditions:Back Pain, Back Pain, Chronic Pain, Other Indications, Metabolic
Therapuetic Areas:Musculoskeletal, Pharmacology / Toxicology, Other
Healthy:No
Age Range:18 - 65
Updated:3/29/2019
Start Date:February 1, 2019
End Date:July 2019
Contact:STAR Study
Email:NeuranaSTARStudy@precisionformedicine.com
Phone:760-688-0401

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Dose Ranging Study of Tolperisone in Acute Muscle Spasm of the Back

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.


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 (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).
We found this trial at
43
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2008 Pacific Avenue
Long Beach, California 90806
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1100 Johnson Ferry Road
Atlanta, Georgia 30342
404-851-9934
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9500 Euclid Avenue
Cleveland, Ohio 44106
216.444.2200
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400 Bald Hill Road
Warwick, Rhode Island 02886
401-739-9350
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Albuquerque, New Mexico
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Ann Arbor, Michigan 48104
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Baytown, Texas 77512
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Bryan, Texas 77802
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Cincinnati, Ohio 45246
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Edgewater, Florida 32132
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Edgewood, Kentucky 41017
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Evansville, Indiana 47714
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Fresno, California 93726
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4611 Northwest 53rd Avenue
Gainesville, Florida 32653
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Houston, Texas 77004
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McAllen, Texas 78504
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Miami, Florida 33126
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5801 Northwest 151st Street
Miami Lakes, Florida 33014
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Newport News, Virginia 23606
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Oklahoma City, Oklahoma 73103
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860 Peachwood Drive
Orange City, Florida 32763
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