Tolperisone in Acute Muscle Spasm of the Back

Study Overview
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Brief Summary
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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.

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

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

Intervention / Treatment
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* Drug: Tolperisone
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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).

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Tolperisone 50 mg<br>TID (150 mg/day) | Drug: Tolperisone<br>* TID<br>|
| Experimental: Tolperisone 100 mg<br>TID (300 mg/day) | Drug: Tolperisone<br>* TID<br>|
| Experimental: Tolperisone 150 mg<br>TID (450 mg/day) | Drug: Tolperisone<br>* TID<br>|
| Experimental: Tolperisone 200 mg<br>TID (600 mg/day) | Drug: Tolperisone<br>* TID<br>|
| Placebo Comparator: Placebo<br>TID | Drug: Placebo<br>* Placebo<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean Effect Size in Subjected-Rated Pain | 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. | Day 1 to Day 14 |