Tolperisone in Acute Muscle Spasm of the Back (STAR)

Neurana Pharmaceuticals

Status and phase: Completed; Phase 2

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

Treatments: Drug: Tolperisone; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT03802565

201

Details and patient eligibility

About

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.

Enrollment: 415 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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415 participants in 5 patient groups, including a placebo group

Tolperisone 50 mg

Experimental group

Description:

TID (150 mg/day)

Treatment:

Drug: Tolperisone

Tolperisone 100 mg

Experimental group

Description:

TID (300 mg/day)

Treatment:

Drug: Tolperisone

Tolperisone 150 mg

Experimental group

Description:

TID (450 mg/day)

Treatment:

Drug: Tolperisone

Tolperisone 200 mg

Experimental group

Description:

TID (600 mg/day)

Treatment:

Drug: Tolperisone

Placebo

Placebo Comparator group

Description:

TID

Treatment:

Drug: Placebo