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Tolperisone in Acute Muscle Spasm of the Back (STAR)

N

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

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

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

Trial documents
2

Trial contacts and locations

43

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Data sourced from clinicaltrials.gov

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