Tolperisone in Acute Muscle Spasm of the Back (STAR)

• ClinicalTrials.gov Identifier: NCT03802565
• Recruitment Status: Completed
• First Posted: January 14, 2019
• Results First Posted: November 10, 2020
• Last Update Posted: February 1, 2022
• Sponsor: Neurana Pharmaceuticals, Inc.
• Information provided by (Responsible Party): Neurana Pharmaceuticals, Inc.

Tracking Information

• First Submitted Date: January 10, 2019
• First Posted Date: January 14, 2019
• Results First Submitted Date: October 19, 2020
• Results First Posted Date: November 10, 2020
• Last Update Posted Date: February 1, 2022
• Actual Study Start Date: February 1, 2019
• Actual Primary Completion Date: June 28, 2019 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: February 19, 2021)

Mean Effect Size in Subjected-Rated Pain [ Time Frame: Day 1 to Day 14 ]

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."

Original Primary Outcome Measures (submitted: January 11, 2019)

Numerical rating scale (NRS), a 0-10 scale, from no pain to worst possible pain [ Time Frame: Day 1 to Day 14 ]

Subject-rated pain "right now" due to acute back spasm

• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Tolperisone in Acute Muscle Spasm of the Back
• Official Title: Dose Ranging Study of Tolperisone in Acute Muscle Spasm of the Back
• Brief Summary: 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.
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Phase 2
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Double (Participant, Investigator); Primary Purpose: Treatment

Condition

• Back Pain
• Acute Pain
• Back Spasm Upper Back
• Back Strain
• Muscle Cramp
• Muscle Spasm
• Low Back Pain

Intervention

• Drug: Tolperisone
  TID
• Drug: Placebo
  Placebo

Study Arms

• Experimental: Tolperisone 50 mg
  TID (150 mg/day)
  Intervention: Drug: Tolperisone
• Experimental: Tolperisone 100 mg
  TID (300 mg/day)
  Intervention: Drug: Tolperisone
• Experimental: Tolperisone 150 mg
  TID (450 mg/day)
  Intervention: Drug: Tolperisone
• Experimental: Tolperisone 200 mg
  TID (600 mg/day)
  Intervention: Drug: Tolperisone
• Placebo Comparator: Placebo
  TID
  Intervention: Drug: Placebo

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: June 14, 2019): 415
• Original Estimated Enrollment (submitted: January 11, 2019): 400
• Actual Study Completion Date: July 12, 2019
• Actual Primary Completion Date: June 28, 2019 (Final data collection date for primary outcome measure)

Eligibility Criteria

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).

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 65 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT03802565
• Other Study ID Numbers: 201
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: No

• Current Responsible Party: Neurana Pharmaceuticals, Inc.
• Original Responsible Party: Same as current
• Current Study Sponsor: Neurana Pharmaceuticals, Inc.
• Original Study Sponsor: Same as current
• Collaborators: Not Provided
• Investigators: Not Provided
• PRS Account: Neurana Pharmaceuticals, Inc.
• Verification Date: January 2022