Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Tolperisone in Acute Muscle Spasm of the Back (STAR)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03802565
Recruitment Status : Completed
First Posted : January 14, 2019
Last Update Posted : September 10, 2019
Sponsor:
Information provided by (Responsible Party):
Neurana Pharmaceuticals, Inc.

Tracking Information
First Submitted Date  ICMJE January 10, 2019
First Posted Date  ICMJE January 14, 2019
Last Update Posted Date September 10, 2019
Actual Study Start Date  ICMJE February 1, 2019
Actual Primary Completion Date June 28, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Tolperisone in Acute Muscle Spasm of the Back
Official Title  ICMJE 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  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE
  • Back Pain
  • Acute Pain
  • Back Spasm Upper Back
  • Back Strain
  • Muscle Cramp
  • Muscle Spasm
  • Low Back Pain
Intervention  ICMJE
  • Drug: Tolperisone
    TID
  • Drug: Placebo
    Placebo
Study Arms  ICMJE
  • 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

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 14, 2019)
415
Original Estimated Enrollment  ICMJE
 (submitted: January 11, 2019)
400
Actual Study Completion Date  ICMJE July 12, 2019
Actual Primary Completion Date June 28, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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).
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03802565
Other Study ID Numbers  ICMJE 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  ICMJE
Plan to Share IPD: No
Responsible Party Neurana Pharmaceuticals, Inc.
Study Sponsor  ICMJE Neurana Pharmaceuticals, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Tom Wessel, MD Neurana Pharmaceuticals, Inc.
PRS Account Neurana Pharmaceuticals, Inc.
Verification Date September 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP