We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Try the New Site
We're building a modernized ClinicalTrials.gov! Visit Beta.ClinicalTrials.gov to try the new functionality.
Working…
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
Results First Posted : November 10, 2020
Last Update Posted : February 1, 2022
Sponsor:
Information provided by (Responsible Party):
Neurana Pharmaceuticals, Inc.

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.

Condition or disease Intervention/treatment Phase
Back Pain Acute Pain Back Spasm Upper Back Back Strain Muscle Cramp Muscle Spasm Low Back Pain Drug: Tolperisone Drug: Placebo Phase 2

Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 415 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Dose Ranging Study of Tolperisone in Acute Muscle Spasm of the Back
Actual Study Start Date : February 1, 2019
Actual Primary Completion Date : June 28, 2019
Actual Study Completion Date : July 12, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Muscle Cramps

Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. 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."


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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).
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03802565


Locations
Show Show 43 study locations
Sponsors and Collaborators
Neurana Pharmaceuticals, Inc.
  Study Documents (Full-Text)

Documents provided by Neurana Pharmaceuticals, Inc.:
Study Protocol  [PDF] May 2, 2019
Statistical Analysis Plan  [PDF] August 6, 2019

More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: Neurana Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT03802565    
Other Study ID Numbers: 201
First Posted: January 14, 2019    Key Record Dates
Results First Posted: November 10, 2020
Last Update Posted: February 1, 2022
Last Verified: January 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Muscle Cramp
Spasm
Hyperkinesis
Back Pain
Low Back Pain
Acute Pain
Pain
Neurologic Manifestations
Neuromuscular Manifestations
 Nervous System Diseases
Muscular Diseases
Musculoskeletal Diseases
Dyskinesias
Tolperisone
Muscle Relaxants, Central
Physiological Effects of Drugs
Neuromuscular Agents
Peripheral Nervous System Agents