Efficacy and Safety of Tolperisone in Subjects With Pain Due to Acute Back Muscle Spasm (RESUME-1)

March 21, 2022 updated by: Neurana Pharmaceuticals, Inc.

A Phase 3, 14-Day, Double-blind, Randomized, Placebo-Controlled, Multicenter Study of the Efficacy and Safety of Tolperisone in Subjects With Pain Due to Acute Back Muscle Spasm

This is a double-blind, randomized, placebo-controlled, multicenter study of the efficacy and safety of tolperisone (a non-opioid) or placebo administered in subjects with pain due to acute back muscle spasm.

Study Overview

Study Type

Interventional

Enrollment (Actual)

1004

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Arizona
      • Surprise, Arizona, United States, 85374
        • Clinical Research Institute of Arizona, LLC
    • Arkansas
      • Little Rock, Arkansas, United States, 72212
        • Applied Research Center of Arkansas
    • California
      • Canoga Park, California, United States, 91304
        • Alliance Research Institute
      • Long Beach, California, United States, 90806
        • Long Beach Clinical Trials Services, Inc
      • Sacramento, California, United States, 95821
        • Northern California Research
      • Torrance, California, United States, 90502
        • Collaborative Neuroscience Research, LLC
    • Colorado
      • Aurora, Colorado, United States, 80012
        • Lynn Institute of Denver
    • District of Columbia
      • Washington, District of Columbia, United States, 20011
        • Emerson Clinical Research Institute
    • Florida
      • Lake City, Florida, United States, 32055
        • Multi-Specialty Research Associates, Inc.
      • Miami, Florida, United States, 33126
        • LCC Medical Research Institute, LLC
      • Miami Lakes, Florida, United States, 33014
        • Savin Medical Group
      • Orange City, Florida, United States, 32763
        • Accel Research Sites
      • Orlando, Florida, United States, 32807
        • Combined Research Orlando
    • Georgia
      • Decatur, Georgia, United States, 30030
        • iResearch Atlanta
      • Lawrenceville, Georgia, United States, 30044
        • Georgia Clinical Research LLC
    • Illinois
      • Chicago, Illinois, United States, 60602
        • IMA Clinical Research, PC
      • Evanston, Illinois, United States, 60201
        • Evanston Premier Healthcare Research LLC
    • Indiana
      • Brownsburg, Indiana, United States, 46112
        • Investigators Research Group
    • Kansas
      • Wichita, Kansas, United States, 67205
        • Professional Research Network of Kansas, LLC
    • Kentucky
      • Owensboro, Kentucky, United States, 42303
        • Research Integrity, LLC
    • Louisiana
      • New Orleans, Louisiana, United States, 70124
        • DelRicht Research
      • Prairieville, Louisiana, United States, 70769
        • DelRicht Research
    • Michigan
      • Ann Arbor, Michigan, United States, 48104
        • Michigan Head Pain and Neurological Institute
      • Rochester Hills, Michigan, United States, 48307
        • Onyx Clinical Research
    • Mississippi
      • Ridgeland, Mississippi, United States, 39157
        • Quinn Healthcare/SKYCRNG
    • Missouri
      • Saint Louis, Missouri, United States, 63117
        • IMA Clinical Research
    • Nebraska
      • Bellevue, Nebraska, United States, 68005
        • Pioneer Clinical Research, LLC
      • Elkhorn, Nebraska, United States, 68022
        • Skyline Medical Center, PC
    • Nevada
      • Las Vegas, Nevada, United States, 89106
        • Jubilee Clinical Research, Inc.
    • New Mexico
      • Albuquerque, New Mexico, United States, 87102
        • Albuquerque Clinical Trials, Inc.
    • New York
      • Brooklyn, New York, United States, 11229
        • Integrative Clinical Trials, LLC
      • Hartsdale, New York, United States, 10530
        • Drug Trials America
      • New York, New York, United States, 10036
        • Manhattan Behavioral Medicine PLLC
      • Staten Island, New York, United States, 10302
        • Advanced Research Solutions, LLC
      • Williamsville, New York, United States, 14221
        • Upstate ClinicalResearch Associates LLC
    • North Carolina
      • Shelby, North Carolina, United States, 28150
        • Carolina Research Center, Inc.
      • Winston-Salem, North Carolina, United States, 27103
        • Progressive Medicine of the Triad, LLC
    • Ohio
      • Cincinnati, Ohio, United States, 45215
        • Hometown Urgent Care and Research
      • Columbus, Ohio, United States, 43214
        • Hometown Urgent Care and Research
      • Dayton, Ohio, United States, 45424
        • Hometown Urgent Care and Research
      • Youngstown, Ohio, United States, 44505
        • Onyx Clinical Research
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73129
        • Today Clinical Research
      • Tulsa, Oklahoma, United States, 74133
        • DelRicht Research
    • Pennsylvania
      • Smithfield, Pennsylvania, United States, 15478
        • Frontier Clinical Research, LLC
    • South Carolina
      • Anderson, South Carolina, United States, 29651
        • PCPMG Clinical Research Unit, LLC
    • Tennessee
      • Knoxville, Tennessee, United States, 37909
        • New Phase Research & Development, LLC
    • Texas
      • Austin, Texas, United States, 78705
        • Central Texas Clinical Research
      • Austin, Texas, United States, 78735
        • Premier Family Physicians
      • Carrollton, Texas, United States, 75007
        • ClinRX Research Joseph INC
      • Houston, Texas, United States, 77058
        • Centex Studies, Inc.
      • Houston, Texas, United States, 77090
        • Centex Studies, Inc.
      • Katy, Texas, United States, 77494
        • R & H Clinical Research
      • Plano, Texas, United States, 75024
        • Village Health Partners
      • San Antonio, Texas, United States, 78215
        • Sun Research Institute
    • Virginia
      • Danville, Virginia, United States, 24541
        • Spectrum Medical, Inc.
      • Newport News, Virginia, United States, 23606
        • Health Research of Hampton Roads, Inc.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 64 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Ambulatory
  • Current acute back pain due to acute muscle spasm starting within 7 days prior to study entry (Day 1) and at least 8 weeks following resolution of the last episode of acute back pain.
  • Willingness to discontinue all previous or ongoing treatment of pain or muscle spasm on study entry at Day 1 through the end of treatment including medication, acupuncture, chiropractic adjustment, massage, transcutaneous electrical nerve stimulation [TENS], or physiotherapy.
  • Pain must be localized from the neck (C-3 or lower) to the inferior gluteal folds and spasm assessed during the Screening physical examination.
  • Body mass index range between 18 and 35 kg/m², inclusive.

Exclusion Criteria:

  • Presence of acute or chronic back pain for the previous 8 days or longer, where back pain is present on more days than not.
  • Presence of neurogenic pain in the back, neck, upper or lower extremities, including pain from (or suspected from) nerve root compression or injury (radicular pain or "pinched nerve") or neuropathic pain. Evidence of these types of exclusionary pain includes radiation of pain that radiates beyond the back, chronic pain, and pain associated with abnormal sensation or loss of sensation in the back or extremities.
  • Presence of pain anywhere other than the target back pain that is bothersome, interferes with activity, or for which pain relief is taken.
  • History of any neck, back, or pelvic surgery.
  • History within the previous 3 years of: spinal fracture or spinal infection; inflammatory arthritis; degenerative spine disease; or any other back or spine condition that may reasonably contribute to current back pain.
  • Subjects who test positive for alcohol by breathalyzer test or have a positive urine drug screen for drugs of abuse (e.g. amphetamines, methamphetamines, barbiturates, benzodiazepines, cocaine, cannabinoids, oxycodone, opiates), including cannabis even where legal, at Screening.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
TID
Experimental: Tolperisone 50 mg
TID
Other Names:
  • Tolperisone
Experimental: Tolpersione 100 mg
Tolperisone 100 mg
TID
Other Names:
  • Tolperisone
Experimental: Tolperisone 200 mg
TID
Other Names:
  • Tolperisone

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Numerical rating scale (NRS)
Time Frame: Day 1 to Day 14
Numerical rating scale (NRS), a 0-10 scale, from no pain to worst possible pain - Subject-rated pain "right now" due to acute back spasm.
Day 1 to Day 14

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 15, 2020

Primary Completion (Actual)

December 13, 2021

Study Completion (Actual)

March 21, 2022

Study Registration Dates

First Submitted

December 10, 2020

First Submitted That Met QC Criteria

December 15, 2020

First Posted (Actual)

December 17, 2020

Study Record Updates

Last Update Posted (Actual)

March 22, 2022

Last Update Submitted That Met QC Criteria

March 21, 2022

Last Verified

March 1, 2022

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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