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

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
1004

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

  • United States
    • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Placebo Comparator: Placebo
Drug: Placebo
TID
Experimental: Tolperisone 50 mg
Drug: Tolperisone Hydrochloride
TID
Other Names:
  • Tolperisone
Experimental: Tolpersione 100 mg
Tolperisone 100 mg
Drug: Tolperisone Hydrochloride
TID
Other Names:
  • Tolperisone
Experimental: Tolperisone 200 mg
Drug: Tolperisone Hydrochloride
TID
Other Names:
  • Tolperisone

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Neurana Pharmaceuticals, Inc.

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.

General Publications

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 15, 2020

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 13, 2021

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 21, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 10, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 15, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 17, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 22, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 21, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CLN-301
  • RESUME-1 (Other Identifier: Neurana Pharmaceuticals)

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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