Tolperisone in Acute Muscle Spasm of the Back (STAR)

January 28, 2022 updated by: Neurana Pharmaceuticals, Inc.

Dose Ranging Study of Tolperisone in Acute Muscle Spasm of the Back

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.

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.
415

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 2

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
    • Alabama
      • Huntsville, Alabama, United States, 35801
        • Tennessee Valley Pain Consultants
    • Arizona
      • Tempe, Arizona, United States, 85283
        • Fiel Family and Sports Medicine
    • Arkansas
      • Little Rock, Arkansas, United States, 72212
        • Center of Applied Research
    • California
      • Fresno, California, United States, 93702
        • Research Center of Fresno
      • Long Beach, California, United States, 90806
        • Long Beach Clinical Trials Services, Inc.
      • Sacramento, California, United States, 95628
        • Northern California Research
      • San Diego, California, United States, 92103
        • Pacific Research Network, LLC
      • San Diego, California, United States, 92120
        • San Diego Sports Medicine
      • Santa Ana, California, United States, 92705
        • CiTrials
    • Florida
      • Edgewater, Florida, United States, 32132
        • Riverside Clinical Research
      • Gainesville, Florida, United States, 32653
        • Empirical Research Group
      • Miami, Florida, United States, 33126
        • LLC Medical Research
      • Miami Lakes, Florida, United States, 33014
        • Savin Medical Group
      • Orange City, Florida, United States, 32763
        • Avail Clinical Research
      • Plantation, Florida, United States, 33313
        • Private Practice
    • Georgia
      • Atlanta, Georgia, United States, 30342
        • NeuroTrials Research, Inc.
      • Marietta, Georgia, United States, 30060
        • Georgia Institute for Clinical Research
      • Snellville, Georgia, United States, 30078
        • Georgia Clinical Research
    • Indiana
      • Evansville, Indiana, United States, 47714
        • Medisphere Medical Research Center
    • Kentucky
      • Edgewood, Kentucky, United States, 41017
        • Otrimed Clinical Research
    • Louisiana
      • Lake Charles, Louisiana, United States, 70601
        • Centex Studies, Inc.
    • Maryland
      • Wheaton, Maryland, United States, 20902
        • Center for Rheumatology and Bone
    • Michigan
      • Ann Arbor, Michigan, United States, 48104
        • Michigan Head Pain and Neurological
    • Missouri
      • Saint Louis, Missouri, United States, 63141
        • Sundance Clinical Research
    • Nevada
      • Las Vegas, Nevada, United States, 89106
        • Jubilee Clinical Research
    • New Mexico
      • Albuquerque, New Mexico, United States, 87102
        • Albuquerque Clinical Trials, Inc.
    • New York
      • Williamsville, New York, United States, 14221
        • Upstate Clinical Research Associates
    • North Carolina
      • Winston-Salem, North Carolina, United States, 27103
        • Clinical Trials of America
    • Ohio
      • Cincinnati, Ohio, United States, 45246
        • Sterling Research Group- Springdale
      • Cleveland, Ohio, United States, 44195
        • Cleveland Clinic
      • Dayton, Ohio, United States, 45439
        • Center for Providence Health Partners
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73103
        • IPS Research
    • Oregon
      • Eugene, Oregon, United States, 97404
        • Williamette Valley Clinical Studies
    • Pennsylvania
      • Smithfield, Pennsylvania, United States, 15478
        • Frontier Clinical Research, Inc.
    • Rhode Island
      • Warwick, Rhode Island, United States, 02886
        • Omega Medical Research
    • South Dakota
      • Rapid City, South Dakota, United States, 57702
        • Health Concepts
    • Texas
      • Baytown, Texas, United States, 77521
        • Inquest Clinical Research
      • Bryan, Texas, United States, 77802
        • DiscoveResearch, Inc.
      • Houston, Texas, United States, 77004
        • HD Research Corp
      • McAllen, Texas, United States, 78504
        • Centex Studies, Inc.
      • Plano, Texas, United States, 75007
        • ClinRX Research Joseph, Inc.
    • Utah
      • Salt Lake City, Utah, United States, 84124
        • Highland Clinical Research
    • Virginia
      • 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 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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).

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.
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

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
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."
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.

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.
February 1, 2019

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.
June 28, 2019

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.
July 12, 2019

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).
January 10, 2019

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.
January 11, 2019

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.
January 14, 2019

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.
February 1, 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.
January 28, 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.
January 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.
  • 201

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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