Back PainPhase 2STARNCT03802565
Tolperisone in Acute Muscle Spasm of the Back
A Phase 2 study testing Tolperisone in people with Back Pain and Acute Pain, run by Neurana Pharmaceuticals, Inc. at 43 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Back Pain, Acute Pain, Back Spasm Upper Back
- What is being tested?
- Tolperisone
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 415 participants
- Where
- 43 sitesUnited States
- Study dates
- 1 Feb 2019to 12 Jul 2019
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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).
Trial locations and contacts
43 sites in 1 country.
43 sites in 1 country
United States43 sites
Albuquerque Clinical Trials, Inc.
Albuquerque, New Mexico, 87102
Michigan Head Pain and Neurological
Ann Arbor, Michigan, 48104
NeuroTrials Research, Inc.
Atlanta, Georgia, 30342
Inquest Clinical Research
Baytown, Texas, 77521
DiscoveResearch, Inc.
Bryan, Texas, 77802
Sterling Research Group- Springdale
Cincinnati, Ohio, 45246
Cleveland Clinic
Cleveland, Ohio, 44195
Center for Providence Health Partners
Dayton, Ohio, 45439
Riverside Clinical Research
Edgewater, Florida, 32132
Otrimed Clinical Research
Edgewood, Kentucky, 41017
Williamette Valley Clinical Studies
Eugene, Oregon, 97404
MediSphere Medical Research Center
Evansville, Indiana, 47714
Research Center of Fresno
Fresno, California, 93702
Empirical Research Group
Gainesville, Florida, 32653
HD Research Corp
Houston, Texas, 77004
Tennessee Valley Pain Consultants
Huntsville, Alabama, 35801
Centex Studies, Inc.
Lake Charles, Louisiana, 70601
Jubilee Clinical Research
Las Vegas, Nevada, 89106
Center of Applied Research
Little Rock, Arkansas, 72212
Long Beach Clinical Trials Services, Inc.
Long Beach, California, 90806
Georgia Institute for Clinical Research
Marietta, Georgia, 30060
Centex Studies, Inc.
McAllen, Texas, 78504
LLC Medical Research
Miami, Florida, 33126
Savin Medical Group
Miami Lakes, Florida, 33014
Health Research of Hampton Roads, Inc.
Newport News, Virginia, 23606
IPS Research
Oklahoma City, Oklahoma, 73103
Avail Clinical Research
Orange City, Florida, 32763
ClinRX Research Joseph, Inc.
Plano, Texas, 75007
Private Practice
Plantation, Florida, 33313
Health Concepts
Rapid City, South Dakota, 57702
Northern California Research
Sacramento, California, 95628
Highland Clinical Research
Salt Lake City, Utah, 84124
Pacific Research Network, LLC
San Diego, California, 92103
San Diego Sports Medicine
San Diego, California, 92120
CITrials
Santa Ana, California, 92705
Frontier Clinical Research, Inc.
Smithfield, Pennsylvania, 15478
Georgia Clinical Research
Snellville, Georgia, 30078
Sundance Clinical Research
St Louis, Missouri, 63141
Fiel Family and Sports Medicine
Tempe, Arizona, 85283
Omega Medical Research
Warwick, Rhode Island, 02886
Center for Rheumatology and Bone
Wheaton, Maryland, 20902
Upstate Clinical Research Associates
Williamsville, New York, 14221
Clinical Trials of America
Winston-Salem, North Carolina, 27103
About this study
Official title: 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.
- Conditions
- Back Pain, Acute Pain, Back Spasm Upper Back, Back Strain, Muscle Cramp, Muscle Spasm
- Being tested
- Tolperisone, Placebo
- Medical subject headings
- Back Pain, Acute Pain, Muscle Cramp, Spasm, Low Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TolperisoneDrug
TID
PlaceboDrug
Placebo
| Study group | Role | What they receive |
|---|---|---|
| Tolperisone 50 mg | Experimental | TID (150 mg/day) Receives: Drug: Tolperisone |
| Tolperisone 100 mg | Experimental | TID (300 mg/day) Receives: Drug: Tolperisone |
| Tolperisone 150 mg | Experimental | TID (450 mg/day) Receives: Drug: Tolperisone |
| Tolperisone 200 mg | Experimental | TID (600 mg/day) Receives: Drug: Tolperisone |
| Placebo | Placebo comparator | TID Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Effect Size in Subjected-Rated Pain
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."
Measured: Day 1 to Day 14
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2019
- Study start1 Feb 2019
- Primary completion28 Jun 2019
- Study completion12 Jul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Back PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 415 participants (actual)
Sponsor and investigators
- Lead sponsor
- Neurana Pharmaceuticals, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03802565
- Sponsor's protocol ID
- 201
- Acronym
- STAR
- Status last verified
- Jan 2022
- First submitted
- 10 Jan 2019
- Last updated
- 1 Feb 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dose Ranging Study of Tolperisone in Acute Muscle Spasm of the Back
- ClinicalTrials.gov ID
- NCT03802565
- Acronym / sponsor ID
- STAR / 201
- Conditions
- Back Pain, Acute Pain, Back Spasm Upper Back, Back Strain, Muscle Cramp, Muscle Spasm
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 415 participants (actual)
- Lead sponsor
- Neurana Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
- Study start
- 1 Feb 2019 (actual)
- Primary completion
- 28 Jun 2019 (actual)
- Study completion
- 12 Jul 2019 (actual)
- First posted
- 14 Jan 2019 (actual)
- Results
- Posted 10 Nov 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Tolperisone 50 mg | Experimental | Drug: TolperisoneTID (150 mg/day) |
| Tolperisone 100 mg | Experimental | Drug: TolperisoneTID (300 mg/day) |
| Tolperisone 150 mg | Experimental | Drug: TolperisoneTID (450 mg/day) |
| Tolperisone 200 mg | Experimental | Drug: TolperisoneTID (600 mg/day) |
| Placebo | Placebo comparator | Drug: PlaceboTID |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TolperisoneTID | Drug | Tolperisone 100 mg, Tolperisone 150 mg, Tolperisone 200 mg, Tolperisone 50 mg |
| PlaceboPlacebo | Drug | Placebo |
Primary outcome
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."
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Feb 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
43 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Tolperisone in people with Back Pain and Acute Pain, run by Neurana Pharmaceuticals, Inc. at 43 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 43 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 10 Nov 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean Effect Size in Subjected-Rated Pain (time frame: Day 1 to Day 14). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Feb 2022; AzTrials last refreshed its copy on 7 Nov 2026.