Back Muscle SpasmPhase 3RESUME-1NCT04671082
Efficacy and Safety of Tolperisone in Subjects With Pain Due to Acute Back Muscle Spasm
A Phase 3 study testing Tolperisone Hydrochloride in people with Back Muscle Spasm and Back Pain, run by Neurana Pharmaceuticals, Inc. at 56 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 64 years
- Conditions the study is for
- Back Muscle Spasm, Back Pain, Back Strain
- What is being tested?
- Tolperisone Hydrochloride
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 1,004 participants
- Where
- 56 sitesUnited States
- Study dates
- 15 Dec 2020to 21 Mar 2022
- Phase
- Phase 3
- Are there results?
- None posted in the registry
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 64 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
56 sites in 1 country.
56 sites in 1 country
United States56 sites
Albuquerque Clinical Trials, Inc.
Albuquerque, New Mexico, 87102
PCPMG Clinical Research Unit, LLC
Anderson, South Carolina, 29651
Michigan Head Pain and Neurological Institute
Ann Arbor, Michigan, 48104
Lynn Institute of Denver
Aurora, Colorado, 80012
Central Texas Clinical Research
Austin, Texas, 78705
Premier Family Physicians
Austin, Texas, 78735
Pioneer Clinical Research, LLC
Bellevue, Nebraska, 68005
Integrative Clinical Trials, LLC
Brooklyn, New York, 11229
Investigators Research Group
Brownsburg, Indiana, 46112
Alliance Research Institute
Canoga Park, California, 91304
ClinRx Research Joseph INC
Carrollton, Texas, 75007
IMA Clinical Research, PC
Chicago, Illinois, 60602
Hometown Urgent Care and Research
Cincinnati, Ohio, 45215
Hometown Urgent Care and Research
Columbus, Ohio, 43214
Spectrum Medical, Inc.
Danville, Virginia, 24541
Hometown Urgent Care and Research
Dayton, Ohio, 45424
iResearch Atlanta
Decatur, Georgia, 30030
Skyline Medical Center, PC
Elkhorn, Nebraska, 68022
Evanston Premier Healthcare Research LLC
Evanston, Illinois, 60201
Drug Trials America
Hartsdale, New York, 10530
Centex Studies, Inc.
Houston, Texas, 77058
Centex Studies, Inc.
Houston, Texas, 77090
R & H Clinical Research
Katy, Texas, 77494
New Phase Research & Development, LLC
Knoxville, Tennessee, 37909
Multi-Specialty Research Associates, Inc.
Lake City, Florida, 32055
Jubilee Clinical Research, Inc.
Las Vegas, Nevada, 89106
Georgia Clinical Research LLC
Lawrenceville, Georgia, 30044
Applied Research Center of Arkansas
Little Rock, Arkansas, 72212
Long Beach Clinical Trials Services, Inc
Long Beach, California, 90806
LCC Medical Research Institute, LLC
Miami, Florida, 33126
Savin Medical Group
Miami Lakes, Florida, 33014
DelRicht Research
New Orleans, Louisiana, 70124
Manhattan Behavioral Medicine PLLC
New York, New York, 10036
Health Research of Hampton Roads, Inc.
Newport News, Virginia, 23606
Today Clinical Research
Oklahoma City, Oklahoma, 73129
Accel Research Sites
Orange City, Florida, 32763
Combined Research Orlando
Orlando, Florida, 32807
Research Integrity, LLC
Owensboro, Kentucky, 42303
Village Health Partners
Plano, Texas, 75024
DelRicht Research
Prairieville, Louisiana, 70769
Quinn Healthcare/SKYCRNG
Ridgeland, Mississippi, 39157
Onyx Clinical Research
Rochester Hills, Michigan, 48307
Northern California Research
Sacramento, California, 95821
Sun Research Institute
San Antonio, Texas, 78215
Carolina Research Center, Inc.
Shelby, North Carolina, 28150
Frontier Clinical Research, LLC
Smithfield, Pennsylvania, 15478
IMA Clinical Research
St Louis, Missouri, 63117
Advanced Research Solutions, LLC
Staten Island, New York, 10302
Clinical Research Institute of Arizona, LLC
Surprise, Arizona, 85374
Collaborative Neuroscience Research, LLC
Torrance, California, 90502
DelRicht Research
Tulsa, Oklahoma, 74133
Emerson Clinical Research Institute
Washington D.C., District of Columbia, 20011
Professional Research Network of Kansas, LLC
Wichita, Kansas, 67205
Upstate ClinicalResearch Associates LLC
Williamsville, New York, 14221
Progressive Medicine of the Triad, LLC
Winston-Salem, North Carolina, 27103
Onyx Clinical Research
Youngstown, Ohio, 44505
About this study
Official title: 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.
- Conditions
- Back Muscle Spasm, Back Pain, Back Strain, Back Spasm Upper, Muscle Spasm, Acute Pain
- Being tested
- Tolperisone Hydrochloride, Placebo
- Medical subject headings
- Back Pain, Spasm, Acute Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tolperisone HydrochlorideDrug
Also called Tolperisone
TID
PlaceboDrug
TID
| Study group | Role | What they receive |
|---|---|---|
| Tolperisone 50 mg | Experimental | Tolperisone 50 mg Receives: Drug: Tolperisone Hydrochloride |
| Tolpersione 100 mg | Experimental | Tolperisone 100 mg Receives: Drug: Tolperisone Hydrochloride |
| Tolperisone 200 mg | Experimental | Tolperisone 200 mg Receives: Drug: Tolperisone Hydrochloride |
| Placebo | Placebo comparator | Placebo Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Numerical rating scale (NRS)
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.
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 posted17 Dec 2020
- Study start15 Dec 2020
- Primary completion13 Dec 2021
- Study completion21 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Back Muscle SpasmStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 1,004 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
- NCT04671082
- Sponsor's protocol ID
- CLN-301
- Other IDs
- RESUME-1
- Acronym
- RESUME-1
- Status last verified
- Mar 2022
- First submitted
- 10 Dec 2020
- Last updated
- 22 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Vaughan SA, Torres K, Kaye R. RESUME-1: a Phase III study of tolperisone in the treatment of painful, acute muscle spasms of the back. Pain Manag. 2022 Jan;12(1):25-33. doi: 10.2217/pmt-2021-0041. Epub 2021 Jul 1.
PubMed 34192885
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT04671082
- Acronym / sponsor ID
- RESUME-1 / CLN-301
- Conditions
- Back Muscle Spasm, Back Pain, Back Strain, Back Spasm Upper, Muscle Spasm, Acute Pain
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,004 participants (actual)
- Lead sponsor
- Neurana Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
- Study start
- 15 Dec 2020 (actual)
- Primary completion
- 13 Dec 2021 (actual)
- Study completion
- 21 Mar 2022 (actual)
- First posted
- 17 Dec 2020 (actual)
- Results
- Not posted in the source record
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, 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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Tolperisone 50 mg | Experimental | Drug: Tolperisone HydrochlorideTolperisone 50 mg |
| Tolpersione 100 mg | Experimental | Drug: Tolperisone HydrochlorideTolperisone 100 mg |
| Tolperisone 200 mg | Experimental | Drug: Tolperisone HydrochlorideTolperisone 200 mg |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
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 |
|---|---|---|
| Tolperisone HydrochlorideAlso: TolperisoneTID | Drug | Tolperisone 200 mg, Tolperisone 50 mg, Tolpersione 100 mg |
| PlaceboTID | Drug | Placebo |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Mar 2022.
- Derived from this study: PubMed 34192885Vaughan SA, Torres K, Kaye R. RESUME-1: a Phase III study of tolperisone in the treatment of painful, acute muscle spasms of the back. Pain Manag. 2022 Jan;12(1):25-33. doi: 10.2217/pmt-2021-0041. Epub 2021 Jul 1.
- Individual participant dataSharing planned: No
Related trials for Back Muscle Spasm
Active, not recruiting
Electrical Neuromodulation for Modifying Spinal Network Involved in Spasticity
Spinal Cord Injuries (Complete and Incomplete), Spinal Cord Injury
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.
56 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Tolperisone Hydrochloride in people with Back Muscle Spasm and Back Pain, run by Neurana Pharmaceuticals, Inc. at 56 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 5 inclusion and 6 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 22 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 56 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Numerical rating scale (NRS) (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?
On the ClinicalTrials.gov record for NCT04671082, which also lists 1 linked publication.
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 22 Mar 2022.