Tolperisone in Acute Muscle Spasm of the Back (STAR)
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|ClinicalTrials.gov Identifier: NCT03802565|
Recruitment Status : Completed
First Posted : January 14, 2019
Results First Posted : November 10, 2020
Last Update Posted : February 1, 2022
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|Condition or disease||Intervention/treatment||Phase|
|Back Pain Acute Pain Back Spasm Upper Back Back Strain Muscle Cramp Muscle Spasm Low Back Pain||Drug: Tolperisone Drug: Placebo||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||415 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||Dose Ranging Study of Tolperisone in Acute Muscle Spasm of the Back|
|Actual Study Start Date :||February 1, 2019|
|Actual Primary Completion Date :||June 28, 2019|
|Actual Study Completion Date :||July 12, 2019|
Experimental: Tolperisone 50 mg
TID (150 mg/day)
Experimental: Tolperisone 100 mg
TID (300 mg/day)
Experimental: Tolperisone 150 mg
TID (450 mg/day)
Experimental: Tolperisone 200 mg
TID (600 mg/day)
Placebo Comparator: Placebo
- 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."
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|Ages Eligible for Study:||18 Years to 65 Years (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- 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.
- 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).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03802565
Documents provided by Neurana Pharmaceuticals, Inc.:
|Responsible Party:||Neurana Pharmaceuticals, Inc.|
|Other Study ID Numbers:||
|First Posted:||January 14, 2019 Key Record Dates|
|Results First Posted:||November 10, 2020|
|Last Update Posted:||February 1, 2022|
|Last Verified:||January 2022|
|Individual Participant Data (IPD) Sharing Statement:|
|Plan to Share IPD:||No|
|Studies a U.S. FDA-regulated Drug Product:||Yes|
|Studies a U.S. FDA-regulated Device Product:||No|
Low Back Pain
Nervous System Diseases
Muscle Relaxants, Central
Physiological Effects of Drugs
Peripheral Nervous System Agents