RESUME-1: a Phase III study of tolperisone in the treatment of painful, acute muscle spasms of the back. Tolperisone is a nonopioid, centrally acting muscle relaxant in clinical development in the USA for the treatment of symptoms associated with acute, painful muscles spasms of the back. CLN-301, RESUME-1, is a 14-day double-blind, randomized, placebo-controlled, parallel-group Phase III study of the efficacy and safety of tolperisone administered orally three-times daily in 1000 male and female subjects at approximately 70 clinical sites in the USA experiencing back pain due to or associated with muscle spasm of acute onset. Tolperisone is a promising therapeutic for managing acute, painful muscle spasms of the back as it appears to lack the off-target CNS effects often seen with conventional
Tolperison (Tolpermyo) Tolperison (Tolpermyo®) | Report | National Health Care Institute Go to content You are here: Home Publications Tolperison (Tolpermyo®) Search within English part of National Health Care Institute Search Tolperison (Tolpermyo®)The National Health Care Institute has drawn up a pharmacotherapeutic report for the medicine tolperison (Tolpermyo®), whereby it reached the following conclusion. Based on the criteria of the Medicines Reimbursement System (GVS), the National Health Care Institute is of the opinion that tolperison is interchangeable with baclofen and tizanidine, and can therefore be included on List 1A of the GVS in cluster 0M03BXAV with a standard dose of 200 mg/day.This report is a summary of recommendations by the National Health Care Institute
Tolperisone for the Treatment of Acute Muscle Spasm of the Back: Results from the Dose-Ranging Phase 2 STAR Study (NCT03802565). Use of skeletal muscle relaxants (SMRs) for acute muscle spasm is confounded by central nervous system adverse events (AEs), including somnolence. Tolperisone is an SMR that does not appear to be associated with somnolence. The aim of this study was to assess the safety and efficacy of tolperisone versus placebo in subjects with acute muscle spasm of the back. STAR (NCT03802565) was a double-blind, randomized, placebo-controlled phase 2 study in subjects with back pain due to acute muscle spasm. Subjects were randomized 1:1:1:1:1 to tolperisone 50, 100, 150, or 200 mg three times daily (TID) or placebo for 14 days. The primary efficacy endpoint was subject
An assessment of the centrally acting muscle relaxant tolperisone on driving ability and cognitive effects compared to placebo and cyclobenzaprine. Tolperisone is a centrally acting muscle relaxant under development in the United States as a treatment for acute and painful symptoms of muscle spasms. The objective of this three-way, randomized, blinded, three-period crossover study was to assess the safety and cognitive effects of tolperisone compared to placebo and the widely used muscle relaxant cyclobenzaprine in healthy volunteers. Subjects were randomized to 1 of 3 treatment arms to receive tolperisone (150 mg), cyclobenzaprine (10 mg) or placebo 3 times per day (TID) in 3 separate study periods. Subjects completed a driving test on the Cognitive Research Corporation's Driving Simulator
Comparative study of therapeutic response to baclofen vs tolperisone in spasticity. Spasticity from the upper motor neuron syndrome can result from a variety of conditions affecting the cortex or spinal cord. Some of the more common conditions associated with spasticity include spinal cord injury, cerebral palsy, and post-stroke syndrome. In this study we compared the efficacy and safety of baclofen vs tolperisone in spasticity. One hundred fifty patients with cerebral palsy or post stroke or spinal cord injury associated spasticity were enrolled in present study. Group I comprised of Seventy-five patients receiving baclofen and group II comprised of 75 patients receiving tolperisone. For efficacy measurement 4 evaluation methods were used, 1) Modified Ashworth Scale for muscle tone, 2
The comparative study of clinical efficacy and safety of baclofen vs tolperisone in spasticity caused by spinal cord injury In the present study we compared the clinical efficacy and safety of baclofen vs tolperisone in spasticity caused by spinal cord injury. A total of 150 patients were enrolled in the present study and were divided into two groups with 75 patients in each group, receiving baclofen or tolperisone, respectively. We used Modified Ashworth Scale, Medical research council scale, Barthel Index, and Coefficient of efficacy to measure clinical efficacy. After 6-week treatment, both groups demonstrated significant improvement in muscle tone, muscle strength and functional outcome (Group I, 1.55 ± 0.053, 2.79 ± 0.032, 59.31 ± 1.32; Group II, 1.57 ± 0.053, 3.04 ± 0.032, 73 ± 1.32
[The experience of the using Tolperisone in a complex conservative therapy of an osteoarthrosis of a hip joint]. The comparison of the efficiency of the standard scheme of a conservative medicinal therapy of an OA of a hip joint and the modified scheme (with the muscle relaxant of the central action - Tolperisone) was the research objective. The prospective research of the complex conservative
The Prognostic Value of Biomarkers and the Effect of Tolperisone in Acute Low Back Pain and Sciatic Pain "BETA" The main purpose of the trial is to identify biomarkers from the blood as well as electrophysiologic and morphometric features (chemical, electrophysiologic and ultrasound biomarkers) that reflect the intensity of pain and/or foretell the efficacy of pharmacological (non-surgical , hypersensitivity to tolperisone in the history, severe liver or kidney disease, other severe diseases (abscess, tumor, etc) in the background of pain. The patients will be given 3 times daily 150 mg tolperisone or placebo in addition to standard therapy in a randomized double-blind design. Treatment will last for 14 days and a final follow-up is performed at 21 days. Clinical condition and biomarkers
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. undefined
Effects of Tolperisone on Measures of Drowsiness and Cognitive Function A Randomized, 4-Period, Crossover Study to characterize the effects of tolperisone 200 mg and 400 mg (supratherapeutic dose) three times a day (TID) over 3 days of dosing on measures of simulated driving performance, cognitive function and drowsiness and compared to placebo and cyclobenzaprine (single-day, residual effect
A Phase 1 PK Study of Tolperisone in Healthy Subjects This is a randomized, single-blind, single and multiple dose crossover subjects in healthy adult subjects This is a single-center, in-patient, treatment sequence-randomized, single-blind SD and MD crossover study in 27 healthy adult male and female subjects. Subjects will be admitted to the clinic on Day-1 and discharged the morning of Day 5
or silperisone or styramate or suxamethonium or "tiemonium methylsulfate" or tizanidine or Tolperisone or toxiferine or "tubocurarine chloride" or vecuronium or vesamicol or Xylazine or Zoxazolamine).ti,ab,hw,kw. 22 exp Antiemetics/ 23 exp Nausea/dt [Drug Therapy] 24 exp Vomiting/dt [Drug Therapy] 25 (((drug* or agent* or medication*) adj3 (nausea or vomit*)) or alizapride or "anti emetic*" or antiemetic
Clinical comparative study: efficacy and tolerability of tolperisone and thiocolchicoside in acute low back pain and spinal muscle spasticity. We performed a multicentric, randomized, comparative clinical trial. Eligible patients were randomly assigned to receive 150 mg of Tolperisone thrice daily or 8 mg of Thiocolchicoside twice daily for 7 days. To assess the efficacy and tolerability of Tolperisone in comparison with Thiocolchicoside in the treatment of acute low back pain with spasm of spinal muscles. No head on clinical trial of Tolperisone with Thiocolchicoside is available and so this study is done. The assessment of muscle spasm was made by measuring the finger-to-floor distance (FFD), articular excursion in degrees on performing Lasegue's maneuver and modified Schober's test