Sanam Ara Vaughan, Kayla Torres & Randall Kaye
The manuscript describes the design of a pivotal Phase 3 study (RESUME-1), a 14-day double-blind, randomized, placebo-controlled, parallel-group study in 1,000 subjects across 70 clinical sites in the US. The study is designed to evaluate the efficacy and safety of tolperisone administered in subjects with pain due to acute back muscle spasms. Secondary objectives include assessing the tolerability, onset of action, and need for rescue medication when treated with tolperisone.
Neurana Pharmaceuticals Announces Publication in Pain Management
Gary Kay, PhD Sanam Ara Vaughan, Nathan Cashdollar, PhD, Randall Kaye
Key Highlights: Effects of tolperisone on driving performance, self-reported sleepiness, cognitive function, and rates of somnolence were comparable to subjects who received placebo. In addition, subjects on cyclobenzaprine indicated that they are “Ready to Drive”; however, the data as demonstrated by SDLP and lane exceedance, indicated that subjects are, in fact, not fine to drive and pose a driving risk.
The Effects of Tolperisone on Simulated Driving Performance, Drowsiness, and Cognitive Function: Comparison With Cyclobenzaprine and Placebo in a Phase 1, Randomized, 4-Period Crossover Study
Key Highlights: Acute muscle spasms of the back are sudden, sustained involuntary contractions of muscles or muscle groups localized within the spine. During a lifetime, approximately 84% of US adults (175 million) experience musculoskeletal spasms. A review of muscle spasms and clinical features and presentation.
Acute Muscle Spasms of the Back
Overview of Muscle Spasm Clinical Features & Presentation
Srinivas Nalamachu, Joseph Pergolizzi, Randall Kaye
Key Highlights: Tolperisone 200 mg TID may be a promising treatment for management of acute muscle spasm, without the somnolence typically associated with SMRs.
Tolperisone for the Treatment of Acute Muscle Spasm of the Back: Results From the Dose-Ranging Phase 2 STAR Study (NCT03802565)
Randall Kaye, MD; Henry Riordan, PhD; Srinivas Nalamachu, MD; Joseph Pergolizzi, MD; Sanam Ara Vaughan
Key Highlights: Approximately 750 subjects are planned to be enrolled at about 60 clinical sites in the United States, with the first subject expected to be enrolled in Fall 2020. A second replicate Phase 3 study will be initiated at a later date.
Tolperisone 100 and 200 mg Three Times Daily (TID) for Acute Muscle Spasm of the Back: A Double-Blind, Randomized, Placebo-Controlled, Multicenter Phase 3 Study
Srinivas Nalamachu, MD; Randall Kaye, MD; Joseph Pergolizzi, MD
Key Highlights: Tolperisone dose of 200 mg TID may be a promising treatment for the management of acute muscle spasm without the somnolence typically experienced with skeletal muscle relaxants.
Tolperisone for Acute Muscle Spasm: Dose-Ranging STAR Study
Judy George, Senior Staff Writer, MedPage Today September 5, 2020
Key Highlights: Tolperisone, a centrally-acting muscle relaxant, may treat symptoms of acute muscle spasms without the sleepiness and cognitive effects associated with other skeletal muscle relaxants.
Novel Form of Muscle Relaxant Shows Benefit
Tolperisone may help pain from acute back spasms without causing drowsiness
Judy Caron PhD; Randall Kaye MD; Thomas Wessel MD, PhD; Amy Halseth PhD; Gary Kay PhD
What is new and conclusion: Subjects who received tolperisone (150 mg TID) experienced no impact on various measures of driving, self-reported sleepiness and cognition measures compared to placebo, in contrast to those who received the widely used muscle relaxant cyclobenzaprine (10 mg TID).
An assessment of the centrally acting muscle relaxant tolperisone on driving ability and cognitive effects compared to placebo and cyclobenzaprine