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
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.
An assessment of the centrally acting muscle relaxant tolperisone on driving ability and cognitive effects compared to placebo and cyclobenzaprine
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).