Clinical Studies to Demonstrate Tolperisone Benefit: Relief from Acute, Painful Muscle Spasms
The Phase 3, RESUME-1 clinical study was initiated in December 2020. The study will enroll ~1,000 patients and will assess tolperisone 50mg, 100mg, 200mg three times per day compared to placebo for 14 days of treatment. Top-line results are expected in Q4 2021.
The Phase 3, RESUME-2 clinical study will initiate following completion of RESUME-1.
PHASE 1: CNS Effects Study
The Phase 1 study, utilizing a validated driving test, confirmed that tolperisone does not impair driving performance. In addition, tolperisone does not appear to cause sleepiness, a side effect often associated with currently available skeletal muscle relaxants.
Tolperisone demonstrated non-inferiority compared to placebo
Cyclobenzaprine exceeded pre-established non- inferiority margin on all three days
PHASE 2: STAR Study
The STAR Study demonstrated that tolperisone was well-tolerated and did not increase sleepiness over placebo. The results enable Neurana to advance tolperisone to Phase 3 clinical studies in 2020.
PHASE 1: Driving Study
The Phase 1 driving simulation study demonstrated that tolperisone was similar to placebo in driving performance. In comparison, cyclobenzaprine, a commonly used muscle relaxant, significantly impacted driving performance. Most individuals on cyclobenzaprine performed similar to those with a blood alcohol concentration above 0.05%, which is considered above the legal limit in most states. In addition, most patients on cyclobenzaprine were unaware of their impairment.
NO IMPACT ON COGNITION WITH TOLPERISONE
In a simulated driving
study, tolperisone performed similar to placebo and with less impairment than cyclobenzaprine