A Phase IIb, Randomized, Prospective, Double-Blind, Placebo-Controlled Study, to Evaluate Safety, Tolerability and Efficacy of PrimeC in Subjects With ALS

• Status: Not yet recruiting
• Trial end date: 2023-10-01

Summary

69 subjects with ALS will be enrolled in the study and randomized at a 2:1 ratio to receive the study drug or placebo tablets. All subjects will be administered the drug/placebo twice daily (BID), two tablets each time, for 6 months. Subjects will be allowed to receive standard of care (SOC) treatment of approved products (i.e., riluzole and edaravone).

Subjects will be evaluated every 2 months for safety, tolerability (adverse events, safety laboratory, vital signs, ECG, withdrawal rates and reasons) and efficacy (e.g. biomarkers, clinical outcomes (ALSFRS-R and SVC, quality of life and survival).

All assessments will be performed during a clinic visit unless authorized to be conducted remotely.

Spontaneous adverse events (AEs) including any death, will be recorded throughout the study.

All subjects who complete the 6 months dosing will be offered to continue taking the study drug for three years, or until marketed or development is stopped by Sponsor.

• Phase: Phase 2

Details

• Lead Sponsor: NeuroSense Therapeutics Ltd.