NCT05357950

A Phase IIb, Multi-Center, Multinational, Double-Blind, Placebo-Controlled Study, With an Open Label Extension, to Evaluate Safety, Tolerability and Efficacy of PrimeC in Subjects With ALS

A Phase IIb, Randomized, Multi-Center, Multinational, Prospective, Double-Blind, Placebo-Controlled Study, With an Open Label Extension, to Evaluate Safety, Tolerability and Efficacy of PrimeC in Subjects With ALS

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 69 (actual)
• Sponsor: NeuroSense Therapeutics Ltd. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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. Randomization sequences will be in random block sizes and stratified for ENCALS risk category \[high risk ≥ -4.5 vs. low risk \< -4.5\], and for background ALS treatment (riluzole and/or edaravone and/or sodium phenylbutyrate and/or taurursodiol) vs. no background ALS treatment. 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). Additionally, subjects will be allowed to receive treatment with off-label sodium phenylbutyrate and taurursodiol, which are accepted for ALS treatment. 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 subjects who complete the 6 months dosing will be switched to the active arm for a 12-month open label extension (OLE).

Conditions

• Amyotrophic Lateral Sclerosis
• ALS

Interventions

Type	Name	Description
DRUG	PrimeC	Ciprofloxacin and celecoxib combination extended release formulation
DRUG	Placebo	Placebo matches active drug in size, color and taste

Timeline

• Start date: 2022-05-31
• Primary completion: 2023-11-02
• Completion: 2024-11-04
• First posted: 2022-05-03
• Last updated: 2025-09-05

Locations

4 sites across 3 countries: Canada, Israel, Italy

Regulatory

• FDA-regulated drug study