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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

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Trial Profile

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 of Trial: Phase II

Latest Information Update: 08 Sep 2026

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At a glance

  • Drugs Celecoxib/ciprofloxacin (Primary)
  • Indications Amyotrophic lateral sclerosis
  • Focus Adverse reactions; Therapeutic Use
  • Acronyms PARADIGM
  • Sponsors NeuroSense Therapeutics

Most Recent Events

  • 31 Aug 2026 According to a NeuroSense Therapeutics media release, company has completed pre-New Drug Submission process with Health Canada and is preparing a New Drug Submission for PrimeC, which the Company continues to target for Dec 2026. If accepted and ultimately approved, this pathway has the potential to make PrimeC available to Canadian patients on the strength of data already generated.
  • 06 Aug 2026 According to a NeuroSense Therapeutics media release, company is targeting December 2026 for the filing of a New Drug Submission (NDS) with Health Canada for PrimeC for amyotrophic lateral sclerosis (ALS).
  • 06 Aug 2026 Results presented in the NeuroSense Therapeutics Media Release.

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