Trial Profile

A phase 3 study study of Celecoxib/ciprofloxacin

Status: Planning

Phase of Trial: Phase III

Latest Information Update: 30 Apr 2025

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At a glance

24 Apr 2025 According to a NeuroSense Therapeutics media release, the company releases letter to shareholders outlining Phase 3 timeline for PrimeC in ALS
11 Dec 2024 According to a NeuroSense Therapeutics media release, company plans to submit a final protocol to the FDA during the first half of 2025 with the aim of commencing enrollment of the pivotal Phase 3 study in mid-2025.
11 Dec 2024 According to a NeuroSense Therapeutics media release, company announced it has concluded a Type C meeting with the U.S. FDA for PrimeC in the treatment of amyotrophic lateral sclerosis (ALS). The purpose of the meeting was to discuss the design of a proposed Phase 3 clinical study and the plan for submission of an eventual 505(b)(2) marketing application. The Company also discussed efficacy and safety measurements regarding planned Phase 3 pivotal study with PrimeC.

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