Trial Profile

A prospective phase 3 study of CNM-Au8 in amyotrophic lateral sclerosis patients

Status: Planning

Phase of Trial: Phase III

Latest Information Update: 25 Mar 2025

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At a glance

24 Mar 2025 According to Clene Nanomedicine media release, this Phase 3 RESTORE-ALS clinical trial, due to launch in mid-2025, is planned to serve as the confirmatory clinical trial required to meet the FDA's guidance for an "underway" clinical trial when a New Drug Application requesting Accelerated Approval is submitted.
10 Dec 2024 According to a Clene Nanomedicine media release, Clene plans to commence the confirmatory Phase 3 RESTORE-ALS trial with participant enrollment beginning prior to the submission of the NDA.
13 Nov 2024 According to a Clene Nanomedicine media release, company presented the design for RESTORE-ALS at the 2024 Annual Northeast Amyotrophic Lateral Sclerosis Consortium.

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