Trial Profile

A Second Intermediate Expanded Access Protocol for Amyotrophic Lateral Sclerosis With CNM-Au8

Status: Recruiting

Phase of Trial: Clinical Phase Unknown

Latest Information Update: 30 Jan 2025

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At a glance

Drugs CNM Au8 (Primary)
Indications Amyotrophic lateral sclerosis
Focus Expanded access; Therapeutic Use
Sponsors Clene Nanomedicine

Most Recent Events

10 Dec 2024 According to a Clene Australia media release, Clene intends to follow the FDAs recommendation to provide data from the ongoing EAPs and believes that it can address the FDAs requests. This additional NfL biomarker collection and analyses to support NDA submission is planned to be completed during second quarter of 2025
22 Feb 2024 Results of pooled analysis of survival analysis of expanded access programs of two trials (EAP01 & EAP02) were presented in a Clene Nanomedicine Media Release.
13 Feb 2023 Status changed from active, no longer recruiting to recruiting.

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