HEALEY ALS Platform Trial - Regimen C CNM-Au8

Status Completed

Clinical Trial Summary

Clinical Trial Description

The HEALEY ALS Platform Trial is a perpetual multi-center, multi-regimen clinical trial evaluating the safety and efficacy of investigational products for the treatment of ALS. This trial is designed as a perpetual platform trial. This means that there is a single Master Protocol dictating the conduct of the trial. The HEALEY ALS Platform Trial Master Protocol is registered as NCT04297683. Once a participant enrolls into the Master Protocol and meets all eligibility criteria, the participant will be eligible to be randomized into any currently enrolling regimen. All participants will have an equal chance of being randomized to any currently enrolling regimen. If a participant is randomized to Regimen C - CNM-Au8, the participant will complete a screening visit to assess additional Regimen C eligibility criteria. Once Regimen C eligibility criteria are confirmed, participants will complete a baseline assessment and be randomized in a 3:1 ratio to either active CNM-Au8 or matching placebo. Regimen C will enroll by invitation, as participants may not choose to enroll in Regimen C. Participants must first enroll into the Master Protocol and be eligible to participate in the Master Protocol before being able to be randomly assigned to Regimen C. For a list of enrolling sites, please see the HEALEY ALS Platform Trial Master Protocol under NCT04297683. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT04414345
Study type	Interventional
Source	Massachusetts General Hospital
Contact
Status	Completed
Phase	Phase 2/Phase 3
Start date	July 30, 2020
Completion date	March 7, 2023

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