HEALEY ALS Platform Trial - Regimen C CNM-Au8

Last updated: June 30, 2023
Sponsor: Merit E. Cudkowicz, MD
Overall Status: Completed

Phase

2/3

Condition

Myasthenia Gravis (Chronic Weakness)

Amyotrophic Lateral Sclerosis (Als)

Treatment

Matching Placebo

CNM-Au8

Clinical Study ID

NCT04414345
2019P003518C
  • Ages > 18
  • All Genders

Study Summary

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.

Regimen C will evaluate the safety and efficacy of a single study drug, CNM-Au8, in participants with ALS.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • No additional inclusion criteria beyond the inclusion criteria specified in the MasterProtocol (NCT NCT04297683).

Exclusion

Exclusion Criteria:

  • The following exclusion criterion is in addition to the exclusion criteria specifiedin the Master Protocol (NCT NCT04297683).
  1. History of allergy to gold, gold salts, or colloidal gold preparations.

Study Design

Total Participants: 161
Treatment Group(s): 2
Primary Treatment: Matching Placebo
Phase: 2/3
Study Start date:
July 30, 2020
Estimated Completion Date:
March 07, 2023

Study 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.

Connect with a study center

  • Healey Center for ALS at Mass General

    Boston, Massachusetts 02114
    United States

    Site Not Available

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