Phase 3
Completed N=161
HEALEY ALS Platform Trial - Regimen C CNM-Au8
Source: ClinicalTrials.gov NCT04414345 ↗Enrolled (actual)
161
Serious AEs
14.3%
Results posted
Jul 2023
Primary outcomePrimary: Disease Progression as Assessed by the ALSFRS-R Total Score — -1.01; -1.03 ALSFRS-R total score points per month
◆ Published Evidence
Emerging
12citations · ~12 / year
CNM-Au8 in Amyotrophic Lateral Sclerosis: The HEALEY ALS Platform Trial.
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.
Linked Publications
-
CNM-Au8 in Amyotrophic Lateral Sclerosis: The HEALEY ALS Platform Trial.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Disease Progression as Assessed by the ALSFRS-R Total Score |
-1.01; -1.03 | — |
| PRIMARY Mortality Event Rate |
0.006; 0.007 | — |
| SECONDARY Respiratory Function |
-9.32; -8.53 | 0.6570 |
| SECONDARY Muscle Strength |
-27.54; -24.44 | 0.3621 |
| SECONDARY Number of Participants That Experienced Death or Death Equivalent |
3; 5 | 0.7398 |
Eligibility Criteria
Inclusion Criteria
- No additional inclusion criteria beyond the inclusion criteria specified in the Master Protocol (NCT NCT04297683).
Exclusion Criteria
- The following exclusion criterion is in addition to the exclusion criteria specified in the Master Protocol (NCT NCT04297683).
- History of allergy to gold, gold salts, or colloidal gold preparations.
Data sourced from ClinicalTrials.gov (NCT04414345) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.