Phase 3
N=161
HEALEY ALS Platform Trial - Regimen C CNM-Au8
Amyotrophic Lateral Sclerosis
Bottom Line
View on ClinicalTrials.gov: NCT04414345 ↗Enrolled (actual)
161
Serious AEs
14.3%
Results posted
Jul 2023
Primary outcome: Primary: Disease Progression as Assessed by the ALSFRS-R Total Score — -1.01; -1.03 ALSFRS-R total score points per month
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- CNM-Au8 (Drug); Matching Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Merit E. Cudkowicz, MD
- Primary completion
- Apr 2022
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 |
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 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). 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.