NCT07410806Active, not recruitingPhase 2/3
HEALEY ALS Platform Trial - Regimen I NUZ-001
Source: ClinicalTrials.gov · Last updated 20 Jul 2026
Brief summary (registry, in English)
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 I will evaluate the safety and efficacy of a single study drug, NUZ-001, in participants with ALS.
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 2/3
- Study type
- Interventional
- Enrollment
- 240 (estimated)
- First submitted
- 8 Feb 2026
- Start date
- 25 Feb 2026
- Primary completion date
- 1 Jul 2027
- Lead sponsor
- Merit E. Cudkowicz, MD
- Diseases
- ALS (motor neurone disease)
- NCT number
- NCT07410806
What you commit to
- Study type: Interventional · Phase 2/3
- Planned participants: 240
- From 25 Feb 2026 to the primary completion date, 1 Jul 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Lab values
- The following exclusion criteria are in addition to the exclusion criteria specified in the Master Protocol (NCT NCT04297683).
- Clinically significant liver disease (e.g., chronic hepatitis B, untreated hepatitis C)
- Prior history of drug-induced liver injury (DILI) and/or laboratory results at Master Protocol Screening that indicate inadequate liver function (ALT, AST or alkaline phosphatase \>3 times the upper limit of normal \[x ULN\] and/or total bilirubin level \>2 x ULN)
- Note: Elevated total bilirubin attributable to documented Gilbert's syndrome is not considered exclusionary when there is no other evidence of clinically significant hepatic dysfunction.
- Family history of SOD1 or VCP-associated ALS or known SOD1 or VCP mutation via genetic testing or self-report
- Use of any prohibited medications as outlined in the Regimen-specific Appendix (RSA) within 30 days prior to Baseline or anticipated use during the study treatment period
- Participants who are taking Nuedexta® and have a prolonged Fridericia-corrected QT (QTcF) interval (QTcF \> 450 ms (males) or \> 470 ms (females)) at Master Protocol Screening
Who the study is looking for
- No additional inclusion criteria beyond the inclusion criteria specified in the Master Protocol (NCT NCT04297683).
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Healey Center for ALS at Massachusetts General Hospital Coordinator of this site? Confirm its status | Boston | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.