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HEALEY ALS Platform Trial - Regimen I NUZ-001

NCT07410806 · Status: ENROLLING_BY_INVITATION · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 160

Last updated 2026-02-17

No results posted yet for this 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 I will evaluate the safety and efficacy of a single study drug, NUZ-001, in participants with ALS.

Conditions

  • Amyotrophic Lateral Sclerosis (ALS)

Interventions

DRUG

NUZ-001

NUZ-001 is administered orally once daily for 36 weeks.

DRUG

Matching placebo

Matching placebo is administered orally once daily for 36 weeks.

Sponsors & Collaborators

  • Neurizon Therapeutics Limited

    collaborator INDUSTRY

  • Merit E. Cudkowicz, MD

    lead OTHER

Principal Investigators

  • Merit Cudkowicz, MD · Massachusetts General Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-02-16
Primary Completion
2027-07-01
Completion
2028-08-01
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07410806 on ClinicalTrials.gov