HEALEY ALS Platform Trial - Regimen I NUZ-001

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
Merit E. Cudkowicz, MD
Study ID
NCT07410806
Phase
PHASE2/PHASE3
Status
Enrolling By Invitation

Conditions

  • Amyotrophic Lateral Sclerosis (ALS)

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • NUZ-001 — DRUG
    NUZ-001 is administered orally once daily for 36 weeks.
  • Matching placebo — DRUG
    Matching placebo is administered orally once daily for 36 weeks.

Study Details

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.

Key Dates

Start date
Feb 16, 2026
Status verified
Feb 2026
Primary completion
Jul 1, 2027
Completion
Aug 1, 2028

Study Design

Enrollment
160 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: NUZ-001
    NUZ-001
  • Placebo Comparator: Matching Placebo
    Placebo Comparator: Matching Placebo

Primary Outcome Measure

Disease Progression [ Time Frame: Baseline to 36 Weeks ]

Locations (1)

FacilityCityStateZIPSite coordinators
Healey Center for ALS at Massachusetts General HospitalBostonMassachusetts02114-

Find similar trials in Boston, MA

By research site
Healey Center for ALS at Massachusetts General Hospital· Boston, MA

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