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HEALEY ALS Platform Trial - Master Protocol

NCT04297683 · Status: RECRUITING · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 1500

Last updated 2026-05-14

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.

Conditions

Interventions

DRUG

Zilucoplan

Drug: Zilucoplan Administration: Subcutaneous injection Dose: Minimum of .0.22 mg/kg daily to a maximum dose of 0.42 mg/kg daily, dependent on weight

DRUG

Verdiperstat

Drug: Verdiperstat Administration: Oral Dose: 600mg twice daily

DRUG

CNM-Au8

Drug: CNM-Au8 Administration: Oral Dose: 30 mg or 60 mg daily

DRUG

Pridopidine

Drug: Pridopidine Administration: Oral Dose: 45mg twice daily

DRUG

SLS-005 Trehalose

Drug: SLS-005 Trehalose Administration: Infusion Dose: 0.75 g/kg weekly

DRUG

ABBV-CLS-7262

Drug: ABBV-CLS-7162 Administration: Oral Dose: Dose 1 or Dose 2

DRUG

DNL343

Drug: DNL343 Administration: Oral Dose: Once per day

DRUG

NUZ-001

Drug: NUZ-001. Administration: Oral. Dose: Once per day.

Sponsors & Collaborators

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
2020-06-14
Primary Completion
2027-07-31
Completion
2028-08-31
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases
Companies

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 NCT04297683 on ClinicalTrials.gov