CI

At a glance

ClinicalIndex Comparison Record
Phase 3Recruiting· 1,500 target
Drug / intervention
Zilucoplan +7 moredrug
Likely dose
Zilucoplan 0.22 mg/kgfrom record
Key inclusion· 9
  • Sporadic or familial ALS diagnosed as clinically possible, probable, lab-supported probable, or definite by revised El Escorial criteria
  • Age 18 years or older
  • Time since onset of weakness ≤24 months at screening
  • Vital Capacity ≥50% of predicted measured by SVC or FVC
Key exclusion· 9
  • Clinically significant unstable medical condition other than ALS posing risk (e.g., cardiovascular instability, systemic infection)
  • Clinically significant abnormal liver or kidney function: ALT or AST >3× ULN or eGFR <30 mL/min/1.73m2
  • Unstable psychiatric disease, cognitive impairment, dementia, or substance abuse impairing informed consent
  • Active cancer or cancer history except treated skin cancers, cervical carcinoma in situ, prostatic carcinoma in situ, or other malignancies curatively treated with ≥3 years disease-free

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04297683
NCT04297683Phase 3RecruitingHigh Momentum
Long Recruiting

HEALEY ALS Platform Trial

Merit E. Cudkowicz, MD·interventional·Posted Mar 5, 2020·Updated Jun 4, 2026

In Brief

A Phase 3 clinical trial evaluating Zilucoplan, Verdiperstat, and 6 other interventions for Amyotrophic Lateral Sclerosis. Currently recruiting, targeting 1,500 participants across 81 sites.

Signals

Enrolling ahead of pace

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

Phase 3Recruiting
202020212022202320242025202620272028
First PostedMar 5, 2020
Enrollment StartJun 14, 2020
Primary CompletionJul 1, 2027
Study CompletionAug 1, 2028
TodayJul 2, 2026
Enrollment to primary: 7.0 yearsPosted 6.3 years agoPrimary completion in 12 months

Interventions

Zilucoplandrug

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

Verdiperstatdrug

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

CNM-Au8drug

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

Pridopidinedrug

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

SLS-005 Trehalosedrug

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

ABBV-CLS-7262drug

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

DNL343drug

Drug: DNL343 Administration: Oral Dose: Once per day

NUZ-001drug

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