HEALEY ALS Platform Trial
Merit E. Cudkowicz, MD
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.
Description
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. This trial is designed as a perpetual platform trial. This means that there is a single Master Protocol dictating the conduct of the trial. In this trial, multiple investigational products for ALS will be tested simultaneously or sequentially. Each investigational product will be tested in a regimen. Each regimen consists of a placebo-controlled trial, meaning that the active investigational product and matching placeb…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: 1. Sporadic or familial ALS diagnosed as clinically possible, probable, lab-supported probable, or definite ALS defined by revised El Escorial criteria. 2. Age 18 years or older. 3. Capable of providing informed consent and complying with study procedures, in the SI's opinion. 4. Time since onset of weakness due to ALS ≤ 24 months at the time of the Master Protocol Screening Visit. 5. Vital Capacity ≥ 50% of predicted capacity at the time of the Master Protocol Screening Visit measured by Slow Vital Capacity (SVC), or, if required due to pandemic-related restrictions, Forc…
Interventions
- DrugZilucoplan
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
- DrugVerdiperstat
Drug: Verdiperstat Administration: Oral Dose: 600mg twice daily
- DrugCNM-Au8
Drug: CNM-Au8 Administration: Oral Dose: 30 mg or 60 mg daily
- DrugPridopidine
Drug: Pridopidine Administration: Oral Dose: 45mg twice daily
- DrugSLS-005 Trehalose
Drug: SLS-005 Trehalose Administration: Infusion Dose: 0.75 g/kg weekly
- DrugABBV-CLS-7262
Drug: ABBV-CLS-7162 Administration: Oral Dose: Dose 1 or Dose 2
- Drug
Locations (78)
- Barrow Neurological InstitutePhoenix, Arizona
- Mayo Clinic ScottsdaleScottsdale, Arizona
- University of Arkansas for Medical SciencesLittle Rock, Arkansas
- Loma Linda University HealthLoma Linda, California
- Kaiser Permanente Los Angeles Medical CenterLos Angeles, California
- University of Southern CaliforniaLos Angeles, California