HEALEY ALS Platform Trial - Regimen A (zilucoplan)
Principal Investigator
Study Number
SFD20018
Summary
The Plaform ALS trial is designed as an ongoing, continuous platform clinical trial. There is a single Master Protocol that is the primary guidance for the conduct of the trial. The interventions (investigational agents/drugs) are added on through a rolling basis. This method creates an opportunity to enroll more patients in a clinical trial setting while sharing control patients, (placebo patients who don?t revieve study intervention), as a method of quickening drug development and potentially approval for medications to treat or work against ALS. The medications/treatments that are part of the trial with change over time and be included as appendixes to the main protocol. Participants that provide consent to the Master Protocol will be screened for Master Protocol-level inclusion and exclusion criteria. Those found to be eligible will be equally randomized across all active active treatment appendices. This perpetual platform trial will continue enrolling research participants if there are treatments that are enrolling. As soon as pre-defined criteria for futility or success are met, or the target number of randomized participants in a regimen has been reached, enrollment will stop in that regimen.
Phase
II/III
Contact
Available at the following location(s)
- Lebanon
View more details at ClinicalTrials.gov
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