Sean M. Healey & AMG Center for ALS
HEALEY ALS Platform Trial Patient Information
HEALEY ALS Platform Trial Patient Navigator
Sean M. Healey & AMG Center for ALS at Mass General
165 Cambridge Street, 6th floor
Boston,
MA
02114
The HEALEY ALS Platform Trial was designed to decrease the amount of time it will take to find successful therapies, improve active study medication to placebo ratio, and increase access for participants. One of the innovative features of the Platform Trial is that enrollment will continue perpetually as more investigational medications are added over time.
Frequently Asked Questions
If you have additional questions about the HEALEY ALS Platform Trial, please contact the Patient Navigator by email at HEALEYALSPlatform@mgh.harvard.edu or by phone at 833-425-8257 (HALT ALS).
To learn more about clinical trials in general, and to view a list of frequently asked questions, visit the introduction to clinical trials web page.
What is a platform trial?
A platform trial tests multiple investigational products in different participants using a common master protocol. New investigational products can be added to the platform; this means more opportunities to find groundbreaking therapies in a faster timeframe.
Why use a platform trial approach?
Platform trials are designed to decrease the time it takes to find effective therapies, reduce the number of participants on placebo, and increase access to research by conducting the same trial at multiple locations. The HEALEY ALS Platform Trial will remain active until safe and effective treatments are found for all people living with ALS.
What phase is this clinical trial?
The Platform Trial is a Phase 2/3 clinical trial, so data from the trial, if positive, could be used to support the approval of a new medication.
How are the investigational products chosen for this trial?
Investigational products are selected by a team of experts after careful review of the pharmaceutical company and the science behind the study drug. Each investigational product is believed to have an equal chance of success for all forms of ALS based on available scientific evidence.
What is meant by the term 'regimen'?
A regimen is designed to test the safety and efficacy of one specific investigational product. Participants in the trial are randomly assigned to a regimen, and then randomized to active study drug or placebo within that regimen.
What is Active Treatment Extension?
After completing the 36-week randomized controlled trial (RCT), the Active Treatment Extension (ATE) allows participants to receive the active drug for the regimen to which they were assigned. The duration of ATE may vary.
Find Out If You're Eligible
We've prepared a short list of questions to help you find out if you might be eligible to participate in the HEALEY ALS Platform Trial.
Please note that the result of this survey does not serve as official confirmation of your eligibility, as many factors are considered prior to study participation (view a full list of inclusion / exclusion criteria here). Determining eligibility for the Platform Trial will depend on a thorough assessment of your clinical symptoms, review of past medical history, and lab work that can only be performed by an investigator (doctor or nurse practitioner) on the trial.
Work With Us
If you're a researcher looking to collaborate with the Healey Center or a patient interested in participating in the Platform Trial, we want to hear from you!