What is the Healey Platform Trial?
- An ALS clinical trial that tests 5 different therapies at 54 different trial sites across the United States. You can learn more about the structure and originality of the trial here.
How many patients will be enrolled in the Healey Trial?
- 160 patients will be enrolled per each of the five treatment arms.
What is the duration of the trial?
- 24 weeks
When does the Healey Trial start?
- There is not an exact date set yet. That being said, best estimates have the trial starting in May or June. People living with ALS are encouraged to contact trial sites near their residence as soon as possible. The enrollment will be competitive, meaning on a first come, first serve basis.
What phase clinical trial is this considered?
- The stages of the therapies in the Healey Trial fall under the phase 2/3 trial or what the FDA considers a pivotal trial.
Please explain the expanded access element of the trial.
- Since the duration of the trial is not very long compared to other pivotal trials, the FDA encourages patients who would like to continue therapy usage after the trial is completed, to do so. This will allow researchers to monitor the long term safety of the therapy.
Click on any of the company logos below to learn about the therapy they are contributing to the platform trial.For more Healey Platform Trial info please click here for the MGH website