Open-label extension petition
Open-label extensions must be foundational to ALS clinical trials. They are vital. Open-label extensions allow people who have participated in clinical trials to gain access to the investigational therapy after their participation in the clinical trial is over, if they choose. They give those who receive a placebo the opportunity to gain access to the therapy, while also offering continued access to those who found the therapy to help stop or slow their progression of ALS.
Open label extensions are mutually beneficial to both sponsors and trial participants. They allow sponsors to continue gathering data on the long-term safety and tolerability of investigational therapies and allow trial volunteers the option to continue on a therapy that they found to be helpful.
For a disease as cruel as ALS, which has no cures or treatments that stop or reverse disease progression, limiting patient access to the very investigational therapies that they helped investigate is inhumane.
The undersigned will choose not to participate or will discourage loved ones from participating in clinical trials that do not provide an open-label extension option that is explained in writing.