Recently it has become clear that ALS is not one disease, but a collection of subtypes that all lead to the same symptoms. There is a possibility that a specific therapy must be developed and tested for each subtype. In addition, it appears that - given the complexity of the disease - international cooperation is necessary.
The Karolinska ALS Clinical Research Center has extensive experience in setting up and conducting trials in ALS. We know that most people with ALS are eager to participate in clinical trials in the hope that it will benefit themselves or future patients. However, currently only 2 percent of all patients with ALS can participate in therapy trials.
This has to change. That is why a new and unique initiative was created: the "Treatment Research Initiative to Cure ALS (TRICALS)".
The goal is simple, but ambitious: to give every ALS patient the opportunity to participate in high-quality therapy trials that increase our knowledge of the disease and identify better, more effective treatments for ALS.
TRICALS introduces innovative methods to conduct trials, so that the burden and the number of people on placebo is as low as possible. TRICALS will also improve the so-called “trial readiness” for ALS, by setting up an efficient and effective infrastructure. For example, the initiative wants to increase the number of ALS trials.
In addition, TRICALS records a beneficial treatment effect for people with ALS in such a way that it is recognized by bodies such as the EMA and FDA. TRICALS starts trials with three promising drugs: Edaravone, Lithium and Triumeq.
More information about TRICALS can be found here.