The MAGNET adaptive platform trial enables the investigation of multiple treatments at the same time. This allows for a rapid screening of new candidate treatments and will speed up the process of finding a cure for ALS. In addition, we can add new candidate drugs to the platform trial at any given time.
Initially, we will study two promising treatments: Triumeq and Lithium carbonate. Both compounds have been shown to be safe in patients with ALS.Learn more about how platform trials work
Triumeq is a drug that is used to treat patients with the human immunodeficiency virus (HIV) and is shown to be safe. It is thought that ancient viruses (retroviruses) have left their genetic material in our DNA during the human evolution. In some people, this old genetic material may become activated and is believed to be a cause of ALS. In a small trial, it has been shown that Triumeq could suppress this genetic reactivation and may slow disease progression in patients with ALS. Triumeq was shown to be safe and well tolerated in patients with ALS. With this treatment arm we aim to confirm the efficacy of Triumeq as a treatment in patients with ALS.
Lithium carbonate has a long history as a treatment for mood disorders. Several studies have highlighted the protective effects of Lithium carbonate in the brain. An analysis of ALS patients treated with Lithium carbonate showed that patients carrying the homozygous UNC13a mutation may respond better than patients who do not carry this gene. The UNC13a gene is known to be associated with the prognosis and symptoms of patients with ALS. Earlier studies have shown that lithium is safe for patients. In this treatment arm we aim to confirm the beneficial effect of Lithium carbonate in patients positive for the homozygous UNC13a mutation.
The MAGNET trial currently consists of two sub-studies to test the efficacy of lithium carbonate and Triumeq. Each sub-study has an active (i.e. real drug) and placebo arm (i.e. fake drug). Patients are randomly allocated in two-steps: first to sub-study and subsequently to active or placebo treatment.
This means that you cannot choose for a specific treatment or sub-study and the choice will be made for you at random. Both you and your physician do not know if you receive the active or the placebo treatment, but you will be aware to which sub-study you are allocated (e.g. lithium or Triumeq sub-study)
Criteria to participate
The criteria for participation in the MAGNET study are different than other clinical trials in ALS and aimed to provide more patients with the opportunity to participate. Instead of a list of stringent requirements, a computer forecast determines whether you are eligible to participate.
This computer forecast is based on your disease characteristics such as age, symptom duration and lung function. The computer makes a forecasts of the expected disease pattern. By using this forecast, more than 75% of the patients will be able to participate as compared to the 25 – 40% when using classical criteria.
In addition, patients that can participate:
- Need to be 18 years or older
- Can not be pregnant or breastfeeding
You can still choose to Riluzole throughout the duration of the study.
Where can I register my interest?
The MAGNET Trial is currently in preparation. If you have been diagnosed with ALS and are interested in participating, you can register with the TRICALS registry.Register as a patient