Oxidative stress is thought to contribute to nerve cell death in ALS. FNP122 is an oral formulation of edaravone, a compound that can help prevent oxidative stress. Therefore, by decreasing oxidative stress, edaravone could potentially slow ALS progression.
The ADORE trial is sponsored by the pharmaceutical company Ferrer. It is a randomised, double-blind, placebo-controlled trial. This means that the effect of FNP122 is compared against a placebo treatment. A placebo is something that looks exactly the same as the study medicine but does not have any active medicine in it. Participants will be randomly assigned to receive FNP122 or placebo. Neither the participant nor the study team will be told which group they have been placed into until after the study has finished.
Both placebo and FNP122 need to be dissolved in water and ingested daily. The study will run for up to 72 weeks. Participants will need to visit the clinic at various occasions:
- For a screening appointment
- For a baseline visit
- At week 4
- At week 12
- Every 12 weeks thereafter
Monthly telephone appointments will take place in between the visits to the clinic until Week 48.
Key eligibility criteria for people with ALS to participate, include:
- Age between 18 – 80 years
- Diagnosis of ALS
- Disease onset within the prior 24 months
- SVC equal to or more than 70% at screening visit
- Change in ALSFRS-R score between 0.35 points and 1.5 points per month (both inclusive) in the period from onset of first symptoms to the Screening visit;
- Patients on riluzole should be on stable doses ≥30 days prior to the baseline visit and this dose should be maintained during the entire trial.
- Female participants should not be (able to become) pregnant or breast-feeding
Participants can continue their treatment with Riluzole for the entire duration of the study.
The study aims to enrol 300 patients across European countries. Several TRICALS Centres will be participating in this trial. Currently, the study is active in the Netherlands, Belgium, Poland, Italy, Germany, Spain and Ireland.