ADORE: a multicentre, double-blind randomised placebo-controlled trial to assess the effect and safety of FAB122 (oral form of edaravone) in patients with Amyotrophic Lateral Sclerosis (ALS).

This phase III study is sponsored by Ferrer Internacional and aims to determine whether ingestion of edaravone by mouth can slow disease progression in ALS. In 2017, the FDA approved an intravenous form of edaravone for the treatment of ALS. A study found that intravenous administration of 60 mg per day for 10-14 days per month slightly slowed the disease progression. Edaravone is a drug that can trap free radicals and thus reduce oxidative stress. The current study aims to study the effect of continuous treatment with edaravone by oral route. Patients will receive either edaravone (100 mg daily) or placebo in a 2:1 ratio and the effect on disease deterioration will be measured. The study will last 48-72 weeks.

Patients with ALS who are aged between 18 and 80 years, have been ill for less than 24 months, have a lung function (SVC) of ≥ 70% and have a disease progression of 0.35 to 1.5 points per month on the ALS-FRS-R are eligible to participate in this study.

Interested, or would you like further information? Contact us at onderzoek@als.be

More info on this study can be found on the website www.clinicaltrialsregister.eu: