Details of Clinical Trial ADORE for Amyotrophic Lateral Sclerosis (ALS)
Ferrer is conducting a phase 3 trial to evaluate the safety and efficacy of the investigational medicinal product FNP122 in the treatment of amyotrophic lateral sclerosis (ALS).
Amyotrophic lateral sclerosis (ALS)
ALS is a rare, progressive, neurodegenerative disease that affects the brain's motor neurons. It is characterised by axonal degeneration and the progressive loss of the upper and lower motor neurons of all the nerves, including the central nervous system (CNS).
FNP122
Oxidative stress is thought to contribute to nerve cell death in ALS, causing atrophy and subsequent muscle paralysis that triggers disease progression. FNP122 is an oral formulation of edaravone, a compound that prevents oxidative stress on a cellular level. Therefore, reducing oxidative stress can delay the progression of ALS.
Study design
This is an international, multicentre, randomised, double-blind, placebo-controlled study.
The participants will be randomly assigned to receive FNP122 or placebo at a ratio of 2:1.
Since this study is double-blind, neither the participant nor the study team will know to which group the patients have been assigned until the end of the study.
In this study, the participants on treatment with Riluzole prior to enrolment (with a stable dose 30 days before entering the study) may continue their treatment with Riluzole during the study.
The study treatment will last 72 weeks. Upon conclusion of the study, the participants will be offered the chance to participate in an extension study in which they will all be given FNP122.
Once the subjects have provided their consent to take part in the study, they will be asked to attend several medical visits in person:
• To review and check the screening criteria (inclusion and exclusion)
• To confirm their participation in the study; baseline visit
• At week 4
• At week 12
• Every 12 weeks thereafter
In the course of the study, monthly telephone visits will also be arranged, which will be held between the in-hospital visits until week 48.
The study's key eligibility criteria are:
1. Age 18 - 80 years;
2. Diagnosis of ALS;
3. Disease onset within the last 24 months;
4. SVC 70% or higher at the screening visit;
5. Change in ALSFRS-R between 0.35 points and 1.5 points per month (both inclusive) in the period from onset of first symptoms to the screening visit;
6. Patients on Riluzole must be on stable doses ≥30 days prior to the baseline visit and this dose should be maintained during the entire trial;
7. Female participants must not be (or be able to become) pregnant or breast-feeding.
The study medication, both the placebo and FNP122, is available in single-dose sachets, which must be dissolved in water and taken daily.
The study aims to recruit 300 patients across several European countries.
The study is currently active in Belgium, Poland, Italy, Germany, Spain, the Netherlands and the United Kingdom, and it is scheduled to begin in other European countries in the near future.
For further information about the study, please refer to:
A Multicenter, Randomized, Double-blind, Placebo-controlled Study to Investigate the Efficacy and Safety of FAB122 in Patients With Amyotrophic Lateral Sclerosis (ADORE). ClinicalTrials.gov [Internet]. 5 January 2022. https://clinicaltrials.gov/ct2/show/NCT05178810
Phase 3 ADORE Trial and Participating Centres. TRICALS [Internet]. 7 December 2022. https://www.tricals.org/en/trials/adore-als-trial/
It is important to remember that the information on this website is not intended to replace the advice of healthcare professionals.
Patients should seek medical advice before beginning or changing their treatment and should also think carefully about participating in any clinical research.
Healthcare professionals should refer to the technical information approved by the patient's country to make sure that they are in possession of updated and suitable information in accordance with the local requirements.