ADORE
Sponsored by Ferrer
Ferrer is conducting a phase 3 trial to evaluate the safety and potential efficacy of FNP122 for people with ALS.
FNP122
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.
Study design
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 48 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.
Inclusion criteria
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 United Kingdom, Ireland, the Netherlands, Belgium, Poland, Italy, Germany, Spain, France and Sweden.
Participating TRICALS centres

AOU Modena
Italy, Modena
Jessica Mandrioli
Professor in Neurology

Bellvitge University Hospital
Spain, Barcelona
Monica Povedano Panades
Coordinator of Unit

Centrum Medyczne Linden
Poland, Krakow
Jakub Antczak
Neurologist and Neurophysiologist

CHRU de Tours - Bretonneau
France, Tours
Philippe Corcia
Professor & Chair of the ALS Centre

CHU Dupuytren
France, Limoges
Philippe Couratier
Neurologist

CHU Gui de Chauliac, Montpellier
France, Montpellier
Florence Esselin
Neurologist

CHU Lille
France, Lille
Veronique Danel Brunaud
Neurologist

CHU Nice
France, Nice
Marie-Helene Soriani
Neurologist

IRCCS ‘Carlo Besta’ Neurological Institute
Italy, Milan
Nilo Riva
Physician scientist

Karolinska Institute
Sweden, Stockholm
Caroline Ingre
Associate Professor of Neurology

King’s College, London
United Kingdom, London
Ammar Al-Chalabi
Professor of Neurology and Complex Disease Genetics

Medical University of Warsaw
Poland, Warsaw
Magdalena Kuzma-Korakiewicz
Professor of Neurology

Trinity College Dublin
Ireland, Dublin
Orla Hardiman
Professor of Neurology

ULS Santa Maria
Portugal, Lisbon
Mamede de Carvalho
Professor of Physiology

UMC Utrecht
The Netherlands, Utrecht
Leonard van den Berg
Professor of Neurology

University and Polytechnic Hospital La Fe
Spain, Valencia
Juan Francisco Vázquez-Costa
Neurologist, Coordinator MND Unit

University Hospital La Paz - Carlos III
Spain, Madrid
Javier Mascias Cadavid
Staff Neurologist

University Hospital of Marseille
France, Marseille
Shahram Attarian
Neurologist

University Hospital of Padova
Italy, Padova
Gianni Sorarù
Associate Professor of Neurology

University Hospital Pitié-Salpêtrière
France, Paris
François Salachas
Neurologist

University Hospital Virgen del Rocío
Spain, Sevilla
Carmen Paradas
Neurologist

University Medical Center Rostock
Germany, Rostock
Andreas Hermann
Senior neurologist

University of Campania 'Luigi Vanvitelli'
Italy, Naples
Gioacchino Tedeschi
Full professor of Neurology

University of Milan Medical School
Italy, Milan
Vincenzo Silani
Professor of Neurology

University of Oxford
United Kingdom, Oxford
Martin Turner
Professor of Clinical Neurology

University of Sheffield
United Kingdom, Sheffield
Chris McDermott
Professor of Translational Neurology

University of Turin
Italy, Torino
Adriano Chiò
Professor of Neurology

UZ Leuven
Belgium, Leuven
Philip van Damme
Professor of Neurology