ADORE clinical trial open to recruitment of people with MND in the UK

The ADORE (ALS Deceleration with ORal Edaravone) clinical trial is a phase 3 clinical trial of the investigational drug FNP122. This is an oral formulation of the drug edaravone, which is licensed for the treatment of MND in some countries including the US and Canada (it is not licensed in the UK).

FNP122 can help prevent oxidative stress, which is thought to contribute to nerve cell death in MND. By decreasing oxidative stress, edaravone could potentially slow the progression of MND.

ADORE is a double-blind, randomised, placebo-controlled trial:

• Double-blind means that neither the participant nor the healthcare team knows if the participant is receiving the investigational drug or the placebo (dummy drug). This reduces bias when the trial data are analysed
• Randomised means that participants are randomly assigned to receive the investigational drug or the placebo
• Placebo-controlled means that some participants will receive a dummy drug while others will receive the investigational drug. Everything else is the same in the two groups, so any difference in their outcome can be attributed to the active treatment.

Both FNP122 and the placebo can be dissolved in water and taken as a drink. This formulation is often easier for people with MND to swallow and reduces the need for visits to hospital to receive an intravenous injection. At the end of the trial, all participants will be offered the chance to enter the open-label extension (OLE), in which they will receive daily FNP122, regardless of whether they received the active drug or the placebo in the initial stage of the trial.

How can you participate in the ADORE trial?

The ADORE trial is currently recruiting at the following sites in the UK:

• King’s College Hospital NHS Foundation Trust (London)
• Sheffield Institute for Translational Neuroscience (Sheffield)
• John Radcliffe Hospital (Oxford)
• The Walton Centre NHS Foundation Trust (Liverpool)
• Salford Royal NHS Foundation Trust (Salford)

The trial will run for up to 48 weeks (approximately 11 months). During this period, you will need to visit the research centre approximately 9 times, and you will also be contacted by telephone 7 times.

The main criteria* to participate in the ADORE trial are:

• You have amyotrophic lateral sclerosis (ALS); this trial is not open to people with other types of MND
• You are aged between 18 and 80
• The first symptoms of your disease were not more than 24 months ago
• Your lung function is at least 70% at your screening visit
• You are not pregnant or breast-feeding for the duration of the trial
• If you are taking riluzole, you must have been on a stable dose for at least 30 days prior to entering the trial. This dose should be maintained for the duration of the trial.

*This list is not exhaustive, and you should speak to your consultant about your suitability to participate in this trial if you are interested. Alternatively, contact the TRICALS consortium at info@tricals.org.