A ground-breaking clinical trial will be the first to examine the important needs of MS patients that are severely disabled.
The trial will test a drug that modifies the disease, and will look at how important it is for wheelchair users to retain the full use of their hands.
The research team, from Barts Health NHS Trust, Queen Mary University of London, and pharmaceutical company, Roche, hopes that the study will enable significant changes in the field.
What is MS?
MS, short for multiple sclerosis, affects around 120,000 people living in the UK and approximately 700,000 throughout Europe. It is a disease of the central nervous system, affecting the brain and spinal cord, and is degenerative by nature. Many of those afflicted deal with the primary progressive type, which is severely disabling. People are often diagnosed in their 40s or 50s, although symptoms may present years earlier. It affects more women than men. Many of those living with MS are wheelchair users. Previous research has looked only at whether tested drugs affect the patient’s ability to walk, as opposed to the use of their hands.
Challenges faced by researchers
In the UK, the NHS discontinues treatment of disease-modifying therapies for people who rely on the use of a wheelchair.
In addition, the European Medicines Agency has also precluded these patients from participating in this type of research, despite evidence indicating that continuing treatment could delay arm and hand functions getting worse, improving the patient’s quality of life dramatically and helping them stay independent.
The new study starts at the end of this year and will look at the safety and efficacy of the drug ocrelizumab versus a placebo. Approximately 1,000 people, across several countries, living with primary progressive MS will be enrolled in the trials. More information on paid clinical trials is available at http://www.trials4us.co.uk/.
For the first time, the Nine-Hole Peg Test — a measure of arm, wrist and hand function — will be used as the main outcome to be measured. Participants will take pegs and put them in nine holes on a board as quickly as they can. Pegs are then removed and placed back into a container.
Ultimately, the team hopes to assess whether ocrelizumab can help patients to retain function of their upper limbs.