Pilot Trial of Domperidone in Relapsing-Remitting Multiple Sclerosis (RRMS)
Status:
Completed
Trial end date:
2019-02-01
Target enrollment:
Participant gender:
Summary
The first major objective of this pilot trial is to demonstrate that it is possible to study
myelin repair in relapsing-remitting multiple sclerosis (RRMS) patients with enhancing
lesions on MRI by using advanced imaging techniques. To demonstrate that this is possible the
investigators will recruit 24 RRMS patients who are being treated with standard disease
modifying therapy (DMT) and have new lesions identified on clinically indicated brain MRI
scans and measure myelin repair at 16 and 32 weeks using MRI measures of myelin repair. The
second major objective is to determine how much repair occurs in participants treated with
domperidone compared with those who are not treated. This will allow us to design larger
trials to confirm that domperidone improves repair. The study will also confirm the safety
and tolerability of domperidone in RRMS, determine circulating prolactin levels during dosing
with domperidone 10mg three times daily in people with RRMS, and explore the impact of other
clinical factors (such as age) on lesion repair.
In addition, blood will be collected to test for metabolomics and the investigators will bank
blood for future study of biomarkers that can help the investigators better understand MS.
Metabolomics is an experimental test where changes in the pattern of the chemicals in blood
cells are compared at different time points (during and after inflammation). There will be
random changes but changes that are common in most study participants may help identify
chemicals that signal stages in injury or repair. The investigators will also compare the
pattern of change in those with the best repair to those with the worst repair. This may help
identify a chemical that is associated with better or worse repair and help develop new
treatment strategies. There are currently no blood tests that help in the diagnosis of MS,
help determine which drug a person will respond to, or help determine a person's expected MS
outcome. Any such tests would be considered biomarkers.