Multiple Sclerosis, Relapsing-Remitting Clinical Trial
Official title:
Randomized, Controlled Pilot Trial of Domperidone in Relapsing-Remitting Multiple Sclerosis
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.
Primary Objectives:
- To demonstrate that the investigators can recruit DMT treated RRMS patients who have
breakthrough enhancing lesions identified on clinically indicated monitoring brain MRI
scans and measure lesion repair over 32 weeks.
- To obtain estimates of the magnitude and variability of lesion repair in DMT treated
RRMS patients who are taking add-on domperidone, or no add-on treatment. The
investigators will evaluate three MRI measures [texture analysis, diffusion tensor
imaging (DTI), and magnetization transfer imaging (MTI)] for their ability to measure
repair within acute enhancing lesions in RRMS. They will also evaluate repair at 16 and
32 weeks. These outcomes will aid in the development of future trials.
No therapies have yet been shown to improve lesion repair, and there is no accepted trial
model to evaluate lesion repair in humans. Therefore, the investigators anticipate that the
data from this trial will inform the design of future phase 2 trials of therapies to promote
lesion repair in MS.
Secondary Objectives:
- To determine the safety and tolerability of domperidone in RRMS
- To determine serum prolactin levels during dosing with domperidone 10mg tid in this
population
- To explore metabolomic profiling during lesion repair.
- To explore the impact of the following variables on lesion repair: prolactin level at 6
weeks, concurrent use of each type of DMT, Vitamin D and B12 levels at baseline, patient
clinical characteristics (MS duration, EDSS), imaging characteristics (T2 lesion volume,
enhancing lesion volume), patient demographics and behaviours (age, sex, smoking
status).
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