The purpose of this clinical trial is to determine if Domperidone in a dose of 40 mg daily can prevent worsening of walking ability in people secondary progressive MS. The number of participants in this study will be 62. A maximum of 75 people with secondary progressive MS will be included. Each patient will be followed for 12 months from inclusion. Domperidone is a medication which has been shown to increase levels of the hormone prolactin. The best understood function of prolactin is the stimulation of milk production in women after delivery. However, the increase in prolactin levels seen in patients treated with standard doses of Domperidone (in doses of up to 80mg per day) usually does not lead to clinical symptoms. Prolactin has been shown to improve myelin repair in mice. Domperidone therefore may also improve myelin repair in people with MS. Domperidone is currently approved in Canada to treat slow moving bowels and nausea, for instance in patients with Parkinson's Disease or Diabetes Mellitus, where too slowly moving bowels can cause constipation. Domperidone is available as a tablet that is usually taken four times per day. Doses up to 80mg per day may be used but we estimate that a dose of only 40mg daily will be needed to stimulate myelin repair. Domperidone is usually well tolerated.
Name: Domperidone
Description: Simon-2-stage design for domperidone futilityType: DrugDomperidone
Description: quantitative ambulation performance test
Measure: Timed 25-Foot Walk (T25W) Time: up to 12 monthsDescription: brief, standardized, quantitative test of upper extremity
Measure: 9-Hole Peg Test Time: administered at baseline, one month, 6 months, and 12 monthsDescription: measures cognitive processing speed and working memory
Measure: Symbol Digit Modalities Test Time: administered at baseline, one month, 6 months, and 12 monthsDescription: EDSS is the standard measure of neurologic impairment that is used to describe disability in MS. The neurological assessment comprises seven functional systems.
Measure: Functional Systems and Expanded Disability Status Scale (EDSS) Time: administered at baseline, one month, 6 months, and 12 monthsDescription: structured, self-report questionnaire with 21 itmes concerning how fatigue impacts patient's life
Measure: Modified Fatigue Impact Scale (MFIS) Time: administered at baseline, one month, 6 months, and 12 monthsDescription: 54-item multidimensional health-related quality of life measure that combines both generic and MS-specific items
Measure: Multiple Sclerosis Quality of Life Scale 54 item version Time: administered at baseline, one month, 6 months, and 12 monthsSingle Group Assignment
There is one SNP
Timed 25-Foot Walk (T25W). --- T25W ---