NCT02308137

Domperidone in Secondary Progressive Multiple Sclerosis (SPMS)

Open-label, Single-center, Single-arm Futility Trial Evaluating Oral Domperidone 10mg QID for Reducing Progression of Disability in Patients With Secondary Progressive Multiple Sclerosis (SPMS)

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 64 (actual)
• Sponsor: University of Calgary · Academic / Other
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

Primary objective To demonstrate non-futility of domperidone for reducing progression of disability, as measured with the timed 25 foot walk (T25FW), in secondary progressive Multiple Sclerosis (SPMS). Secondary objectives * To assess the safety of domperidone in the study population for the duration of the study. * To assess the effect of domperidone on hand dexterity as measured with the 9HPT * To assess the effect of domperidone on cognition, as measured with the SDMT * To assess the effect of domperidone on health related quality of life, as measured with the MSQOL-54 * To assess the effect of domperidone on fatigue, as measured with the MFIS * To establish the Simon-2-stage model as a study model in MS research. The application of this methodology to studies in progressive MS will have important consequences for the design and conduct of clinical and translational research in progressive MS, in particular for phase II trials in progressive MS

Conditions

• Multiple Sclerosis, Secondary Progressive

Interventions

Type	Name	Description
DRUG	Domperidone	Simon-2-stage design for domperidone futility

Timeline

• Start date: 2015-02-01
• Primary completion: 2020-01-03
• Completion: 2020-01-03
• First posted: 2014-12-04
• Last updated: 2020-02-24

Locations

1 site across 1 country: Canada