Domperidone in Secondary Progressive Multiple Sclerosis (SPMS)

February 20, 2020 updated by: Dr. Marcus Werner Koch, University of Calgary

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)

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.

Study Overview

Status

Completed

Intervention / Treatment

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

Study Type

Interventional

Enrollment (Actual)

64

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Alberta
      • Calgary, Alberta, Canada, T2N 2T9
        • Calgary MS Clinic at Foothills Medical Centre

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • written informed consent obtained
  • with Multiple Sclerosis, and with secondary progressive disease course
  • screening Expanded Disability Status Scale (EDSS) score between 4.0 and 6.5 inclusive
  • screening timed 25 foot walk (average of two trials) lof 9 seconds or more

Exclusion Criteria:

  • Long QT interval, defined as corrected QT interval of more than 470 msec in men and more than 450 msec in women on baseline ECG
  • Patients with known long-QT syndrome
  • Patients with known ventricular arrhythmia
  • Patients with a known electrolyte disturbance
  • Patients undergoing treatment with drugs that increase the QTc interval
  • Patients undergoing treatment with drugs that inhibit CYP3A4, in particular: Ketoconazole, Fluconazole, Erythromycin, Clarithromycin, Ritonavir
  • Patients with a history of breast cancer or carcinoma in situ
  • Patients with known renal insufficiency
  • Patients with known allergy or other intolerability to domperidone
  • Patients currently using Fampridine or 4-aminopyridine
  • Patients planning to start Fampridine or 4-aminopyridine during the study period
  • Patients planning to start Baclofen or Tizanidine during the duration of the study
  • Patients planning to increase or decrease their dose of Baclofen or Tizanidine during the study period
  • Patients planning to receive treatment with Botulinum toxin in the leg muscles during the duration of the study
  • Patients with a significiant hepatic impairment
  • Patients with a prolactinoma
  • Patients in whom gastrointestinal stimulation could be dangerous
  • Patients using MAO inhibitors
  • Patients with a history of breast cancer
  • Pregnant or breast-feeding women

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Domperidone
Treatment: Oral domperidone four times daily Target dose: 40mg per day Duration: 1 year
Simon-2-stage design for domperidone futility
Other Names:
  • domperidone maleate

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Timed 25-Foot Walk (T25W)
Time Frame: up to 12 months
quantitative ambulation performance test
up to 12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
9-Hole Peg Test
Time Frame: administered at baseline, one month, 6 months, and 12 months
brief, standardized, quantitative test of upper extremity
administered at baseline, one month, 6 months, and 12 months
Symbol Digit Modalities Test
Time Frame: administered at baseline, one month, 6 months, and 12 months
measures cognitive processing speed and working memory
administered at baseline, one month, 6 months, and 12 months
Functional Systems and Expanded Disability Status Scale (EDSS)
Time Frame: administered at baseline, one month, 6 months, and 12 months
EDSS is the standard measure of neurologic impairment that is used to describe disability in MS. The neurological assessment comprises seven functional systems.
administered at baseline, one month, 6 months, and 12 months
Modified Fatigue Impact Scale (MFIS)
Time Frame: administered at baseline, one month, 6 months, and 12 months
structured, self-report questionnaire with 21 itmes concerning how fatigue impacts patient's life
administered at baseline, one month, 6 months, and 12 months
Multiple Sclerosis Quality of Life Scale 54 item version
Time Frame: administered at baseline, one month, 6 months, and 12 months
54-item multidimensional health-related quality of life measure that combines both generic and MS-specific items
administered at baseline, one month, 6 months, and 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Marcus W Koch, MD, PhD, University of Calgary

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2015

Primary Completion (Actual)

January 3, 2020

Study Completion (Actual)

January 3, 2020

Study Registration Dates

First Submitted

December 2, 2014

First Submitted That Met QC Criteria

December 3, 2014

First Posted (Estimate)

December 4, 2014

Study Record Updates

Last Update Posted (Actual)

February 24, 2020

Last Update Submitted That Met QC Criteria

February 20, 2020

Last Verified

February 1, 2020

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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