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Domperidone in Secondary Progressive Multiple Sclerosis (SPMS)

This study is currently recruiting participants.
See Contacts and Locations
Verified May 2016 by Dr. Marcus Werner Koch, University of Calgary
Sponsor:
Collaborator:
Alberta Innovates Health Solutions
Information provided by (Responsible Party):
Dr. Marcus Werner Koch, University of Calgary
ClinicalTrials.gov Identifier:
NCT02308137
First received: December 2, 2014
Last updated: May 10, 2016
Last verified: May 2016
  Purpose
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.

Condition Intervention Phase
Multiple Sclerosis, Secondary Progressive Drug: Domperidone Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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)

Resource links provided by NLM:


Further study details as provided by Dr. Marcus Werner Koch, University of Calgary:

Primary Outcome Measures:
  • Timed 25-Foot Walk (T25W) [ Time Frame: up to 12 months ]
    quantitative ambulation performance test


Secondary Outcome Measures:
  • 9-Hole Peg Test [ Time Frame: administered at baseline, one month, 6 months, and 12 months ]
    brief, standardized, quantitative test of upper extremity

  • Symbol Digit Modalities Test [ Time Frame: administered at baseline, one month, 6 months, and 12 months ]
    measures cognitive processing speed and working memory

  • 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.

  • 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

  • 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


Estimated Enrollment: 62
Study Start Date: February 2015
Estimated Study Completion Date: January 2019
Estimated Primary Completion Date: January 2019 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Domperidone
Treatment: Oral domperidone four times daily Target dose: 40mg per day Duration: 1 year
Drug: Domperidone
Simon-2-stage design for domperidone futility
Other Name: domperidone maleate

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
  Eligibility

Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02308137

Contacts
Contact: Marcus W Koch, MD, PhD 403-944-2579 mwkoch@ucalgary.ca
Contact: Luanne M Metz, MD 403-944-4241 lmetz@ucalgary.ca

Locations
Canada, Alberta
Calgary MS Clinic at Foothills Medical Centre Recruiting
Calgary, Alberta, Canada, T2N 2T9
Contact: Janet Kim    403-944-2579    Janet.Kim@albertahealthservices.ca   
Sponsors and Collaborators
University of Calgary
Alberta Innovates Health Solutions
Investigators
Principal Investigator: Marcus W Koch, MD, PhD University of Calgary
  More Information

Publications:

Responsible Party: Dr. Marcus Werner Koch, Neurologist, Assistant Professor, University of Calgary
ClinicalTrials.gov Identifier: NCT02308137     History of Changes
Other Study ID Numbers: Domperidone_MS01
Study First Received: December 2, 2014
Last Updated: May 10, 2016

Additional relevant MeSH terms:
Domperidone
Sclerosis
Multiple Sclerosis
Neoplasm Metastasis
Multiple Sclerosis, Chronic Progressive
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Neoplastic Processes
Neoplasms
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Dopamine Antagonists
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on June 26, 2017