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Domperidone in Secondary Progressive Multiple Sclerosis (SPMS)

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ClinicalTrials.gov Identifier: NCT02308137
Recruitment Status : Recruiting
First Posted : December 4, 2014
Last Update Posted : April 17, 2019
Sponsor:
Collaborator:
Alberta Innovates Health Solutions
Information provided by (Responsible Party):
Dr. Marcus Werner Koch, University of Calgary

Tracking Information
First Submitted Date  ICMJE December 2, 2014
First Posted Date  ICMJE December 4, 2014
Last Update Posted Date April 17, 2019
Actual Study Start Date  ICMJE February 2015
Estimated Primary Completion Date January 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 3, 2014)
Timed 25-Foot Walk (T25W) [ Time Frame: up to 12 months ]
quantitative ambulation performance test
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02308137 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: December 3, 2014)
  • 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
Original Secondary Outcome Measures  ICMJE
 (submitted: December 3, 2014)
  • 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
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Domperidone in Secondary Progressive Multiple Sclerosis (SPMS)
Official Title  ICMJE 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)
Brief 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
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Multiple Sclerosis, Secondary Progressive
Intervention  ICMJE Drug: Domperidone
Simon-2-stage design for domperidone futility
Other Name: domperidone maleate
Study Arms  ICMJE Experimental: Domperidone
Treatment: Oral domperidone four times daily Target dose: 40mg per day Duration: 1 year
Intervention: Drug: Domperidone
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: December 3, 2014)
62
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE January 2020
Estimated Primary Completion Date January 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 60 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Marcus W Koch, MD, PhD 403-944-2579 mwkoch@ucalgary.ca
Contact: Luanne M Metz, MD 403-944-4241 lmetz@ucalgary.ca
Listed Location Countries  ICMJE Canada
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02308137
Other Study ID Numbers  ICMJE Domperidone_MS01
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Dr. Marcus Werner Koch, University of Calgary
Study Sponsor  ICMJE University of Calgary
Collaborators  ICMJE Alberta Innovates Health Solutions
Investigators  ICMJE
Principal Investigator: Marcus W Koch, MD, PhD University of Calgary
PRS Account University of Calgary
Verification Date April 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP