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Domperidone in Secondary Progressive Multiple Sclerosis (SPMS)

Primary Purpose

Multiple Sclerosis, Secondary Progressive

Status

Completed

Phase

Phase 2

Locations

Canada

Study Type

Interventional

Intervention

Domperidone

About this trial

This is an interventional treatment trial for Multiple Sclerosis, Secondary Progressive

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Calgary MS Clinic at Foothills Medical Centre

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Domperidone

Arm Description

Treatment: Oral domperidone four times daily Target dose: 40mg per day Duration: 1 year

Outcomes

Primary Outcome Measures

Timed 25-Foot Walk (T25W)

quantitative ambulation performance test

Secondary Outcome Measures

9-Hole Peg Test

brief, standardized, quantitative test of upper extremity

Symbol Digit Modalities Test

measures cognitive processing speed and working memory

Functional Systems and Expanded Disability Status Scale (EDSS)

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)

structured, self-report questionnaire with 21 itmes concerning how fatigue impacts patient's life

Multiple Sclerosis Quality of Life Scale 54 item version

54-item multidimensional health-related quality of life measure that combines both generic and MS-specific items

Full Information

NCT ID

NCT02308137

First Posted

December 2, 2014

Last Updated

February 20, 2020

Sponsor

University of Calgary

Collaborators

Alberta Innovates Health Solutions

1. Study Identification

Unique Protocol Identification Number

NCT02308137

Brief Title

Domperidone in Secondary Progressive Multiple Sclerosis (SPMS)

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)

Study Type

Interventional

2. Study Status

Record Verification Date

February 2020

Overall Recruitment Status

Completed

Study Start Date

February 2015 (Actual)

Primary Completion Date

January 3, 2020 (Actual)

Study Completion Date

January 3, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of Calgary

Collaborators

Alberta Innovates Health Solutions

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Multiple Sclerosis, Secondary Progressive

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

64 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Domperidone

Arm Type

Experimental

Arm Description

Treatment: Oral domperidone four times daily Target dose: 40mg per day Duration: 1 year

Intervention Type

Drug

Intervention Name(s)

Domperidone

Other Intervention Name(s)

domperidone maleate

Intervention Description

Simon-2-stage design for domperidone futility

Primary Outcome Measure Information:

Title

Timed 25-Foot Walk (T25W)

Description

quantitative ambulation performance test

Time Frame

up to 12 months

Secondary Outcome Measure Information:

Title

9-Hole Peg Test

Description

brief, standardized, quantitative test of upper extremity

Time Frame