Status:
COMPLETED
Domperidone in Secondary Progressive Multiple Sclerosis (SPMS)
Lead Sponsor:
University of Calgary
Collaborating Sponsors:
Alberta Innovates Health Solutions
Conditions:
Multiple Sclerosis, Secondary Progressive
Eligibility:
All Genders
18-60 years
Phase:
PHASE2
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 th...
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
February 1 2015
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 3 2020
Estimated Enrollment :
64 Patients enrolled
Trial Details
Trial ID
NCT02308137
Start Date
February 1 2015
End Date
January 3 2020
Last Update
February 24 2020
Active Locations (1)
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1
Calgary MS Clinic at Foothills Medical Centre
Calgary, Alberta, Canada, T2N 2T9