Domperidone in Secondary Progressive Multiple Sclerosis (SPMS)
NCT ID: NCT02308137
Last Updated: 2020-02-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
64 participants
INTERVENTIONAL
2015-02-28
2020-01-03
Brief Summary
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Detailed Description
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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
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Domperidone
Treatment: Oral domperidone four times daily Target dose: 40mg per day Duration: 1 year
Domperidone
Simon-2-stage design for domperidone futility
Interventions
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Domperidone
Simon-2-stage design for domperidone futility
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
60 Years
ALL
No
Sponsors
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Alberta Innovates Health Solutions
OTHER
University of Calgary
OTHER
Responsible Party
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Dr. Marcus Werner Koch
Neurologist, Assistant Professor
Principal Investigators
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Marcus W Koch, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Calgary
Locations
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Calgary MS Clinic at Foothills Medical Centre
Calgary, Alberta, Canada
Countries
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References
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Noseworthy JH, Lucchinetti C, Rodriguez M, Weinshenker BG. Multiple sclerosis. N Engl J Med. 2000 Sep 28;343(13):938-52. doi: 10.1056/NEJM200009283431307. No abstract available.
Nylander A, Hafler DA. Multiple sclerosis. J Clin Invest. 2012 Apr;122(4):1180-8. doi: 10.1172/JCI58649. Epub 2012 Apr 2.
Weinshenker BG, Bass B, Rice GP, Noseworthy J, Carriere W, Baskerville J, Ebers GC. The natural history of multiple sclerosis: a geographically based study. 2. Predictive value of the early clinical course. Brain. 1989 Dec;112 ( Pt 6):1419-28. doi: 10.1093/brain/112.6.1419.
Lassmann H, van Horssen J, Mahad D. Progressive multiple sclerosis: pathology and pathogenesis. Nat Rev Neurol. 2012 Nov 5;8(11):647-56. doi: 10.1038/nrneurol.2012.168. Epub 2012 Sep 25.
Rovaris M, Confavreux C, Furlan R, Kappos L, Comi G, Filippi M. Secondary progressive multiple sclerosis: current knowledge and future challenges. Lancet Neurol. 2006 Apr;5(4):343-54. doi: 10.1016/S1474-4422(06)70410-0.
Patrikios P, Stadelmann C, Kutzelnigg A, Rauschka H, Schmidbauer M, Laursen H, Sorensen PS, Bruck W, Lucchinetti C, Lassmann H. Remyelination is extensive in a subset of multiple sclerosis patients. Brain. 2006 Dec;129(Pt 12):3165-72. doi: 10.1093/brain/awl217. Epub 2006 Aug 18.
Franklin RJ, ffrench-Constant C, Edgar JM, Smith KJ. Neuroprotection and repair in multiple sclerosis. Nat Rev Neurol. 2012 Nov 5;8(11):624-34. doi: 10.1038/nrneurol.2012.200. Epub 2012 Oct 2.
Tselis A, Khan OA, Lisak RP. Approaches to neuroprotective strategies in multiple sclerosis. Expert Opin Pharmacother. 2010 Dec;11(17):2869-78. doi: 10.1517/14656566.2010.508070. Epub 2010 Aug 5.
Zhornitsky S, Yong VW, Weiss S, Metz LM. Prolactin in multiple sclerosis. Mult Scler. 2013 Jan;19(1):15-23. doi: 10.1177/1352458512458555. Epub 2012 Aug 29.
Rudick R, Antel J, Confavreux C, Cutter G, Ellison G, Fischer J, Lublin F, Miller A, Petkau J, Rao S, Reingold S, Syndulko K, Thompson A, Wallenberg J, Weinshenker B, Willoughby E. Recommendations from the National Multiple Sclerosis Society Clinical Outcomes Assessment Task Force. Ann Neurol. 1997 Sep;42(3):379-82. doi: 10.1002/ana.410420318.
Koch MW, Sage K, Kaur S, Kim J, Cerchiaro G, Yong VW, Cutter GR, Metz LM. Repurposing Domperidone in Secondary Progressive Multiple Sclerosis: A Simon 2-Stage Phase 2 Futility Trial. Neurology. 2021 May 4;96(18):e2313-e2322. doi: 10.1212/WNL.0000000000011863. Epub 2021 Mar 23.
Other Identifiers
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Domperidone_MS01
Identifier Type: -
Identifier Source: org_study_id
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