Hydroxychloroquine in Primary Progressive Multiple Sclerosis
What it found
A paper reports the results; we have not read it yet. See Papers below.
What was tested
Treatment tested
- Hydroxychloroquine
What it measured
Main measures
Timed 25-Foot Walk (T25FW)
Change in Timed 25-Foot Walk performance between the 6 month and 18 month visit.
Disability progressionWalking and mobility
Other measures (5)
9-Hole Peg Test
baseline, 1 month follow-up, 6 months follow-up, 12 months follow-up, and 18 months follow-up
Disability progressionArm and hand functionSymbol Digit Modalities Test
baseline, 1 month follow-up, 6 months follow-up, 12 months follow-up, and 18 months follow-up
Thinking and memoryFunctional Systems and Expanded Disability Status Scale (EDSS)
baseline, 1 month follow-up, 6 months follow-up, 12 months follow-up, and 18 months follow-up
Disability progressionModified Fatigue Impact Scale (MFIS)
baseline, 1 month follow-up, 6 months follow-up, 12 months follow-up, and 18 months follow-up
FatigueQuality of life (reported by participants)Multiple Sclerosis Quality of Life Scale 54 item version
baseline, 1 month follow-up, 6 months follow-up, 12 months follow-up, and 18 months follow-up
Quality of life (reported by participants)
Who could take part
Progressive MS · 18 to 65
Inclusion Criteria: * Written informed consent obtained * Men and women aged of 18 and 65 years inclusive * Who are followed at the Calgary MS Clinic * With Primary Progressive Multiple Sclerosis, according to current diagnostic criteria * Screening Expanded Disability Status Scale score between 4.0 and 6.5 inclusive. * Screening timed 25 foot walk (average of two trials) of 5.5 seconds or more. Exclusion Criteria: * Patients undergoing treatment with antimalarial drugs, amiodarone, dapsone or digoxin * Patients with known retinopathy * Patients whose screening ophthalmological exam shows retinopathy * Patients whose screening MRI scan shows gadolinium enhancing lesions * Patients with known renal insufficiency * Patients with known significant hepatic impairment * Patients with known porphyria * Patients with known allergy or other intolerability to HCQ, or to gadolinium MRI contrast agent * 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 who increase the dose of Baclofen or Tizanidine during the study period * Patients who receive treatment with Botulinum toxin in the leg muscles during the study period * Patients using amiodarone, dapsone, digoxin or antimalarial drugs other than HCQ * Patients who are unable or unwilling to undergo gadolinium enhanced MRI scans * Pregnant or breast-feeding women
As registered. Criteria can change, so ask the trial team or your neurologist.
About this trial
In the sponsor's words
The purpose of this clinical trial is to determine if HCQ in a dose of 400mg daily can prevent worsening of walking ability in people PPMS. The number of participants in this study will be 35. A maximum of 42 people with PPMS will be included. The trial is funded through a private donation to the Hotchkiss Brain Institute MS Translational Clinical Trials Research Program and the University of Calgary. There is no sponsorship from the pharmaceutical industry.
Papers
Results
Baeva ME, Tottenham I, Koch M, Camara-Lemarroy C. Biomarkers of disability worsening in inactive primary progressive multiple sclerosis. J Neuroimmunol. 2024 Feb 15;387:578268. doi: 10.1016/j.jneuroim.2023.578268. Epub 2023 Dec 23.Results
Camara-Lemarroy C, Silva C, Gohill J, Yong VW, Koch M. Serum neurofilament-light and glial fibrillary acidic protein levels in hydroxychloroquine-treated primary progressive multiple sclerosis. Eur J Neurol. 2023 Jan;30(1):187-194. doi: 10.1111/ene.15588. Epub 2022 Oct 25.Results
Brown D, Moezzi D, Dong Y, Koch M, Yong VW. Combination of Hydroxychloroquine and Indapamide Attenuates Neurodegeneration in Models Relevant to Multiple Sclerosis. Neurotherapeutics. 2021 Jan;18(1):387-400. doi: 10.1007/s13311-020-01002-5. Epub 2021 Jan 6.
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History
Started
Nov 2016
Main results due
Jun 2021
Finished
Jun 2021
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