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Hydroxychloroquine and Indapamide in SPMS

Open-label, Single-center, Single-arm Futility Trial Evaluating the Combination of Oral Hydroxychloroquine 200mg BID and Indapamide 2.5mg OD for Reducing Progression of Disability in People With Secondary Progressive Multiple Sclerosis (SPMS)
Status unknownPhase 2Progressive MSNCT05013463

We could not find results for this trial

I know where the results are

What it found

No result found

We found no results in the registry or in papers.

What was tested

Treatment tested

  • Hydroxychloroquine
  • Indapamide

    Thiazide-sensitive sodium-chloride cotransporter inhibitor

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 function

  • Symbol Digit Modalities Test

    baseline, 1 month follow-up, 6 months follow-up, 12 months follow-up, and 18 months follow-up

    Thinking and memory

  • Functional 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 progressionWalking and mobility

  • Modified 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 60

Inclusion Criteria: * Written informed consent obtained * Men and women aged 18 and 60 years inclusive * With SPMS, 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 9 seconds or more Exclusion Criteria: * Individuals with retinopathy * Individuals whose screening ophthalmological exam shows retinopathy * Individuals with renal insufficiency (pre-existing or developing during the trial) * Individuals with significant hepatic impairment (pre-existing or developing during the trial) * Individuals with abnormal screening labs * Individuals with cardiac arrhythmia * Individuals with a prolonged QT interval: individuals with frequency corrected QT (QTc) intervals of more than 450ms (men) or 470ms (women) at the screening examination will not be included in the study, and participants with QTc intervals of greater than 500ms on any of the other ECG examinations throughout the study will be excluded from the study. * Individuals with porphyria * Individuals with an allergy or other intolerability to HCQ or IND * Individuals who use Fampridine or 4-aminopyridine * Individuals who start Fampridine or 4-aminopyridine during the trial * Individuals who start Baclofen or Tizanidine during the trial * Individuals who increase the dose of Baclofen or Tizanidine during the trial * Individuals who receive treatment with Botulinum toxin in the leg muscles during the trial * Individuals who use siponimod, amiodarone, dapsone, digoxin or antimalarial drugs other than HCQ * 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 and indapamide in a dose of 2.5mg daily can help in reducing the progression of disability in people with secondary progressive multiple sclerosis. The number of participants in this study will be 35. A maximum of 42 people with SPMS will be included. The trial is funded through internal funding through the University of Calgary. There is no sponsorship from any pharmaceutical industry.

Papers

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    History

      1. Started

        Oct 2021

      2. Main results due

        Sept 2023

      3. Finished

        Sept 2024

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