CompletedPhase 2Progressive MSNCT02913157

What it found

Result in a paper, not read yet

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 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 progression
  • 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 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

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Related trials

History

    1. Started

      Nov 2016

    2. Main results due

      Jun 2021

    3. Finished

      Jun 2021

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