UnknownPhase 2

Hydroxychloroquine and Indapamide in SPMS

Canada35 participantsStarted 2021-10-01

Plain-language summary

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.

Who can participate

Age range

18 Years – 60 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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 durin…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Timed 25-Foot Walk (T25FW)

Timeframe: Change in Timed 25-Foot Walk performance between the 6 month and 18 month visit

Trial details

NCT IDNCT05013463

SponsorUniversity of Calgary

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-09-01

Contact for this trial

Marcus Koch

4032106790 mwkoch@ucalgary.ca

View on ClinicalTrials.gov More Multiple Sclerosis, Secondary Progressive trials