Hydroxychloroquine and Indapamide in SPMS

• Status: Not yet recruiting
• Trial end date: 2024-09-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Calgary
• Treatments: Hydroxychloroquine; Indapamide

Criteria

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