Recruiting
Phase 2

Hydroxychloroquine & Indapamide

Sponsor:

University of Calgary

Code:

NCT05013463

Conditions

Multiple Sclerosis, Secondary Progressive

Eligibility Criteria

Sex: All

Age: 18 - 60

Healthy Volunteers: Not accepted

Interventions

Hydroxychloroquine Pill

Indapamide Pill

Study Details

Brief 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.

Conditions

Multiple Sclerosis, Secondary Progressive

Study ID

NCT05013463

Start date

Oct 1, 2021

Status verified date

May, 2022

Completion date

Sep 1, 2024

Anticipated

Primary completion date

Sep 1, 2023

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 60

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

35 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Hydroxychloroquine and Indapamide

Oral Hydroxychloroquine, 200mg BID Oral Indapamide, 2.5 mg OD

Interventions

Hydroxychloroquine Pill

Oral Hydroxychloroquine, 200mg BID

Indapamide Pill

Oral Indapamide, 2.5 mg OD

Primary outcome measure

  • Timed 25-Foot Walk (T25FW) [ Time Frame: Change in Timed 25-Foot Walk performance between the 6 month and 18 month visit ]

Central Contacts and Locations

Central contacts

Marcus Koch

4032106790mwkoch@ucalgary.ca

Graziela Cerchiaro

403 944-4315graziela.cerchiaro@albertahealthservices.ca

Locations

Foothills Medical Centre

Recruiting

Calgary, Alberta, Canada, T2N 2T9

Contacts

Martha Rojas

(403) 944-4244Martha.RojasZavala@ahs.ca

Graziela Cerchiaro

(403) 944-4315Graziela.Cerchiaro@ahs.ca

Principal Investigator:

Marcus Koch

More Information

Sponsor

University of Calgary

Last update posted

May 18, 2022

Last verified

May, 2022

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Calgary on 2022-05-18.