Hydroxychloroquine and Indapamide in SPMS

NCT05013463 | Unknown Phase 2 DMC

• 1 other identifier: HCQ_IND_MS01
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Timed 25-Foot Walk (T25FW)

  quantitative ambulation performance test

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

Secondary Outcomes (5)

• 9-Hole Peg Test

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

• Symbol Digit Modalities Test

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

• 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

• Modified Fatigue Impact Scale (MFIS)

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

• 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

Study Arms (1)

Hydroxychloroquine and Indapamide

EXPERIMENTAL

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

Drug: Hydroxychloroquine Pill; Drug: Indapamide Pill

Interventions

Hydroxychloroquine Pill DRUG

Oral Hydroxychloroquine, 200mg BID

Also known as: Plaquenil

Hydroxychloroquine and Indapamide

Indapamide Pill DRUG

Oral Indapamide, 2.5 mg OD

Also known as: Lozol

Hydroxychloroquine and Indapamide

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Calgary: lead

Study Sites (1)

Foothills Medical Centre

Calgary, Alberta, T2N 2T9, Canada

RECRUITING

MeSH Terms

Conditions

Multiple Sclerosis, Chronic Progressive

Interventions

Hydroxychloroquine; Indapamide

Condition Hierarchy (Ancestors)

Multiple Sclerosis; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Chloroquine; Aminoquinolines; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Sulfonamides; Amides; Organic Chemicals; Sulfones; Sulfur Compounds; Indoles

Central Study Contacts

Marcus Koch

CONTACT

4032106790; mwkoch@ucalgary.ca

Graziela Cerchiaro

CONTACT

403 944-4315; graziela.cerchiaro@albertahealthservices.ca

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Simon-2-stage MinMax design

Study Record Dates

• First Submitted: August 16, 2021
• First Posted: August 19, 2021
• Study Start: October 1, 2021
• Primary Completion: September 1, 2023
• Study Completion: September 1, 2024
• Last Updated: May 18, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will share

Locations

CA (1)