Hydroxychloroquine in Primary Progressive Multiple Sclerosis

NCT02913157 | Completed Phase 2 DMC

• 1 other identifier: HCQ_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 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.

Conditions

Multiple Sclerosis, Primary 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

EXPERIMENTAL

Oral Hydroxychloroquine, 200mg BID

Drug: Hydroxychloroquine

Interventions

Hydroxychloroquine DRUG

Orally administered Hydroxychloroquine

Also known as: Plaquenil

Hydroxychloroquine

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Calgary: lead

Study Sites (1)

MS Clinic Foothills Medical Centre

Calgary, Alberta, T2N2T9, Canada

Location

Related Publications (3)

• Baeva ME, Tottenham I, Koch M, Camara-Lemarroy C. Biomarkers of disability worsening in inactive primary progressive multiple sclerosis. J Neuroimmunol. 2024 Feb 15;387:578268. doi: 10.1016/j.jneuroim.2023.578268. Epub 2023 Dec 23.

  PMID: 38157653 DERIVED

• Camara-Lemarroy C, Silva C, Gohill J, Yong VW, Koch M. Serum neurofilament-light and glial fibrillary acidic protein levels in hydroxychloroquine-treated primary progressive multiple sclerosis. Eur J Neurol. 2023 Jan;30(1):187-194. doi: 10.1111/ene.15588. Epub 2022 Oct 25.

  PMID: 36214614 DERIVED

• Brown D, Moezzi D, Dong Y, Koch M, Yong VW. Combination of Hydroxychloroquine and Indapamide Attenuates Neurodegeneration in Models Relevant to Multiple Sclerosis. Neurotherapeutics. 2021 Jan;18(1):387-400. doi: 10.1007/s13311-020-01002-5. Epub 2021 Jan 6.

  PMID: 33410109 DERIVED

MeSH Terms

Conditions

Multiple Sclerosis, Chronic Progressive

Interventions

Hydroxychloroquine

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

Study Officials

• Marcus Koch

  University of Calgary

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor, University of Calgary

Study Record Dates

• First Submitted: September 20, 2016
• First Posted: September 23, 2016
• Study Start: November 1, 2016
• Primary Completion: June 1, 2021
• Study Completion: June 1, 2021
• Last Updated: July 30, 2021

Record last verified: 2021-07

Data Sharing

• IPD Sharing: Will share

Locations

CA (1)