Hydroxychloroquine in Primary Progressive Multiple Sclerosis

• Status: Completed
• Trial end date: 2021-06-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this clinical trial is to determine if HCQ in a dose of 400mg daily 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.

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

Details

• Lead Sponsor: University of Calgary
• Treatments: Hydroxychloroquine

Criteria

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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

• Pregnant or breast-feeding women