Hydroxychloroquine in Primary Progressive Multiple Sclerosis

• Register: ClinicalTrials.gov
• Last refreshed on: 10 August 2021
• Main ID: NCT02913157
• Date of registration: 20/09/2016
• Prospective Registration: Yes
• Primary sponsor: University of Calgary
• Public title: Hydroxychloroquine in Primary Progressive Multiple Sclerosis
• Scientific title: Open-label, Single-center, Single-arm Futility Trial Evaluating Oral Hydroxychloroquine 200mg BID for Reducing Progression of Disability in Patients With Primary Progressive Multiple Sclerosis (PPMS)
• Date of first enrolment: November 2016
• Target sample size: 35
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02913157
• Study type: Interventional
• Study design: Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 2

Countries of recruitment

Canada

Contacts

• Name: Marcus Koch
• Affiliation: University of Calgary

Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: 65 Years
Gender: All

Health Condition(s) or Problem(s) studied

Multiple Sclerosis, Primary Progressive

Intervention(s)

Drug: Hydroxychloroquine

Primary Outcome(s)

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

Secondary Outcome(s)

Modified Fatigue Impact Scale (MFIS) [Time Frame: 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) [Time Frame: 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 [Time Frame: baseline, 1 month follow-up, 6 months follow-up, 12 months follow-up, and 18 months follow-up]

9-Hole Peg Test [Time Frame: baseline, 1 month follow-up, 6 months follow-up, 12 months follow-up, and 18 months follow-up]

Symbol Digit Modalities Test [Time Frame: baseline, 1 month follow-up, 6 months follow-up, 12 months follow-up, and 18 months follow-up]

Secondary ID(s)

HCQ_MS01

Source(s) of Monetary Support

Please refer to primary and secondary sponsors