Open-Label Trial of Minocycline in Early Multiple Sclerosis: Confirmation of Treatment Benefit
Year Awarded: 2020
Term: 5 years
Funding Amount: $336,252
Affiliation(s): University of Calgary
Researcher(s): Dr. Luanne Metz
Impact Goal(s): Advance Treatment and Care
Background: Minocycline could serve as an early, immediate treatment for multiple sclerosis (MS), from first symptom onset to treatment. During this period, people with MS and suspected MS often feel afraid and helpless, as early treatment is recommended. The current treatment gap ranges from weeks to months while clinical investigations are completed (e.g. the need for MRI scans, visits to neurologist, etc.), and insurance issues are managed. Minocycline is an inexpensive, safe, available drug that may be able to bridge this treatment gap, but confirmation of its benefit is required to be able to promote this as standard care.
Overview: Prior research from this team showed that minocycline reduced the relative risk of new inflammation in people with MS by 44.6% at 6 months. This result compared well with the benefit of other therapies at 6 months and 12 months, but it is unclear whether the benefit continues to 24 months. Dr. Luanne Metz aims to confirm that minocycline reduces the risk of a second relapse or new inflammatory disease activity (e.g. lesions on brain MRI) after a first clinical demyelinating event. Although the benefit of minocycline has been shown in a previous clinical trial, this requires a confirmatory trial that demonstrates the benefit lasts over 24 months. The study will be an open-label, non-inferiority design. The study will determine if new inflammation occurs as infrequently as it did in the previous trial, confirming the prior results.
Impact: Based on the results of this confirmatory study, minocycline may be integrated into standard clinical care in Canada as a bridge therapy to reduce the risk of new brain injury before long-term treatment is initiated. It can even be initiated by family physicians while referral to a neurologist and MRI are being coordinated.