What question did this study set out to answer?

To evaluate the neuroprotective efficacy of three repurposed oral drugs—amiloride, fluoxetine, and riluzole—compared with a shared placebo in slowing disease progression in secondary progressive multiple sclerosis.

August 1, 2018BMJ OpenOpen Access

Multiple Sclerosis-Secondary Progressive Multi-Arm Randomisation Trial (MS-SMART): a multiarm phase IIb randomised, double-blind, placebo-controlled clinical trial comparing the efficacy of three neuroprotective drugs in secondary progressive multiple sclerosis

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Authors

PCPeter ConnickNHS Lothian FAFloriana De AngelisQueen Mary University of London RPRichard ParkerUniversity of East Anglia

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Implication

Randomized double-blind trial tests neuroprotective therapies in secondary progressive multiple sclerosis, highlighting multi-arm drug repurposing strategies.

Key Points

To evaluate the neuroprotective efficacy of three repurposed oral drugs—amiloride, fluoxetine, and riluzole—compared with a shared placebo in slowing disease progression in secondary progressive multiple sclerosis.
Multi-arm, phase IIb, double-blind, randomized controlled trial conducted across neuroscience centers in England and Scotland (NCT01910259).
Enrollment of 440 patients with secondary progressive multiple sclerosis randomized 1:1:1:1 (110 per arm) to amiloride, fluoxetine, riluzole, or matched placebo for 96 weeks.
Primary endpoint is percentage brain volume change from baseline to 96 weeks, measured via structural brain MRI using the Structural Image Evaluation, using Normalisation, of Atrophy method.
Trial design yields 90% power to detect a 40% reduction in percentage brain volume change in any active arm versus placebo with 90 evaluable patients per arm at a two-sided 5% significance level.
Analysis is powered at 80% to identify a 35% reduction in brain volume loss for each active intervention compared to placebo using analysis of covariance adjusted for multiple testing.

Cite This Study

Connick et al. (2018) studied this question.

synapsesocial.com/papers/6a8334f45db41a8ba7af96a2 https://doi.org/10.1136/bmjopen-2018-021944

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Implication

Randomized double-blind trial tests neuroprotective therapies in secondary progressive multiple sclerosis, highlighting multi-arm drug repurposing strategies.

Multiple Sclerosis-Secondary Progressive Multi-Arm Randomisation Trial (MS-SMART): a multiarm phase IIb randomised, double-blind, placebo-controlled clinical trial comparing the efficacy of three neuroprotective drugs in secondary progressive multiple sclerosis

Discussion

Member takes

Implication

Key Points

Cite This Study

Multiple Sclerosis-Secondary Progressive Multi-Arm Randomisation Trial (MS-SMART): a multiarm phase IIb randomised, double-blind, placebo-controlled clinical trial comparing the efficacy of three neuroprotective drugs in secondary progressive multiple sclerosis

Discussion

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Implication

Key Points

Cite This Study

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