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While there are many treatment options for relapsing-remitting multiple sclerosis (MS), progressive MS is mostly untreatable, making it a challenge in therapy development.
Phase 2 clinical trials are crucial for exploring new treatments for progressive MS, but many trials will likely be needed due to the disease's complexity.
This review highlights strategies like cohort selection, outcome selection, cohort enrichment, and dosing selection to make phase 2 trials more efficient and effective in identifying successful treatments.
Article Abstract
While relapsing-remitting multiple sclerosis (MS) has many therapeutic options, progressive forms of MS remain largely untreatable. Phase 2 clinical trials are our main tool to advance new treatments for progressive MS. Given the complexities of progressive MS, it will likely require many phase 2 trials to improve its treatment. To conduct informative and efficient phase 2 trials, it is important that such trials are designed in a way that they can identify a successful treatment as quickly and with as few participants as possible. In this topical review, we discuss cohort selection, outcome selection, cohort enrichment, and dosing selection as strategies to optimize the efficiency of phase 2 clinical trials in progressive MS.
