Subsequent to FDA feedback, MediciNova (NASDAQ:MNOV) has finalized the protocol for a Phase 3 clinical trial evaluating MN-166 (ibudilast) in patients with secondary progressive multiple sclerosis (MS) without relapses.
The primary endpoint will be the time to three-month confirmed disability progression as measured by a scale called EDSS, the same endpoint used for other drugs approved for progressive MS.
The agency indicated that one study may be sufficient to support a marketing application.
The size of the study and its projected start date are not provided.
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