Epidermolysis Bullosa Clinical Trial
Official title:
A Neurokinin-1 Receptor Antagonist for the Treatment of Pruritus in Patients With Epidermolysis Bullosa
To determine if Serlopitant (when taken by mouth) is safe and works on itch in patients aged 13 and above with EB.
The investigator will determine whether more patients taking serlopitant 5 mg daily as compared to placebo can achieve at least a 3-point reduction in the 24-hour Average Itch Numeric Rating Scale (NRS) following two months of treatment. Secondary objectives include; 1. comparative weekly change in daily worst itch NRS, 2. comparative weekly change in daily average itch NRS, 3. the proportion of patients who achieve at least 30% or 50% reduction in Average Itch NRS at month 2, 4. proportion of patients achieving 2-point and 4-point reductions in Average Itch NRS at month 2, 5. Patient Global Impression of Change (PGIC) at month 2, the change in participant static assessment of itch at month 2, and 6. assessment of the safety of serlopitant in adolescents (≥13 y.o.) and adults with epidermolysis bullosa-related itch. ;
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