A Neurokinin-1 Receptor Antagonist for the Treatment of Itch in Epidermolysis Bullosa (EB) Patients
Status: Closed
Eligibility:
- Clinical diagnosis of EB (ANY type)
- Age 13 or older
- Medically stable to travel to Stanford
- Suffer from chronic, constant, and severe itch
- Resident of the USA
- Has not been previously enrolled in a Serlopitant study
About the clinical trial:
The primary objective of this trial is to determine if Serlopitant (a pill that is taken by mouth – but can also be administered via G-tube) is safe and works on EB itch in patients aged 13 and above when compared to placebo (a sugar pill which can also be administered by G-tube).
The EB team at Stanford previously completed a trial of Serlopitant for itch in EB. This trial will enroll more participants than the first trial. The results of that trial are published here.
There are 2 on-site study visits to Stanford over a 2 month period. There are NO skin biopsies. The study will involve monthly blood and urine tests (either at Stanford or a lab near your home). If you have routine blood draws performed by non-study doctors (e.g. your primary care doctor or EB doctor), it is possible that we may be able to use those results instead of drawing blood at study visits.
We will pay the travel and laboratory expenses related to this trial. Participants will be compensated for time spent.
Once the study is completed, participants will have the option to continue receiving the drug for up to 1 year.
This study does NOT require participation in the “Characteristics” study first.
Contact:
Link on clinicaltrials.gov: https://clinicaltrials.gov/ct2/show/NCT03836001
Link to previous study on clinicaltrials.gov:
https://clinicaltrials.gov/ct2/show/NCT02654483
This study is funded by a grant from EB Research Partnership and the EB Medical Research Foundation.
Study drug and placebo are provided at no cost by Menlo Therapeutics.
