A Neurokinin-1 Receptor Antagonist for the Treatment of Pruritus in Patients With Epidermolysis Bullosa
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|ClinicalTrials.gov Identifier: NCT03836001|
Recruitment Status : Recruiting
First Posted : February 11, 2019
Last Update Posted : May 16, 2019
|Condition or disease||Intervention/treatment||Phase|
|Epidermolysis Bullosa||Drug: Serlopitant Tablet Drug: Placebo Oral Tablet||Phase 2|
The investigator will determine whether more patients taking serlopitant 5 mg daily as compared to placebo can achieve a 3 point or greater reduction in itch severity as measured by numeric rating scale (NRS) score following two months of treatment.
Secondary objectives include;
- continuous change in NRS itch score over time,
- the proportion of patients who achieve at a least 30% or 50% reduction in NRS severity from baseline at the end of two months of treatment
- proportion of patients achieving 2 point and 4 point reductions in itch severity following two months of treatment, and
- change in median NRS score over time as compared to baseline.
- assessment on the safety of Serlopitant in adolescents (≥13 y.o.) and adults with pruritus associated with epidermolysis bullosa (EB).
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||40 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||This is an investigator-initiated, single-center, randomized, double-blind, placebo controlled, parallel arm trial evaluating the effects of serlopitant at 5 mg by mouth daily on EB-related itch.|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Masking Description:||This is a double-blind study.|
|Official Title:||A Neurokinin-1 Receptor Antagonist for the Treatment of Pruritus in Patients With Epidermolysis Bullosa|
|Actual Study Start Date :||April 18, 2019|
|Estimated Primary Completion Date :||September 30, 2021|
|Estimated Study Completion Date :||March 28, 2022|
Placebo Comparator: Placebo Oral Tablet
We aim to recruit at least 20 patients who will undergo two months of dosing with placebo (inactive drug or sugar pill), followed by one month of wash-out. All patients will be offered the option of participating in a 12-month open label extension with serlopitant at 5 mg (taken by mouth) daily for continued safety monitoring.
Drug: Placebo Oral Tablet
The placebo is a tablet that looks like a drug but has no drug or other active ingredient in it.
Other Name: Sugar pill
Active Comparator: Serlopitant Tablet
We aim to recruit at least 20 patients who will undergo two months of Serlopitant dosing, followed by one month of wash-out. All patients will be offered the option of participating in a 12-month open label extension with serlopitant 5 mg (taken by mouth) daily for continued safety monitoring.
Drug: Serlopitant Tablet
Serlopitant is a small molecule, highly selective NK1-R (neurokinin-1 receptor) antagonist. Two critical mediators of the urge to scratch are Substance P, or SP, and its receptor, NK1-R. SP is a naturally occurring peptide in the tachykinin neuropeptide family. Tachykinins have a broad range of functions in the nervous and immune systems. SP binding of NK1-R has been shown to be a key mediator of sensory nerve signaling, including the itch-scratch reflex and the vomiting reflex.
Other Name: VPD-737
- The proportion of patients who achieve at least a 3-point reduction in NRS itch severity from baseline and after two months of treatment. [ Time Frame: 2 months ]Subjects will be asked to complete itch surveys (NRS) and daily before bedtime regarding their daily average itch score and their wound score while bathing/bandage changing.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03836001
|Contact: Clinical Trial Coodinatorfirstname.lastname@example.org|
|Contact: Clinical Trial Coordinatoremail@example.com|
|United States, California|
|Redwood City, California, United States, 94063|
|Contact: Clinical Trial Coordinator 650-721-7149 firstname.lastname@example.org|
|Principal Investigator:||Albert S Chiou, MD/MBA||Stanford University|