Neurokinin-1 Receptor Antagonist for the Treatment of Itch in EB Patients
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|ClinicalTrials.gov Identifier: NCT02654483|
Recruitment Status : Active, not recruiting
First Posted : January 13, 2016
Last Update Posted : July 12, 2018
|Condition or disease||Intervention/treatment||Phase|
|Epidermolysis Bullosa Pruritus||Drug: VPD-737 Other: Placebo||Phase 2|
Itch is the most common complaint reported by patients with EB of all subtypes, and there is no current effective treatment. Itch often triggers scratching that creates new wounds and increases EB disease severity. This study aims to target the physiological mechanisms of pruritus (itch) in patients with EB .
Substance P is a major mediator of pruritus and binds to the receptor neurokinin-1 (NK1), which is expressed in the central nervous system and the skin.
VPD-737 (serlopitant), a novel drug that inhibits the NK1 receptor, has been shown to reduce severe itch in a previous study of 257 adult patients with chronic pruritus.
The investigators are now testing VPD-737 in 14 patients with EB in a Phase II randomized, placebo-controlled, double-blinded clinical trial.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||14 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||A Phase 2 Trial of Neurokinin-1 Receptor Antagonist for the Treatment of Itch in Epidermolysis Bullosa Patients|
|Actual Study Start Date :||August 31, 2016|
|Estimated Primary Completion Date :||August 31, 2018|
|Estimated Study Completion Date :||November 2018|
Experimental: 5 mg VPD-737
5 mg tablets of VPD-737 to be taken daily by mouth for 56 days
VPD-737 inhibits the receptor neurokinin-1.
Other Name: Serlopitant
Placebo Comparator: Placebo
Placebo tablets to be taken daily by mouth for 56 days
Matching tablets to VPD-737 tablets without active drug
- Change in EB associated itch [ Time Frame: NRS recorded by subject daily, from screening visit through the end of the study ]Determine the efficacy of Serlopitant compared with placebo on reducing EB itch as measured by patient self-reports using a numeric rating scale (NRS) for itch severity and the Stanford EB itch questionnaire. NRS is included in the Stanford EB Itch survey.
- Wound healing determination [ Time Frame: screening, month 1, month 2 ]Wound dimensions, including length, width, and area (in cm2), will be obtained using the Canfield system. Changes in dimensions between visits as well as changes in dimensions from baseline will be recorded.
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): NCT02654483
|United States, California|
|Stanford, California, United States, 94305|
|Principal Investigator:||Jean Tang, MD, PhD||Stanford University|