Neurokinin-1 Receptor Antagonist for the Treatment of Itch in EB Patients
NCT ID: NCT02654483
Last Updated: 2020-03-23
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
14 participants
INTERVENTIONAL
2016-08-31
2018-07-27
Brief Summary
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Detailed Description
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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.
Each patient will be un-blinded individually after completing 3 months of study period.
All patients who complete the study will be offered a 2-month period on active drug. Patient who received active drug in the first period will be contacted and asked if they would like to continue on active drug for an additional 2 months.
Patients who received placebo in the first period will be contacted and asked if they would like to repeat the study on open label for 2 months.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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5 mg VPD-737
5 mg tablets of VPD-737 to be taken daily by mouth for 56 days
VPD-737
VPD-737 inhibits the receptor neurokinin-1.
Placebo
Placebo tablets to be taken daily by mouth for 56 days
Placebo
Matching tablets to VPD-737 tablets without active drug
Interventions
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VPD-737
VPD-737 inhibits the receptor neurokinin-1.
Placebo
Matching tablets to VPD-737 tablets without active drug
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
13 Years
ALL
No
Sponsors
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Epidermolysis Bullosa Research Partnership
OTHER_GOV
Vyne Therapeutics Inc.
INDUSTRY
Jean Yuh Tang
OTHER
Responsible Party
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Jean Yuh Tang
Associate Professor
Principal Investigators
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Jean Tang, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Stanford University
Locations
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Stanford
Stanford, California, United States
Countries
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References
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Chiou AS, Choi S, Barriga M, Dutt-Singkh Y, Solis DC, Nazaroff J, Bailey-Healy I, Li S, Shu K, Joing M, Kwon P, Tang JY. Phase 2 trial of a neurokinin-1 receptor antagonist for the treatment of chronic itch in patients with epidermolysis bullosa: A randomized clinical trial. J Am Acad Dermatol. 2020 Jun;82(6):1415-1421. doi: 10.1016/j.jaad.2019.09.014. Epub 2019 Sep 18.
Provided Documents
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Document Type: Informed Consent Form
Document Type: Study Protocol and Statistical Analysis Plan
Related Links
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Phase 2 trial of a neurokinin-1 receptor antagonist for the treatment of chronic itch in patients with epidermolysis bullosa: A randomized clinical trial.
Other Identifiers
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34182
Identifier Type: -
Identifier Source: org_study_id
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