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Neurokinin-1 Receptor Antagonist for the Treatment of Itch in EB Patients

This study is currently recruiting participants.
See Contacts and Locations
Verified August 2016 by Jean Yuh Tang, Stanford University
Sponsor:
Collaborators:
Epidermolysis Bullosa Research Partnership
Menlo Therapeutics Inc.
Information provided by (Responsible Party):
Jean Yuh Tang, Stanford University
ClinicalTrials.gov Identifier:
NCT02654483
First received: January 11, 2016
Last updated: August 23, 2016
Last verified: August 2016
  Purpose
Itch, or pruritus, is the most common complain reported by patients with epidermolysis bullosa (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. 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 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. Our goals is to determine whether daily oral administration of VPD-737 (5 mg) is effective and safe in adolescents and adults with EB.

Condition Intervention Phase
Epidermolysis Bullosa Pruritus Drug: VPD-737 Drug: Placebo Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase 2 Trial of Neurokinin-1 Receptor Antagonist for the Treatment of Itch in Epidermolysis Bullosa Patients

Resource links provided by NLM:


Further study details as provided by Jean Yuh Tang, Stanford University:

Primary Outcome Measures:
  • Visual Analog Scale [ Time Frame: 8 weeks ]
    Patients will complete a VAS every day.


Secondary Outcome Measures:
  • Itchman Scale [ Time Frame: 8 weeks ]
  • Stanford EB Itch Survey [ Time Frame: 8 weeks ]

Estimated Enrollment: 14
Study Start Date: July 2016
Estimated Study Completion Date: August 2018
Estimated Primary Completion Date: August 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 5 mg VPD-737
5 mg tablets of VPD-737 to be taken daily by mouth for 56 days
Drug: VPD-737
VPD-737 inhibits the receptor neurokinin-1.
Other Name: Serlopitant
Placebo Comparator: Placebo
Placebo tablets to be taken daily by mouth for 56 days
Drug: Placebo
Matching tablets to VPD-737 tablets without active drug

  Eligibility

Ages Eligible for Study:   13 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Clinical diagnosis of epidermolysis bullosa and pruritus

Exclusion Criteria:

  • Have chronic liver or renal disease
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02654483

Contacts
Contact: Yana Dutt-Singh (650) 721-7166 yanad@stanford.edu

Locations
United States, California
Stanford Recruiting
Stanford, California, United States, 94305
Contact: Yana Dutt-Singkh       yanad@stanford.edu   
Sponsors and Collaborators
Jean Yuh Tang
Epidermolysis Bullosa Research Partnership
Menlo Therapeutics Inc.
Investigators
Principal Investigator: Jean Tang, MD, PhD Stanford University
  More Information

Responsible Party: Jean Yuh Tang, Associate Professor, Stanford University
ClinicalTrials.gov Identifier: NCT02654483     History of Changes
Other Study ID Numbers: 34182
Study First Received: January 11, 2016
Last Updated: August 23, 2016

Additional relevant MeSH terms:
Epidermolysis Bullosa
Pruritus
Skin Diseases
Skin Manifestations
Signs and Symptoms
Skin Abnormalities
Congenital Abnormalities
Skin Diseases, Genetic
Genetic Diseases, Inborn
Skin Diseases, Vesiculobullous
Neurokinin A
Substance P
Neurokinin-1 Receptor Antagonists
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on August 22, 2017