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

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Brief Title

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

Official Title

A Phase 2 Trial of Neurokinin-1 Receptor Antagonist for the Treatment of Itch in Epidermolysis Bullosa Patients

Brief Summary

      Our goal is to determine whether daily oral administration of VPD-737 (5 mg) is effective and
      safe in treating moderate to severe pruritus in patients with Epidermolysis Bullosa (EB).
    

Detailed Description

      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.

      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.
    

Study Phase

Phase 2

Study Type

Interventional


Primary Outcome

Comparative Weekly Change in NRS Itch Score Over the 8-week Active Treatment Period

Secondary Outcome

 Wound Healing Determination

Condition

Epidermolysis Bullosa

Intervention

VPD-737

Study Arms / Comparison Groups

 5 mg VPD-737
Description:  5 mg tablets of VPD-737 to be taken daily by mouth for 56 days

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

14

Start Date

August 31, 2016

Completion Date

July 27, 2018

Primary Completion Date

June 28, 2018

Eligibility Criteria

        Inclusion Criteria:

          -  Clinical diagnosis of Epidermolysis Bullosa (EB) and pruritus

        Exclusion Criteria:

          -  Chronic liver or renal disease
      

Gender

All

Ages

13 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Jean Tang, MD, PhD, , 

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT02654483

Organization ID

34182


Responsible Party

Sponsor-Investigator

Study Sponsor

Jean Yuh Tang

Collaborators

 Epidermolysis Bullosa Research Partnership

Study Sponsor

Jean Tang, MD, PhD, Principal Investigator, Stanford University


Verification Date

March 2020