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

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02654483
• Date of registration: 11/01/2016
• Prospective Registration: Yes
• Primary sponsor: Jean Yuh Tang
• Public title: Neurokinin-1 Receptor Antagonist for the Treatment of Itch in EB Patients
• Scientific title: A Phase 2 Trial of Neurokinin-1 Receptor Antagonist for the Treatment of Itch in Epidermolysis Bullosa Patients
• Date of first enrolment: August 31, 2016
• Target sample size: 14
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02654483
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
• Phase: Phase 2

Countries of recruitment

United States

Contacts

• Name: Jean Tang, MD, PhD
• Affiliation: Stanford University

Key inclusion & exclusion criteria

Inclusion Criteria:

- Clinical diagnosis of Epidermolysis Bullosa (EB) and pruritus

Exclusion Criteria:

- Chronic liver or renal disease



Age minimum: 13 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Pruritus

Epidermolysis Bullosa

Intervention(s)

Drug: VPD-737

Other: Placebo

Primary Outcome(s)

Comparative Weekly Change in NRS Itch Score Over the 8-week Active Treatment Period [Time Frame: Baseline and 8 weeks]

Secondary Outcome(s)

Change in Mean NRS Itch Score During Bathing/Dressing Changes [Time Frame: Baseline and 8 weeks]

Wound Healing Determination [Time Frame: Baseline and 8 weeks]

Secondary ID(s)

34182

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Epidermolysis Bullosa Research Partnership

Menlo Therapeutics Inc.

Results

• Results available: Yes
• Date Posted: 02/07/2019
• URL: https://clinicaltrials.gov/ct2/show/results/NCT02654483