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Spots Global Cancer Trial Database for Naloxone Hydrochloride Study for Relief of Pruritus in Patients With MF or SS Forms of CTCL

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Trial Identification

Brief Title: Naloxone Hydrochloride Study for Relief of Pruritus in Patients With MF or SS Forms of CTCL

Official Title: A Double Blind Randomized Vehicle Controlled Crossover Study to Evaluate the Safety and Efficacy of Topical Naloxone Hydrochloride Lotion 0.5% for the Relief of Pruritus in Patients With the MF or SS Forms of Cutaneous T-Cell Lymphoma

Study ID: NCT02811783

Study Description

Brief Summary: This multi-center, double-blind, vehicle-controlled, randomized crossover design study will evaluate the safety and efficacy of topically applied naloxone lotion, 0.5%, for the treatment of pruritus in patients with the mycosis fungoides (MF) or Sézary syndrome (SS) Forms of Cutaneous T-cell Lymphoma (CTCL). This study will also determine if there is systemic absorption of the drug in a subset of subjects and if so, describe the range and mean plasma levels reached after two weeks of three time daily (TID) dosing. Funding Source - FDA OOPD

Detailed Description: There will be 160 subjects enrolled in the study. The study consists of a Screening Period of up to 7 days during which inclusion / exclusion criteria will be reviewed. Subjects meeting inclusion / exclusion criteria including the diagnostic criteria for MF or SS and a score of at least 5 on the 11-Point Numeric Rating Scale (NRS) for Pruritus will complete the one week Screening Period. Subjects will complete a daily diary for NRS for Pruritus scores and Sleep scores. At the end of the Screening Period, subjects who have a NRS for Pruritus score of at least 5 recorded in the diary on at least 4 of the 7 days preceding Day 0 will be eligible to continue. Baseline assessments will be recorded for vital signs, pruritic body surface area, skin integrity, PQOL, and laboratory results. The Baseline period will be followed by a 2 week Treatment Period 1 in which subjects will be randomized to Naloxone Lotion 0.5% or Placebo Lotion to be applied TID for 14 days. During the 2 week Treatment Period subjects will complete daily diaries of NRS for Pruritis scores and Sleep scores. On Day 14 subjects will return to the clinic to review diaries, adverse events (AEs), concomitant medications, and to record body surface area for pruritus, skin integrity, PQOL, and laboratory results. Subjects will then enter a Washout Period for up to 56 days until the subject again scores at least 5 on the NRS for Pruritus on 4 consecutive or 4 of the past 7 days or 56 days pass. Subjects will then enter a 2 week Treatment Period 2 during which the same procedures as Treatment Period 1 will be performed except subjects will receive the alternate treatment to that assigned in Treatment Period 1. Subjects will then have the option to enter a 26 Week Open Label Treatment Period 3 during which the same procedures as Treatment Period 1 and 2 will be performed except subjects will return only at Week 13 and Week 26 and all subjects will be treated with Naloxone Lotion 0.5%.

Eligibility

Minimum Age: 21 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

University of Arkansas for Medical Sciences, Little Rock, Arkansas, United States

City of Hope, Duarte, California, United States

Stanford University, Palo Alto, California, United States

USSF Health Morsani Center for Advanced Healthcare, Tampa, Florida, United States

Cleveland Clinic Indian River Hospital, Vero Beach, Florida, United States

Robert H. Lurie Comprehensive Cancer Center, Chicago, Illinois, United States

Rush University Medical Center, Chicago, Illinois, United States

Dawes Fretzin Clinical Research Group, LLC, Indianapolis, Indiana, United States

University of Minnesota, Minneapolis, Minnesota, United States

St. Louis University Dermatology, Saint Louis, Missouri, United States

Washington University School of Medicine St. Louis, Saint Louis, Missouri, United States

Stony Brook Dermatology, Stony Brook, New York, United States

University Hospitals Cleveland Medical Center, Cleveland, Ohio, United States

University of Texas MD Anderson Cancer Center, Houston, Texas, United States

Inova Schar Cancer Institute, Fairfax, Virginia, United States

University of Washington / Seattle Cancer Care Alliance (SCCA), Seattle, Washington, United States

Contact Details

Name: Scott B Phillips, MD

Affiliation: Elorac, Inc.

Role: STUDY_DIRECTOR

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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