Clinical Trial: Naloxone Hydrochloride Study for Relief of Pruritus in Patients With Mycosis Fungoides (MF) Form of CTCL

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

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 Form o

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) form 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 Summary: 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 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. 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, 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, and laboratory results. Subjects will then enter a Washout Period for up to 28 days until the subject again scores at least 5 on the NRS for Pruritus on 4 consecutive or 4 of the past 7 days. Subjects who remain eligible will 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.
Sponsor: Elorac, Inc.

Current Primary Outcome: Numeric Rating Scale (NRS) for Pruritus [ Time Frame: Baseline and 2 Weeks ]

Change from Baseline to Day 14 in average NRS for Pruritus for each Treatment Period


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Responder Analysis - The difference in the proportion of subjects with a meaningful clinically significant improvement at the end of the two periods. [ Time Frame: Baseline and 2 Weeks ]
    The difference in the proportion of subjects with a meaningful clinically significant improvement at the end of the two periods. A clinically significant improvement is defined as an improvement of at least one category on the 4-point (none, mild, moderate, severe) Likert Scale verbal rating scale (VRS) and at least two points on the 11-point NRS for Pruritus. The NRS for Pruritus scores will be converted to VRS scores as follows for the analysis: 0=none, 1-3=mild, 4-6=moderate, and 7-10=severe.
  • Numeric Rating Scale for Sleep [ Time Frame: Baseline and 1 and 2 weeks ]
    The change from Baseline at each week of the NRS for Sleep average score for each Treatment Period.
  • Numeric Rating Scale for Pruritus [ Time Frame: Baseline and 1 week ]
    The change from Baseline at Week 1 of the NRS for Pruritus average score for each Treatment Period.
  • Categorical Rating Scale (CRS) for Skin Integrity [ Time Frame: Baseline and 2 weeks ]
    The change from Baseline at Week 2 of the CRS for Skin Integrity for each Treatment Period.


Original Secondary Outcome: Same as current

Information By: Elorac, Inc.

Dates:
Date Received: June 15, 2016
Date Started: January 2017
Date Completion: August 2019
Last Updated: April 13, 2017
Last Verified: April 2017