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

NCT02811783 | Terminated Phase 3

• 2 other identifiers: EL-1007-01-011R01FD005396-01A1
• Study Type: interventional
• Target: 59
• Locations: 1 country
• Sites: 16

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

Conditions

Mycosis Fungoides; Lymphoma, T-Cell, Cutaneous; Sézary Syndrome

Keywords

Pruritus; Mycosis Fungoides; CTCL; naloxone; opiate antagonist; Sézary Syndrome

Outcome Measures

Primary Outcomes (1)

• Numeric Rating Scale (NRS) for Pruritus

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

  Baseline and 2 Weeks

Secondary Outcomes (5)

• Responder Analysis - The difference in the proportion of subjects with a meaningful clinically significant improvement at the end of the two periods.

  Baseline and 2 Weeks

• Numeric Rating Scale for Sleep

  Baseline and 1 and 2 weeks

• Numeric Rating Scale for Pruritus

  Baseline and 1 week

• Categorical Rating Scale (CRS) for Skin Integrity

  Baseline and 2 weeks

• Pruritus Quality of Life Score (PQOL)

  Baseline and Day 14 of each Treatment period

Study Arms (2)

Naloxone Hydrochloride Lotion, 0.5%

ACTIVE COMPARATOR

Naloxone Hydrochloride Lotion 0.5%

Drug: Naloxone Hydrochloride Lotion, 0.5%

Placebo Lotion

PLACEBO COMPARATOR

Placebo Lotion

Drug: Placebo Lotion

Interventions

Naloxone Hydrochloride Lotion, 0.5% DRUG

Topical TID for 2 weeks

Naloxone Hydrochloride Lotion, 0.5%

Placebo Lotion DRUG

Topical TID for 2 weeks

Placebo Lotion

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• All subjects must meet the following criteria for admission into the study:
• Signed informed consent has been obtained.
• Subject is at least 21 years of age.
• Diagnosis of mycosis fungoides (MF) or Sézary syndrome (SS) will be based on a combination of histological, clinical, and immunophenotypical criteria. The histological criteria will be based on skin biopsy from the most representative skin area. The diagnostic criteria used for each subject will be specified in the case report forms and the specific classification of MF or SS will be identified. The TNMB system will be used to classify the stage of disease (See Section 8.4 for details).
• Completion of the mSWAT assessment.
• A history of pruritus that meets following criteria:
• At Screening Day -7:
• present on a daily basis for greater than one month prior to Screening Day -7,
• NRS for Pruritus score ≥5 as rated by the subject at the Day -7 Visit. Note: If the score is \<5 and subject is taking or has taken a medication which may be affecting pruritus (e.g. systemic antihistamine or topical steroid), and if Investigator and subject agree, subject may washout or continue washout of medication and return for Day -7 Visit procedures after washout.
• At Baseline Period 1 Day 0:
• NRS for Pruritus score of at least 5 recorded in the subject diary on at least 4 of the 7 days preceding Baseline Period 1 Day 0.
• Pruritic treatment area of 5-95% of the subject's total treatable body surface area.
• Subject can be expected to reliably follow treatment instructions and visit schedule.
• Non-pregnant, non-lactating females of childbearing potential who agree to use medically acceptable forms of birth control (abstinence, hormonal contraceptives, diaphragm with spermicide, condom with spermicide, or intrauterine device) throughout the study or females of non-childbearing potential (surgically sterile \[hysterectomy or bilateral tubal ligation\] or post-menopausal ≥ 1 year). A negative urine pregnancy test must be confirmed at Baseline screening for all female subjects who are not post-menopausal \> 1 year or surgically sterile.
• The subject agrees not to begin any new concomitant medications during their participation in the study, with the exception of medications necessary to treat infection, and to continue any concomitant medication throughout the study.

You may not qualify if:

• Subjects meeting any of the following criteria will be excluded from study participation:
• Pregnant or lactating female.
• History of clinically significant heart failure.
• Myocardial infarction within the past six months.
• A history of ventricular arrhythmia requiring treatment.
• Any medical condition which would, in the Investigator's opinion, preclude the subject from successfully participating in the study.
• A known allergy to naloxone hydrochloride or any excipient in the formulation.
• Previous naloxone use for pruritus.
• Positive urine drug screen at Day 0 for opiates. Positive urine drug screen for anything other than opiates not explained, e.g., by concomitant medication, would also exclude the subject.
• Treatment with any of the following during the restricted time period prior to Day -7, and at any time during the study, is not allowed:
• Medication/Treatment Restriction:
• Systemic narcotic analgesics (e.g. morphine, codeine) 7 days, Topical antihistamines to any skin surface \[e.g. Zonalon® (doxepin)\] 7 days, Other investigational drugs (excluding any therapies for the treatment of MF or SS) 30 days

Sponsors & Collaborators

• Elorac, Inc.: lead

Study Sites (16)

University of Arkansas for Medical Sciences

Little Rock, Arkansas, 72205, United States

Location

City of Hope

Duarte, California, 91010, United States

Location

Stanford University

Palo Alto, California, 94304, United States

Location

USSF Health Morsani Center for Advanced Healthcare

Tampa, Florida, 33612, United States

Location

Cleveland Clinic Indian River Hospital

Vero Beach, Florida, 32960, United States

Location

Robert H. Lurie Comprehensive Cancer Center

Chicago, Illinois, 60611, United States

Location

Rush University Medical Center

Chicago, Illinois, 60612, United States

Location

Dawes Fretzin Clinical Research Group, LLC

Indianapolis, Indiana, 46250, United States

Location

University of Minnesota

Minneapolis, Minnesota, 55455, United States

Location

St. Louis University Dermatology

St Louis, Missouri, 63104, United States

Location

Washington University School of Medicine St. Louis

St Louis, Missouri, 63110, United States

Location

Stony Brook Dermatology

Stony Brook, New York, 11790, United States

Location

University Hospitals Cleveland Medical Center

Cleveland, Ohio, 44106, United States

Location

University of Texas MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Inova Schar Cancer Institute

Fairfax, Virginia, 22031, United States

Location

University of Washington / Seattle Cancer Care Alliance (SCCA)

Seattle, Washington, 98109, United States

Location

Related Publications (1)

• Valipour A, Jager M, Wu P, Schmitt J, Bunch C, Weberschock T. Interventions for mycosis fungoides. Cochrane Database Syst Rev. 2020 Jul 7;7(7):CD008946. doi: 10.1002/14651858.CD008946.pub3.

  PMID: 32632956 DERIVED

MeSH Terms

Conditions

Mycosis Fungoides; Lymphoma, T-Cell, Cutaneous; Sezary Syndrome; Pruritus

Condition Hierarchy (Ancestors)

Lymphoma, T-Cell; Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Skin Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Scott B Phillips, MD

  Elorac, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 15, 2016
• First Posted: June 23, 2016
• Study Start: January 1, 2017
• Primary Completion: September 1, 2022
• Study Completion: September 1, 2022
• Last Updated: October 28, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (16)