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

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ClinicalTrials.gov Identifier: NCT02811783
Recruitment Status : Recruiting
First Posted : June 23, 2016
Last Update Posted : October 30, 2017
Information provided by (Responsible Party):

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

Condition or disease Intervention/treatment Phase
Mycosis Fungoides Lymphoma, T-Cell, Cutaneous Sézary Syndrome Drug: Naloxone Hydrochloride Lotion, 0.5% Drug: Placebo Lotion Phase 3

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.

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 160 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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
Actual Study Start Date : January 2017
Estimated Primary Completion Date : June 2019
Estimated Study Completion Date : August 2019

Arms and Interventions

Arm Intervention/treatment
Active Comparator: Naloxone Hydrochloride Lotion, 0.5%
Naloxone Hydrochloride Lotion 0.5%
Drug: Naloxone Hydrochloride Lotion, 0.5%
Topical TID for 2 weeks
Placebo Comparator: Placebo Lotion
Placebo Lotion
Drug: Placebo Lotion
Topical TID for 2 weeks

Outcome Measures

Primary Outcome Measures :
  1. 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

Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. Pruritus Quality of Life Score (PQOL) [ Time Frame: Baseline and Day 14 of each Treatment period ]
    The change from Baseline in the final categorization of the PQOL at Day 14 of each Treatment Period

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

All subjects must meet the following criteria for admission into the study:

  1. Signed informed consent has been obtained.
  2. Subject is at least 21 years of age.
  3. 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).
  4. Completion of the mSWAT assessment.
  5. 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.
  6. Pruritic treatment area of 5-95% of the subject's total treatable body surface area.
  7. Subject can be expected to reliably follow treatment instructions and visit schedule.
  8. 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.
  9. 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.
  10. Subject has no visual or motor impairments that will make it difficult to complete the Daily Diary or apply the study medication.
  11. Subject is able to speak, read, and write English and agrees to participate and comply with the study procedures.
  12. Subject has a body mass index (BMI) between 18.5 and 30.5 kglm2 (see Appendix C, Body Mass Index Table) (subjects in PK subset only).

Exclusion Criteria:

Subjects meeting any of the following criteria will be excluded from study participation:

  1. Pregnant or lactating female.
  2. History of clinically significant heart failure.
  3. Myocardial infarction within the past six months.
  4. A history of ventricular arrhythmia requiring treatment.
  5. Any medical condition which would, in the Investigator's opinion, preclude the subject from successfully participating in the study.
  6. A known allergy to naloxone hydrochloride or any excipient in the formulation.
  7. Previous naloxone use for pruritus.
  8. 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.
  9. 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

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02811783

Contact: Scott B Phillips, MD 8473628200 scott@eloracpharma.com
Contact: Heidi Fezatte, BS 8473628200 hfezatte@eloracpharma.com

United States, Alabama
University of Alabama Medical Center Recruiting
Birmingham, Alabama, United States, 35233
Contact: Wendy Cantrell       wcantrell@uabmc.edu   
Principal Investigator: Craig Elmets, MD         
United States, Arkansas
University of Arkansas for Medical Sciences Recruiting
Little Rock, Arkansas, United States, 72205
Contact: Chris Golden    501-686-8174    cdgolden@uams.edu   
Principal Investigator: Henry Wong, MD         
United States, California
City of Hope Recruiting
Duarte, California, United States, 91010
Contact: Donna Bui    626-256-4673 ext 81987    dbui@coh.org   
Principal Investigator: Christiane Querfeld, MD         
United States, Colorado
University of Colorado Cancer Center Recruiting
Aurora, Colorado, United States, 80045
Contact: Matthew Skoch    720-848-0668    matthew.skoch@ucdenver.edu   
Principal Investigator: Theresa R Pacheco, MD         
United States, Illinois
Robert H. Lurie Comprehensive Cancer Center Recruiting
Chicago, Illinois, United States, 60611
Contact: Linda Serrano       linda.serrano@northwestern.edu   
Principal Investigator: Joan Guitart, MD         
Rush University Medical Center Recruiting
Chicago, Illinois, United States, 60612
Contact: Carmen Petrizzo    312-563-4001    carmen_m_petrizzo@rush.edu   
Principal Investigator: Michael D Tharp, MD         
The University of Chicago Medicine Recruiting
Chicago, Illinois, United States, 60637
Contact: K. Yazmin Reyna-Blanco    773-702-7696    kreynablanco@medicine.bsd.uchicago.edu   
Principal Investigator: Vesna Petronic-Rosic, MD         
United States, Louisiana
Tulane University Health Sciences Center Recruiting
New Orleans, Louisiana, United States, 70112
Contact: Edward Coleman    504-988-5135    ecoleman@tulane.edu   
Principal Investigator: Erin Boh, MD         
United States, Missouri
Washington University School of Medicine St. Louis Recruiting
Saint Louis, Missouri, United States, 63110
Contact: Mary Tabacchi       mtabacchi@wustl.edu   
Principal Investigator: Amy Musiek, MD         
United States, New York
Columbia University Medical Center Recruiting
New York, New York, United States, 10032
Contact: Grace Ulerio       gu2102@cumc.columbia.edu   
Principal Investigator: Larisa Geskin, MD         
United States, North Carolina
Duke University Medical Center Recruiting
Durham, North Carolina, United States, 27710
Contact: Pam Brown    919-660-9179    pamela.r.brown@duke.edu   
Principal Investigator: Elise A. Olsen, MD         
United States, Pennsylvania
University of Pennsylvania Recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Deborah Leahy       deborah.leahy@upenn.edu   
Principal Investigator: Jennifer Villasenor-Park, MD         
United States, Tennessee
Vanderbilt Dermatology Recruiting
Nashville, Tennessee, United States, 37204
Contact: Mary L. Downey, RN    615-343-8010    mary.l.downey@vanderbilt.edu   
Principal Investigator: John Zic, MD         
United States, Texas
University of Texas South Western Medical Center Not yet recruiting
Dallas, Texas, United States, 75390
Contact: Seli Dzogbeta       seli.dzogbeta@utsouthwestern.edu   
Principal Investigator: Heather Wickless, MD         
University of Texas MD Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
Contact: Auris Huen, MD    713-745-1113    aohuen@mdanderson.org   
Principal Investigator: Auris Huen, MD         
United States, Virginia
Inova Schar Cancer Institute Not yet recruiting
Fairfax, Virginia, United States, 22031
Contact: Kelly Jerffords    703-970-6548    kelly.jeffords@inova.org   
Principal Investigator: Jennifer A DeSimone, MD         
United States, Washington
University of Washington / Seattle Cancer Care Alliance (SCCA) Recruiting
Seattle, Washington, United States, 98109
Contact: Niall Curley    206-606-1231    ncurley8@seattlecca.org   
Principal Investigator: Michi Shinohara, MD         
Sponsors and Collaborators
Elorac, Inc.
Study Director: Scott B Phillips, MD Elorac, Inc.
More Information

Responsible Party: Elorac, Inc.
ClinicalTrials.gov Identifier: NCT02811783     History of Changes
Other Study ID Numbers: EL-1007-01-01
1R01FD005396-01A1 ( U.S. FDA Grant/Contract )
First Posted: June 23, 2016    Key Record Dates
Last Update Posted: October 30, 2017
Last Verified: October 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Elorac, Inc.:
Mycosis Fungoides
opiate antagonist
Sézary Syndrome

Additional relevant MeSH terms:
Mycosis Fungoides
Sezary Syndrome
Lymphoma, T-Cell
Lymphoma, T-Cell, Cutaneous
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lymphoma, Non-Hodgkin
Skin Diseases
Skin Manifestations
Signs and Symptoms
Narcotic Antagonists
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents