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



Status:Recruiting
Conditions:Allergy, Infectious Disease, Lymphoma
Therapuetic Areas:Immunology / Infectious Diseases, Oncology, Otolaryngology
Healthy:No
Age Range:21 - Any
Updated:3/10/2019
Start Date:January 2017
End Date:August 2021
Contact:Scott B Phillips, MD
Email:scott@eloracpharma.com
Phone:8473628200

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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

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

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.

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
We found this trial at
27
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Minneapolis, Minnesota 55455
(612) 625-5000
Principal Investigator: Kimberly Bohjanen, MD
Phone: 612-626-8681
Univ of Minnesota With a flagship campus in the heart of the Twin Cities, and...
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529 West Markham Street
Little Rock, Arkansas 72205
(501) 686-7000
Principal Investigator: Henry Wong, MD
Phone: 501-686-8174
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Aurora, Colorado 80045
Principal Investigator: Theresa R Pacheco, MD
Phone: 720-848-0668
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Birmingham, Alabama 35233
Principal Investigator: Craig Elmets, MD
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Boston, Massachusetts 02118
Principal Investigator: Adam Lerner, MD
Phone: 617-638-8260
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Boston, Massachusetts 02114
Principal Investigator: Steven T. Chen, M.D.
Phone: 617-726-5066
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Chicago, Illinois 60611
Principal Investigator: Joan Guitart, MD
Phone: 312-503-6568
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1653 W. Congress Parkway
Chicago, Illinois 60612
(312) 942-5000
Principal Investigator: Timothy Kuzel, MD
Phone: 312-563-4001
Rush University Medical Center Rush University Medical Center encompasses a 664-bed hospital serving adults and...
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Chicago, Illinois 60637
Principal Investigator: Vesna Petronic-Rosic, MD
Phone: 773-702-7696
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Dallas, Texas 75325
Principal Investigator: Heather Goff, MD
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Duarte, California 91010
Principal Investigator: Christiane Querfeld, MD
Phone: 626-256-4673
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2301 Erwin Rd
Durham, North Carolina 27710
919-684-8111
Principal Investigator: Elise A. Olsen, MD
Phone: 919-668-5610
Duke Univ Med Ctr As a world-class academic and health care system, Duke Medicine strives...
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Fairfax, Virginia 22031
Principal Investigator: Jennifer A DeSimone, MD
Phone: 703-970-6548
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1515 Holcombe Blvd
Houston, Texas 77030
 713-792-2121
Principal Investigator: Auris Huen, MD
Phone: 713-745-1113
University of Texas M.D. Anderson Cancer Center The mission of The University of Texas MD...
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1 Medical Center Dr
Lebanon, New Hampshire 03756
 (603) 650-5000
Principal Investigator: Joi Carter, M.D.
Phone: 603-650-3693
Dartmouth Hitchcock Medical Center Dartmouth-Hitchcock is a national leader in patient-centered health care and building...
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Nashville, Tennessee 37204
Principal Investigator: John Zic, MD
Phone: 615-875-1725
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1430 Tulane Ave Suite SL32
New Orleans, Louisiana 70112
(504) 588-5912
Principal Investigator: Erin Boh, MD
Phone: 504-988-5135
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630 W 168th St
New York, New York
212-305-2862
Principal Investigator: Larisa Geskin, MD
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Palo Alto, California 94304
Principal Investigator: Youn H. Kim, M.D.
Phone: 650-721-6118
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3451 Walnut St
Philadelphia, Pennsylvania 19104
1 (215) 898-5000
Principal Investigator: Jennifer Villasenor-Park, MD
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Philadelphia, Pennsylvania 19107
Principal Investigator: Neda Nikbakht, M.D.
Phone: 215-955-9295
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Pittsburgh, Pennsylvania 15213
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660 South Euclid Avenue
Saint Louis, Missouri 63110
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3660 Vista Avenue
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Principal Investigator: M. Yadira Hurley, MD
Phone: 314-256-3404
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Scottsdale, Arizona 85259
Principal Investigator: Aaron Mangold, MD
Phone: 480-301-4714
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Seattle, Washington 98109
Principal Investigator: Michi Shinohara, MD
Phone: 206-606-1231
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Tampa, Florida 33612
Principal Investigator: Lucia Seminario-Vidal, M.D.
Phone: 813-396-9172
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