- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02811783
Naloxone Hydrochloride Study for Relief of Pruritus in Patients With MF or SS Forms of CTCL
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
Study Overview
Status
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Phase 3
Contacts and Locations
Study Locations
-
-
Arkansas
-
Little Rock, Arkansas, United States, 72205
- University of Arkansas for Medical Sciences
-
-
California
-
Duarte, California, United States, 91010
- City of Hope
-
Palo Alto, California, United States, 94304
- Stanford University
-
-
Florida
-
Tampa, Florida, United States, 33612
- USSF Health Morsani Center for Advanced Healthcare
-
Vero Beach, Florida, United States, 32960
- Cleveland Clinic Indian River Hospital
-
-
Illinois
-
Chicago, Illinois, United States, 60612
- Rush University Medical Center
-
Chicago, Illinois, United States, 60611
- Robert H. Lurie Comprehensive Cancer Center
-
-
Indiana
-
Indianapolis, Indiana, United States, 46250
- Dawes Fretzin Clinical Research Group, LLC
-
-
Minnesota
-
Minneapolis, Minnesota, United States, 55455
- University of Minnesota
-
-
Missouri
-
Saint Louis, Missouri, United States, 63104
- St. Louis University Dermatology
-
Saint Louis, Missouri, United States, 63110
- Washington University School of Medicine St. Louis
-
-
New York
-
Stony Brook, New York, United States, 11790
- Stony Brook Dermatology
-
-
Ohio
-
Cleveland, Ohio, United States, 44106
- University Hospitals Cleveland Medical Center
-
-
Texas
-
Houston, Texas, United States, 77030
- University of Texas MD Anderson Cancer Center
-
-
Virginia
-
Fairfax, Virginia, United States, 22031
- Inova Schar Cancer Institute
-
-
Washington
-
Seattle, Washington, United States, 98109
- University of Washington / Seattle Cancer Care Alliance (SCCA)
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
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.
- Subject has no visual or motor impairments that will make it difficult to complete the Daily Diary or apply the study medication.
- Subject is able to speak, read, and write English and agrees to participate and comply with the study procedures.
- 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:
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Naloxone Hydrochloride Lotion, 0.5%
Naloxone Hydrochloride Lotion 0.5%
|
Topical TID for 2 weeks
|
Placebo Comparator: Placebo Lotion
|
Topical TID for 2 weeks
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
Baseline and 2 Weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
Baseline and 2 Weeks
|
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.
|
Baseline and 1 and 2 weeks
|
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.
|
Baseline and 1 week
|
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.
|
Baseline and 2 weeks
|
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
|
Baseline and Day 14 of each Treatment period
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: Scott B Phillips, MD, Elorac, Inc.
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Skin Diseases
- Infections
- Immune System Diseases
- Neoplasms by Histologic Type
- Neoplasms
- Lymphoproliferative Disorders
- Lymphatic Diseases
- Immunoproliferative Disorders
- Lymphoma, Non-Hodgkin
- Bacterial Infections and Mycoses
- Skin Manifestations
- Lymphoma
- Mycoses
- Lymphoma, T-Cell
- Pruritus
- Lymphoma, T-Cell, Cutaneous
- Mycosis Fungoides
- Sezary Syndrome
- Physiological Effects of Drugs
- Peripheral Nervous System Agents
- Sensory System Agents
- Narcotic Antagonists
- Naloxone
Other Study ID Numbers
- EL-1007-01-01
- 1R01FD005396-01A1 (U.S. FDA Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Lymphoma, T-Cell, Cutaneous
-
University of WashingtonNational Cancer Institute (NCI)TerminatedCutaneous T-cell Lymphoma Stage I | Cutaneous T-cell Lymphoma Stage II | Cutaneous T-cell Lymphoma Stage III | Cutaneous T-cell Lymphoma Stage IVUnited States
-
SciTech Development, LLCRush University Medical CenterRecruitingMycosis Fungoides | Cutaneous T-cell Lymphoma | Peripheral T-cell Lymphoma | Angioimmunoblastic T-cell Lymphoma | T-cell Lymphoma | Cutaneous/Peripheral T-Cell Lymphoma | Peripheral T-Cell Lymphoma, Not Classified | Primary Cutaneous T-cell Lymphoma | Cutaneous T-Cell Lymphoma, Unspecified | Follicular... and other conditionsUnited States
-
Kyowa Kirin, Inc.Active, not recruitingCutaneous T-Cell Lymphoma Refractory | Cutaneous T-Cell Lymphoma, RelapsedUnited States, United Kingdom, Spain, France, Italy
-
John ReneauActive, not recruitingRecurrent T-Cell Non-Hodgkin Lymphoma | Recurrent Primary Cutaneous T-Cell Non-Hodgkin Lymphoma | Stage III Cutaneous T-Cell Non-Hodgkin Lymphoma | Stage IV Cutaneous T-Cell Non-Hodgkin Lymphoma | Primary Cutaneous Anaplastic Large Cell Lymphoma | Refractory Primary Cutaneous T-Cell Non-Hodgkin... and other conditionsUnited States
-
Weiyun AiCelgene CorporationCompletedLymphoma | T-Cell Lymphoma | Cutaneous LymphomaUnited States
-
Dana-Farber Cancer InstituteRecruitingCutaneous T Cell Lymphoma | Peripheral T Cell LymphomaUnited States
-
Legend Biotech USA IncActive, not recruitingT-Cell Lymphoma | Peripheral T-Cell Lymphoma Refractory | Cutaneous T-Cell Lymphoma Refractory | Cutaneous T-Cell Lymphoma Recurrent | Peripheral T-Cell Lymphoma RecurrentUnited States
-
Karyopharm Therapeutics IncTerminatedCutaneous T-cell Lymphoma (CTCL) | Peripheral T-cell Lymphoma (PTCL)Australia, Singapore
-
Northwestern UniversityNot yet recruitingCutaneous T Cell LymphomaUnited States
-
Universitätsmedizin MannheimKlinikum Ludwigshafen; Wuerzburg University Hospital; KKS Netzwerk; Klinikum Minden and other collaboratorsCompletedCutaneous T Cell LymphomaGermany
Clinical Trials on Naloxone Hydrochloride Lotion, 0.5%
-
Reata, a wholly owned subsidiary of BiogenAbbVieCompleted
-
Reata, a wholly owned subsidiary of BiogenAbbVieCompleted
-
Actavis Inc.Teva Pharmaceuticals USACompleted
-
Mayne Pharma International Pty LtdbioRASI, LLCCompleted
-
Taro Pharmaceuticals USACompletedLice; Head LiceUnited States
-
Taro Pharmaceuticals USACompleted
-
United LaboratoriesCompletedPediculosis CapitisPhilippines
-
China Medical University, ChinaCompleted
-
Finnish Institute for Health and WelfareCompletedNaloxone | Gambling | Spray | OpioidFinland
-
Opiant Pharmaceuticals IncCompleted