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Phase 2 Trial to Evaluate 18-Methoxycoronaridine Efficacy, Safety and Tolerability in Cutaneous Leishmaniasis Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03084952
Recruitment Status : Not yet recruiting
First Posted : March 21, 2017
Last Update Posted : March 19, 2020
Sponsor:
Information provided by (Responsible Party):
Infan Industria Quimica Farmaceutica Nacional

Study Description
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Brief Summary:
It is a randomized phase II clinical study, unicentre aimed to evaluate the tolerability, safety and efficacy of 18-Methoxyoronaridine as a candidate of tegumentary leishmaniasis treatment.

Condition or disease Intervention/treatment Phase
Leishmaniasis; American, Cutaneous Drug Side Effect Drug: 18-Methoxycoronaridine Drug: Glucantime Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 52 participants
Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 2, Randomized, Unicentric Clinical Trial With Dose Scaling for Safety, Tolerability and Efficacy Assessment of 18-Methoxycoronaridine Administered to Cutaneous Leishmaniasis Patients
Estimated Study Start Date : May 2021
Estimated Primary Completion Date : December 2023
Estimated Study Completion Date : July 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Leishmaniasis

Arms and Interventions
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Arm Intervention/treatment
Experimental: 1 mg/day Drug: 18-Methoxycoronaridine
Drug under evaluation for leishmaniasis treatment
Experimental: 4 mg/day Drug: 18-Methoxycoronaridine
Drug under evaluation for leishmaniasis treatment
Experimental: 8 mg/day Drug: 18-Methoxycoronaridine
Drug under evaluation for leishmaniasis treatment
Experimental: 12 mg/day Drug: 18-Methoxycoronaridine
Drug under evaluation for leishmaniasis treatment
Active Comparator: Glucantime Drug: Glucantime
Leishmaniasis standard drug in Brazil
Experimental: Best dose 18-MC Drug: 18-Methoxycoronaridine
Drug under evaluation for leishmaniasis treatment
Experimental: Minimum effective dose 18-MC Drug: 18-Methoxycoronaridine
Drug under evaluation for leishmaniasis treatment


Outcome Measures
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Primary Outcome Measures :
  1. Lesion Reduction and Re-epithelization - Definitive Cure [ Time Frame: 6 months at the follow-up visit. ]
    complete epithelization of all ulcers and complete disappearance of inflammatory hardening of all lesions at 6 months at the follow-up visit.

  2. Lesion Reduction and Re-epithelization - Partial Cure [ Time Frame: 6 months at the follow-up visit. ]

    incomplete epithelialization or incomplete regression of inflammatory hardening of one or more lesions, and without the appearance of new lesions.

    Apparent cure: complete epithelization of all ulcers and regression ≥ 70% of the inflammatory hardening of all lesions.


  3. Clinical Failure [ Time Frame: 6 months at the follow-up visit. ]
    Any of the following topics as clinical failure: residual readers with the presence of non-GiemsaDiff-Quick print parasites, or the appearance of new lesions or ≥ 20% increase or no improvement of lesions previously documented.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 59 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age between 18 and 59 years of age;
  • Clinical diagnosis of leishmaniasis with at least one ulcerated lesion with evolution time from one month;
  • Parasitological confirmation;
  • Women of childbearing potential should not be pregnant or breastfeeding, confirmed by examination of b-HCG (Gonadotrophic-Chorionic Hormone beta) at the time of screening;
  • Men and women should use barrier contraceptive methods during the course of the study;

Exclusion Criteria:

  • History of any disease or comorbidities that, in the opinion of the investigator, can either put the individual at risk or influence the results and ability of the subject to participate in the study;
  • History or presence of gastrointestinal, hepatic, cardiac, renal disease or any other known condition that may interfere with the absorption, distribution, metabolism or excretion of the investigational product;
  • Any evidence of underlying serious disease (cardiac, renal, hepatic or pulmonary);
  • Pregnancy or the patient's unwillingness to use barrier contraceptive methods during and 3 months after therapy;
  • History of gastrointestinal ulcer disease, inflammatory bowel disease, symptoms of indigestion;
  • Any clinically important abnormality in biochemistry, hematology, urinalysis or clinical outcomes judged by the investigator;
  • Any positive screening result for hepatitis B antigens, hepatitis C antibodies, and human immunodeficiency virus (HIV);
  • Any clinically significant abnormalities in the rate, or driving the resting ECG morphology that may interfere with the interpretation of the QT interval variations;
  • History of cancer;
  • History of drug abuse, judging by the investigator
  • History of alcohol abuse or excessive alcohol consumption, judged by the investigator;
  • History of smoking
  • History of severe allergy / hypersensitivity, judged by the investigator;
  • History of hypersensitivity to drugs with similar chemical structure.
Contacts and Locations
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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): NCT03084952


Contacts
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Contact: Jan Carlo Delorenzi, PhD +55(11)989780869 jancarlo@hebron.com.br

Sponsors and Collaborators
Infan Industria Quimica Farmaceutica Nacional
More Information
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Responsible Party: Infan Industria Quimica Farmaceutica Nacional
ClinicalTrials.gov Identifier: NCT03084952    
Other Study ID Numbers: HB/F2-002/2016
First Posted: March 21, 2017    Key Record Dates
Last Update Posted: March 19, 2020
Last Verified: March 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Infan Industria Quimica Farmaceutica Nacional:
safety
pharmacokynetics
leishmaniasis treatment
Additional relevant MeSH terms:
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Leishmaniasis
Leishmaniasis, Cutaneous
Drug-Related Side Effects and Adverse Reactions
Euglenozoa Infections
Protozoan Infections
Parasitic Diseases
Infections
Skin Diseases, Parasitic
 Vector Borne Diseases
Skin Diseases, Infectious
Skin Diseases
Chemically-Induced Disorders
Meglumine Antimoniate
Antiprotozoal Agents
Antiparasitic Agents
Anti-Infective Agents