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

Phase 2

• Conditions: Drug Side Effect; Leishmaniasis; American, Cutaneous
• Interventions: Drug: 18-Methoxycoronaridine; Drug: Glucantime

• Registration Number: NCT03084952
• Lead Sponsor: Infan Industria Quimica Farmaceutica Nacional

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-03-14
• Study First Submitted QC: 2017-03-14
• Study First Posted: 2017-03-21
• Status Verified: 2020-03
• Last Update Submitted: 2020-03-17
• Last Update Posted: 2020-03-19
• Study Start: 2021-05
• Primary Completion: 2023-12
• Study Completion: 2024-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 52

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
4 mg/day	18-Methoxycoronaridine	-
12 mg/day	18-Methoxycoronaridine	-
8 mg/day	18-Methoxycoronaridine	-
Minimum effective dose 18-MC	18-Methoxycoronaridine	-
1 mg/day	18-Methoxycoronaridine	-
Best dose 18-MC	18-Methoxycoronaridine	-
Glucantime	Glucantime	-

Primary Outcome Measures

Name	Time	Method
Lesion Reduction and Re-epithelization - Definitive Cure	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.
Lesion Reduction and Re-epithelization - Partial Cure	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.
Clinical Failure	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.