Clinical Trial of Miltefosine to Treat Mucosal Leishmaniasis

Phase 2

Completed

• Conditions: Leishmaniasis; Leishmaniasis, Mucocutaneous
• Interventions: Drug: Standard Treatment Meglumine antimoniate; Drug: Miltefosine

• Registration Number: NCT01377974
• Lead Sponsor: Brasilia University Hospital

Brief Summary

The purpose of this study is to determine whether miltefosine is effective in the treatment of mucosal leishmaniasis compared to meglumine antimoniate, the standard treatment.

Detailed Description

Mucosal leishmaniasis is a rare form of the disease, that affects only 6% of the patients with cutaneous leishmaniasis in the New World. It causes deformities and may be lethal if not treated. It is part of the neglected tropical diseases because on the past sixty years there was few progress regarding other treatment options or improvement at quality of life of its patients. Also, there was little interest from the pharmaceutical industry and government authorities to develop new researches. The standard treatment, meglumine antimoniate, is toxic, invasive, requires trained personnel and has many adverse effects and restrictions. On the other hand, miltefosine is the first oral drug to demonstrate efficacy against mucocutaneous leishmaniasis. Few clinical trials have being performed in Central and South American countries, but so far, just one involved mucosal leishmaniasis patients, and compared miltefosine to amphotericin B. None studies comparing its efficacy to the standard treatment have being done.

Study Timeline

• Study Start: 2009-07
• Study First Submitted: 2011-06-20
• Study First Submitted QC: 2011-06-20
• Study First Posted: 2011-06-22
• Primary Completion: 2013-06
• Study Completion: 2014-12
• Status Verified: 2015-06
• Last Update Submitted: 2015-06-08
• Last Update Posted: 2015-06-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

• Clinical diagnosis of mucosal leishmaniasis
• Not previously treated, or last treatment must have occurred more than 6 months before the enrollment on the study
• Use of contraceptive method, if female on child bearing age
• Sign the agreement and consent form

Exclusion Criteria

• Previous leishmanicidal treatment on the past 6 months before the enrollment on the study
• Electrocardiogram abnormalities on the pretreatment exams
• Previous kidney, liver and/or heart diseases
• Diabetes Mellitus
• Hypersensitivity to miltefosine or meglumine antimoniate
• Pregnant women or breastfeeding mothers
• Hiv patients

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Standard Treatment	Standard Treatment Meglumine antimoniate	Meglumine antimoniate as recommended by the Brazilian Ministry of Health
Tested Intervention	Miltefosine	Miltefosine as the tested intervention

Primary Outcome Measures

Name	Time	Method
Cure	6 months	Re-epithelizations of mucosal ulcers or regression of symptoms

Secondary Outcome Measures

Name	Time	Method
Adverse effects	6 months	laboratory tests of blood, kidney, liver and cardiac functions, partients will be asked about nausea, vomiting, diarrhea, myalgia, or other symptoms

Trial Locations

Locations (1)

Brasilia University Hospital; 🇧🇷 Brasilia, DF, Brazil