Clinical Trial of Miltefosine to Treat Mucosal Leishmaniasis

Leishmaniasis Clinical Trial

Official title:

Randomized Clinical Trial of Miltefosine to Treat Mucosal Leishmaniasis at Federal District, Brazil

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01377974
• Other study ID #: MILTHUB
• Status: Completed
• Phase: Phase 2
• First received: June 20, 2011
• Last updated: June 8, 2015
• Start date: July 2009
• Est. completion date: December 2014

Study information

• Verified date: June 2015
• Source: Brasilia University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: National Committee of Ethics in Research
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: December 2014
• Est. primary completion date: June 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 12 Years to 90 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Leishmaniasis
• Leishmaniasis, Mucocutaneous

Intervention

Drug:
• Miltefosine
1 Capsule of 50mg, taken orally 2 times a day for 28 days
• Standard Treatment Meglumine antimoniate
20mgKg daily intravenous Meglumine antimoniate as oriented by the Brazilian Ministry of Health

Locations

Country	Name	City	State
Brazil	Brasilia University Hospital	Brasilia	DF

Sponsors (1)

Lead Sponsor	Collaborator
Brasilia University Hospital

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cure	Re-epithelizations of mucosal ulcers or regression of symptoms	6 months	No
Secondary	Adverse effects	laboratory tests of blood, kidney, liver and cardiac functions, partients will be asked about nausea, vomiting, diarrhea, myalgia, or other symptoms	6 months	No