NCT01377974

Clinical Trial of Miltefosine to Treat Mucosal Leishmaniasis

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: Brasilia University Hospital · Academic / Other
• Sex: All
• Age: 12 Years – 90 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Leishmaniasis
• Leishmaniasis, Mucocutaneous

Interventions

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

Timeline

• Start date: 2009-07-01
• Primary completion: 2013-06-01
• Completion: 2014-12-01
• First posted: 2011-06-22
• Last updated: 2015-06-09

Locations

1 site across 1 country: Brazil