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Leprosy, Multibacillary clinical trials

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NCT ID: NCT05243654 Recruiting - Leprosy Clinical Trials

Efficacy and Tolerability of Adjunct Metformin for Multibacillary Leprosy

MetLep
Start date: October 1, 2022
Phase: Phase 2
Study type: Interventional

This trial aims to evaluate the efficacy, tolerability and safety of adjunct metformin added to standard-of-care multi-drug therapy (MDT) in patients with multibacillary leprosy, and explore its effects on immunological endpoints. A double-blind, placebo controlled proof-of-concept trial will be performed in which patients with newly diagnosed multibacillary leprosy will be randomized (1:1) to metformin 1000mg OD versus placebo for 24 weeks in addition to MDT during 48 weeks. The main research question is whether adjunctive metformin, combined with MDT, will improve the clinical outcomes of patients with multibacillary leprosy by mitigating leprosy reactions, thereby reducing nerve damage and corticosteroid use and its associated morbidity. The second aim is to explore whether adjunct metformin, added to MDT, has an acceptable tolerability and safety in patients with multibacillary leprosy.

NCT ID: NCT03384641 Completed - Clinical trials for Leprosy, Multibacillary

A Study to Evaluate the Efficacy and Safety of Bedaquiline (TMC207) in Participants With Multibacillary Leprosy

Start date: September 26, 2018
Phase: Phase 2
Study type: Interventional

The purpose of this study is to assess the efficacy of an 8-week bedaquiline monotherapy regimen in participants with treatment-naive, multibacillary (MB) leprosy.

NCT ID: NCT01290744 Completed - Lepromatous Leprosy Clinical Trials

Effect of Additional Clofazimine on Erythema Nodosum Leprosum (ENL) Reactions in Leprosy

Start date: August 2010
Phase: Phase 4
Study type: Interventional

This study is a double-blind, randomized controlled trial examining the effect on ENL reactions of giving an additional year of clofazimine after completion of MDT in leprosy.