Efficacy and Tolerability of Adjunct Metformin for Multibacillary Leprosy
Recruiting
Phase 2
Interventional Study
Leprosy
Leprosy, Multibacillary
Neglected Tropical Diseases
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 18 – 65
- Sex
- Any
- Trial phase
- Phase 2
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 166 (estimated)
- Sponsor
- Oxford University Clinical Research Unit Indonesia · Other
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About This Trial
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 met…
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
* Participant is a male or female, aged ≥18 and ≤65 years.
* Participant is newly diagnosed with MB leprosy and has been receiving MDT ≤ 28 days.
* Participant is willing and able to give informed consent for participation in the trial.
* Participant is willing to adhere to stud…
Contacts