CI

At a glance

ClinicalIndex Comparison Record
N/AActive· 550 target
Drug / intervention
Methotrexate +2 moredrug
Likely dose
Prednisolone 40 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03775460
NCT03775460N/AActiveUpdate OverdueUpdated 9mo ago · Completion was 9mo ago
Enrollment Stalled
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Methotrexate and Prednisolone Study in Erythema Nodosum Leprosum (MaPS in ENL

London School of Hygiene and Tropical Medicine·interventional·Posted Dec 14, 2018·Updated Sep 10, 2025

In Brief

A clinical study evaluating Methotrexate, Placebo, and 1 other intervention for Erythema Nodosum Leprosum. Active but no longer recruiting, targeting 550 participants across 7 sites in 6 countries.

Signals

Enrollment appears stalled

Detailed Summary

Erythema Nodosum Leprosum (ENL) is a painful, debilitating complication of leprosy. Patients often require high doses of corticosteroids for prolonged periods. Thalidomide is expensive and not available in most countries. The use of corticosteroids for long periods is associated with adverse effects and mortality. It is a priority to identify alternative agents to treat ENL. Methotrexate (MTX) is a cheap, widely used medication which has been reported to be effective in ENL resistant to steroids and thalidomide.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsErythema Nodosum Leprosum
CountriesBangladesh, Brazil, Ethiopia, India, Indonesia, Nepal
CollaboratorsDr. Soetomo General Hospital, The Leprosy Mission Trust, India, Alert Hospital, Ethiopia, The Leprosy Mission Bangladesh, Bombay Leprosy Project, India, Oswaldo Cruz Foundation, Leprosy Research Initiative, The Leprosy Mission Nepal

Timeline

N/AActiveOverdue
20192020202120222023202420252026
First PostedDec 14, 2018
Enrollment StartJan 15, 2023
Primary CompletionSep 1, 2025
Study CompletionOct 1, 2025
TodayJul 2, 2026
Enrollment to primary: 2.6 yearsPosted 7.5 years ago

Interventions

Methotrexatedrug

Participants in the intervention group will receive methotrexate along side prednisolone

Placebodrug

Participants in the control arm will receive placebo along side prednisolone

Prednisolonedrug

Participants in both arm will receive prednisolone, which will be the same dosage: 40 mg (initial dose) decreasing dosage for 20 weeks