Clinical Trial

Methotrexate and Prednisolone Study in Erythema Nodosum Leprosum

Study acronym: MaPs
Active, Not Recruiting
View on ClinicalTrials.gov →
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.
Protocol Amendment History 8 amendments
This ClinicalTrials.gov record has been amended 8 times since 2018-12-13; most recent amendment 2025-09-03.
Status change: Recruiting → Active, Not Recruiting 2025-09-03
Status change: Not Yet Recruiting → Recruiting 2023-03-10
Trial Details
NCT Number NCT03775460
Lead Sponsor London School of Hygiene and Tropical Medicine
Collaborators: Dr. 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
Conditions Erythema Nodosum Leprosum
Enrollment 550 participants
Start Date 2023-01-15
Primary Completion 2025-09-01 (estimated)
Study Completion 2025-10-01 (estimated)
Updated on ClinicalTrials.gov 2025-09-10