Track this trial free. DataLookout checks ClinicalTrials.gov daily and emails you which fields changed on NCT03775460 (status, enrollment, completion dates, endpoints, sites) when this record is updated. Free accounts track up to 5 trials.

Track this trial

Methotrexate and Prednisolone Study in Erythema Nodosum Leprosum

Study acronym: MaPs
StatusActive, Not Recruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗

Record History

See every version on ClinicalTrials.gov ↗

  1. Trial status: Recruiting to Active, Not Recruiting
    • Site details revised at 7 of 7 sites
    v9
  2. Primary completion date: Dec 1, 2023 to Sep 1, 2025
    • Study completion date: Dec 1, 2024 to Oct 1, 2025
    v8
  3. Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Nov 15, 2022 to Jan 15, 2023
    • Site details revised at 7 of 7 sites
    v7
  4. Primary completion date: Apr 1, 2022 to Dec 1, 2023
    • Start date: Mar 1, 2021 to Nov 15, 2022
    • Study completion date: Apr 1, 2022 to Dec 1, 2024
    v6
  5. Start date: Jan 1, 2020 to Mar 1, 2021v5
Show 3 earlier versionsHide 3 earlier versions
  1. Start date: Apr 1, 2019 to Jan 1, 2020v4
  2. Study sites: 0 to 7v3
  3. Primary endpoints revised (2)
    • Secondary endpoints revised (11)
    • Study description expanded, about 8 words
    v2
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
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
(from sponsor)		 Erythema Nodosum Leprosum
Related terms Leprosy
Enrollment 550 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov