UnknownNot Applicable

Montelukast in ENL Reaction

Bangladesh60 participantsStarted 2006-12

Plain-language summary

Objective of the trial is to assess the safety and efficacy of Montelukast in treatment of Erythema Nodosum leprosum (ENL) reaction in multibacillary leprosy patients either in combination with prednisolone or alone. Hypothesis is that montelukast will reduce the severity of ENL reaction in Multibacillary leprosy patients without causing an unacceptably high incidence of adverse effects. Design is a multicentre hospital-based single-blind prospective trial for leprosy patients with ENL reaction. prior written consent will be taken from the patients who will undergo the trial. Endpoints are decrease in severity of ENL and absence of new nerve function impairment

Who can participate

Age range

15 Years – 65 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * MB leprosy * ENL reaction * age 15-65 * weight \>35kg * patient willing to participate,including agrees to investigations and admission * adequate past records * no steroid received in past 4 weeks Exclusion Criteria: * pregnant or breast feeding * other active serious infection * history of intolerance to concerned drug * known or suspected immunodeficiency * needs high dose steroid for other condition * recent new nerve funcion impairment * recent hepatitis or impaired liver function * thrombocytopenia, moderate or severe renal impairment * received high dose clofazimine in past 3 months

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

decrease in ENL score

absence of new nerve function impairment

incidence of adverse effects

Trial details

NCT IDNCT00406861

SponsorThe Leprosy Mission Bangladesh

Sponsor typeOTHER

Study typeINTERVENTIONAL

Contact for this trial

Abdul H Salim, MBBS

880173011135 dfsalim@citechco.net

View on ClinicalTrials.gov More Erythema Nodosum Leprosum trials