Montelukast in ENL Reaction

• Status: Unknown status
• Trial end date: 2009-06-01
• Target enrollment: 0
• Participant gender: All

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

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: The Leprosy Mission Bangladesh
• Treatments: Montelukast

Criteria

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