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Montelukast in ENL Reaction

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00406861
Recruitment Status : Unknown
Verified November 2006 by The Leprosy Mission Bangladesh.
Recruitment status was:  Not yet recruiting
First Posted : December 4, 2006
Last Update Posted : December 4, 2006
Information provided by:
The Leprosy Mission Bangladesh

Brief 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

Condition or disease Intervention/treatment Phase
Erythema Nodosum Leprosum Leprosy Drug: montelukast in treatment of ENL reaction Not Applicable

Detailed Description:

Leprosy is still a common medical problem in many countries including Bangladesh, and currently there are at least 3500 leprosy patients in this country at risk of ENL reaction, which is a distressing complication of Multibacillary (MB) leprosy liable to result in permanent disability if not well treated. The drug of choice is either prednisolone ( which often causes adverse effects especially with prolonged use) or thalidomide which is not available in Bangladesh.Clofazimine in high doses is recommended as an alternative but supplies are difficult to obtain. Hence the need for an alternative drug which could be used as a steroid sparing agent or an alternative to steroids in ENL reaction. Montelukast is a leukotriene inhibitor already available on the open market in this country as an immunomodulator, and a small clinical trial with zafirlukast ( very similar drug) suggested that drugs in this group may be effective for ENL.

This is a phase two trial to assess the safety and efficacy of montelukast as an alternative or supplementarry treatment for ENL reaction.

Eligible patients presenting to one of the participating hospitals with ENL reaction will be randomly allocated to one of three groups to receive prednisolone only or prednisolone plus montelukast or montelukast alone. Any patients who have major contra-indications to steroids will be put into a separate observational group and receive montelukast only.

Drug regimens are prednisolone starting at 40 mg od nd tapered over 12 weeks. Montelukast 10mg od for 16 weeks.

The patients will be monitored weekly for 8 weeks then monthly for 4 months.

At least 20 patients will be enrolled in each group.

The patients will be closely observed for adverse effects, and any who deteriorate will receieve additional steroid according to the protocol. Any who develop new nerve function impairment will be removed from the trial and given a full course of prednisolone.

Analysis will be done on an intention to treat basis and will look for any statistically significant difference in ENL score at 2 weeks, 12 weeks and 24 weeks, or a difference in the number of patients who develop new nerve function impairment, as well as the incidence and severity of any adverse effects in each group.

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Study Type : Interventional  (Clinical Trial)
Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single
Primary Purpose: Treatment
Official Title: Montelukast as an Alternative or Supplementary Treatment in ENL Reaction in Leprosy
Study Start Date : December 2006
Study Completion Date : June 2009

Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics: Leprosy
Drug Information available for: Montelukast

Primary Outcome Measures :
  1. decrease in ENL score
  2. absence of new nerve function impairment
  3. incidence of adverse effects

Information from the National Library of Medicine

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Ages Eligible for Study:   15 Years to 65 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00406861

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Contact: Abdul H Salim, MBBS 880173011135
Contact: Cynthia R Butlin, MBBCh MRCGP 0551 61372 ext 235

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Danish Bangladesh Leprosy Mission Hospital
Nilphamari,, Nilphamari, Bangladesh, 5300
Principal Investigator: Cynthia R Butlin, MBBCh MRCGP         
Sponsors and Collaborators
The Leprosy Mission Bangladesh
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Principal Investigator: Abdul H Salim, MBBS Damien Foundation Bangladesh
Layout table for additonal information Identifier: NCT00406861    
Other Study ID Numbers: BMRCERC2004-2007627
First Posted: December 4, 2006    Key Record Dates
Last Update Posted: December 4, 2006
Last Verified: November 2006
Keywords provided by The Leprosy Mission Bangladesh:
Additional relevant MeSH terms:
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Erythema Nodosum
Skin Diseases
Skin Manifestations
Mycobacterium Infections
Actinomycetales Infections
Gram-Positive Bacterial Infections
Bacterial Infections
Drug Eruptions
Drug Hypersensitivity
Immune System Diseases
Drug-Related Side Effects and Adverse Reactions
Chemically-Induced Disorders
Anti-Asthmatic Agents
Respiratory System Agents
Leukotriene Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Cytochrome P-450 CYP1A2 Inducers
Cytochrome P-450 Enzyme Inducers
Molecular Mechanisms of Pharmacological Action