Erythema Nodosum LeprosumNCT00406861
Montelukast in ENL Reaction
A study testing montelukast in treatment of ENL reaction in people with Erythema Nodosum Leprosum and Leprosy, run by The Leprosy Mission Bangladesh at 1 site in Bangladesh.
Trial 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. Read more about this study
- Who is it for?
- Ages 15 to 65 years
- Conditions the study is for
- Erythema Nodosum Leprosum, Leprosy
- What is being tested?
- montelukast in treatment of ENL reaction
- How many people
- 60 participants
- Where
- 1 siteBangladesh
- Study dates
- Dec 2006to Jun 2009
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 to 65 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- recent hepatitis or impaired liver function
- thrombocytopenia, moderate or severe renal impairment
- received high dose clofazimine in past 3 months
Trial locations and contacts
1 site in 1 country.
Bangladesh1 site
Danish Bangladesh Leprosy Mission Hospital
Nilphamari, Nilphamari, 5300
Cynthia R Butlin, MBBCh MRCGP
About this study
Official title: Montelukast as an Alternative or Supplementary Treatment in ENL Reaction in Leprosy
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
Read the 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.
- Conditions
- Erythema Nodosum Leprosum, Leprosy
- Being tested
- montelukast in treatment of ENL reaction
- Keywords
- reaction, ENL, leprosy
- Medical subject headings
- Leprosy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
montelukast in treatment of ENL reactionDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
decrease in ENL score
absence of new nerve function impairment
incidence of adverse effects
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2006 (estimated)
- Study startDec 2006
- Study completionJun 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Erythema Nodosum LeprosumStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Enrolment
- 60 participants
Sponsor and investigators
- Lead sponsor
- The Leprosy Mission Bangladesh
- Sponsor type
- University, hospital or other
- Investigators
- Abdul H Salim, MBBS, Principal investigator, Damien Foundation Bangladesh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00406861
- Sponsor's protocol ID
- BMRCERC2004-2007627
- Status last verified
- Nov 2006
- First submitted
- 1 Dec 2006
- Last updated
- 4 Dec 2006
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Montelukast as an Alternative or Supplementary Treatment in ENL Reaction in Leprosy
- ClinicalTrials.gov ID
- NCT00406861
- Acronym / sponsor ID
- BMRCERC2004-2007627
- Conditions
- Erythema Nodosum Leprosum, Leprosy
- Keywords
- reaction, ENL, leprosy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants
- Lead sponsor
- The Leprosy Mission BangladeshUniversity, hospital or other
- Study start
- Dec 2006
- Study completion
- Jun 2009
- First posted
- 4 Dec 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
Who may qualify
- Ages
- 15 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (7 listed)
- MB leprosy
- ENL reaction
- age 15-65
- weight >35kg
- patient willing to participate,including agrees to investigations and admission
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| montelukast in treatment of ENL reaction | Drug | – |
Primary outcome
decrease in ENL score
absence of new nerve function impairment
incidence of adverse effects
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Dec 2006.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Abdul H Salim, MBBS principal investigator
Damien Foundation Bangladesh
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing montelukast in treatment of ENL reaction in people with Erythema Nodosum Leprosum and Leprosy, run by The Leprosy Mission Bangladesh at 1 site in Bangladesh.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 4 Dec 2006. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Bangladesh. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Abdul H Salim, MBBS (880173011135, dfsalim@citechco.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
decrease in ENL score. The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Dec 2006.