Condition category
Infections and Infestations
Date applied
04/12/2005
Date assigned
04/04/2006
Last edited
03/02/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Leprosy is caused by a bacterium and is curable with a combination of antibiotics known as multi-drug therapy that patients take for 6 or 12 months. However, many leprosy patients experience inflammation in their skin and/or nerves, which may occur even after successful completion of multi-drug therapy. These episodes of inflammation are called leprosy Type 1 reactions. Type 1 reactions are an important complication of leprosy because they may result in nerve damage that leads to disability and deformity. Type 1 reactions require treatment with immunosuppressive agents such as corticosteroids. The best dose and duration of corticosteroid treatment is currently unclear. The aim of this study is to see if it would be safe to use a large dose of a corticosteroid called methylprednisolone for three days at the start of 16 weeks of treatment with the corticosteroid prednisolone.

Who can participate?
Patients age 16-65 with leprosy Type 1 reactions and nerve damage present for less than six months.

What does the study involve?
Participants are randomly allocated to one of two groups. One group is treated with methylprednisolone intravenously (given into a vein) and placebo (dummy) tablets for the first three days of treatment. The other group is treated with a placebo intravenous infusion and prednisolone tablets for the first three days of treatment. Both groups are then treated with prednisolone tablets for 16 weeks.

What are the possible benefits and risks of participating?
Not provided at time of registration

Where is the study run from?
London School of Hygiene and Tropical Medicine (UK)

When is the study starting and how long is it expected to run for?
December 2005 to December 2007

Who is funding the study?
LEPRA (UK), American Leprosy Mission (USA), Hospital for Tropical Diseases London (UK)

Who is the main contact?
Dr Diana Lockwood
diana.lockwood@lshtm.ac.uk

Trial website

Contact information

Type

Scientific

Primary contact

Dr Diana Lockwood

ORCID ID

Contact details

Clinical Research Unit
Department of Infectious Diseases
London School of Hygiene and Tropical Medicine
Keppel Street
London
WC1E 7HT
United Kingdom
-
diana.lockwood@lshtm.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

4022

Study information

Scientific title

A phase II trial to investigate the safety of early high dose methylprednisolone in acute leprous neuritis and leprosy type 1 reactions with neuritis in Nepal

Acronym

MPSTUDY

Study hypothesis

Early high dose steroids will improve recovery of acute neuritis and prevent relapse

Ethics approval

1. London School of Hygiene and Tropical Medicine, 28/11/2005, ref: 4022
2. Nepal Medical Research Council

Study design

Randomised double-blind trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Leprosy

Intervention

Study arm receives intravenous (IV) methylprednisolone in the first three days of type 1 reaction or acute neuritis treatment. The control arm receives a standard treatment of 40 mg prednisolone plus a normal saline (placebo) infusion. Those receiving IV methylprednisolone are given placebo tablets to ensure complete blinding. The following sixteen weeks of treatment are identical for both groups.

Intervention type

Drug

Phase

Phase II

Drug names

Methylprednisolone, prednisolone

Primary outcome measures

Nerve function

Secondary outcome measures

Amount of additional steroid required

Overall trial start date

07/12/2005

Overall trial end date

31/12/2007

Reason abandoned

Eligibility

Participant inclusion criteria

1. Those with type 1 reaction with new nerve function impairment
2. Age 16-65 years

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

60

Participant exclusion criteria

1. Type 1 reaction without new nerve function impairment
2. Systemic corticosteroids in the preceding three months
3. Contraindications to steroids
4. Pregnancy
5. Severe active infection
6. Severe intercurrent illness

Recruitment start date

07/12/2005

Recruitment end date

31/12/2007

Locations

Countries of recruitment

Nepal

Trial participating centre

London School of Hygiene and Tropical Medicine
London
WC1E 7HT
United Kingdom

Sponsor information

Organisation

London School of Hygiene and Tropical Medicine (UK)

Sponsor details

Keppel Street
London
WC1E 7HT
United Kingdom
-
diana.lockwood@lshtm.ac.uk

Sponsor type

University/education

Website

Funders

Funder type

Charity

Funder name

LEPRA (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

American Leprosy Mission (USA)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Hospital for Tropical Diseases London (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

1. 2011 results in http://www.ncbi.nlm.nih.gov/pubmed/21532737
2. 2012 results in http://www.ncbi.nlm.nih.gov/pubmed/23133681

Publication citations

  1. Results

    Walker SL, Nicholls PG, Dhakal S, Hawksworth RA, Macdonald M, Mahat K, Ruchal S, Hamal S, Hagge DA, Neupane KD, Lockwood DN, A phase two randomised controlled double blind trial of high dose intravenous methylprednisolone and oral prednisolone versus intravenous normal saline and oral prednisolone in individuals with leprosy type 1 reactions and/or nerve function impairment., PLoS Negl Trop Dis, 2011, 5, 4, e1041, doi: 10.1371/journal.pntd.0001041.

  2. Results

    Cogen AL, Walker SL, Roberts CH, Hagge DA, Neupane KD, Khadge S, Lockwood DN, Human beta-defensin 3 is up-regulated in cutaneous leprosy type 1 reactions., PLoS Negl Trop Dis, 2012, 6, 11, e1869, doi: 10.1371/journal.pntd.0001869.

Additional files

Editorial Notes

03/02/2016: Plain English summary added.