Plain English Summary

Lay summary under review 3

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

Acronym

MPSTUDY

Study hypothesis

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

Ethics approval

Approved by the London School of Hygiene and Tropical Medicine on 28/11/2005, reference number 4022 and by the Nepal Medical Research Council

Study design

Randomised double blind trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

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

High dose methylprednisolone

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

Clinical Research Unit
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.

Editorial Notes