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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
ISRCTN ISRCTN31894035
DOI 10.1186/ISRCTN31894035
ClinicalTrials.gov identifier
EudraCT number
Public 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
Scientific title
Acronym MPSTUDY
Serial number at source 4022
Study hypothesis Early high dose steroids will improve recovery of acute neuritis and prevent relapse
Lay summary Lay summary under review 3
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
Countries of recruitment Nepal
Disease/condition/study domain Leprosy
Participants - inclusion criteria 1. Those with type 1 reaction with new nerve function impairment
2. Age 16-65 years
Participants - 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
Anticipated start date 07/12/2005
Anticipated end date 31/12/2007
Status of trial Completed
Patient information material Not available in web format, please use the contact details below to request a patient information sheet
Target number of participants 60
Interventions 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.
Primary outcome measure(s) Nerve function
Secondary outcome measure(s) Amount of additional steroid required
Sources of funding 1. LEPRA (UK)
2. American Leprosy Mission (USA)
3. Hospital for Tropical Diseases London (UK)
Trial website
Publications 1. 2011 results in http://www.ncbi.nlm.nih.gov/pubmed/21532737
2. 2012 results in http://www.ncbi.nlm.nih.gov/pubmed/23133681
Contact name Dr  Diana  Lockwood
  Address Clinical Research Unit
Department of Infectious Diseases
London School of Hygiene and Tropical Medicine
Keppel Street
  City/town London
  Zip/Postcode WC1E 7HT
  Country United Kingdom
  Email diana.lockwood@lshtm.ac.uk
Sponsor London School of Hygiene and Tropical Medicine (UK)
  Address Keppel Street
  City/town London
  Zip/Postcode WC1E 7HT
  Country United Kingdom
  Email diana.lockwood@lshtm.ac.uk
Date applied 04/12/2005
Last edited 01/11/2013
Date ISRCTN assigned 04/04/2006
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