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ISRCTN
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ISRCTN31894035
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DOI
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10.1186/ISRCTN31894035
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ClinicalTrials.gov identifier
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EudraCT number
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Public title
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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
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Scientific title
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Acronym
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MPSTUDY
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Serial number at source
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4022
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Study hypothesis
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Early high dose steroids will improve recovery of acute neuritis and prevent relapse
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Lay summary
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Lay summary under review 3
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Ethics approval
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Approved by the London School of Hygiene and Tropical Medicine on 28/11/2005, reference number 4022 and by the Nepal Medical Research Council
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Study design
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Randomised double blind trial
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Countries of recruitment
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Nepal
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Disease/condition/study domain
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Leprosy
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Participants - inclusion criteria
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1. Those with type 1 reaction with new nerve function impairment
2. Age 16-65 years
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Participants - exclusion criteria
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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
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Anticipated start date
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07/12/2005
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Anticipated end date
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31/12/2007
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Status of trial
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Completed |
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Patient information material
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Not available in web format, please use the contact details below to request a patient information sheet
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Target number of participants
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60
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Interventions
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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.
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Primary outcome measure(s)
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Nerve function
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Secondary outcome measure(s)
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Amount of additional steroid required
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Sources of funding
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1. LEPRA (UK)
2. American Leprosy Mission (USA)
3. Hospital for Tropical Diseases London (UK)
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Trial website
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Publications
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1. 2011 results in http://www.ncbi.nlm.nih.gov/pubmed/21532737
2. 2012 results in http://www.ncbi.nlm.nih.gov/pubmed/23133681
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Contact name
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Dr
Diana
Lockwood
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Address
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Clinical Research Unit
Department of Infectious Diseases
London School of Hygiene and Tropical Medicine
Keppel Street
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City/town
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London
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Zip/Postcode
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WC1E 7HT
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Country
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United Kingdom
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Email
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diana.lockwood@lshtm.ac.uk
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Sponsor
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London School of Hygiene and Tropical Medicine (UK)
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Address
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Keppel Street
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City/town
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London
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Zip/Postcode
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WC1E 7HT
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Country
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United Kingdom
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Email
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diana.lockwood@lshtm.ac.uk
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Date applied
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04/12/2005
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Last edited
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09/04/2013
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Date ISRCTN assigned
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04/04/2006
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