Two randomized controlled clinical trials to study the effectiveness of prednisolone treatment in preventing and restoring clinical nerve function loss in leprosy: the TENLEP study protocolsReportar como inadecuado

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BMC Neurology

, 12:159

Demyelinating diseases


BackgroundNerve damage in leprosy often causes disabilities and deformities. Prednisolone is used to treat nerve function impairment NFI. However, optimal dose and duration of prednisolone treatment has not been established yet. Besides treating existing NFI it would be desirable to prevent NFI. Studies show that before NFI is clinically detectable, nerves often show subclinical damage. Within the ‘Treatment of Early Neuropathy in LEProsy’ TENLEP study two double blind randomized controlled trials RCT will be carried out: a trial to establish whether prednisolone treatment of 32 weeks duration is more effective than 20 weeks in restoring nerve function in leprosy patients with clinical NFI Clinical trial and a trial to determine whether prednisolone treatment of early sub-clinical NFI can prevent clinical NFI Subclinical trial.

MethodsTwo RCTs with a follow up of 18 months will be conducted in six centers in Asia. In the Clinical trial leprosy patients with recent < 6 months clinical NFI, as determined by Monofilament Test and Voluntary Muscle Test, are included. The primary outcomes are the proportion of patients with restored or improved nerve function. In the Subclinical trial leprosy patients with subclinical neuropathy, as determined by Nerve Conduction Studies NCS and-or Warm Detection Threshold WDT, and without any clinical signs of NFI are randomly allocated to a placebo group or treatment group receiving 20 weeks prednisolone. The primary outcome is the proportion of patients developing clinical NFI. Reliability and normative studies are carried out before the start of the trial.

DiscussionThis study is the first RCT testing a prednisolone regimen with a duration longer than 24 weeks. Also it is the first RCT assessing the effect of prednisolone in the prevention of clinical NFI in patients with established subclinical neuropathy. The TENLEP study will add to the current understanding of neuropathy due to leprosy and provide insight in the effectiveness of prednisolone on the prevention and recovery of NFI in leprosy patients. In this paper we present the research protocols for both Clinical and Subclinical trials and discuss the possible findings and implications.

Trial registrationNetherlands Trial Register: NTR2300

Clinical Trial Registry India: CTRI-2011-09-002022

KeywordsLeprosy Prednisolone Nerve function impairment Subclinical neuropathy AbbreviationsBIBacteriological Index

CNFICount of nerve function impairment

GCPGood clinical practice

ISCInternational steering committee

MBMulti bacillary

MDTMulti drug treatment

MFTMonofilament test

MIMotor impairment

MNCMotor nerve conduction

MRCMedical research council

NCSNerve conduction study

NFINerve function impairment


PIPrincipal investigator

PODPrevention of disability

RCTRandomized controlled trial

RSSReaction severity scale

SALSAScreening of activity limitation and safety Awareness

SISensory impairment

SNCSensory nerve conduction

SNFSSubclinical nerve function Score

TENLEPTreatment of early neuropathy in LEProsy

VMTVoluntary muscle test

WDTWarm detection threshold.

Electronic supplementary materialThe online version of this article doi:10.1186-1471-2377-12-159 contains supplementary material, which is available to authorized users.

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Autor: Inge Wagenaar - Wim Brandsma - Erik Post - Wim van Brakel - Diana Lockwood - Peter Nicholls - Paul Saunderson - Cairns Smi


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