03620nas a2200433   4500000000100000008004100001260001600042653001500058653001000073653002300083653002400106653003300130653001100163653002000174653001100194653001200205653000900217653001600226653003900242653001700281653002200298100001700320700001900337700001600356700001600372700001300388700001500401700001700416700001500433700001100448700001800459245019600477856006600673300000800739490000700747050001800754520240000772022001403172       2012                            d  c2012 Dec 1810aAdolescent10aAdult10aClinical Protocols10aDouble-Blind Method10aDrug Administration Schedule10aFemale10aGlucocorticoids10aHumans10aleprosy10aMale10aMiddle Aged10aPeripheral Nervous System Diseases10aPrednisolone10aTreatment Outcome1 aRichardus JH1 aWilder-Smith E1 aLockwood DN1 aNicholls PG1 aSmith WC1 aWagenaar I1 aSaunderson P1 aBrandsma W1 aPost E1 avan Brakel WH00aTwo randomized controlled clinical trials to study the effectiveness of prednisolone treatment in preventing and restoring clinical nerve function loss in leprosy: the TENLEP study protocols.  uhttp://www.biomedcentral.com/content/pdf/1471-2377-12-159.pdf  a1590 v12  aWAGENAAR 20123 a<p><b>BACKGROUND: </b>Nerve 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).</p><p><b>METHODS: </b>Two 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.</p><p><b>DISCUSSION: </b>This 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.</p><p><b>TRIAL REGISTRATION: </b>Netherlands Trial Register: NTR2300 Clinical Trial Registry India: CTRI/2011/09/002022.</p>  a1471-2377