TENLEP Research Study - Treatment of Early Neuropathy in Leprosy – a multicentre study.
This is an international multicentre double blind randomised trial (Bangladesh, Brazil, India-Agra, India-Mumbai, Indonesia, Nepal). LLSC is a key centre being the largest sampling site of all the above centres.
The study aims to determine whether the preclinical development of neuropathy in leprosy can be effectively detected and prevented and whether early leprosy neuropathy can be ameliorated or cured with strengthened treatment.
The study has two Trial arms:
Trial 1: New leprosy patients with early sub-clinical nerve function impairment(only detectable by nerve conduction equipment). It aims to determine whether 20 week prednisolone treatment before symptoms appear helps prevent clinical nerve damage. It compares two regimens -
20 weeks prednisolone
20 weeks placebo
Trial 2: Leprosy patients already with clinical nerve damage:It aims to determine whether 32-week prednisolone course is more effective than treatment of 20-week duration in restoring nerve. It compares -