Do we forget the problem of neuritis?

Leprosy Mailing List – February 4^th, 2011

Re.:     Do we forget the problem of neuritis?

From:  Erik Post, Amsterdam, The Netherlands

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Dear Salvatore,

The Royal Tropical Institute has engaged in the Treatment of Early Neuropathy in Leprosy (TENLEP) Trials for the period 2010-2013.  These clinical trials are financed by the Turing Foundation, the Netherlands Leprosy Relief (NLR), the Ordre de Malta, the American Leprosy Missions, and the German TB & Leprosy Relief Association.

The TENLEP Trials proposal builds on the findings of the INFIR Cohort Study and the recommendations of the NLR-funded International Workshop on Neuropathology in Leprosy in the Netherlands in 2007.  At this workshop, several key research questions were prioritised. These included:

How effective is steroid treatment of sub-clinical neuropathy detected at diagnosis in reducing the proportion of patients with sensory and/or motor nerve function impairment (NFI) one year after the start of MDT?

What is the optimal steroid treatment regimen for patients with clinical sensory and/or motor NFI of recent onset (<6 months)?

The TENLEP Trials will use a randomised double-blind controlled trial design to answer the above questions in 2 integrated trials. We have the following hypotheses:

Trial 1: A 20-week course of steroid treatment of sub-clinical neuropathy detected at diagnosis will significantly reduce the proportion of patients with sensory and/or motor NFI 18 months after the start of MDT.

Trial 2: Steroid treatment of 32 weeks duration is more effective than treatment of 20 weeks duration in restoring nerve function in patients with clinical sensory and/or motor NFI of recent onset (<6 months).

Currently there are six research sites involved in the study:

• Foundation for Medical Research ( Mumbai , India )
• JALMA ( Agra , India )
• Lalgadh ( Nepal )
• Nilphamari ( Bangladesh )
• Dr. Soetomo Hospital (Surabaya, Indonesia)
• University of Sao Paulo ( Brazil )

An International Steering Committee is overseeing the trials. Wim Brandsma is the study manager. At present the logistics of the trials is being set up and is gaining momentum. In the coming years we will communicate results through relevant conferences and journal articles.
Our hopes are high! Best regards,

Erik Post
International Coordinator TENLEPKIT, Amsterdam