TENLEP study investigates ways to prevent and better treat nerve damage in leprosy.
|TENLEP training session at The Leprosy Mission International-Bangladesh research site at Nilphamari|
Leprosy is a curable disease, yet delayed diagnosis can lead to permanent disability. The main cause of disability in leprosy is nerve damage.
Early detection and adequate treatment can prevent this, but leprosy is frequently diagnosed too late and often patients develop nerve damage to the hands, feet or eyes while on treatment. Prednisolone, a synthetic steroid, is the drug of choice to prevent this.
The TENLEP study involves two related drug trials aimed at preventing nerve damage or treating it when it is still in the early stages. TENLEP stands for Treatment of Early Neuropathy in Leprosy.
The project is funded by five different organizations: Netherlands Leprosy Relief, German Leprosy and TB Relief Association, Order of Malta, American Leprosy Missions and the Turing Foundation.
One trial deals with Clinical Neuropathy: nerve damage that has already resulted in loss of sensation in hands or feet, or weakness or paralysis of muscles. It looks at whether treatment with steroids for 32 weeks is better than the WHO-recommended regimen of 16 weeks.
The second trial deals with Sub-clinical Neuropathy: nerve damage that has not yet resulted in functional loss. It investigates if treatment with steroids at this very early stage can prevent loss of sensation and/or muscle strength.
TENLEP is a multicenter study taking place in Bangladesh, Indonesia, India and Nepal. A total of seven centers are participating. The study is coordinated through the Royal Tropical Institute in Amsterdam, with local teams responsible for the day-to-day running of the project.
The study started in 2011 with training sessions and workshop meetings for all centers. Patient intake started in April 2012 and will continue through most of this year and into 2013.
Many centers are participating because the study demands large numbers of patients to be able to show the effect of different doses and durations of treatment with prednisolone.
If activities go as planned, preliminary results will be available in 2014. Researchers hope these may lead to better treatment recommendations to prevent or treat nerve function loss, thus preventing the 'disabilities' so characteristic of leprosy. (Contributed by Erik Post, study coordinator, and Wim Brandsma, study manager, Royal Tropical Institute, Amsterdam.)