Huntington Disease Clinical Trial
Official title:
Neuroleptic and Huntington Disease. Comparison of : Olanzapine, la Tetrabenazine and Tiapride. A Multicentric, Randomised, Controlled Study.
Huntington's disease (HD) is autosomal dominant neurodegenerative disease, starting in average (with high variability) in the fourth decade. The disease progression is classically characterized by a cognitive deterioration (cortical-frontal dementia), motor disorders (associating chorea, dystonia and bradykinesia), psychiatric disturbances (combining depression and irritability) and metabolic disorder (cachexia). The disease is fatal within 15 to 20 years in most patients. HD has no cure. Neuroleptics are the main drug used and the only to demonstrate its efficacy on chorea in clinical trials. But neuroleptics have also beneficial and adverse effects on other disease characteristics (motor, psychiatric, cognitive or metabolic). Their profile between beneficial and adverse effects could be different according the neuroleptics and their classification. The aim of this study is to compare beneficial and adverse effects of 3 different neuroleptics in HD.
We proposed a randomized controlled trial, including 180 patients, in 3 groups: Olanzapine,
Tetrabenazine and Tiapride, followed during 12 months. These treatments have been selected
according their profile and their frequency of use.
The principal criteria is the Independence scale, one of the functional scales of the Unified
Huntington's Disease Rating Scale, the only validated scale in HD.
Secondary criteria will assess motor,functional, psychiatric and cognitive functions,
metabolic parameters, tolerance and cost.
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