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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
180
Olanzapine Mylan oral dispersible form 5 to 10 mg / 2,5 à 20 mg per day
Xenazine (tetrabenazine) tabs of 25mg , from 25 mg to 200 mg
Tiapridal (Tiapride), tabs 100 mg / from 300 to 800 mg per day
CHU Henri Mondor
Créteil, France
the Independence scale
Time frame: at 12 month
motor scale
Time frame: at 3, 6, 9 and 12 month
Psychiatric scale
Time frame: at 3, 6, 9 and 12 month
cognitive function scale
Time frame: at 3, 6, 9 and 12 month
metabolic parameters
Time frame: at 3, 6, 9 and 12 month
tolerance
Time frame: at 3, 6, 9 and 12 month
cost
Time frame: at 3, 6, 9 and 12 month
Function scale (TFC and Functionnal Appreciation Scale)
Time frame: at 3, 6, 9 and 12 month
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