Huntington Disease
Conditions
Keywords
Huntington, Neuroleptic, Unified Huntington Disease Rating Scale (UHDRS), Independence Scale, Neuroleptic Prescription required
Brief summary
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.
Detailed description
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.
Interventions
DRUGOlanzapine
Olanzapine Mylan oral dispersible form 5 to 10 mg / 2,5 à 20 mg per day
DRUGXenazine
Xenazine (tetrabenazine) tabs of 25mg , from 25 mg to 200 mg
DRUGTiapridal
Tiapridal (Tiapride), tabs 100 mg / from 300 to 800 mg per day
Sponsors
Assistance Publique - Hôpitaux de Paris
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Symptomatic disease with motor, behavioural and/or psychiatric disorder required medical treatment. 2. HD diagnosed with abnormal number of CAG repeats: 38 ≤ nucleotide expansion (CAG) (amendment n°5 suppressed the limit ≤ 48) 3. Neuroleptic Prescription required. 4. Age ≥ 18 (amendment n°5 suppressed the limit ≤ 65 years old) 5. Patient gave its written consent 6. Realization of medical examination and a Electroencephalogram
Exclusion criteria
1. Severe cognitive impairment or neuropsychiatric troubles. 2. Existing diabetes. 3. Neuroleptic prescription forbidden according to the neurologist decision. 4. Current participation to another clinical trial. 5. No drug compliance to previous treatment. 6. No national health insurance affiliation
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| the Independence scale | at 12 month |
Secondary
| Measure | Time frame |
|---|---|
| Psychiatric scale | at 3, 6, 9 and 12 month |
| cognitive function scale | at 3, 6, 9 and 12 month |
| metabolic parameters | at 3, 6, 9 and 12 month |
| motor scale | at 3, 6, 9 and 12 month |
| cost | at 3, 6, 9 and 12 month |
| Function scale (TFC and Functionnal Appreciation Scale) | at 3, 6, 9 and 12 month |
| tolerance | at 3, 6, 9 and 12 month |
Countries
France
Outcome results
None listed