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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | Olanzapine Mylan |
|
| 2 | Active Comparator | Xenazine |
|
| 3 | Active Comparator | Tiapridal |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Olanzapine | Drug | Olanzapine Mylan oral dispersible form 5 to 10 mg / 2,5 Ã 20 mg per day |
|
| Measure | Description | Time Frame |
|---|---|---|
| the Independence scale | at 12 month |
| Measure | Description | Time Frame |
|---|---|---|
| motor scale | at 3, 6, 9 and 12 month | |
| Psychiatric scale | at 3, 6, 9 and 12 month | |
| cognitive function scale |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Anne-Catherine BACHOUD LEVI, PH | Assistance Publique - Hôpitaux de Paris | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU Henri Mondor | Créteil | 94 | France |
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| ID | Term |
|---|---|
| D006816 | Huntington Disease |
| ID | Term |
|---|---|
| D001480 | Basal Ganglia Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D000077152 | Olanzapine |
| D013747 | Tetrabenazine |
| D063325 | Tiapride Hydrochloride |
| ID | Term |
|---|---|
| D001569 | Benzodiazepines |
| D001552 | Benzazepines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
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| Xenazine | Drug | Xenazine (tetrabenazine) tabs of 25mg , from 25 mg to 200 mg |
|
|
| Tiapridal | Drug | Tiapridal (Tiapride), tabs 100 mg / from 300 to 800 mg per day |
|
|
| at 3, 6, 9 and 12 month |
| metabolic parameters | at 3, 6, 9 and 12 month |
| tolerance | 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 |
| D003704 | Dementia |
| D002819 | Chorea |
| D020820 | Dyskinesias |
| D009069 | Movement Disorders |
| D020271 | Heredodegenerative Disorders, Nervous System |
| D019636 | Neurodegenerative Diseases |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D003072 | Cognition Disorders |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
| D006571 | Heterocyclic Compounds |
| D011807 | Quinolizines |
| D005021 | Ethylamines |
| D000588 | Amines |
| D009930 | Organic Chemicals |
| D001549 | Benzamides |
| D001565 | Benzoates |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |