NCT00632645

Neuroleptic and Huntington Disease Comparison of : Olanzapine, la Tetrabenazine and Tiapride

Neuroleptic and Huntington Disease. Comparison of : Olanzapine, la Tetrabenazine and Tiapride. A Multicentric, Randomised, Controlled Study.

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 180 (actual)
• Sponsor: Assistance Publique - Hôpitaux de Paris · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Huntington Disease

Interventions

Type	Name	Description
DRUG	Olanzapine	Olanzapine Mylan oral dispersible form 5 to 10 mg / 2,5 à 20 mg per day
DRUG	Xenazine	Xenazine (tetrabenazine) tabs of 25mg , from 25 mg to 200 mg
DRUG	Tiapridal	Tiapridal (Tiapride), tabs 100 mg / from 300 to 800 mg per day

Timeline

• Start date: 2009-04-01
• Primary completion: 2017-04-28
• Completion: 2017-04-28
• First posted: 2008-03-11
• Last updated: 2018-01-19

Locations

1 site across 1 country: France