drugset / Trial / NCT00632645

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

NCT00632645

Phase 3 Completed 180 enrolled Assistance Publique - Hôpitaux de Paris
RandomizedParallel-groupOpen-labelTreatment

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.

Timeline

Start
2009-04
Primary completion
2017-04-28
Completion
2017-04-28

Drugs

EvaluationDrugModalityDoseRoute
Subject Olanzapine Small molecule 2.5 mg Oral
Subject Olanzapine Small molecule 5 mg Oral
Subject Olanzapine Small molecule 10 mg Oral
Subject Olanzapine Small molecule 20 mg Oral
Comparator Tetrabenazine Unknown 25 mg Oral
Comparator Tetrabenazine Unknown 200 mg Oral
Comparator Tiapride Small molecule 300 mg Oral
Comparator Tiapride Small molecule 800 mg Oral

Indications