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

NCT00632645 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 180

Last updated 2018-01-19

No results posted yet for this study

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.

Conditions

  • Huntington Disease

Interventions

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

Sponsors & Collaborators

  • Assistance Publique - Hôpitaux de Paris

    lead OTHER

Principal Investigators

  • Anne-Catherine BACHOUD LEVI, PH · Assistance Publique - Hôpitaux de Paris

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-04-30
Primary Completion
2017-04-28
Completion
2017-04-28

Countries

  • France

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00632645 on ClinicalTrials.gov