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

Sponsor

Assistance Publique - Hôpitaux de Paris (Other)

Overall Status

Completed

CT.gov ID

NCT00632645

Collaborator

(none)

180

Enrollment

Location

Arms

96.9

Actual Duration (Months)

1.9

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Huntington Disease	Drug: Olanzapine Drug: Xenazine Drug: Tiapridal	Phase 3

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

180 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Apr 1, 2009

Actual Primary Completion Date :

Apr 28, 2017

Actual Study Completion Date :

Apr 28, 2017

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 1 Olanzapine Mylan	Drug: Olanzapine Olanzapine Mylan oral dispersible form 5 to 10 mg / 2,5 à 20 mg per day Other Names: Olanzapine Mylan
Active Comparator: 2 Xenazine	Drug: Xenazine Xenazine (tetrabenazine) tabs of 25mg , from 25 mg to 200 mg Other Names: tetrabenazine
Active Comparator: 3 Tiapridal	Drug: Tiapridal Tiapridal (Tiapride), tabs 100 mg / from 300 to 800 mg per day Other Names: tiapride

Arm

Intervention/Treatment

Experimental: 1

Olanzapine Mylan

Drug: Olanzapine

Olanzapine Mylan oral dispersible form 5 to 10 mg / 2,5 à 20 mg per day

Other Names:

Olanzapine Mylan

Active Comparator: 2

Xenazine

Drug: Xenazine

Xenazine (tetrabenazine) tabs of 25mg , from 25 mg to 200 mg

Other Names:

tetrabenazine

Active Comparator: 3

Tiapridal

Drug: Tiapridal

Tiapridal (Tiapride), tabs 100 mg / from 300 to 800 mg per day

Other Names:

tiapride

Outcome Measures

Primary Outcome Measures

the Independence scale [at 12 month]

Secondary Outcome Measures

motor scale [at 3, 6, 9 and 12 month]
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]
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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Symptomatic disease with motor, behavioural and/or psychiatric disorder required medical treatment.
HD diagnosed with abnormal number of CAG repeats: 38 ≤ nucleotide expansion (CAG) (amendment n°5 suppressed the limit ≤ 48)
Neuroleptic Prescription required.
Age ≥ 18 (amendment n°5 suppressed the limit ≤ 65 years old)
Patient gave its written consent
Realization of medical examination and a Electroencephalogram