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NEUROHD: Olanzapine vs Tetrabenazine vs Tiapride in Huntington Disease

NCT00632645Phase 3

Key facts

Status: Completed
Start: Apr 2009
Primary completion: Apr 2017
Countries: 1
Sponsor: Assistance publique - Hôpitaux de Paris
Modality: Small Molecules

Drugs: olanzapine
Conditions: Huntington disease (HD)

Overview

Phase 3, randomised, open-label trial of olanzapine in Huntington disease (HD) (3 arms), sponsored by Assistance publique - Hôpitaux de Paris. Primary endpoint: Unified Huntington's Disease Rating Scale (UHDRS) Independence Scale at 12 months. Started Apr 2009; status: completed.

Design

3 arms

Study design: RandomizedOpen-label

Olanzapine
Olanzapine Mylan oral dispersible form 5 to 20 mg per day
Tetrabenazine
Xenazine (tetrabenazine) 25 mg to 200 mg per day
Tiapride
Tiapridal (Tiapride) 300 to 800 mg per day

Who it enrols

Adult patients with symptomatic Huntington's disease (CAG repeats >= 38) requiring neuroleptic treatment. Patients with severe cognitive impairment, severe neuropsychiatric troubles, or existing diabetes are excluded.

Endpoints

Primary

Unified Huntington's Disease Rating Scale (UHDRS) Independence Scale12 months

Secondary

Unified Huntington's Disease Rating Scale (UHDRS) Motor Scale12 months
Psychiatric Assessment Scale12 months
Cognitive Function Assessment Scale12 months
Metabolic Parameters12 months
Tolerance and Safety12 months
Treatment Cost12 months
Total Functional Capacity12 months
Functional Appreciation Scale12 months

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