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

Huntington Disease Clinical Trial

— NEUROHD  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00632645
• Other study ID #: P060211
• Status: Completed
• Phase: Phase 3
• First received: February 29, 2008
• Last updated: January 18, 2018
• Start date: April 2009
• Est. completion date: April 28, 2017

Study information

• Verified date: January 2018
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 180
• Est. completion date: April 28, 2017
• Est. primary completion date: April 28, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Symptomatic disease with motor, behavioural and/or psychiatric disorder required medical treatment.

2. HD diagnosed with abnormal number of CAG repeats: 38 = nucleotide expansion (CAG) (amendment n°5 suppressed the limit = 48)

3. Neuroleptic Prescription required.

4. Age = 18 (amendment n°5 suppressed the limit = 65 years old)

5. Patient gave its written consent

6. Realization of medical examination and a Electroencephalogram

Exclusion Criteria:

1. Severe cognitive impairment or neuropsychiatric troubles.

2. Existing diabetes.

3. Neuroleptic prescription forbidden according to the neurologist decision.

4. Current participation to another clinical trial.

5. No drug compliance to previous treatment.

6. No national health insurance affiliation

Related Conditions & MeSH terms

• Huntington Disease

Intervention

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

Locations

Country	Name	City	State
France	CHU Henri Mondor	Creteil

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	the Independence scale		at 12 month
Secondary	motor scale		at 3, 6, 9 and 12 month
Secondary	Psychiatric scale		at 3, 6, 9 and 12 month
Secondary	cognitive function scale		at 3, 6, 9 and 12 month
Secondary	metabolic parameters		at 3, 6, 9 and 12 month
Secondary	tolerance		at 3, 6, 9 and 12 month
Secondary	cost		at 3, 6, 9 and 12 month
Secondary	Function scale (TFC and Functionnal Appreciation Scale)		at 3, 6, 9 and 12 month