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

• ClinicalTrials.gov Identifier: NCT00632645
• Recruitment Status: Completed
• First Posted: March 11, 2008
• Last Update Posted: January 19, 2018
• Sponsor: Assistance Publique - Hôpitaux de Paris
• Information provided by (Responsible Party): Assistance Publique - Hôpitaux de Paris

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 (Clinical Trial)
• 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: April 2009
• Actual Primary Completion Date: April 28, 2017
• Actual Study Completion Date: April 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 Name: Olanzapine Mylan
Active Comparator: 2; Xenazine	Drug: Xenazine; Xenazine (tetrabenazine) tabs of 25mg , from 25 mg to 200 mg; Other Name: tetrabenazine
Active Comparator: 3; Tiapridal	Drug: Tiapridal; Tiapridal (Tiapride), tabs 100 mg / from 300 to 800 mg per day; Other Name: tiapride

Outcome Measures

Primary Outcome Measures :

1. the Independence scale [ Time Frame: at 12 month ]

Secondary Outcome Measures :

1. motor scale [ Time Frame: at 3, 6, 9 and 12 month ]
2. Psychiatric scale [ Time Frame: at 3, 6, 9 and 12 month ]
3. cognitive function scale [ Time Frame: at 3, 6, 9 and 12 month ]
4. metabolic parameters [ Time Frame: at 3, 6, 9 and 12 month ]
5. tolerance [ Time Frame: at 3, 6, 9 and 12 month ]
6. cost [ Time Frame: at 3, 6, 9 and 12 month ]
7. Function scale (TFC and Functionnal Appreciation Scale) [ Time Frame: at 3, 6, 9 and 12 month ]

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

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

Contacts and Locations

Locations

France

CHU Henri Mondor

Creteil, France, 94

Sponsors and Collaborators

Assistance Publique - Hôpitaux de Paris

Investigators

• Principal Investigator: Anne-Catherine BACHOUD LEVI, PH; Assistance Publique - Hôpitaux de Paris

More Information

• Responsible Party: Assistance Publique - Hôpitaux de Paris
• ClinicalTrials.gov Identifier: NCT00632645
• Other Study ID Numbers: P060211
• First Posted: March 11, 2008
• Last Update Posted: January 19, 2018
• Last Verified: January 2018

Keywords provided by Assistance Publique - Hôpitaux de Paris:

Huntington; Neuroleptic; Unified Huntington Disease Rating Scale (UHDRS); Independence Scale; Neuroleptic Prescription required

Additional relevant MeSH terms:

Huntington Disease; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Dementia; Chorea; Dyskinesias; Movement Disorders; Heredodegenerative Disorders, Nervous System; Neurodegenerative Diseases; Genetic Diseases, Inborn; Cognition Disorders; Neurocognitive Disorders; Mental Disorders; Olanzapine; Tiapride Hydrochloride; Tetrabenazine; Antiemetics; Autonomic Agents; Peripheral Nervous System Agents; Physiological Effects of Drugs; Gastrointestinal Agents; Antipsychotic Agents; Tranquilizing Agents; Central Nervous System Depressants; Psychotropic Drugs; Serotonin Uptake Inhibitors; Neurotransmitter Uptake Inhibitors; Membrane Transport Modulators