We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00632645
Recruitment Status : Completed
First Posted : March 11, 2008
Last Update Posted : January 19, 2018
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris

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.

Layout table for study information
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

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
Drug: Xenazine
Xenazine (tetrabenazine) tabs of 25mg , from 25 mg to 200 mg
Other Name: tetrabenazine

Active Comparator: 3
Drug: Tiapridal
Tiapridal (Tiapride), tabs 100 mg / from 300 to 800 mg per day
Other Name: tiapride

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 ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00632645

Layout table for location information
CHU Henri Mondor
Creteil, France, 94
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Layout table for investigator information
Principal Investigator: Anne-Catherine BACHOUD LEVI, PH Assistance Publique - Hôpitaux de Paris
Layout table for additonal information
Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT00632645    
Other Study ID Numbers: P060211
First Posted: March 11, 2008    Key Record Dates
Last Update Posted: January 19, 2018
Last Verified: January 2018
Keywords provided by Assistance Publique - Hôpitaux de Paris:
Unified Huntington Disease Rating Scale (UHDRS)
Independence Scale
Neuroleptic Prescription required
Additional relevant MeSH terms:
Layout table for MeSH terms
Huntington Disease
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Heredodegenerative Disorders, Nervous System
Neurodegenerative Diseases
Genetic Diseases, Inborn
Cognition Disorders
Neurocognitive Disorders
Mental Disorders
Tiapride Hydrochloride
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