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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified July 2015 by Assistance Publique - Hôpitaux de Paris.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00632645
First Posted: March 11, 2008
Last Update Posted: July 31, 2015
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.
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris
  Purpose
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 Intervention Phase
Huntington Disease Drug: Olanzapine Drug: Xenazine Drug: Tiapridal Phase 3

Study Type: Interventional
Study Design: 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.

Resource links provided by NLM:


Further study details as provided by Assistance Publique - Hôpitaux de Paris:

Primary Outcome Measures:
  • the Independence scale [ Time Frame: at 12 month ]

Secondary Outcome Measures:
  • motor scale [ Time Frame: at 3, 6, 9 and 12 month ]
  • Psychiatric scale [ Time Frame: at 3, 6, 9 and 12 month ]
  • cognitive function scale [ Time Frame: at 3, 6, 9 and 12 month ]
  • metabolic parameters [ Time Frame: at 3, 6, 9 and 12 month ]
  • tolerance [ Time Frame: at 3, 6, 9 and 12 month ]
  • cost [ Time Frame: at 3, 6, 9 and 12 month ]
  • Function scale (TFC and Functionnal Appreciation Scale) [ Time Frame: at 3, 6, 9 and 12 month ]

Estimated Enrollment: 180
Study Start Date: April 2009
Estimated Study Completion Date: March 2017
Estimated Primary Completion Date: March 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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
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


Contacts
Contact: Bachoud-Levi Anne-Catherine, PH +33 (0)1 49 81 23 01 bachoud@gmail.com
Contact: Rialland Amandine (0)1 49 81 36 24 ext + 33 amandine.rialland@hmn.aphp.fr

Locations
France
CHU Henri Mondor Recruiting
Creteil, France, 94
Contact: Anne Catherine BACHOUD-LEVI, PH    +33(0) 1 49 81 27 67    bachoud@gmail.com   
Principal Investigator: Anne Catherine Bachoud-Lévi, PH         
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     History of Changes
Other Study ID Numbers: P060211
First Submitted: February 29, 2008
First Posted: March 11, 2008
Last Update Posted: July 31, 2015
Last Verified: July 2015

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