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

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2014 by Assistance Publique - Hôpitaux de Paris
Sponsor:
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier:
NCT00632645
First received: February 29, 2008
Last updated: October 29, 2014
Last verified: October 2014
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • motor scale [ Time Frame: at 3, 6, 9 and 12 month ] [ Designated as safety issue: Yes ]
  • Psychiatric scale [ Time Frame: at 3, 6, 9 and 12 month ] [ Designated as safety issue: Yes ]
  • cognitive function scale [ Time Frame: at 3, 6, 9 and 12 month ] [ Designated as safety issue: Yes ]
  • metabolic parameters [ Time Frame: at 3, 6, 9 and 12 month ] [ Designated as safety issue: Yes ]
  • tolerance [ Time Frame: at 3, 6, 9 and 12 month ] [ Designated as safety issue: Yes ]
  • cost [ Time Frame: at 3, 6, 9 and 12 month ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 180
Study Start Date: April 2009
Estimated Study Completion Date: March 2016
Estimated Primary Completion Date: March 2015 (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, psychiatric and cognitive functions, metabolic parameters, tolerance and cost.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
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 between ≥ 18 (amendment n°5 suppressed the limit ≤ 65 ans)
  5. Patient gave its written consent

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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT00632645     History of Changes
Other Study ID Numbers: P060211
Study First Received: February 29, 2008
Last Updated: October 29, 2014
Health Authority: France: Ministry of Health

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
Cognition Disorders
Delirium, Dementia, Amnestic, Cognitive Disorders
Dementia
Dyskinesias
Genetic Diseases, Inborn
Heredodegenerative Disorders, Nervous System
Mental Disorders
Movement Disorders
Nervous System Diseases
Neurodegenerative Diseases
Antipsychotic Agents
Olanzapine
Tetrabenazine
Tiapride Hydrochloride
Adrenergic Agents
Adrenergic Uptake Inhibitors
Antiemetics
Autonomic Agents
Central Nervous System Agents
Central Nervous System Depressants
Dopamine Agents
Dopamine Antagonists
Gastrointestinal Agents
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents

ClinicalTrials.gov processed this record on November 20, 2014