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

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

February 29, 2008
March 11, 2008
January 19, 2018
April 2009
April 28, 2017   (Final data collection date for primary outcome measure)
the Independence scale [ Time Frame: at 12 month ]
Same as current
Complete list of historical versions of study NCT00632645 on ClinicalTrials.gov Archive Site
  • 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 ]
  • 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 ]
Not Provided
Not Provided
 
Neuroleptic and Huntington Disease Comparison of : Olanzapine, la Tetrabenazine and Tiapride
Neuroleptic and Huntington Disease. Comparison of : Olanzapine, la Tetrabenazine and Tiapride. A Multicentric, Randomised, Controlled Study.
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.

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.

Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Huntington Disease
  • Drug: Olanzapine
    Olanzapine Mylan oral dispersible form 5 to 10 mg / 2,5 à 20 mg per day
    Other Name: Olanzapine Mylan
  • Drug: Xenazine
    Xenazine (tetrabenazine) tabs of 25mg , from 25 mg to 200 mg
    Other Name: tetrabenazine
  • Drug: Tiapridal
    Tiapridal (Tiapride), tabs 100 mg / from 300 to 800 mg per day
    Other Name: tiapride
  • Experimental: 1
    Olanzapine Mylan
    Intervention: Drug: Olanzapine
  • Active Comparator: 2
    Xenazine
    Intervention: Drug: Xenazine
  • Active Comparator: 3
    Tiapridal
    Intervention: Drug: Tiapridal
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
180
April 28, 2017
April 28, 2017   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
France
 
 
NCT00632645
P060211
Yes
Not Provided
Not Provided
Assistance Publique - Hôpitaux de Paris
Assistance Publique - Hôpitaux de Paris
Not Provided
Principal Investigator: Anne-Catherine BACHOUD LEVI, PH Assistance Publique - Hôpitaux de Paris
Assistance Publique - Hôpitaux de Paris
January 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP