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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

Tracking Information
First Submitted Date  ICMJE February 29, 2008
First Posted Date  ICMJE March 11, 2008
Last Update Posted Date January 19, 2018
Actual Study Start Date  ICMJE April 2009
Actual Primary Completion Date April 28, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 10, 2008)
the Independence scale [ Time Frame: at 12 month ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT00632645 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: July 30, 2015)
  • 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 ]
Original Secondary Outcome Measures  ICMJE
 (submitted: March 10, 2008)
  • 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 ]
Current Other Outcome Measures  ICMJE Not Provided
Original Other Outcome Measures  ICMJE Not Provided
 
Descriptive Information
Brief Title  ICMJE Neuroleptic and Huntington Disease Comparison of : Olanzapine, la Tetrabenazine and Tiapride
Official Title  ICMJE Neuroleptic and Huntington Disease. Comparison of : Olanzapine, la Tetrabenazine and Tiapride. A Multicentric, Randomised, Controlled Study.
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.
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 Type  ICMJE Interventional
Study Phase Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Huntington Disease
Intervention  ICMJE
  • 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
Study Arms
  • Experimental: 1
    Olanzapine Mylan
    Intervention: Drug: Olanzapine
  • Active Comparator: 2
    Xenazine
    Intervention: Drug: Xenazine
  • Active Comparator: 3
    Tiapridal
    Intervention: Drug: Tiapridal
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 10, 2008)
180
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date April 28, 2017
Actual Primary Completion Date April 28, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00632645
Other Study ID Numbers  ICMJE P060211
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Assistance Publique - Hôpitaux de Paris
Study Sponsor  ICMJE Assistance Publique - Hôpitaux de Paris
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Anne-Catherine BACHOUD LEVI, PH Assistance Publique - Hôpitaux de Paris
PRS Account Assistance Publique - Hôpitaux de Paris
Verification Date January 2018

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