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Completed

NCT Number: NCT00632645

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

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.

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Key information

Conditions

Huntington Disease Basal Ganglia Diseases Brain Diseases Central Nervous System Diseases Chorea Cognition Disorders Congenital, Hereditary, and Neonatal Diseases and Abnormalities Dementia Dyskinesias Genetic Diseases, Inborn Heredodegenerative Disorders, Nervous System Mental Disorders Movement Disorders Nervous System Diseases Neurocognitive Disorders Neurodegenerative Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

CHU Henri Mondor

Créteil, 94, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Symptomatic disease with motor, behavioural and/or psychiatric disorder required medical treatment.
  • HD diagnosed with abnormal number of CAG repeats: 38 ≤ nucleotide expansion (CAG) (amendment n°5 suppressed the limit ≤ 48)
  • Neuroleptic Prescription required.
  • Age ≥ 18 (amendment n°5 suppressed the limit ≤ 65 years old)
  • Patient gave its written consent
  • Realization of medical examination and a Electroencephalogram

Exclusion criteria

  • Severe cognitive impairment or neuropsychiatric troubles.
  • Existing diabetes.
  • Neuroleptic prescription forbidden according to the neurologist decision.
  • Current participation to another clinical trial.
  • No drug compliance to previous treatment.
  • No national health insurance affiliation

Treatment and study plan

Olanzapine

Drug

Olanzapine Mylan oral dispersible form 5 to 10 mg / 2,5 à 20 mg per day

Other names: Olanzapine Mylan

Xenazine

Drug

Xenazine (tetrabenazine) tabs of 25mg , from 25 mg to 200 mg

Other names: tetrabenazine

Tiapridal

Drug

Tiapridal (Tiapride), tabs 100 mg / from 300 to 800 mg per day

Other names: tiapride

Primary outcomes

  1. the Independence scale

    Time frame: at 12 month

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Registry information

Official study title

Neuroleptic and Huntington Disease. Comparison of : Olanzapine, la Tetrabenazine and Tiapride. A Multicentric, Randomised, Controlled Study.

Acronym: NEUROHD

Important dates

Study start
2009
Primary completion
2017
Study completion
2017
First posted
Mar 11, 2008
Registry last updated
Jan 19, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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