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Search / Trial NCT00632645

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

Launched by ASSISTANCE PUBLIQUE - HÔPITAUX DE PARIS · Mar 10, 2008

Trial Information

Current as of May 12, 2025

Completed

Keywords

Huntington Neuroleptic Unified Huntington Disease Rating Scale (Uhdrs) Independence Scale Neuroleptic Prescription Required

ClinConnect Summary

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.

Gender

ALL

Eligibility 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

About Assistance Publique Hôpitaux De Paris

Assistance Publique - Hôpitaux de Paris (AP-HP) is a leading public hospital system in France, renowned for its commitment to healthcare excellence and innovative medical research. As a prominent clinical trial sponsor, AP-HP plays a pivotal role in advancing medical knowledge and improving patient care through rigorous scientific investigations across a wide range of therapeutic areas. With a focus on collaboration and interdisciplinary approaches, AP-HP leverages its extensive network of hospitals and expert clinicians to facilitate high-quality clinical trials that adhere to the highest ethical and regulatory standards, ultimately aiming to translate research findings into tangible health benefits for diverse patient populations.

Locations

Creteil, , France

Patients applied

0 patients applied

Trial Officials

Anne-Catherine BACHOUD LEVI, PH

Principal Investigator

Assistance Publique - Hôpitaux de Paris

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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