Official Title: “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.

Study Type: Interventional

Study Design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study

Study Primary Completion Date: March 2011

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.

Intervention(s) in this Clinical Trial

• Drug: Zyprexa
  • Zyprexa VELOTABS (Olanzapine) oral dispersible form 5 to 10 mg / 5 à 20 mg per day
• Drug: Xénazine
  • Xénazine (tétrabénazine) tabs of 25mg , from 25 mg to 200 mg
• Drug: Tiapride
  • Tiapride (Tiapridal), tabs 100 mg / from 300 to 800 mg per day

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: 1
  • zyprexa
• Active Comparator: 2
  • Xenazine
• Active Comparator: 3
  • Tiapride

Primary Measures

• the Independence scale
  • Time Frame: at 12 month
    Safety Issue?: Yes

Secondary Measures

• motor scale
  • Time Frame: at 3, 6, 9 and 12 month
    Safety Issue?: Yes
• Psychiatric scale
  • Time Frame: at 3, 6, 9 and 12 month
    Safety Issue?: Yes
• cognitive function scale
  • Time Frame: at 3, 6, 9 and 12 month
    Safety Issue?: Yes
• metabolic parameters
  • Time Frame: at 3, 6, 9 and 12 month
    Safety Issue?: Yes
• tolerance
  • Time Frame: at 3, 6, 9 and 12 month
    Safety Issue?: Yes
• cost
  • Time Frame: at 3, 6, 9 and 12 month
    Safety Issue?: Yes

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 ≤ CAG ≤ 48
• 3. Neuroleptic Prescription required.
• 4. Age between ≥ 18 and ≤ 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 RCT.
• 5. No drug compliance to previous treatment.
• 6. No national health insurance affiliation

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 65 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Assistance Publique - Hôpitaux de Paris

Overall Clinical Trial Officials and Contacts

Anne-Catherine BACHOUD LEVI, PH Principal Investigator Assistance Publique - Hôpitaux de Paris  

Overall Contact: Bachoud-Levi Anne-Catherine, PH +33 (0)1 49 81 23 01 bachoud@gmail.com

Information obtained from ClinicalTrials.gov on October 10, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00632645

Study ID Number: P060211

ClinicalTrials.gov Identifier: NCT00632645

Health Authority: France: Ministry of Health