Neuroleptic and Huntington Disease Comparison of : Olanzapine, la Tetrabenazine and Tiapride (NEUROHD)
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Huntington Disease |
Drug: Zyprexa Drug: Xenazine Drug: Tiapride |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Neuroleptic and Huntington Disease. Comparison of : Olanzapine, la Tetrabenazine and Tiapride. A Multicentric, Randomised, Controlled Study. |
- the Independence scale [ Time Frame: at 12 month ] [ Designated as safety issue: Yes ]
- motor scale [ Time Frame: at 3, 6, 9 and 12 month ] [ Designated as safety issue: Yes ]
- Psychiatric scale [ Time Frame: at 3, 6, 9 and 12 month ] [ Designated as safety issue: Yes ]
- cognitive function scale [ Time Frame: at 3, 6, 9 and 12 month ] [ Designated as safety issue: Yes ]
- metabolic parameters [ Time Frame: at 3, 6, 9 and 12 month ] [ Designated as safety issue: Yes ]
- tolerance [ Time Frame: at 3, 6, 9 and 12 month ] [ Designated as safety issue: Yes ]
- cost [ Time Frame: at 3, 6, 9 and 12 month ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 180 |
| Study Start Date: | May 2009 |
| Estimated Study Completion Date: | March 2013 |
| Estimated Primary Completion Date: | March 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 1
zyprexa
|
Drug: Zyprexa
Zyprexa VELOTABS (Olanzapine) oral dispersible form 5 to 10 mg / 5 à 20 mg per day
Other Name: olanzapine
|
|
Active Comparator: 2
Xenazine
|
Drug: Xenazine
Xenazine (tetrabenazine) tabs of 25mg , from 25 mg to 200 mg
Other Name: tetrabenazine
|
|
Active Comparator: 3
Tiapride
|
Drug: Tiapride
Tiapride (Tiapridal), tabs 100 mg / from 300 to 800 mg per day
Other Name: tiapridal
|
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, psychiatric and cognitive functions, metabolic parameters, tolerance and cost.
Eligibility| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Symptomatic disease with motor, behavioural and/or psychiatric disorder required medical treatment.
- HD diagnosed with abnormal number of CAG repeats: 38 ≤ CAG (amendment n°5 suppressed the limit ≤ 48)
- Neuroleptic Prescription required.
- Age between ≥ 18 (amendment n°5 suppressed the limit ≤ 65 ans)
- Patient gave its written consent
Exclusion Criteria:
- Severe cognitive impairment or neuropsychiatric troubles.
- Existing diabetes.
- Neuroleptic prescription forbidden according to the neurologist decision.
- Current participation to another RCT.
- No drug compliance to previous treatment.
- No national health insurance affiliation
Contacts and Locations| Contact: Bachoud-Levi Anne-Catherine, PH | +33 (0)1 49 81 23 01 | bachoud@gmail.com |
| Contact: Rialland Amandine | (0)1 49 81 36 24 ext + 33 | amandine.rialland@hmn.aphp.fr |
| France | |
| CHU Henri Mondor | Recruiting |
| Creteil, France, 94 | |
| Contact: Anne Catherine BACHOUD-LEVI, PH +33(0) 1 49 81 27 67 bachoud@gmail.com | |
| Principal Investigator: Anne Catherine Bachoud-Lévi, PH | |
| Principal Investigator: | Anne-Catherine BACHOUD LEVI, PH | Assistance Publique - Hôpitaux de Paris |
More Information
No publications provided
| Responsible Party: | Assistance Publique - Hôpitaux de Paris |
| ClinicalTrials.gov Identifier: | NCT00632645 History of Changes |
| Other Study ID Numbers: | P060211 |
| Study First Received: | February 29, 2008 |
| Last Updated: | November 19, 2012 |
| Health Authority: | France: Ministry of Health |
Keywords provided by Assistance Publique - Hôpitaux de Paris:
|
Huntington Neuroleptic UHDRS Independence Scale Neuroleptic Prescription required |
Additional relevant MeSH terms:
|
Huntington Disease Basal Ganglia Diseases Brain Diseases Central Nervous System Diseases Nervous System Diseases Dementia Chorea Dyskinesias Movement Disorders Heredodegenerative Disorders, Nervous System Neurodegenerative Diseases Genetic Diseases, Inborn Cognition Disorders Delirium, Dementia, Amnestic, Cognitive Disorders Mental Disorders |
Tetrabenazine Tiapride Olanzapine Antipsychotic Agents Adrenergic Uptake Inhibitors Adrenergic Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Neurotransmitter Uptake Inhibitors Physiological Effects of Drugs Tranquilizing Agents Central Nervous System Depressants Central Nervous System Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on June 18, 2013