Huntington DiseasePhase 3NEUROHDNCT00632645
Neuroleptic and Huntington Disease Comparison of : Olanzapine, la Tetrabenazine and Tiapride
A Phase 3 study testing Olanzapine, Xenazine and Tiapridal in people with Huntington Disease, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial 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)… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Huntington Disease
- What is being tested?
- Olanzapine, Xenazine and Tiapridal
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- 1 siteFrance
- Study dates
- Apr 2009to 28 Apr 2017
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Huntington Disease
- Being tested
- Olanzapine, Xenazine, Tiapridal
- Keywords
- Huntington, Neuroleptic, Unified Huntington Disease Rating Scale (UHDRS), Independence Scale, Neuroleptic Prescription required
- Medical subject headings
- Huntington Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OlanzapineDrug
Also called Olanzapine Mylan
Olanzapine Mylan oral dispersible form 5 to 10 mg / 2,5 à 20 mg per day
XenazineDrug
Also called tetrabenazine
Xenazine (tetrabenazine) tabs of 25mg , from 25 mg to 200 mg
TiapridalDrug
Also called tiapride
Tiapridal (Tiapride), tabs 100 mg / from 300 to 800 mg per day
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Olanzapine Mylan Receives: Drug: Olanzapine |
| 2 | Active comparator | Xenazine Receives: Drug: Xenazine |
| 3 | Active comparator | Tiapridal Receives: Drug: Tiapridal |
What is being measured
The primary outcome is the main question the study is designed to answer.
the Independence scale
Measured: at 12 month
Secondary outcomes (7)
motor scale
Measured: at 3, 6, 9 and 12 month
Psychiatric scale
Measured: at 3, 6, 9 and 12 month
cognitive function scale
Measured: at 3, 6, 9 and 12 month
metabolic parameters
Measured: at 3, 6, 9 and 12 month
tolerance
Measured: at 3, 6, 9 and 12 month
cost
Measured: at 3, 6, 9 and 12 month
Function scale (TFC and Functionnal Appreciation Scale)
Measured: at 3, 6, 9 and 12 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2008 (estimated)
- Study startApr 2009
- Primary completion28 Apr 2017
- Study completion28 Apr 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Huntington DiseaseStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 180 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Anne-Catherine BACHOUD LEVI, PH, Principal investigator, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00632645
- Sponsor's protocol ID
- P060211
- Acronym
- NEUROHD
- Status last verified
- Jan 2018
- First submitted
- 29 Feb 2008
- Last updated
- 19 Jan 2018
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 19 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neuroleptic and Huntington Disease. Comparison of : Olanzapine, la Tetrabenazine and Tiapride. A Multicentric, Randomised, Controlled Study.
- ClinicalTrials.gov ID
- NCT00632645
- Acronym / sponsor ID
- NEUROHD / P060211
- Conditions
- Huntington Disease
- Keywords
- Huntington, Neuroleptic, Unified Huntington Disease Rating Scale (UHDRS), Independence Scale, Neuroleptic Prescription required
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 180 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- Apr 2009 (actual)
- Primary completion
- 28 Apr 2017 (actual)
- Study completion
- 28 Apr 2017 (actual)
- First posted
- 11 Mar 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: OlanzapineOlanzapine Mylan |
| 2 | Active comparator | Drug: XenazineXenazine |
| 3 | Active comparator | Drug: TiapridalTiapridal |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OlanzapineAlso: Olanzapine MylanOlanzapine Mylan oral dispersible form 5 to 10 mg / 2,5 à 20 mg per day | Drug | 1 |
| XenazineAlso: tetrabenazineXenazine (tetrabenazine) tabs of 25mg , from 25 mg to 200 mg | Drug | 2 |
| TiapridalAlso: tiaprideTiapridal (Tiapride), tabs 100 mg / from 300 to 800 mg per day | Drug | 3 |
Primary outcome
the Independence scale
Time frame: at 12 month
7 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jan 2018.
Related trials for Huntington Disease
RecruitingPhase 2/3
Study to Evaluate the Pharmacodynamics, Safety and Efficacy of SKY-0515 in Participants With Huntington's Disease
Huntington Disease
RecruitingPhase 3
Pridopidine Phase 3 Study in Huntington's Disease
Huntington Disease
Not yet recruiting
Creatine and Beta-Hydroxy-Beta-Methylbutyrate (HMB) Supplementation Plus Home-Based Exercise for Sarcopenia in Huntington's Disease
Huntington Disease, Sarcopenia
Recruiting
Feasibility and Acceptability of an LLM-based Chatbot for Family Caregivers: Evaluation Study
Caregivers
RecruitingObservational study
Development of Non-Invasive Prenatal Diagnosis for Single Gene Disorders
Invasive PreNatal Diagnosis in a Context of Family History of Single-gene Disorders, Including, Sickle Cell Disease
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anne-Catherine BACHOUD LEVI, PH principal investigator
Assistance Publique - Hôpitaux de Paris
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Olanzapine, Xenazine and Tiapridal in people with Huntington Disease, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the Independence scale (time frame: at 12 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jan 2018.