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Based on the previous symptomatic treatment of Chinese HD patients, this study intends to further optimize the treatment regimen of Chinese HD patients so as to further improve the prognosis of patients.
The purpose of the study is to evaluate symptomatic treatment regimen efficacy based on different disease stages. We previously used symptomatic treatment on Chinese HD patients and most of them got improved both in the motor symptoms and life quality. So this study intends to further optimize the treatment regimen, and set a control group to further evaluate the treatment efficacy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 | Experimental | Mild to moderate HD patients receive medicine treatment with different doses of Deutetrabenazine(Austedo), Risperidone, Zoloft+Idebenone, according to their symptoms. The mode of administration is oral. Capsules will be swallowed whole with water. Zoloft should be taken 50mg once in the morning and Risperidone 1mg once at night. Deutetrabenazine(Austedo) should be taken 6mg once a day, or increase dose according to AUSTEDO® tablets Prescribing Information. Idebenone should be taken 30mg three times a day. Study drug can be taken irrespective of meals. Duration:5 years. |
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| Group 2 | Experimental | Mild to moderate HD patients receive medicine treatment with different doses of Haloperidol, Risperidone, Zoloft+Idebenone, according to their symptoms. The mode of administration is oral. Capsules will be swallowed whole with water. Haloperidol should be taken 0.5mg~1mg three times a day. The administration of Zoloft, Risperidone and Idebenone are same as group 1. Study drug can be taken irrespective of meals. Duration:5 years. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Haloperidol 2Mg Tab | Drug | Haloperidol take 0.5mg~2mg three time a day. |
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| Measure | Description | Time Frame |
|---|---|---|
| The Unified Huntington's Disease Rating Scale | The Unified Huntington's Disease Rating Scale consist of four subscales, including motor(0-124), MMSE (0-30), psychiatric (0-176), and functional domains(1-13). Four subscale scores are summed to compute a total score. Higher motor and psychiatric scores represent worse outcomes but higher MMSE score and functional scores indicate good outcome. | Five years |
| Measure | Description | Time Frame |
|---|---|---|
| Brain MRI | Brain MRI is used to assess the atrophy of caudate nucleus and cortex in HD patients | Five years |
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Inclusion Criteria:
Exclusion Criteria:
(1) Movement disorder due to other definite causes instead of Huntington's disease (2) Severe Lung, kidney or liver disease (3) Neoplastic Disease
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Zhi-Ying Wu, MD | Contact | 0086-571-87783569 | zhiyingwu@zju.edu.cn | |
| Xiao-Yan Li | Contact | 0086-17816872805 | 827011044@qq.com |
| Name | Affiliation | Role |
|---|---|---|
| Zhi-Ying Wu | Second affiliated Hospital, Zhejiang University School of Medicine | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Second Affiliated Hospital,Zhejiang University School of Medicine | Recruiting | Hangzhou | Zhejiang | 310009 | China |
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| ID | Term |
|---|---|
| D006816 | Huntington Disease |
| ID | Term |
|---|---|
| D001480 | Basal Ganglia Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D006220 | Haloperidol |
| D018967 | Risperidone |
| D020280 | Sertraline |
| D013607 | Tablets |
| C036619 | idebenone |
| C000609690 | deutetrabenazine |
| ID | Term |
|---|---|
| D002090 | Butyrophenones |
| D007659 | Ketones |
| D009930 | Organic Chemicals |
| D011744 | Pyrimidinones |
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Case group use Deutetrabenazine,Risperidone,Zoloft and Idebenone(depending on demand and symptom).
Control group use Haloperidol,Risperidone,Zoloft and Idebenone(depending on demand and symptom).
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| Risperidone 1Mg Tab | Drug | Risperidone take 1mg once at night. |
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| Zoloft 50Mg Tablet | Drug | Zoloft take 50mg once in the morning. |
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| Idebenone | Drug | Idebebone take 30mg three times a day. |
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| Deutetrabenazine Oral Tablet [Austedo] | Drug | The recommended starting dose of Austedo is 6 mg administered orally once daily, and dose may be increased at weekly intervals in increments of 6 mg per day to a maximum recommended daily dosage of 48 mg. |
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| D003704 | Dementia |
| D002819 | Chorea |
| D020820 | Dyskinesias |
| D009069 | Movement Disorders |
| D020271 | Heredodegenerative Disorders, Nervous System |
| D019636 | Neurodegenerative Diseases |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D003072 | Cognition Disorders |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
| D011743 |
| Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D015057 | 1-Naphthylamine |
| D000588 | Amines |
| D009281 | Naphthalenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D011083 | Polycyclic Compounds |
| D004304 | Dosage Forms |
| D004364 | Pharmaceutical Preparations |