Symptomatic Therapy for Patients With Huntington's Disease

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Non-randomized Control Clinical Trial to Evaluate the Efficacy and Safety of Symptomatic Drug Therapy for Mild to Moderate Huntington's Disease Patients

Conditions
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Huntington Disease

Intervention / Treatment
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* Drug: Haloperidol 2Mg Tab
* Drug: Risperidone 1Mg Tab
* Drug: Zoloft 50Mg Tablet
* Drug: Idebenone
* Drug: Deutetrabenazine Oral Tablet [Austedo]


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Genetic diagnosis of Huntington's disease Symptomatic patients with Huntington's disease Disease duration less than 5 years - 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 -
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Interventional Model Description: 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).
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group 1<br>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. | Drug: Risperidone 1Mg Tab<br>* Risperidone take 1mg once at night.<br>* Other names: Risperidone, H20010309;Drug: Zoloft 50Mg Tablet<br>* Zoloft take 50mg once in the morning.<br>* Other names: Sertraline Hydrochloride Tablets, H10980141;Drug: Idebenone<br>* Idebebone take 30mg three times a day.<br>* Other names: Idebenone,H10970363;Drug: Deutetrabenazine Oral Tablet [Austedo]<br>* 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.<br>* Other names: Deutetrabenazine;|
| Experimental: Group 2<br>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. | Drug: Haloperidol 2Mg Tab<br>* Haloperidol take 0.5mg 2mg three time a day.<br>* Other names: Haloperidol Tables, H31021234;Drug: Risperidone 1Mg Tab<br>* Risperidone take 1mg once at night.<br>* Other names: Risperidone, H20010309;Drug: Zoloft 50Mg Tablet<br>* Zoloft take 50mg once in the morning.<br>* Other names: Sertraline Hydrochloride Tablets, H10980141;Drug: Idebenone<br>* Idebebone take 30mg three times a day.<br>* Other names: Idebenone,H10970363;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Brain MRI | Brain MRI is used to assess the atrophy of caudate nucleus and cortex in HD patients | Five years |