Back to resultsSymptomatic Therapy for Patients With Huntington's Disease
Primary Purpose
Huntington Disease
Status
Recruiting
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
Haloperidol 2Mg Tab
Risperidone 1Mg Tab
Zoloft 50Mg Tablet
Idebenone
Deutetrabenazine Oral Tablet [Austedo]
Sponsored by
About this trial
This is an interventional treatment trial for Huntington Disease
Eligibility Criteria
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
-
Sites / Locations
- Second Affiliated Hospital,Zhejiang University School of MedicineRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Group 1
Group 2
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Brain MRI
Brain MRI is used to assess the atrophy of caudate nucleus and cortex in HD patients
Full Information
NCT ID
NCT04071639
First Posted
August 26, 2019
Last Updated
March 30, 2021
Sponsor
Second Affiliated Hospital, School of Medicine, Zhejiang University
1. Study Identification
Unique Protocol Identification Number
NCT04071639
Brief Title
Symptomatic Therapy for Patients With Huntington's Disease
Official Title
Non-randomized Control Clinical Trial to Evaluate the Efficacy and Safety of Symptomatic Drug Therapy for Mild to Moderate Huntington's Disease Patients
Study Type
Interventional
2. Study Status
Record Verification Date
March 2021
Overall Recruitment Status
Recruiting
Study Start Date
March 12, 2020 (Actual)
Primary Completion Date
December 31, 2024 (Anticipated)
Study Completion Date
December 31, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Second Affiliated Hospital, School of Medicine, Zhejiang University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Huntington Disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
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)
Allocation
Non-Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Group 1
Arm Type
Experimental
Arm Description
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.
Arm Title
Group 2
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Haloperidol 2Mg Tab
Other Intervention Name(s)
Haloperidol Tables, H31021234
Intervention Description
Haloperidol take 0.5mg~2mg three time a day.
Intervention Type
Drug
Intervention Name(s)
Risperidone 1Mg Tab
Other Intervention Name(s)
Risperidone, H20010309
Intervention Description
Risperidone take 1mg once at night.
Intervention Type
Drug
Intervention Name(s)
Zoloft 50Mg Tablet
Other Intervention Name(s)
Sertraline Hydrochloride Tablets, H10980141
Intervention Description
Zoloft take 50mg once in the morning.
Intervention Type
Drug
Intervention Name(s)
Idebenone
Other Intervention Name(s)
Idebenone,H10970363
Intervention Description
Idebebone take 30mg three times a day.
Intervention Type
Drug
Intervention Name(s)
Deutetrabenazine Oral Tablet [Austedo]
Other Intervention Name(s)
Deutetrabenazine
Intervention Description
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.
Primary Outcome Measure Information:
Title
The Unified Huntington's Disease Rating Scale
Description
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.
Time Frame
Five years
Secondary Outcome Measure Information:
Title
Brain MRI
Description
Brain MRI is used to assess the atrophy of caudate nucleus and cortex in HD patients
Time Frame
Five years
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
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
-
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Zhi-Ying Wu, MD
Phone
0086-571-87783569
Email
zhiyingwu@zju.edu.cn
First Name & Middle Initial & Last Name or Official Title & Degree
Xiao-Yan Li
Phone
0086-17816872805
Email
827011044@qq.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Zhi-Ying Wu
Organizational Affiliation
Second affiliated Hospital, Zhejiang University School of Medicine
Official's Role
Study Chair
Facility Information:
Facility Name
Second Affiliated Hospital,Zhejiang University School of Medicine
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310009
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zhi-Ying Wu, MD&PhD
Phone
+86-571-87783569
Email
zhiyingwu@zju.edu.cn
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Symptomatic Therapy for Patients With Huntington's Disease
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