Symptomatic Therapy for Patients With Huntington's Disease

NCT ID: NCT04071639

Last Updated: 2021-04-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE1

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-03-12

Study Completion Date

2024-12-31

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.

Conditions

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Huntington Disease

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

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).
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Group 1

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.

Group Type EXPERIMENTAL

Risperidone 1Mg Tab

Intervention Type DRUG

Risperidone take 1mg once at night.

Zoloft 50Mg Tablet

Intervention Type DRUG

Zoloft take 50mg once in the morning.

Idebenone

Intervention Type DRUG

Idebebone take 30mg three times a day.

Deutetrabenazine Oral Tablet [Austedo]

Intervention Type 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.

Group 2

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.

Group Type EXPERIMENTAL

Haloperidol 2Mg Tab

Intervention Type DRUG

Haloperidol take 0.5mg\~2mg three time a day.

Risperidone 1Mg Tab

Intervention Type DRUG

Risperidone take 1mg once at night.

Zoloft 50Mg Tablet

Intervention Type DRUG

Zoloft take 50mg once in the morning.

Idebenone

Intervention Type DRUG

Idebebone take 30mg three times a day.

Interventions

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Haloperidol 2Mg Tab

Haloperidol take 0.5mg\~2mg three time a day.

Intervention Type DRUG

Risperidone 1Mg Tab

Risperidone take 1mg once at night.

Intervention Type DRUG

Zoloft 50Mg Tablet

Zoloft take 50mg once in the morning.

Intervention Type DRUG

Idebenone

Idebebone take 30mg three times a day.

Intervention Type DRUG

Deutetrabenazine Oral Tablet [Austedo]

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.

Intervention Type DRUG

Other Intervention Names

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Haloperidol Tables, H31021234 Risperidone, H20010309 Sertraline Hydrochloride Tablets, H10980141 Idebenone,H10970363 Deutetrabenazine

Eligibility Criteria

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Inclusion Criteria

1. Genetic diagnosis of Huntington's disease
2. Symptomatic patients with Huntington's disease
3. 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

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Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Second Affiliated Hospital, School of Medicine, Zhejiang University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Zhi-Ying Wu

Role: STUDY_CHAIR

Second affiliated Hospital, Zhejiang University School of Medicine

Locations

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Second Affiliated Hospital,Zhejiang University School of Medicine

Hangzhou, Zhejiang, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Zhi-Ying Wu, MD

Role: CONTACT

0086-571-87783569

Xiao-Yan Li

Role: CONTACT

0086-17816872805

Facility Contacts

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Zhi-Ying Wu, MD&PhD

Role: primary

+86-571-87783569

Other Identifiers

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2019238

Identifier Type: -

Identifier Source: org_study_id

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