Symptomatic Therapy for Patients With Huntington's Disease

Zhejiang University

Status and phase: Enrolling; Phase 1

Conditions: Huntington Disease

Treatments: Drug: Risperidone 1Mg Tab; Drug: Zoloft 50Mg Tablet; Drug: Idebenone; Drug: Haloperidol 2Mg Tab; Drug: Deutetrabenazine Oral Tablet [Austedo]

Study type: Interventional

Funder types: Other

Identifiers

NCT04071639

2019238

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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60 participants in 2 patient groups

Group 1

Experimental group

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.

Treatment:

Drug: Deutetrabenazine Oral Tablet [Austedo]

Drug: Idebenone

Drug: Zoloft 50Mg Tablet

Drug: Risperidone 1Mg Tab

Group 2

Experimental group

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.

Treatment:

Drug: Haloperidol 2Mg Tab

Drug: Idebenone

Drug: Zoloft 50Mg Tablet

Drug: Risperidone 1Mg Tab