Symptomatic Therapy for Patients With Huntington's Disease

Huntington Disease Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04071639
• Other study ID #: 2019238
• Status: Recruiting
• Phase: Phase 1
• Start date: March 12, 2020
• Est. completion date: December 31, 2024

Study information

• Verified date: March 2021
• Source: Second Affiliated Hospital, School of Medicine, Zhejiang University
• Contact: Zhi-Ying Wu, MD
• Phone: 0086-571-87783569
• Email: zhiyingwu[@]zju.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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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Related Conditions & MeSH terms

• Huntington Disease

Intervention

Drug:
• Haloperidol 2Mg Tab
Haloperidol take 0.5mg~2mg three time a day.
• Risperidone 1Mg Tab
Risperidone take 1mg once at night.
• Zoloft 50Mg Tablet
Zoloft take 50mg once in the morning.
• Idebenone
Idebebone take 30mg three times a day.
• 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.

Locations

Country	Name	City	State
China	Second Affiliated Hospital,Zhejiang University School of Medicine	Hangzhou	Zhejiang

Sponsors (1)

Lead Sponsor	Collaborator
Second Affiliated Hospital, School of Medicine, Zhejiang University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Brain MRI	Brain MRI is used to assess the atrophy of caudate nucleus and cortex in HD patients	Five years