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Symptomatic Therapy for Patients With Huntington's Disease

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

Status
UNKNOWN
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04071639
Enrollment
60
Registered
2019-08-28
Start date
2020-03-12
Completion date
2024-12-31
Last updated
2021-04-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Huntington Disease

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.

Interventions

DRUGHaloperidol 2Mg Tab

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

DRUGRisperidone 1Mg Tab

Risperidone take 1mg once at night.

Zoloft take 50mg once in the morning.

DRUGIdebenone

Idebebone take 30mg three times a day.

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.

Sponsors

Second Affiliated Hospital, School of Medicine, Zhejiang University
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Intervention 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).

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

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 \-

Design outcomes

Primary

MeasureTime frameDescription
The Unified Huntington's Disease Rating ScaleFive yearsThe 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

MeasureTime frameDescription
Brain MRIFive yearsBrain MRI is used to assess the atrophy of caudate nucleus and cortex in HD patients

Countries

China

Contacts

Primary ContactZhi-Ying Wu, MD
zhiyingwu@zju.edu.cn0086-571-87783569
Backup ContactXiao-Yan Li
827011044@qq.com0086-17816872805

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026