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Symptomatic Therapy for Patients With Huntington's Disease

Sponsor
Second Affiliated Hospital, School of Medicine, Zhejiang University (Other)
Overall Status
Recruiting
CT.gov ID
NCT04071639
Collaborator
(none)
60
Enrollment
1
Location
2
Arms
57.7
Anticipated Duration (Months)
1
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Haloperidol 2Mg Tab
  • Drug: Risperidone 1Mg Tab
  • Drug: Zoloft 50Mg Tablet
  • Drug: Idebenone
  • Drug: Deutetrabenazine Oral Tablet [Austedo]
 Phase 1

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
60 participants
Allocation:
Non-Randomized
Intervention Model:
Single Group Assignment
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).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)
Primary Purpose:
Treatment
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
Actual Study Start Date :
Mar 12, 2020
Anticipated Primary Completion Date :
Dec 31, 2024
Anticipated Study Completion Date :
Dec 31, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: 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.

Drug: Risperidone 1Mg Tab
Risperidone take 1mg once at night.
Other Names:
  • Risperidone, H20010309

    • Drug: Zoloft 50Mg Tablet
    Zoloft take 50mg once in the morning.
    Other Names:
  • Sertraline Hydrochloride Tablets, H10980141

    • Drug: Idebenone
    Idebebone take 30mg three times a day.
    Other Names:
  • Idebenone,H10970363

    • 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.
    Other Names:
  • Deutetrabenazine

    		•
    Experimental: 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.

    Drug: Haloperidol 2Mg Tab
    Haloperidol take 0.5mg~2mg three time a day.
    Other Names:
  • Haloperidol Tables, H31021234

    • Drug: Risperidone 1Mg Tab
    Risperidone take 1mg once at night.
    Other Names:
  • Risperidone, H20010309

    • Drug: Zoloft 50Mg Tablet
    Zoloft take 50mg once in the morning.
    Other Names:
  • Sertraline Hydrochloride Tablets, H10980141

    • Drug: Idebenone
    Idebebone take 30mg three times a day.
    Other Names:
  • Idebenone,H10970363

    		•

    Outcome Measures

    Primary Outcome Measures

    1. The Unified Huntington's Disease Rating Scale [Five years]

      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

    1. Brain MRI [Five years]

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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A and Older
    Sexes Eligible for Study:
    All
    Accepts 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

    -

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Second Affiliated Hospital,Zhejiang University School of Medicine Hangzhou Zhejiang China 310009

    Sponsors and Collaborators

    • Second Affiliated Hospital, School of Medicine, Zhejiang University

    Investigators

    • Study Chair: Zhi-Ying Wu, Second affiliated Hospital, Zhejiang University School of Medicine

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Second Affiliated Hospital, School of Medicine, Zhejiang University
    ClinicalTrials.gov Identifier:
    NCT04071639
    Other Study ID Numbers:
    • 2019238
    First Posted:
    Aug 28, 2019
    Last Update Posted:
    Apr 2, 2021
    Last Verified:
    Mar 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Huntington Disease
    Ubiquinone
    Haloperidol
    Risperidone
    Haloperidol decanoate
    Sertraline
    Tetrabenazine
    Idebenone

    Study Results

    No Results Posted as of Apr 2, 2021