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Symptomatic Therapy for Patients With Huntington's Disease

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ClinicalTrials.gov Identifier: NCT04071639
Recruitment Status : Recruiting
First Posted : August 28, 2019
Last Update Posted : April 2, 2021
Sponsor:
Information provided by (Responsible Party):
Second Affiliated Hospital, School of Medicine, Zhejiang University

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
Huntington Disease 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.

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Study Type : Interventional  (Clinical Trial)
Estimated 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).

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 : March 12, 2020
Estimated Primary Completion Date : December 31, 2024
Estimated Study Completion Date : December 31, 2024

Resource links provided by the National Library of Medicine


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 Name: Risperidone, H20010309

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

Drug: Idebenone
Idebebone take 30mg three times a day.
Other Name: 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 Name: 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 Name: Haloperidol Tables, H31021234

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

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

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




Primary Outcome Measures :
  1. The Unified Huntington's Disease Rating Scale [ Time Frame: 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 [ Time Frame: Five years ]
    Brain MRI is used to assess the atrophy of caudate nucleus and cortex in HD patients



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04071639


Contacts
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Contact: Zhi-Ying Wu, MD 0086-571-87783569 zhiyingwu@zju.edu.cn
Contact: Xiao-Yan Li 0086-17816872805 827011044@qq.com

Locations
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China, Zhejiang
Second Affiliated Hospital,Zhejiang University School of Medicine Recruiting
Hangzhou, Zhejiang, China, 310009
Contact: Zhi-Ying Wu, MD&PhD    +86-571-87783569    zhiyingwu@zju.edu.cn   
Sponsors and Collaborators
Second Affiliated Hospital, School of Medicine, Zhejiang University
Investigators
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Study Chair: Zhi-Ying Wu Second affiliated Hospital, Zhejiang University School of Medicine
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Responsible Party: Second Affiliated Hospital, School of Medicine, Zhejiang University
ClinicalTrials.gov Identifier: NCT04071639    
Other Study ID Numbers: 2019238
First Posted: August 28, 2019    Key Record Dates
Last Update Posted: April 2, 2021
Last Verified: March 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Huntington Disease
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Dementia
Chorea
Dyskinesias
Movement Disorders
Heredodegenerative Disorders, Nervous System
Neurodegenerative Diseases
Genetic Diseases, Inborn
Cognition Disorders
Neurocognitive Disorders
Mental Disorders
Ubiquinone
Haloperidol
Risperidone
Haloperidol decanoate
Sertraline
Tetrabenazine
Idebenone
Serotonin Antagonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants