Symptomatic Therapy for Patients With Huntington's Disease

NCT04071639 | Unknown Phase 1 DMC

• 1 other identifier: 2019238
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Huntington Disease

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Brain MRI

  Five years

Study Arms (2)

Group 1

EXPERIMENTAL

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; Drug: Zoloft 50Mg Tablet; Drug: Idebenone; Drug: Deutetrabenazine Oral Tablet [Austedo]

Group 2

EXPERIMENTAL

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; Drug: Risperidone 1Mg Tab; Drug: Zoloft 50Mg Tablet; Drug: Idebenone

Interventions

Haloperidol 2Mg Tab DRUG

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

Also known as: Haloperidol Tables, H31021234

Group 2

Risperidone 1Mg Tab DRUG

Risperidone take 1mg once at night.

Also known as: Risperidone, H20010309

Group 1; Group 2

Zoloft 50Mg Tablet DRUG

Zoloft take 50mg once in the morning.

Also known as: Sertraline Hydrochloride Tablets, H10980141

Group 1; Group 2

Idebenone DRUG

Idebebone take 30mg three times a day.

Also known as: Idebenone,H10970363

Group 1; Group 2

Deutetrabenazine Oral Tablet [Austedo] DRUG

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.

Also known as: Deutetrabenazine

Group 1

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Genetic diagnosis of Huntington's disease
• Symptomatic patients with Huntington's disease
• Disease duration less than 5 years -

You may not qualify if:

• (1) Movement disorder due to other definite causes instead of Huntington's disease (2) Severe Lung, kidney or liver disease (3) Neoplastic Disease

Sponsors & Collaborators

• Second Affiliated Hospital, School of Medicine, Zhejiang University: lead

Study Sites (1)

Second Affiliated Hospital,Zhejiang University School of Medicine

Hangzhou, Zhejiang, 310009, China

RECRUITING

MeSH Terms

Conditions

Huntington Disease

Interventions

Haloperidol; Risperidone; Sertraline; Tablets; idebenone; deutetrabenazine

Condition Hierarchy (Ancestors)

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; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Butyrophenones; Ketones; Organic Chemicals; Pyrimidinones; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; 1-Naphthylamine; Amines; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Polycyclic Compounds; Dosage Forms; Pharmaceutical Preparations

Study Officials

• Zhi-Ying Wu

  Second affiliated Hospital, Zhejiang University School of Medicine

  STUDY CHAIR

Central Study Contacts

Zhi-Ying Wu, MD

CONTACT

0086-571-87783569; zhiyingwu@zju.edu.cn

Xiao-Yan Li

CONTACT

0086-17816872805; 827011044@qq.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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).

Study Record Dates

• First Submitted: August 26, 2019
• First Posted: August 28, 2019
• Study Start: March 12, 2020
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: April 2, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)