A Phase 1 interventional study of Haloperidol 2Mg Tab and Risperidone 1Mg Tab in Huntington Disease, sponsored by Second Affiliated Hospital, School of Medicine, Zhejiang University. Status unknown at 1 site in China. Per ClinicalTrials.gov, last updated 2021-04-02.
Sponsored by Second Affiliated Hospital, School of Medicine, Zhejiang University · Phase 1, Interventional, and Treatment
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.
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.
285 studies on the registry are indexed under Huntington Disease; 49 are open to participants now.
This study's planned enrollment of 60 is above the median of 40 across 203 interventional studies indexed under Huntington Disease.
Browse Huntington Disease studies →Second Affiliated Hospital, School of Medicine, Zhejiang University is the lead sponsor of 1,058 studies on the registry; 511 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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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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]
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
Haloperidol take 0.5mg\~2mg three time a day.
Also known as: Haloperidol Tables, H31021234
Risperidone take 1mg once at night.
Also known as: Risperidone, H20010309
Zoloft take 50mg once in the morning.
Also known as: Sertraline Hydrochloride Tablets, H10980141
Idebebone take 30mg three times a day.
Also known as: Idebenone,H10970363
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
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.
Time frame: Five years
Brain MRI
Brain MRI is used to assess the atrophy of caudate nucleus and cortex in HD patients
Time frame: Five years
Plan to share: No
No publications or documents are linked to this record.
This study is status unknown, as verified in Mar 2021. You cannot join it, but the record below documents what was studied.
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Second Affiliated Hospital, School of Medicine, Zhejiang University