Huntington DiseasePhase 1NCT04071639
Symptomatic Therapy for Patients With Huntington's Disease
A Phase 1 study testing Haloperidol 2Mg Tab, Risperidone 1Mg Tab and Zoloft 50Mg Tablet in people with Huntington Disease, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Huntington Disease
- What is being tested?
- Haloperidol 2Mg Tab, Risperidone 1Mg Tab and Zoloft 50Mg Tablet
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 12 Mar 2020to 31 Dec 2024
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Genetic diagnosis of Huntington's disease
- Symptomatic patients with Huntington's disease
- Disease duration less than 5 years -
Who cannot join
- Movement disorder due to other definite causes instead of Huntington's disease (2) Severe Lung, kidney or liver disease (3) Neoplastic Disease
- -
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Second Affiliated Hospital,Zhejiang University School of Medicine
Hangzhou, Zhejiang, 310009
Zhi-Ying Wu, MD&PhD, +86-571-87783569, zhiyingwu@zju.edu.cn
About this study
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
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.
Read the 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.
- Conditions
- Huntington Disease
- Being tested
- Haloperidol 2Mg Tab, Risperidone 1Mg Tab, Zoloft 50Mg Tablet, Idebenone, Deutetrabenazine Oral Tablet [Austedo]
- Medical subject headings
- Huntington Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Haloperidol 2Mg TabDrug
Also called Haloperidol Tables, H31021234
Haloperidol take 0.5mg~2mg three time a day.
Risperidone 1Mg TabDrug
Also called Risperidone, H20010309
Risperidone take 1mg once at night.
Zoloft 50Mg TabletDrug
Also called Sertraline Hydrochloride Tablets, H10980141
Zoloft take 50mg once in the morning.
IdebenoneDrug
Also called Idebenone,H10970363
Idebebone take 30mg three times a day.
Deutetrabenazine Oral Tablet [Austedo]Drug
Also called Deutetrabenazine
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: Haloperidol 2Mg Tab; Drug: Risperidone 1Mg Tab; Drug: Zoloft 50Mg Tablet; Drug: Idebenone |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Five years
Secondary outcomes (1)
Brain MRI
Brain MRI is used to assess the atrophy of caudate nucleus and cortex in HD patients
Measured: Five years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2019
- Study start12 Mar 2020
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Huntington DiseaseStudies of the same condition, open and under way.
- More trials run by Second Affiliated Hospital, Zhejiang University, School of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- 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)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Zhi-Ying Wu, Study chair, Second Affiliated Hospital, Zhejiang University, School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04071639
- Sponsor's protocol ID
- 2019238
- Status last verified
- Mar 2021
- First submitted
- 26 Aug 2019
- Last updated
- 2 Apr 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04071639
- Acronym / sponsor ID
- 2019238
- Conditions
- Huntington Disease
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of MedicineUniversity, hospital or other
- Study start
- 12 Mar 2020 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 28 Aug 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
- 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).
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Experimental | 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 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. |
| Group 2 | Experimental | Drug: Haloperidol 2Mg Tab, Drug: Risperidone 1Mg Tab, Drug: Zoloft 50Mg Tablet, Drug: IdebenoneMild 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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Genetic diagnosis of Huntington's disease
- Symptomatic patients with Huntington's disease
- Disease duration less than 5 years -
Key exclusion criteria (2 listed)
- Movement disorder due to other definite causes instead of Huntington's disease (2) Severe Lung, kidney or liver disease (3) Neoplastic Disease
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Haloperidol 2Mg TabAlso: Haloperidol Tables, H31021234Haloperidol take 0.5mg~2mg three time a day. | Drug | Group 2 |
| Risperidone 1Mg TabAlso: Risperidone, H20010309Risperidone take 1mg once at night. | Drug | Group 1, Group 2 |
| Zoloft 50Mg TabletAlso: Sertraline Hydrochloride Tablets, H10980141Zoloft take 50mg once in the morning. | Drug | Group 1, Group 2 |
| IdebenoneAlso: Idebenone,H10970363Idebebone take 30mg three times a day. | Drug | Group 1, Group 2 |
| Deutetrabenazine Oral Tablet [Austedo]Also: DeutetrabenazineThe 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. | Drug | Group 1 |
Primary outcome
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.
1 secondary outcome
Brain MRI
Time frame: Five years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Apr 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Zhi-Ying Wu study chair
Second Affiliated Hospital, Zhejiang University, School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Haloperidol 2Mg Tab, Risperidone 1Mg Tab and Zoloft 50Mg Tablet in people with Huntington Disease, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 2 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Zhi-Ying Wu, MD (0086-571-87783569, zhiyingwu@zju.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Unified Huntington's Disease Rating Scale (time frame: Five years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Apr 2021.