Parkinson DiseasePhase 4NCT04952194
Clinical Study of Stalevo in the Treatment of Early Parkinson's Disease
A Phase 4 study testing Stalevo in people with Parkinson Disease, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
Trial summary
The main goal of PD research is to develop disease-modifying drugs to delay or prevent the underlying neurodegenerative process. Levodopa, as the gold standard for PD treatment, is associated with the occurrence of motor complications. Read more about this study
- Who is it for?
- Ages 30 to 70 years
- Conditions the study is for
- Parkinson Disease
- What is being tested?
- Stalevo
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2022to 31 Dec 2023
- Phase
- Phase 4
- 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 30 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Volunteer to participate in the trial and sign the informed consent
- The enrolled patients were 30 to 70 years old, diagnosed as primary Parkinson's disease according to the 2015 MDS Parkinson's disease diagnostic criteria, H-Y grade <3, and the onset time was less than 5 years
- Patients can take stable dopamine receptor agonists or other anti-Parkinson's disease drugs (drugs have not been adjusted in the past 4 weeks), and have not used amantadine or entacapone within 1 year.
Who cannot join
- Atypical Parkinsonism and Secondary parkinsonism
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Second Affilliated Hospital Zhejiang University
Hangzhou, Zhejiang, 310009
jun tian, tianjun198127@163.com
About this study
The main goal of PD research is to develop disease-modifying drugs to delay or prevent the underlying neurodegenerative process. Levodopa, as the gold standard for PD treatment, is associated with the occurrence of motor complications. Many previous studies have confirmed that Stalevo can reduce the side effects of levodopa alone. Moreover, the effects of Stalevo on the treatment of PD patients have been extensively studied, but the efficacy of Stalevo in early PD patients has been less studied. Therefore, it is necessary to further study the treatment of early PD with Stalevo, and observe whether increasing the number of medication can reduce the occurrence of dyskinesis. The research results will help to deepen the understanding of Stalevo in the treatment of early PD and its clinical efficacy.
- Conditions
- Parkinson Disease
- Being tested
- Stalevo, Carbidopa and Levodopa Controlled Release Tablets
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
StalevoDrug
Also called Entacapone, Levodopa and Carbidopa Tablets
The dose of Stalevo initially ranges from (Levodopa/Carbidopa/Entacapone) 50/12.5/200 mg 3 times a day to a target dose of 100/25/200 mg 5 times a day, with an interval of 3 hours. No other anti-Parkinson's disease drugs are added.
Carbidopa and Levodopa Controlled Release TabletsDrug
The dose of Carbidopa and Levodopa Controlled Release Tablets initially ranges from (Levodopa/Carbidopa) 50/12.5mg 3 times a day to a target dose of 100/25 mg 5 times a day, with an interval of 3 hours. No other anti-Parkinson's disease drugs are added.
| Study group | Role | What they receive |
|---|---|---|
| Stalevo group | Experimental | Stalevo is taken five times a day, three hours apart. Compare the incidence of dyskinesia. Receives: Drug: Stalevo |
| Control group | Active comparator | Carbidopa and Levodopa Sustained-release Tablets is taken five times a day, three hours apart. Compare the incidence of dyskinesia. Receives: Drug: Carbidopa and Levodopa Controlled Release Tablets |
What is being measured
The primary outcome is the main question the study is designed to answer.
The occurrence and frequency of dyskinesia of participants in two groups were assessed by blind method.
The duration of the study is 96 weeks. Follow-up: Baseline, 4 weeks, 8 weeks, 12 weeks, 24 weeks, 36 weeks, 48 weeks, 60 weeks, 72 weeks, 84 weeks, 96 weeks. At each visit, the doctor performs a blind assessment of dyskinesia. The proportion of patients with no dyskinesias in the two groups at each visit was recorded. The Kaplan-Meier line was used to analyze the relationship between the drug and the occurrence of dyskinesia.
Measured: 1 year
The Movement Disorder Society-Sponsored Revision of the Unified Parkinson's Disease Rating Scale (MDS-UPDRS) of participants in two groups were assessed by blind method.
At each visit, the patient completed the MDS-UPDRS. The doctor performs a blind assessment of MDS-UPDRS parts II, III, and IV. MDS-UPDRS part II, Motor Experiences of Daily Living (13 items); part III, Motor Examination (33 items); and part IV, Motor Complications. (6 items). All items have five response options with uniform anchors of 0 = normal, 1 = slight, 2 = mild, 3 = moderate, and 4 = severe. The more severe the symptoms, the higher the score.
Measured: 1 year
The 9-Item Wearing-Off Questionnaire （WOQ-9） score of participants in two groups were assessed by blind method.
During the double-blind period, subjects completed WOQ-9 at each visit. WOQ-9 was used to assess symptoms of wearing-off. The nine symptoms include tremor, anxiety, mood changes, slowness of movement, reduced dexterity, general stiffness, pain/aching, slowness of thinking , and muscle cramping. The presence of one of these symptoms and relief after the next dose is indicative of wearing-off.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2021
- Study start1 Jan 2022
- Primary completion31 Dec 2023 (estimated)
- Study completion31 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04952194
- Sponsor's protocol ID
- 2021-0279
- Status last verified
- Feb 2023
- First submitted
- 3 Jun 2021
- Last updated
- 16 Feb 2023
- Results posted
- No
- 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 16 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study of Stalevo in the Treatment of Early Parkinson's Disease
- ClinicalTrials.gov ID
- NCT04952194
- Acronym / sponsor ID
- 2021-0279
- Conditions
- Parkinson Disease
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of MedicineUniversity, hospital or other
- Study start
- 1 Jan 2022 (actual)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 7 Jul 2021 (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.
The main goal of PD research is to develop disease-modifying drugs to delay or prevent the underlying neurodegenerative process. Levodopa, as the gold standard for PD treatment, is associated with the occurrence of motor complications. Many previous studies have confirmed that Stalevo can reduce the side effects of levodopa alone. Moreover, the effects of Stalevo on the treatment of PD patients have been extensively studied, but the efficacy of Stalevo in early PD patients has been less studied. Therefore, it is necessary to further study the treatment of early PD with Stalevo, and observe whether increasing the number of medication can reduce the occurrence of dyskinesis. The research results will help to deepen the understanding of Stalevo in the treatment of early PD and its clinical efficacy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Stalevo group | Experimental | Drug: StalevoStalevo is taken five times a day, three hours apart. Compare the incidence of dyskinesia. |
| Control group | Active comparator | Drug: Carbidopa and Levodopa Controlled Release TabletsCarbidopa and Levodopa Sustained-release Tablets is taken five times a day, three hours apart. Compare the incidence of dyskinesia. |
Who may qualify
- Ages
- 30 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Volunteer to participate in the trial and sign the informed consent
- The enrolled patients were 30 to 70 years old, diagnosed as primary Parkinson's disease according to the 2015 MDS Parkinson's disease diagnostic criteria, H-Y grade <3, and the onset time was less than 5 years
- Patients can take stable dopamine receptor agonists or other anti-Parkinson's disease drugs (drugs have not been adjusted in the past 4 weeks), and have not used amantadine or entacapone within 1 year.
Key exclusion criteria (1 listed)
- Atypical Parkinsonism and Secondary parkinsonism
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 |
|---|---|---|
| StalevoAlso: Entacapone, Levodopa and Carbidopa TabletsThe dose of Stalevo initially ranges from (Levodopa/Carbidopa/Entacapone) 50/12.5/200 mg 3 times a day to a target dose of 100/25/200 mg 5 times a day, with an interval of 3 hours. No other anti-Parkinson's disease drugs are added. | Drug | Stalevo group |
| Carbidopa and Levodopa Controlled Release TabletsThe dose of Carbidopa and Levodopa Controlled Release Tablets initially ranges from (Levodopa/Carbidopa) 50/12.5mg 3 times a day to a target dose of 100/25 mg 5 times a day, with an interval of 3 hours. No other anti-Parkinson's disease drugs are added. | Drug | Control group |
Primary outcome
The occurrence and frequency of dyskinesia of participants in two groups were assessed by blind method.
Time frame: 1 year
The duration of the study is 96 weeks. Follow-up: Baseline, 4 weeks, 8 weeks, 12 weeks, 24 weeks, 36 weeks, 48 weeks, 60 weeks, 72 weeks, 84 weeks, 96 weeks. At each visit, the doctor performs a blind assessment of dyskinesia. The proportion of patients with no dyskinesias in the two groups at each visit was recorded. The Kaplan-Meier line was used to analyze the relationship between the drug and the occurrence of dyskinesia.
The Movement Disorder Society-Sponsored Revision of the Unified Parkinson's Disease Rating Scale (MDS-UPDRS) of participants in two groups were assessed by blind method.
Time frame: 1 year
At each visit, the patient completed the MDS-UPDRS. The doctor performs a blind assessment of MDS-UPDRS parts II, III, and IV. MDS-UPDRS part II, Motor Experiences of Daily Living (13 items); part III, Motor Examination (33 items); and part IV, Motor Complications. (6 items). All items have five response options with uniform anchors of 0 = normal, 1 = slight, 2 = mild, 3 = moderate, and 4 = severe. The more severe the symptoms, the higher the score.
The 9-Item Wearing-Off Questionnaire （WOQ-9） score of participants in two groups were assessed by blind method.
Time frame: 1 year
During the double-blind period, subjects completed WOQ-9 at each visit. WOQ-9 was used to assess symptoms of wearing-off. The nine symptoms include tremor, anxiety, mood changes, slowness of movement, reduced dexterity, general stiffness, pain/aching, slowness of thinking , and muscle cramping. The presence of one of these symptoms and relief after the next dose is indicative of wearing-off.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Feb 2023.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Stalevo in people with Parkinson 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 1 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 16 Feb 2023. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 JUN TIAN, MD (+8215967109923, tianjun198127@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The occurrence and frequency of dyskinesia of participants in two groups were assessed by blind method. (time frame: 1 year). The study lists 3 primary outcomes in all. 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 16 Feb 2023.