Clinical Study of Stalevo in the Treatment of Early Parkinson's Disease

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

180 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-01-01

Study Completion Date

2023-12-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Parkinson Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Stalevo group

Stalevo is taken five times a day, three hours apart. Compare the incidence of dyskinesia.

Group Type EXPERIMENTAL

Stalevo

Intervention Type DRUG

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.

Control group

Carbidopa and Levodopa Sustained-release Tablets is taken five times a day, three hours apart. Compare the incidence of dyskinesia.

Group Type ACTIVE_COMPARATOR

Carbidopa and Levodopa Controlled Release Tablets

Intervention Type DRUG

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.

Interventions

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Stalevo

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.

Intervention Type DRUG

Carbidopa and Levodopa Controlled Release Tablets

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.

Intervention Type DRUG

Other Intervention Names

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Entacapone, Levodopa and Carbidopa Tablets

Eligibility Criteria

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Inclusion Criteria

* 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.