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

Zhejiang University

Status and phase: Enrolling; Phase 4

Conditions: Parkinson Disease

Treatments: Drug: Carbidopa and Levodopa Controlled Release Tablets; Drug: Stalevo

Study type: Interventional

Funder types: Other

Identifiers

NCT04952194

2021-0279

Details and patient eligibility

About

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.

Enrollment: 180 estimated patients

Sex: All

Ages: 30 to 70 years old

Volunteers: No Healthy Volunteers

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.

Exclusion criteria

• Atypical Parkinsonism and Secondary parkinsonism

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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180 participants in 2 patient groups

Stalevo group

Experimental group

Description:

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

Treatment:

Drug: Stalevo

Control group

Active Comparator group

Description:

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

Treatment:

Drug: Carbidopa and Levodopa Controlled Release Tablets