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

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 Overview

• Status: Recruiting
• Conditions: Parkinson Disease
• Intervention / Treatment: Drug: Stalevo; Drug: Carbidopa and Levodopa Controlled Release Tablets

• Study Type: Interventional
• Enrollment (Anticipated): 180
• Phase: Phase 4

Contacts and Locations

Study Locations

• China
  • Zhejiang
    • Hangzhou, Zhejiang, China, 310009
      • Recruiting
      • Second Affilliated Hospital Zhejiang University
      • Contact: jun tian; Email: tianjun198127@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Stalevo group; Stalevo is taken five times a day, three hours apart. Compare the incidence of dyskinesia.	Drug: 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.; Other Names: Entacapone, Levodopa and Carbidopa Tablets
Active Comparator: Control group; Carbidopa and Levodopa Sustained-release Tablets is taken five times a day, three hours apart. Compare the incidence of dyskinesia.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	1 year

Collaborators and Investigators

• Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2022
• Primary Completion (Anticipated): December 31, 2023
• Study Completion (Anticipated): December 31, 2023

Study Registration Dates

• First Submitted: June 3, 2021
• First Submitted That Met QC Criteria: July 4, 2021
• First Posted (Actual): July 7, 2021

Study Record Updates

• Last Update Posted (Actual): February 16, 2023
• Last Update Submitted That Met QC Criteria: February 14, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Parkinsonian Disorders; Basal Ganglia Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Parkinson Disease; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Dopamine Agents; Antiparkinson Agents; Anti-Dyskinesia Agents; Catechol O-Methyltransferase Inhibitors; Aromatic Amino Acid Decarboxylase Inhibitors; Levodopa; Carbidopa; Entacapone
• Other Study ID Numbers: 2021-0279

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No