A Study of the Efficacy and Safety of Carbidopa-Levodopa Extended-Release Tablets in Patients With Parkinson's Disease
NCT ID: NCT05036473
Last Updated: 2021-11-01
Study Results
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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UNKNOWN
PHASE2
40 participants
INTERVENTIONAL
2021-10-12
2022-09-16
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
Placebo group is the group of Parkinson's disease patients who will receive the placebo-matching tablets.
TREATMENT
DOUBLE
Study Groups
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25/100mg treatment group
25/100mg WD-1603
WD-1603 Carbidopa-Levodopa Extended-Release Tablets
Taking WD-1603 tablets or placebo orally three times a day, in the morning before meals, and the second and third medications will be taken after meals, once every 5 hours (±30 minutes).
25/150mg treatment group
25/150mg WD-1603
WD-1603 Carbidopa-Levodopa Extended-Release Tablets
Taking WD-1603 tablets or placebo orally three times a day, in the morning before meals, and the second and third medications will be taken after meals, once every 5 hours (±30 minutes).
2x25/100mg treatment group
2x25/100mg WD-1603
WD-1603 Carbidopa-Levodopa Extended-Release Tablets
Taking WD-1603 tablets or placebo orally three times a day, in the morning before meals, and the second and third medications will be taken after meals, once every 5 hours (±30 minutes).
placebo group
placebo are tablets-matching with the same active groups.
Placebo
placebo tablets-matching the active groups.
Interventions
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WD-1603 Carbidopa-Levodopa Extended-Release Tablets
Taking WD-1603 tablets or placebo orally three times a day, in the morning before meals, and the second and third medications will be taken after meals, once every 5 hours (±30 minutes).
Placebo
placebo tablets-matching the active groups.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Able to understand and willing to sign an informed consent form (ICF) voluntarily.
3. The diagnosis of Parkinson's disease complies with idiopathic Parkinson's disease (2015 version of MDS Parkinson's disease diagnostic criteria).
4. Modified Hoehn and Yahr Scale≥1, ≤2.5 points.
5. Agree to use medically acceptable contraceptive methods throughout the study and within 1 month after completing the study.
Exclusion Criteria
2. Pregnancy or breastfeeding.
3. Diagnosed as atypical Parkinson's disease or any known secondary Parkinson's syndrome.
4. The investigator believes that the placebo treatment cannot be tolerated.
5. Acute psychosis or hallucinations, using any antipsychotic to treat psychosis or clinically obvious depression.
6. History of epilepsy or epilepsy.
7. The history of narrow-angle glaucoma.
8. Subjects with a history of malignant melanoma.
9. Patients with obvious cognitive impairment.
10. The investigator believes that there are clinically significant medical or surgical diseases and patients who are not suitable for participating in clinical trials.
30 Years
75 Years
ALL
No
Sponsors
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Shanghai WD Pharmaceutical Co., Ltd.
INDUSTRY
Responsible Party
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Principal Investigators
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Xiaoxiong(Jim) Wei, MD,PhD
Role: STUDY_DIRECTOR
Shanghai WD Pharmaceutical Co., Ltd.
Locations
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Shanghai Huashan Hospital
Shanghai, Shanghai Municipality, China
Countries
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Central Contacts
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Facility Contacts
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Yuran Cao
Role: primary
Other Identifiers
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WD-1603-2001
Identifier Type: -
Identifier Source: org_study_id