- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05036473
A Study of the Efficacy and Safety of Carbidopa-Levodopa Extended-Release Tablets in Patients With Parkinson's Disease
A Phase II Randomized, Parallel, Double-blind, Placebo-controlled, Multi-center Clinical Trial of the Efficacy and Safety of WD-1603 Carbidopa-Levodopa Extended-Release Tablets in Patients With Parkinson's Disease
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Anticipated)
Phase
- Phase 2
Contacts and Locations
Study Contact
- Name: Xiaoxiong(Jim) Wei, MD,PhD
- Phone Number: +86-19957106650
- Email: weix@wdpharma.com
Study Locations
-
-
Shanghai
-
Shanghai, Shanghai, China, 200040
- Recruiting
- Shanghai Huashan Hospital
-
Contact:
- Yuran Cao
- Phone Number: 021-52888041
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Male/female patients with early Parkinson's disease who are over 30 years old and under 75 years old (including cut-off values).
- Able to understand and willing to sign an informed consent form (ICF) voluntarily.
- The diagnosis of Parkinson's disease complies with idiopathic Parkinson's disease (2015 version of MDS Parkinson's disease diagnostic criteria).
- Modified Hoehn and Yahr Scale≥1, ≤2.5 points.
- Agree to use medically acceptable contraceptive methods throughout the study and within 1 month after completing the study.
Exclusion Criteria:
- Have a history of severe allergic reactions or allergies to levodopa or carbidopa.
- Pregnancy or breastfeeding.
- Diagnosed as atypical Parkinson's disease or any known secondary Parkinson's syndrome.
- The investigator believes that the placebo treatment cannot be tolerated.
- Acute psychosis or hallucinations, using any antipsychotic to treat psychosis or clinically obvious depression.
- History of epilepsy or epilepsy.
- The history of narrow-angle glaucoma.
- Subjects with a history of malignant melanoma.
- Patients with obvious cognitive impairment.
- The investigator believes that there are clinically significant medical or surgical diseases and patients who are not suitable for participating in clinical trials.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 25/100mg treatment group
25/100mg WD-1603
|
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).
Other Names:
|
Experimental: 25/150mg treatment group
25/150mg WD-1603
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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).
Other Names:
|
Experimental: 2x25/100mg treatment group
2x25/100mg WD-1603
|
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).
Other Names:
|
Placebo Comparator: placebo group
placebo are tablets-matching with the same active groups.
|
placebo tablets-matching the active groups.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
To compare the changes from the baseline mean value before the study to the mean value on the 27th day of the study between each dose group and the placebo group.
Time Frame: 27 days- from the baseline to the 27th day
|
To compare the changes from the baseline mean value before the study to the mean value on the 27th day of the study of the sum of MDS-Unified Parkinson's Disease Rating Scale-Part II (MDS-UPDRS-II) and MDS-Unified Parkinson's Disease Rating Scale-Part III (MDS-UPDRS-III) between each dose group and the placebo group.
MDS-UPDRS-II is Motor Experiences of Daily Living, and MDS-UPDRS-III is Motor Examination.
Each item is rated on a 5-point Likert-type scale (0-4), with higher scores suggesting more severe impairment.
|
27 days- from the baseline to the 27th day
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
To compare the change from the baseline mean value before the study to the mean value on the 14th day of the study between each dose group and the placebo group.
Time Frame: 14 days-from the baseline to the 14th day
|
To compare the changes from the baseline mean value before the study to the mean value on the 14th day of the study of the sum of MDS-Unified Parkinson's Disease Rating Scale-Part II (MDS-UPDRS-II) and MDS-Unified Parkinson's Disease Rating Scale-Part III (MDS-UPDRS-III) between each dose group and the placebo group.
MDS-UPDRS-II is Motor Experiences of Daily Living, and MDS-UPDRS-III is Motor Examination.
Each item is rated on a 5-point Likert-type scale (0-4), with higher scores suggesting more severe impairment.
|
14 days-from the baseline to the 14th day
|
To compare the change from the baseline mean value before the study to the mean value on the 14th and 27th days of the study between each dose group and the placebo group.
Time Frame: Day -21- -2, Day -1, Day 14, and Day 27
|
Complete the MDS-Unified Parkinson's Disease Rating Scale-Part II (MDS-UPDRS-II) assessment on the morning of each visiting period.
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Day -21- -2, Day -1, Day 14, and Day 27
|
To compare the change from the baseline mean value before the study to the mean value on the 14th and 27th days of the study of MDS-UPDRS-III between each dose group and the placebo group.
Time Frame: 14 days and 27 days-from the baseline to the 14th and 27th day
|
During the screening period, an outpatient evaluation is performed before administration.
In the other visit periods, 6 assessments of the MDS-Unified Parkinson's Disease Rating Scale-Part III (MDS-UPDRS-III) are carried out at the time point of the clinical trial administration.
|
14 days and 27 days-from the baseline to the 14th and 27th day
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To evaluate Cmax
Time Frame: 1 day- on the 28th day
|
To evaluate Cmax (Maximum Plasma Concentration) of the pharmacokinetics of WD-1603 on the 28th day.
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1 day- on the 28th day
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To evaluate Cmin
Time Frame: 1 day- on the 28th day
|
To evaluate Cmin (Minimum Plasma Concentration) of the pharmacokinetics of WD-1603 on the 28th day.
|
1 day- on the 28th day
|
To evaluate the AUC
Time Frame: 1 day- on the 28th day
|
To evaluate the AUC (Area under the plasma concentration versus time curve) of the pharmacokinetics of WD-1603 on the 28th day.
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1 day- on the 28th day
|
To evaluate levodopa blood concentration fluctuation index.
Time Frame: 1 day- on the 28th day
|
To evaluate levodopa blood concentration fluctuation index of WD-1603 on the 28th day. Plasma levodopa is summarized according to the blood sampling time point of the protocol; describe and compare the mean of the blood concentration of levodopa and carbidopa in each dose group, and calculate the fluctuation index ([Cmax-Cmin]/Cavg, Cavg= AUC0-t/t), where Cmax is Maximum Plasma Concentration, Cmin is Minimum Plasma Concentration, Cave is Average Plasma Concentration, AUC0-t is Area under the Plasma Concentration versus Time Curve Calculated from 0 to the Last Measurable Observation. |
1 day- on the 28th day
|
To evaluate reported adverse events (AEs) of WD-1603 in patients with Parkinson's disease.
Time Frame: 28 days-from baseline to the 28th day.
|
AEs refer to all adverse medical events in clinical research subjects, which can be manifested as symptoms and signs, diseases, or abnormal laboratory tests, but they may not have a causal relationship with the study drug.
The following must be recorded as AE when at least one of the following criteria is met: 1. Accompanying symptoms and signs; 2. The results of the examination require treatment measures (such as surgical intervention); 3. The result of the inspection leads to changes in the dosing schedule of the study drug (such as dose change, dosing delay, discontinuation) of the study.
The following can be referred to do AE severity classification. 1 (Mild): Asymptomatic or mild; only clinically seen; 2(Moderate): Requires minor, or non-invasive treatment; 3 (Severe): Severe or medically significant but not immediately life-threatening; 4 (Life-threatening): Urgent treatment is needed; 5 (Death): Death related to adverse events.
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28 days-from baseline to the 28th day.
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To evaluate Beck Depression Inventory-II (BDI-II) scale of WD-1603 in patients with Parkinson's disease.
Time Frame: 28 days-from baseline to the 28th day.
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BDI-II scores are collected for safety assessment.
BDI-II is a 21-item self-administered survey which is scored on a scale of 0-3 in a list of four statements arranged in increasing severity about a particular symptom of depression.
Total score of 0-13 is considered minimal range, 14-19 is mild, 20-28 is moderate, and 29-63 is severe.
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28 days-from baseline to the 28th day.
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Collaborators and Investigators
Investigators
- Study Director: Xiaoxiong(Jim) Wei, MD,PhD, Shanghai WD Pharmaceutical Co., Ltd.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
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
- Immunologic Factors
- Dopamine Agonists
- Dopamine Agents
- Adjuvants, Immunologic
- Antiparkinson Agents
- Anti-Dyskinesia Agents
- Aromatic Amino Acid Decarboxylase Inhibitors
- Levodopa
- Carbidopa
- Carbidopa, levodopa drug combination
Other Study ID Numbers
- WD-1603-2001
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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