Back to resultsA Study of the Efficacy and Safety of Carbidopa-Levodopa Extended-Release Tablets in Patients With Parkinson's Disease
Primary Purpose
Parkinson Disease
Status
Unknown status
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
WD-1603 Carbidopa-Levodopa Extended-Release Tablets
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Parkinson Disease focused on measuring WD-1603, Carbidopa-Levodopa Extended-Release Tablets
Eligibility Criteria
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.
Sites / Locations
- Shanghai Huashan HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Experimental
Placebo Comparator
Arm Label
25/100mg treatment group
25/150mg treatment group
2x25/100mg treatment group
placebo group
Arm Description
25/100mg WD-1603
25/150mg WD-1603
2x25/100mg WD-1603
placebo are tablets-matching with the same active groups.
Outcomes
Primary Outcome Measures
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.
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.
Secondary Outcome Measures
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.
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.
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.
Complete the MDS-Unified Parkinson's Disease Rating Scale-Part II (MDS-UPDRS-II) assessment on the morning of each visiting period.
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.
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.
To evaluate Cmax
To evaluate Cmax (Maximum Plasma Concentration) of the pharmacokinetics of WD-1603 on the 28th day.
To evaluate Cmin
To evaluate Cmin (Minimum Plasma Concentration) of the pharmacokinetics of WD-1603 on the 28th day.
To evaluate the AUC
To evaluate the AUC (Area under the plasma concentration versus time curve) of the pharmacokinetics of WD-1603 on the 28th day.
To evaluate levodopa blood concentration fluctuation index.
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.
To evaluate reported adverse events (AEs) of WD-1603 in patients with Parkinson's disease.
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.
To evaluate Beck Depression Inventory-II (BDI-II) scale of WD-1603 in patients with Parkinson's disease.
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.
Full Information
NCT ID
NCT05036473
First Posted
August 10, 2021
Last Updated
October 28, 2021
Sponsor
Shanghai WD Pharmaceutical Co., Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT05036473
Brief Title
A Study of the Efficacy and Safety of Carbidopa-Levodopa Extended-Release Tablets in Patients With Parkinson's Disease
Official Title
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 Type
Interventional
2. Study Status
Record Verification Date
August 2021
Overall Recruitment Status
Unknown status
Study Start Date
October 12, 2021 (Actual)
Primary Completion Date
May 16, 2022 (Anticipated)
Study Completion Date
September 16, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Shanghai WD Pharmaceutical Co., Ltd.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
It is 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. The objective of the study is to access the safety and efficacy of WD-1603 carbidopa-levodopa extended-release tablets in patients with Parkinson's disease.
Detailed Description
Eligible subjects of the study will be randomly assigned into four groups at a ratio of 1:1:1:1: three treatment groups and one placebo group. The subjects will take trial drugs 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson Disease
Keywords
WD-1603, Carbidopa-Levodopa Extended-Release Tablets
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Model Description
Active groups are the groups of Parkinson's disease patients who will receive WD-1603 tablets with 3 different dosages.
Placebo group is the group of Parkinson's disease patients who will receive the placebo-matching tablets.
Masking
ParticipantInvestigator
Masking Description
The active drugs and placebo are labeled from the company and the study staff will give the drug to the subjects who are randomized.
Allocation
Randomized
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
25/100mg treatment group
Arm Type
Experimental
Arm Description
25/100mg WD-1603
Arm Title
25/150mg treatment group
Arm Type
Experimental
Arm Description
25/150mg WD-1603
Arm Title
2x25/100mg treatment group
Arm Type
Experimental
Arm Description
2x25/100mg WD-1603
Arm Title
placebo group
Arm Type
Placebo Comparator
Arm Description
placebo are tablets-matching with the same active groups.
Intervention Type
Drug
Intervention Name(s)
WD-1603 Carbidopa-Levodopa Extended-Release Tablets
Other Intervention Name(s)
WD-1603
Intervention Description
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).
Intervention Type
Drug
Intervention Name(s)
Placebo
Other Intervention Name(s)
Placebo of WD-1603
Intervention Description
placebo tablets-matching the active groups.
Primary Outcome Measure Information:
Title
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.
Description
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.
Time Frame
27 days- from the baseline to the 27th day
Secondary Outcome Measure Information:
Title
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.
Description
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.
Time Frame
14 days-from the baseline to the 14th day
Title
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.
Description
Complete the MDS-Unified Parkinson's Disease Rating Scale-Part II (MDS-UPDRS-II) assessment on the morning of each visiting period.
Time Frame
Day -21- -2, Day -1, Day 14, and Day 27
Title
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.
Description
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.
Time Frame
14 days and 27 days-from the baseline to the 14th and 27th day
Title
To evaluate Cmax
Description
To evaluate Cmax (Maximum Plasma Concentration) of the pharmacokinetics of WD-1603 on the 28th day.
Time Frame
1 day- on the 28th day
Title
To evaluate Cmin
Description
To evaluate Cmin (Minimum Plasma Concentration) of the pharmacokinetics of WD-1603 on the 28th day.
Time Frame
1 day- on the 28th day
Title
To evaluate the AUC
Description
To evaluate the AUC (Area under the plasma concentration versus time curve) of the pharmacokinetics of WD-1603 on the 28th day.
Time Frame
1 day- on the 28th day
Title
To evaluate levodopa blood concentration fluctuation index.
Description
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.
Time Frame
1 day- on the 28th day
Title
To evaluate reported adverse events (AEs) of WD-1603 in patients with Parkinson's disease.
Description
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.
Time Frame
28 days-from baseline to the 28th day.
Title
To evaluate Beck Depression Inventory-II (BDI-II) scale of WD-1603 in patients with Parkinson's disease.
Description
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.
Time Frame
28 days-from baseline to the 28th day.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Xiaoxiong(Jim) Wei, MD,PhD
Phone
+86-19957106650
Email
weix@wdpharma.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Xiaoxiong(Jim) Wei, MD,PhD
Organizational Affiliation
Shanghai WD Pharmaceutical Co., Ltd.
Official's Role
Study Director
Facility Information:
Facility Name
Shanghai Huashan Hospital
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200040
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yuran Cao
Phone
021-52888041
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
A Study of the Efficacy and Safety of Carbidopa-Levodopa Extended-Release Tablets in Patients With Parkinson's Disease
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