A Study of the Efficacy and Safety of Carbidopa-Levodopa Extended-Release Tablets in Patients With Parkinson's Disease

NCT05036473 | Unknown Phase 2 FDA Drug

• 1 other identifier: WD-1603-2001
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Parkinson Disease

Keywords

WD-1603; Carbidopa-Levodopa Extended-Release Tablets

Outcome Measures

Primary Outcomes (1)

• 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.

  27 days- from the baseline to the 27th day

Secondary Outcomes (9)

• 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.

  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.

  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.

  14 days and 27 days-from the baseline to the 14th and 27th day

• To evaluate Cmax

  1 day- on the 28th day

• To evaluate Cmin

  1 day- on the 28th day

Study Arms (4)

25/100mg treatment group

EXPERIMENTAL

25/100mg WD-1603

Drug: WD-1603 Carbidopa-Levodopa Extended-Release Tablets

25/150mg treatment group

EXPERIMENTAL

25/150mg WD-1603

Drug: WD-1603 Carbidopa-Levodopa Extended-Release Tablets

2x25/100mg treatment group

EXPERIMENTAL

2x25/100mg WD-1603

Drug: WD-1603 Carbidopa-Levodopa Extended-Release Tablets

placebo group

PLACEBO COMPARATOR

placebo are tablets-matching with the same active groups.

Drug: Placebo

Interventions

WD-1603 Carbidopa-Levodopa Extended-Release Tablets DRUG

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).

Also known as: WD-1603

25/100mg treatment group; 25/150mg treatment group; 2x25/100mg treatment group

Placebo DRUG

placebo tablets-matching the active groups.

Also known as: Placebo of WD-1603

placebo group

Eligibility Criteria

• Age: 30 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shanghai WD Pharmaceutical Co., Ltd.: lead

Study Sites (1)

Shanghai Huashan Hospital

Shanghai, Shanghai Municipality, 200040, China

RECRUITING

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Study Officials

• Xiaoxiong(Jim) Wei, MD,PhD

  Shanghai WD Pharmaceutical Co., Ltd.

  STUDY DIRECTOR

Central Study Contacts

Xiaoxiong(Jim) Wei, MD,PhD

CONTACT

+86-19957106650; weix@wdpharma.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: The active drugs and placebo are labeled from the company and the study staff will give the drug to the subjects who are randomized.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: August 10, 2021
• First Posted: September 5, 2021
• Study Start: October 12, 2021
• Primary Completion: May 16, 2022
• Study Completion: September 16, 2022
• Last Updated: November 1, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)