A Study to Evaluate the Efficacy and Safety of HRG2010 in Parkinson's Disease With Motor Fluctuations

Study Results

Results pending

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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Recruitment Status

RECRUITING

Clinical Phase

PHASE3

Total Enrollment

450 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-11-06

Study Completion Date

2027-02-14

Brief Summary

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The study is a multicenter, randomized, double-blind, double-dummy, active-controlled, Phase III clinical study. The aim of this trial is to evaluated the efficacy and assessed the safety of HRG2010 compared with a sustained-release cabridopa-levodopa formulation in Parkinson's Disease With Motor Fluctuations.

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Detailed Description

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Conditions

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Parkinson's Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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HRG2010 and Sustained-release Carbidopa/Levodopa administered placebo

Group Type EXPERIMENTAL

HRG2010; Sustained-release Carbidopa/Levodopa administered placebo

Intervention Type DRUG

Subjects will receive HRG2010 and Sustained-release Carbidopa/Levodopa administered placebo administered orally.

Sustained-release Carbidopa/Levodopa and HRG2010 placebo

Group Type ACTIVE_COMPARATOR

Sustained-release Carbidopa/Levodopa; HRG2010 placebo

Intervention Type DRUG

Subjects will receive Sustained-release Carbidopa/Levodopa and HRG2010 placebo administered orally.

Interventions

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HRG2010; Sustained-release Carbidopa/Levodopa administered placebo

Subjects will receive HRG2010 and Sustained-release Carbidopa/Levodopa administered placebo administered orally.

Intervention Type DRUG

Sustained-release Carbidopa/Levodopa; HRG2010 placebo

Subjects will receive Sustained-release Carbidopa/Levodopa and HRG2010 placebo administered orally.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

1. Male or female who are at age 40\~80 years with PD, consistent with the International Parkinson and Movement Disorder Society Clinical Diagnostic Criteria and who are being treated with stable regimens of DDCI+LD but experiencing motor fluctuations.
2. Mini Mental State Examination (MMSE) ≥ 24 at Screening Visit.
3. Hoehn and Yahr Stage I-IV when "on" at Screening Visit.
4. At Screening, the participant has predictable "Off" periods.
5. Able and willing to provide a written informed consent.

Exclusion Criteria

1. Diagnosed with atypical or secondary parkinsonism.
2. History of narrow angle glaucoma、peptic ulcer disease or upper gastrointestinal hemorrhage.
3. Had prior functional neurosurgical treatment for PD or if such procedure(s) are planned or anticipated during the study period.
4. Nonresponsive to LD therapy.
5. In the opinion of the clinical investigator, Subjects who should not participate in the study.
6. Subjects who are allergic to the investigational drug to be used in this study.
7. Pregnant or breastfeeding.
8. Participants who have previously participated in an HRG2010 study.

Minimum Eligible Age

40 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No