Pharmacokinetics,Pharmacodynamics,Efficacy and Safety of HRG2010 in Parkinson's Disease Patients With Motor Fluctuations

A Randomized, Open-label, Controlled, Single-dose, Multiple-dose Phase II Study to Evaluate the Pharmacokinetics,Pharmacodynamics,Efficacy and Safety of HRG2010 in Parkinson's Disease Patients With Motor Fluctuations

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT06614153

Enrollment

Registered

2024-09-26

Start date

2023-05-16

Completion date

2024-03-04

Last updated

2024-09-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Parkinson's Disease

Brief summary

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

Interventions

DRUGHRG2010(I)

HRG2010(I)

DRUGHRG2010(II)

HRG2010(II)

DRUGSustained-release Carbidopa/Levodopa

Sustained-release Carbidopa/Levodopa

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

40 Years to 75 Years

Healthy volunteers

Inclusion criteria

1. Male or female participants diagnosed at age ≥ 40 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) ≥ 25 at Screening Visit. 3. Hoehn and Yahr Stage II-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. Female who is pregnant, breast-feeding or intends to become pregnant or is of childbearing potential and not using an adequate contraceptive method. 5. In the opinion of the clinical investigator, Subjects who should not participate in the study.

Design outcomes

Primary

Measure	Time frame
Change from baseline in average percent Off time during waking hours at Day 33	Last three days collected at the end of treatment period

Secondary

Measure	Time frame
Off andOn time hours during in clinic observation	Days 1 and 13
MDS-UPDRS Part III	Days 1 and 33
Change from baseline in Off time at Day 33	Last three days collected at the end of treatment period
Change from baseline in the Movement Disorders Society Version of the Unified Parkinson's Disease Rating Scale (MDS-UPDRS) at Day 33	Day 33

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026