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

Jiangsu HengRui Medicine Co., Ltd.1 site in 1 country61 target enrollmentMay 16, 2023

ConditionsParkinson's Disease

InterventionsHRG2010(I)HRG2010(II)Sustained-release Carbidopa/Levodopa

DrugsHRG2010(I)HRG2010(II)Sustained-release Carbidopa/Levodopa

Overview

Phase: Phase 2
Intervention: HRG2010(I)
Conditions: Parkinson's Disease
Sponsor: Jiangsu HengRui Medicine Co., Ltd.
Enrollment: 61
Locations: 1
Primary Endpoint: Change from baseline in average percent "Off" time during waking hours at Day 33
Status: Completed
Last Updated: last year

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

May 16, 2023

End Date

March 4, 2024

Last Updated

last year

Study Type

Interventional

Study Design

Crossover

Sex

All

Investigators

Sponsor

Jiangsu HengRui Medicine Co., Ltd.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•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.
•Mini Mental State Examination (MMSE) ≥ 25 at Screening Visit.
•Hoehn and Yahr Stage II-IV when "on" at Screening Visit.
•At Screening, the participant has predictable "Off" periods.
•Able and willing to provide a written informed consent.

Exclusion Criteria

•Diagnosed with atypical or secondary parkinsonism.
•History of narrow angle glaucoma、peptic ulcer disease or upper gastrointestinal hemorrhage.
•Had prior functional neurosurgical treatment for PD or if such procedure(s) are planned or anticipated during the study period.
•Female who is pregnant, breast-feeding or intends to become pregnant or is of childbearing potential and not using an adequate contraceptive method.
•In the opinion of the clinical investigator, Subjects who should not participate in the study.

Arms & Interventions

Group A，Subjects will receive HRG2010(I)

administered orally

Intervention: HRG2010(I)

Group B，Subjects will receive HRG2010(II)

administered orally

Intervention: HRG2010(II)

Group C，Subjects will receive Sustained-release

Carbidopa/Levodopa administered orally

Intervention: Sustained-release Carbidopa/Levodopa

Outcomes

Primary Outcomes

Change from baseline in average percent "Off" time during waking hours at Day 33

Time Frame: Last three days collected at the end of treatment period

Secondary Outcomes

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)
"Off" and"On" time hours during in clinic observation(Days 1 and 13)
Change from baseline in the Movement Disorders Society Version of the Unified Parkinson's Disease Rating Scale (MDS-UPDRS) at Day 33(Day 33)