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

Phase 2

Completed

• Conditions: Parkinson's Disease
• Interventions: Drug: HRG2010(I); Drug: HRG2010(II); Drug: Sustained-release Carbidopa/Levodopa

• Registration Number: NCT06614153
• Lead Sponsor: Jiangsu HengRui Medicine Co., Ltd.

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-05-16
• Primary Completion: 2024-01-31
• Study Completion: 2024-03-04
• Status Verified: 2024-09
• Study First Submitted: 2024-09-23
• Study First Submitted QC: 2024-09-23
• Last Update Submitted: 2024-09-23
• Study First Posted: 2024-09-26
• Last Update Posted: 2024-09-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 61

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Group A，Subjects will receive HRG2010(I)	HRG2010(I)	administered orally
Group B，Subjects will receive HRG2010(II)	HRG2010(II)	administered orally
Group C，Subjects will receive Sustained-release	Sustained-release Carbidopa/Levodopa	Carbidopa/Levodopa administered orally

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
"Off" and"On" 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

Trial Locations

Locations (1)

Beijing Hospital; 🇨🇳 Beijing, Beijing, China