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

Hengrui Medicine

Status and phase: Completed; Phase 2

Conditions: Parkinson's Disease

Treatments: Drug: HRG2010(I); Drug: Sustained-release Carbidopa/Levodopa; Drug: HRG2010(II)

Study type: Interventional

Funder types: Industry

Identifiers

NCT06614153

HRG2010-201

Details and patient eligibility

About

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.

Enrollment: 61 patients

Sex: All

Ages: 40 to 75 years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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61 participants in 3 patient groups

Group A，Subjects will receive HRG2010(I)

Experimental group

Description:

administered orally

Treatment:

Drug: HRG2010(I)

Group B，Subjects will receive HRG2010(II)

Experimental group

Description:

administered orally

Treatment:

Drug: HRG2010(II)

Group C，Subjects will receive Sustained-release

Active Comparator group

Description:

Carbidopa/Levodopa administered orally

Treatment:

Drug: Sustained-release Carbidopa/Levodopa