Search / Trial NCT06614153

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

Launched by JIANGSU HENGRUI MEDICINE CO., LTD. · Sep 23, 2024

Trial Information

Current as of December 22, 2024

Completed

Keywords

ClinConnect Summary

No description provided

Gender

ALL

Eligibility criteria

  • 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.

About Jiangsu Hengrui Medicine Co., Ltd.

Jiangsu Hengrui Medicine Co., Ltd. is a leading pharmaceutical company based in China, dedicated to the research, development, manufacturing, and commercialization of innovative therapies across various medical fields, including oncology, anesthesia, and imaging. Established in 1970, Hengrui is committed to advancing healthcare through cutting-edge drug development and a robust pipeline of both novel and generic medications. The company emphasizes rigorous clinical research and adheres to international regulatory standards, positioning itself as a key player in the global pharmaceutical landscape. With a strong focus on quality and patient-centered solutions, Hengrui aims to improve health outcomes and enhance the quality of life for patients worldwide.

Locations

Beijing, Beijing, China

People applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

Discussion 0