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Completed

NCT Number: NCT06614153

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

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.

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Key information

Conditions

Parkinson's Disease Basal Ganglia Diseases Brain Diseases Central Nervous System Diseases Movement Disorders Nervous System Diseases Neurodegenerative Diseases Parkinson Disease Parkinsonian Disorders Synucleinopathies

Age range

40 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Beijing Hospital

Beijing, Beijing Municipality, 100730, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

HRG2010(I)

Drug

HRG2010(I)

HRG2010(II)

Drug

HRG2010(II)

Sustained-release Carbidopa/Levodopa

Drug

Sustained-release Carbidopa/Levodopa

Primary outcomes

  1. 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

  1. "Off" and"On" time hours during in clinic observation

    Time frame: Days 1 and 13

  2. MDS-UPDRS Part III

    Time frame: Days 1 and 33

  3. Change from baseline in "Off" time at Day 33

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

  4. Change from baseline in the Movement Disorders Society Version of the Unified Parkinson's Disease Rating Scale (MDS-UPDRS) at Day 33

    Time frame: Day 33

Sponsors and collaborators

Lead sponsor

Jiangsu HengRui Medicine Co., Ltd.

Industry

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Sep 26, 2024
Registry last updated
Sep 26, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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