NCT06614153CompletedPhase 2
Pharmacokinetics,Pharmacodynamics,Efficacy and Safety of HRG2010 in Parkinson's Disease Patients With Motor Fluctuations
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
Source: ClinicalTrials.gov · Last updated 26 Sept 2024
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 61 (actual)
- First submitted
- 23 Sept 2024
- Start date
- 16 May 2023
- Primary completion date
- 31 Jan 2024
- Lead sponsor
- Jiangsu HengRui Medicine Co., Ltd.
- Diseases
- Parkinson disease
- NCT number
- NCT06614153
What you commit to
- Study type: Interventional · Phase 2
- Participants enrolled: 61
- From 16 May 2023 to the primary completion date, 31 Jan 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Had prior functional neurosurgical treatment for PD or if such procedure(s) are planned or anticipated during the study period.
Other illness
- History of narrow angle glaucoma、peptic ulcer disease or upper gastrointestinal hemorrhage.
Other
- Diagnosed with atypical or secondary parkinsonism.
- 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.
Who the study is looking for
- 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.
Age in the registry: 40 years to 75 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Beijing Hospital Coordinator of this site? Confirm its status | Beijing | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.