Parkinson's DiseasePhase 2NCT06614153
Pharmacokinetics,Pharmacodynamics,Efficacy and Safety of HRG2010 in Parkinson's Disease Patients With Motor Fluctuations
A Phase 2 study testing HRG2010(I), HRG2010(II) and Sustained-release Carbidopa/Levodopa in people with Parkinson's Disease, run by Jiangsu HengRui Medicine Co., Ltd. at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 40 to 75 years
- Conditions the study is for
- Parkinson's Disease
- What is being tested?
- HRG2010(I), HRG2010(II) and Sustained-release Carbidopa/Levodopa
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 61 participants
- Where
- 1 siteChina
- Study dates
- 16 May 2023to 4 Mar 2024
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official 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
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.
- Conditions
- Parkinson's Disease
- Being tested
- HRG2010(I), HRG2010(II), Sustained-release Carbidopa/Levodopa
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HRG2010(I)Drug
HRG2010(I)
HRG2010(II)Drug
HRG2010(II)
Sustained-release Carbidopa/LevodopaDrug
Sustained-release Carbidopa/Levodopa
| Study group | Role | What they receive |
|---|---|---|
| Group A，Subjects will receive HRG2010(I) | Experimental | administered orally Receives: Drug: HRG2010(I) |
| Group B，Subjects will receive HRG2010(II) | Experimental | administered orally Receives: Drug: HRG2010(II) |
| Group C，Subjects will receive Sustained-release | Active comparator | Carbidopa/Levodopa administered orally Receives: Drug: Sustained-release Carbidopa/Levodopa |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in average percent "Off" time during waking hours at Day 33
Measured: Last three days collected at the end of treatment period
Secondary outcomes (4)
"Off" and"On" time hours during in clinic observation
Measured: Days 1 and 13
MDS-UPDRS Part III
Measured: Days 1 and 33
Change from baseline in "Off" time at Day 33
Measured: 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
Measured: Day 33
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2024
- Study start16 May 2023
- Primary completion31 Jan 2024
- Study completion4 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson's DiseaseStudies of the same condition, open and under way.
- More trials run by Jiangsu HengRui Medicine Co., Ltd.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 61 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jiangsu HengRui Medicine Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06614153
- Sponsor's protocol ID
- HRG2010-201
- Status last verified
- Sep 2024
- First submitted
- 23 Sep 2024
- Last updated
- 26 Sep 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT06614153
- Acronym / sponsor ID
- HRG2010-201
- Conditions
- Parkinson's Disease
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 61 participants (actual)
- Lead sponsor
- Jiangsu HengRui Medicine Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 16 May 2023 (actual)
- Primary completion
- 31 Jan 2024 (actual)
- Study completion
- 4 Mar 2024 (actual)
- First posted
- 26 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group A，Subjects will receive HRG2010(I) | Experimental | Drug: HRG2010(I)administered orally |
| Group B，Subjects will receive HRG2010(II) | Experimental | Drug: HRG2010(II)administered orally |
| Group C，Subjects will receive Sustained-release | Active comparator | Drug: Sustained-release Carbidopa/LevodopaCarbidopa/Levodopa administered orally |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HRG2010(I)HRG2010(I) | Drug | Group A，Subjects will receive HRG2010(I) |
| HRG2010(II)HRG2010(II) | Drug | Group B，Subjects will receive HRG2010(II) |
| Sustained-release Carbidopa/LevodopaSustained-release Carbidopa/Levodopa | Drug | Group C，Subjects will receive Sustained-release |
Primary outcome
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
4 secondary outcomes
"Off" and"On" time hours during in clinic observation
Time frame: Days 1 and 13
MDS-UPDRS Part III
Time frame: Days 1 and 33
Change from baseline in "Off" time at Day 33
Time frame: 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
Time frame: Day 33
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Sep 2024.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing HRG2010(I), HRG2010(II) and Sustained-release Carbidopa/Levodopa in people with Parkinson's Disease, run by Jiangsu HengRui Medicine Co., Ltd. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Sep 2024.