VG081821AC for Parkinson's (NCT07725562)
Can new medication improve movement
- Trial ID
- NCT07725562
- Official Title
- A Randomized, Double-Blind, Placebo-Controlled, Multicenter Phase IIb Clinical Trial to Evaluate the Efficacy and Safety of Oral VG081821AC Tablets Monotherapy (Without Concomitant Levodopa) in Patients With Early to Mid-Stage Parkinson's Disease
- Goal
- Can new medication improve movement
- Phase
- PHASE2, PHASE3
- Status
- RECRUITING
- Sponsor
- Zhejiang Vimgreen Pharmaceuticals, Ltd.
- Study Type
- INTERVENTIONAL
- Enrollment
- 152 participants
- Conditions
- Parkinson Disease (PD)
- Interventions
- VG081821AC, Placebo
Summary For Families
They are testing whether a new oral medication called VG081821AC can improve movement symptoms in people with early to mid-stage Parkinson's, measured by change on a standard movement exam (MDS-UPDRS Part III) after 12 weeks. VG081821AC works by blocking a brain protein called the adenosine A2A receptor, and the trial gives one of three doses twice daily or a placebo while participants do not take levodopa, so researchers can see if it helps on its own. The study will enroll 152 adults in China, ages 18 to 80, diagnosed within the last seven years with moderate symptoms (stages 1 to 3) and a movement score of at least 22, and who have not used levodopa for at least four weeks.
Eligibility at a Glance
Key requirements found in this trial's official criteria, in plain language. Only what the listing states is shown; the study team makes the final call.
- Disease stage: Stage 1 on the Hoehn and Yahr scale
- Levodopa: Must be taking levodopa (criteria text: "have not taken anti-parkinson drugs containing levodopa within 4 weeks prior to screening \[see main text section 5")
- Time since diagnosis: Diagnosed within the last 7 years (criteria text: "diagnosed with parkinson's disease per the chinese diagnostic criteria for parkinson's disease (2016 edition), and time from initial diagnosis <= 7 years")
- Movement score (MDS-UPDRS): MDS-UPDRS movement score of at least 22 (criteria text: "mds-updrs part iii score >= 22 at screening")
Locations
- Xuanwu Hospital of Capital Medical University, Beijing, China
Making Contact: How to Call This Study Site
Who to ask for
Ask for the study coordinator. Some sites call this person the research coordinator. They are the right person for questions about joining a study. If you reach a front desk or a doctor's office scheduler, ask them to connect you with the research team for this study.
What to say
It is fine to read this out loud, word for word:
Hello, my name is ____. I am calling about a Parkinson's study at your site. The study number is NCT07725562. It is the one about "Can new medication improve movement". Could I speak with the study coordinator about taking part?
If you are calling for a family member, use their name and mention that you help with their care.
What they will ask you
- The year of diagnosis
- Current medications and their doses
- Other health conditions
- Any procedures already done, such as deep brain stimulation (DBS)
- How far you are able to travel for study visits
- Whether a care partner can come to visits with you
What to have ready
- A written list of current medications and doses
- Your neurologist's name and phone number
- The diagnosis date. The year is enough.
- A recent visit summary from the neurologist, if you have one
What to ask them
- How many visits are there, and how long does each visit take? The listing already answers this: You will visit the study center 8 times for study checks. Ask the coordinator to confirm it still applies.
- Is travel, parking, or my time reimbursed?
- Is there a placebo group, and what is my chance of being in it? The listing already answers this: This trial has 4 groups, and 1 is a placebo group. Because assignment is random, you have about a 1 in 4 chance (roughly 25%) of being in the placebo group, assuming the groups are filled equally. Ask the coordinator to confirm the exact assignment ratio.
- Would I need to stop or pause any of my current medications? The listing already answers this: If you previously took levodopa-containing anti-Parkinson drugs, you must have stopped them for a 4-week washout period before screening. Ask the coordinator to confirm it still applies.
- What happens when the study ends? Could I stay on the treatment if it helps?
What to expect
- Expect to wait a few days for a callback. A week is common. Calling or emailing again after that is fine and normal.
- Many callers do not end up joining. Screening out is common and is not a judgment about you or your health.
- Asking questions commits you to nothing. You can stop the process at any point.
Frequently Asked Questions
- What is this trial testing?
- This trial is studying VG081821AC. They are testing whether a new oral medication called VG081821AC can improve movement symptoms in people with early to mid-stage Parkinson's, measured by change on a standard movement exam (MDS-UPDRS Part III) after 12 weeks. VG081821AC works by blocking a brain protein called the adenosine A2A receptor, and the trial gives one of three doses twice daily or a placebo while participants do not take levodopa, so researchers can see if it helps on its own. The study will enroll 152 adults in China, ages 18 to 80, diagnosed within the last seven years with moderate symptoms (stages 1 to 3) and a movement score of at least 22, and who have not used levodopa for at least four weeks.
- Who can participate?
- Participants must be between 18 Years and 80 Years.
- Where is this trial located?
- This trial is recruiting at 1 location.
- Does it cost anything to join?
- You are never charged a fee to join a legitimate clinical trial, and the study treatment and study-specific tests are provided by the trial sponsor at no charge. In the US, routine care you would receive anyway can still be billed to you or your insurance; coverage rules differ by country, and trials in the UK and Canada usually run through public health systems. Travel, parking, and time are real costs, and some trials reimburse them while others do not. Before enrolling, ask the study coordinator to explain in writing what is and is not covered.
- How long does the trial last?
- This Phase 2/Phase 3 trial is estimated to last approximately 1 year and 2 months.
- Can I leave the trial if I change my mind?
- Yes. You can withdraw from any clinical trial at any time, for any reason, without affecting your standard medical care. Trials are voluntary by law. The team may ask if you are willing to do a brief exit visit so they can collect safety information, but you are not obligated.
- Can my spouse or care partner come with me to visits?
- In most cases yes, and it is often encouraged. Care partners can help with notes, questions, and getting home safely after a long visit. Some study assessments do need to happen one on one, but care partners are usually welcome for the rest of the appointment.
- Will I get a placebo in this trial?
- This trial has 4 groups, and 1 is a placebo group. Because assignment is random, you have about a 1 in 4 chance (roughly 25%) of being in the placebo group, assuming the groups are filled equally. Ask the coordinator to confirm the exact assignment ratio.
- How many visits does this trial involve?
- You will visit the study center 8 times for study checks.
- Is there a medication washout in this trial?
- If you previously took levodopa-containing anti-Parkinson drugs, you must have stopped them for a 4-week washout period before screening.