Lu AF28996 for Parkinson's (NCT07513441)
Can new medication be tolerated
- Trial ID
- NCT07513441
- Official Title
- Interventional, Open-label, Trial Investigating the Safety, Tolerability, and Pharmacokinetic Properties of Lu AF28996 in Chinese Men and Women With Parkinson's Disease
- Goal
- Can new medication be tolerated
- Phase
- PHASE1
- Status
- RECRUITING
- Sponsor
- H. Lundbeck A/S
- Study Type
- INTERVENTIONAL
- Enrollment
- 10 participants
- Conditions
- Parkinson Disease
- Interventions
- Lu AF28996
- Registry Record Last Updated
- 2026-08-10 (this month)
- Estimated Commitment
- Commitment level unclear from the registry data — ask the study coordinator what taking part involves.
Summary For Families
Goal: an early-phase (phase 1) trial to check whether a new medication is safe, how well people tolerate it, and how the body absorbs and clears it in people with Parkinson's disease. Approach: everyone in the open-label trial will receive the new medication and be closely monitored for side effects, tolerability at different dose levels, and how the drug moves through the body. Eligibility: looking for Chinese men and women aged 35 to 85 with a Parkinson's diagnosis by standard criteria, who are in a moderate stage with predictable motor fluctuations including disabling morning OFF episodes; people recently on dopamine agonists, those who have had Parkinson's brain surgery, recent traditional Chinese medicine use, or other conditions that would interfere with treatment are excluded.
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: Hoehn and Yahr stage 2 to 5
- Motor fluctuations: Must have motor fluctuations (off periods when medication wears off) (criteria text: "* the participant experiences well recognizable and predictable motor fluctuations in the awake time including predictable morning off episodes causing clini...")
- Deep brain stimulation: Cannot join after DBS surgery (deep brain stimulation) (criteria text: "The participant has undergone a neurosurgical intervention for Parkinson's disease (such as pallidotomy, thalamotomy, foetal or stem cell transplantation or deep brain stimulation).")
Do I Likely Qualify? — Self-Check Dimensions
The trial page offers an interactive self-check built from this trial's parsed criteria. It covers these dimensions; anything the criteria don't state clearly is answered "ask the study coordinator", never assumed.
- This trial enrolls people aged 35 to 85.
- This trial does not enroll people who have had (or are scheduled for) DBS surgery.
- This trial requires motor fluctuations (off periods).
- This trial requires Hoehn and Yahr stage 2 to 5.
Locations
- Beijing TiantanHospital, CapitalMedical University, Beijing, Beijing Municipality, China
- Xuanwu Hospital Capital Medical University, Beijing, Beijing Municipality, China
- Fudan University - Huashan Hospital - Institute of Urology, Shanghai Shi, Shanghai Municipality, China
- West China Hospital, Sichuan University, Chengdu, Sichuan, 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 NCT07513441. It is the one about "Can new medication be tolerated". 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?
- 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: Everyone in this trial receives the experimental treatment. There is no placebo group. Ask the coordinator to confirm it still applies.
- Would I need to stop or pause any of my current medications?
- 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 Lu AF28996. Goal: an early-phase (phase 1) trial to check whether a new medication is safe, how well people tolerate it, and how the body absorbs and clears it in people with Parkinson's disease. Approach: everyone in the open-label trial will receive the new medication and be closely monitored for side effects, tolerability at different dose levels, and how the drug moves through the body. Eligibility: looking for Chinese men and women aged 35 to 85 with a Parkinson's diagnosis by standard criteria, who are in a moderate stage with predictable motor fluctuations including disabling morning OFF episodes; people recently on dopamine agonists, those who have had Parkinson's brain surgery, recent traditional Chinese medicine use, or other conditions that would interfere with treatment are excluded.
- Who can participate?
- Participants must be between 35 Years and 85 Years.
- Where is this trial located?
- This trial is recruiting at 4 locations.
- Does it cost anything to join?
- Being asked to pay to join a trial is a red flag: legitimate trials do not charge a participation fee, and the study treatment and study-specific tests are provided by the trial sponsor. What you might still pay depends on where you live: in the US, routine care you would receive anyway can be billed to you or your insurance; 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 1 trial is estimated to last approximately 1 year.
- 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?
- Everyone in this trial receives the experimental treatment. There is no placebo group.