--- title: Can new medication be tolerated nct_id: NCT07513441 phase: PHASE1 status: RECRUITING sponsor: H. Lundbeck A/S study_type: INTERVENTIONAL canonical_url: "https://parkinsonspathways.com/trial/NCT07513441" clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT07513441" last_fetched: "2026-08-11T14:00:07.306Z" source: "Parkinson's Pathways (curated)" --- # Can new medication be tolerated **Goal (in five words):** Can new medication be tolerated **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 **Trial ID:** [NCT07513441](https://clinicaltrials.gov/study/NCT07513441) ## Key Facts - **Phase:** PHASE1 - **Status:** RECRUITING - **Study Type:** INTERVENTIONAL - **Sponsor:** H. Lundbeck A/S - **Target Enrollment:** 10 participants - **Start Date:** 2026-05-26 - **Completion Date:** 2027-05-31 - **Conditions:** Parkinson Disease - **Interventions:** Lu AF28996 - **Intervention Types:** DRUG - **Registry Record Last Updated:** 2026-08-10 (this month) ## 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. **Estimated commitment:** Commitment level unclear from the registry data — ask the study coordinator what taking part involves. ## What This Actually Involves **Placebo** _(From the protocol)_: Everyone in this trial receives the experimental treatment. There is no placebo group. **Visits** _(Ask the coordinator)_: Ask the coordinator how many in-person visits the study involves, how long each one takes, and over what total period. **Procedures** _(Ask the coordinator)_: Ask the coordinator what tests and procedures are involved, for example blood draws, scans, or questionnaires, and whether any are uncomfortable or invasive. **Washout** _(Ask the coordinator)_: Ask the coordinator whether you would need to stop or pause any of your current medications before or during the study (a washout period), and for how long. **Travel & reimbursement** _(Ask the coordinator)_: Ask the coordinator whether travel, parking, or your time is reimbursed or compensated, and what is covered. _Fields marked “From the protocol” come from the trial's registry record or quoted protocol text. Fields marked “Ask the coordinator” are not reliably available and should be confirmed directly._ ## 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. ## Eligibility - **Minimum age:** 35 Years - **Maximum age:** 85 Years - **Sex:** ALL ### Full Criteria ``` Key Inclusion Criteria: * The participant is Chinese, defined as having four Chinese grandparents being born in China. * The participant is diagnosed with idiopathic Parkinson's disease (consistent with the United Kingdom PD Society Brain Bank Criteria for the Diagnosis of PD). * The participant's Modified Hoehn and Yahr score is ≥2 and ≤4 (in OFF) and ≤3 in the ON state. * The participant experiences well recognizable and predictable motor fluctuations in the awake time including predictable morning OFF episodes causing clinically significant disability during the last 3 months prior to screening, as evaluated by the investigator. Key Exclusion Criteria: * The participant has received oral or transdermal dopamine agonist treatment ≤4 weeks prior to screening. * The participant has undergone a neurosurgical intervention for Parkinson's disease (such as pallidotomy, thalamotomy, foetal or stem cell transplantation or deep brain stimulation). * The participant has any other disorder for which the treatment takes priority over treatment of Parkinson's disease or is likely to interfere with trial treatment or impair treatment compliance. * The participant has received Traditional Chinese Medicine treatment ≤4 weeks prior to screening. Note: Other protocol-defined inclusion and exclusion criteria may apply. ``` ## Locations (4) - Beijing TiantanHospital, CapitalMedical University, Beijing, Beijing Municipality, China _(39.9075, 116.3972)_ - Xuanwu Hospital Capital Medical University, Beijing, Beijing Municipality, China _(39.9075, 116.3972)_ - Fudan University - Huashan Hospital - Institute of Urology, Shanghai Shi, Shanghai Municipality, China - West China Hospital, Sichuan University, Chengdu, Sichuan, China _(30.6667, 104.0667)_ ## Central Contacts - Email contact via H. Lundbeck A/S, (CONTACT), +45 36301311, HQ_Medinfo@Lundbeck.com ## 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. --- *Canonical: https://parkinsonspathways.com/trial/NCT07513441* *HTML version: https://parkinsonspathways.com/trial/NCT07513441* *Source data: https://clinicaltrials.gov/study/NCT07513441*