Skip to content
Clinical Trials – home

Rare diseases

Investigational molecules

Locations

Our offerNewsroom

Not yet recruiting

A Randomized Trial of lu af28996 dh1 to Reduce Motor Fluctuations in Adults with Parkinson’s Disease

Verified siteInvestigational
Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

What is this trial about?

A plain-language summary of the goals, design and what participants do

Parkinson’s disease is a brain condition that causes shaking, stiffness, slow movements and can lead to “motor fluctuations,” meaning that medication may work well at some times (called “ON” time) and wear off at other times (“OFF” time). These fluctuations can also bring unwanted movements called dyskinesia, which may be uncomfortable or disruptive.

The trial compares an oral capsule of the experimental drug Lu AF28996 with a matching placebo to see if it can increase the amount of good “ON” time and reduce “OFF” time and troublesome dyskinesia. Participants will take the assigned capsule for about 19 weeks, record their daily experiences in a simple diary, and attend a few clinic visits for safety checks. The purpose is to assess whether the drug improves motor complications in people with Parkinson’s disease. In this context, “ON time” means periods when symptoms are well controlled, “OFF time” means periods when symptoms return, and “dyskinesia” refers to involuntary movements that can be bothersome.

The research process

The trial runs in 9 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Enrollment and consent

    After you agree to join the study, you will sign a consent form that explains the purpose of the trial and what is expected of you.

  2. Step 2

    Baseline assessments

    You will complete a series of questionnaires that ask about your daily motor symptoms, sleep, quality of life, and overall health.

    You will start a daily hauser diary in which you record the amount of time each day that you feel "on" (symptoms well‑controlled) and "off" (symptoms not well‑controlled), as well as any dyskinesia (involuntary movements).

    Your current use of levodopa and other Parkinson’s medications will be recorded.

  3. Step 3

    Randomization

    Based on a computer‑generated process, you will be assigned to receive either the study drug lu af28996 or a matching placebo. you will not know which one you receive.

  4. Step 4

    Start of study medication

    You will begin taking an oral capsule each day. each capsule contains 00 mg of the assigned product.

    The trial uses a flexible‑dose design, meaning the study team may adjust the number of capsules you take per day based on your response and any side effects.

  5. Step 5

    Daily diary recording

    Every day you will continue to fill out the daily hauser diary, noting the hours you spend in good "on" time, "off" time, and any periods with troublesome dyskinesia.

    The diary information is used to measure the primary and secondary outcomes of the study.

  6. Step 6

    Regular clinic visits

    You will attend scheduled visits at the study site (for example, at weeks 4, 8, 12, and 16). during each visit the staff will check your safety, review your diary entries, and decide if a dose change is needed.

    Blood samples may be taken to measure the concentration of lu af28996 and its metabolites in your plasma.

  7. Step 7

    Continuation of medication and monitoring

    You will keep taking the study medication daily and recording your diary for a total treatment period of 19 weeks.

    The dose may be increased or decreased during this period according to the flexible‑dose protocol.

  8. Step 8

    Final assessment at week 19

    At the end of week 19 you will complete the same set of questionnaires and diary entries as at baseline.

    Additional assessments will include rating scales for motor function and dyskinesia, as well as a final blood draw to check drug levels.

    The results will be compared with your baseline data to determine any changes.

  9. Step 9

    End of study

    After the week 19 visit, you will stop taking the study medication and will be discharged from the trial.

    Any further follow‑up will be arranged by the study team according to the protocol.

Who can join the trial?

5 criteria

  • Be diagnosed with Parkinson’s disease at least 3 years ago, with the diagnosis made after you turned 30, and it must meet the standard doctor guidelines (the Movement Disorders Society Clinical Diagnostic Criteria) for a clear or likely case.
  • Your disease stage, measured by the modified Hoehn and Yahr scale, must be 3 or lower when you are feeling your best (the “ON” state) and between 2 and 4 when your medication is wearing off (the “OFF” state). This scale is a simple way doctors describe how much Parkinson’s affects movement.
  • You must have noticeable, regular changes in your movement called motor fluctuations that cause significant trouble in daily life, and these have been present for at least 3 months before the screening.
  • You need to experience these movement changes every day, measured as time spent in the “OFF” state while you are awake.
  • Both men and women are eligible to take part in the study.

Who cannot join the trial?

8 criteria

  • The participant has already taken the study drug Lu AF28996.
  • The participant was in another clinical trial less than 30 days before the screening visit.
  • The participant is pregnant, breastfeeding, planning to become pregnant, or could become pregnant and is not willing to use reliable birth‑control methods.
  • The participant has used any investigational medicinal product (IMP) within the last 3 months or for a period longer than five half‑lives (the time it takes for half of a drug to leave the body), whichever is longer.
  • The participant’s score on the Montreal Cognitive Assessment (MoCA) test is 24 or lower (this test checks thinking abilities and is adjusted for education).
  • The participant has an atypical, secondary, or drug‑induced Parkinsonism (for example, caused by certain medicines), a metabolic or genetic disorder such as Wilson’s disease, brain inflammation called encephalitis, or other atypical Parkinsonian syndromes like progressive supranuclear palsy or multiple system atrophy.
  • The participant has severe, widespread, disabling dyskinesia (involuntary movements) that could make participation unsafe, such as increasing the risk of falling or choking.
  • The participant has unpredictable changes in motor symptoms, shown by a score of 3 or higher on the MDS‑UPDRS Part IV Item 4.5 test, or the investigator judges that the participant experiences wide, unpredictable symptom swings.
Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

Tell us about your condition – we search every trial in Europe and connect you with the right site.

We usually reply within a few days

Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Trial locations

Where you can join this trial

Countries are shaded by recruitment status. Click a recruiting country to ask about joining there.

Not yet recruiting
Not finding your country?

Not sure what to do next?

Joining a clinical trial can seem overwhelming. We guide you step by step, so you know exactly what to expect and how we support you through the process.

See the full process and FAQ

Investigated drugs

LU AF28996 DH1 is an experimental oral capsule that is being studied to see if it can help adults with Parkinson’s disease who have motor fluctuations. In this trial, participants take the capsule by mouth, and researchers will compare how well it works at reducing motor complications compared with a placebo. The study is designed to be double‑blind, meaning neither the participants nor the doctors know who receives the active capsule, which helps ensure the results are reliable. The goal is to determine whether this new medication can improve the control of movement problems in people with Parkinson’s disease.

What is already known about the treatment

LU AF28996 DH1 - The drug is taken by mouth as a hard capsule, which the patient swallows whole. It is an investigational medicine that is still in clinical testing and has not yet been approved for general use. The intended use is to help adults with Parkinson’s disease who have motor fluctuations, aiming to improve their movement control. It works as a small‑molecule agent that modulates dopamine‑related pathways in the brain, classifying it as an experimental dopaminergic modulator.

Investigated diseases

Parkinson’s disease - Parkinson’s disease is a brain disorder that mainly affects movement. It develops when nerve cells that produce dopamine gradually die, leading to reduced dopamine levels. Early signs often include slight tremor, stiffness, or slower movements. Over time, symptoms can spread to cause difficulty walking, balance problems, and facial expression changes. Many people also experience non‑motor symptoms such as sleep disturbances, mood changes, and decreased sense of smell as the condition advances. The disease typically progresses slowly, with symptoms becoming more noticeable and widespread over several years.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IITrial ID2025-524655-30-00Protocol codeDARE2, 20309AEstimated enrolment221 patientsSponsorH. Lundbeck A/S

sourced from the EU Clinical Trials Register and site verification

Want to learn more about this trial or check if you can participate?

Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

Tell us about your condition – we search every trial in Europe and connect you with the right site.