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

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What is this study about?

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.

Who Can Join the Study?

  • 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 Study?

  • 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.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Other Sites

Site Name City Country Status
curiositas ad sanum Studien und Beratungs GmbH Haag in Obb Germany
Karolinska University Hospital Solna Sweden
Krakowska Akademia Neurologii Sp. z o.o. Cracow Poland
Hopital Beaujon Clichy France
Admwplh Ouvxiusbizo dg Pbyhou Padua Italy
Hkynoaei Ukddxdnxrdpb Gfuqelf Dv Cuccuqwvk Sant Cugat Del Valles Spain
Ppknablbfp scbwom Prague Czechia
Hgjellqt Varf dikcpbhh Barcelona Spain
Royecq Ssrqd Sgpeeh Uazwdauzrppgboyckiy Lund Sweden
Ikohx Sxt Rdbvqdwd Rfqn Sclkcf Rome Italy
Cmc Cncwklum Trfst Ckaspvapkcw Ag Uppsala Sweden
Fvpcvpac Nxgpepztv U Ss Aegd V Bdgl Brno-Stred Czechia
Vbvwtfyzt Fsfuqtnv Nrzvyluzy V Pgklm Prague Czechia
Hkeaefsb Uwbhsaekhxbbw Db Lt Ppmbihmh Madrid Spain
Uxseryeubz Dlpxa Sfswk Df Bodfdha Brescia Italy
Iyvx mnntcmb sfgyat Prague Czechia
Ezi Nrzckumjkbuh Sfo z olxn Warsaw Poland
Cncfscb Mebiageu Nwvpdmpb Sra z ofdu Bydgoszcz Poland
Nyuqiwlthneo Geyvlud Lgjzogog Pjyty Adodfse Bzcqxze Lodz Poland

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Czechia Czechia
Not yet recruiting
15.09.2026
France France
Not yet recruiting
15.09.2026
Germany Germany
Not yet recruiting
15.09.2026
Italy Italy
Not yet recruiting
15.09.2026
Poland Poland
Not yet recruiting
15.09.2026
Spain Spain
Not yet recruiting
15.09.2026
Sweden Sweden
Not yet recruiting
15.09.2026

Trial locations

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.

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 ID:
2025-524655-30-00
Protocol code:
DARE2, 20309A
NCT ID:
NCT07514858
Trial Phase:
Therapeutic exploratory (Phase II)

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