Interventional, randomized, double-blind, parallel-group, placebo-controlled, flexible-dose trial of Lu AF28996 in adults with Parkinson’s disease experiencing motor fluctuations.
Parkinson's disease affects movement and can cause shaking, stiffness, and slowness. Over time, standard Parkinson's medicines can wear off between doses. This causes 'OFF' periods where symptoms return, or it may trigger uncontrollable jerking movements known as dyskinesia. This Phase II trial is testing an investigational medicine called Lu AF28996 to see if it can provide smoother, more reliable symptom relief. Over 19 weeks, researchers will compare the new medicine against an inactive dummy pill (placebo). Participants will keep a daily diary to track their movement, noting when their medication is working well ('good ON time') and when it wears off. The study will also assess overall movement, sleep quality, and everyday wellbeing. The goal is to see if Lu AF28996 safely helps people with Parkinson's gain more control over their daily routines.
At a glance
What is this study about?
Parkinson’s disease is a condition where the brain gradually loses nerve cells that produce dopamine, a chemical essential for smooth muscle control. Many people take medicines like levodopa to replace this missing chemical. However, after several years, the benefits of standard treatments can start wearing off between doses. People often experience 'OFF' times when stiffness and tremors return, or they may develop involuntary twisting and twitching movements known as dyskinesia.
This clinical study is testing an investigational drug called Lu AF28996. The main goal is to find out whether it can increase a person's 'good ON time'. This refers to the hours in the day when Parkinson's symptoms are well managed, allowing you to move normally without distressing involuntary movements. The trial will also measure whether the medicine can reduce the total time spent struggling with 'OFF' periods.
Finding treatments that provide steady symptom relief is vital. If successful, Lu AF28996 could help smooth out daily ups and downs, making it easier for people living with Parkinson's to sleep better, stay active, and carry out ordinary daily tasks with confidence.
Key takeaways
- Phase II clinical study testing a new drug called Lu AF28996 for Parkinson's disease.
- Aims to increase the daily time symptoms are well managed ('good ON time').
- Compares the new medicine against an inactive dummy pill (placebo) over 19 weeks.
- Open to adults aged 18 and over who experience symptom fluctuations between medication doses.
- Involves tracking your movement in a daily diary and attending regular specialist clinic checks.
Who may be eligible?
This trial is open to adults aged 18 and older who have a confirmed diagnosis of Parkinson's disease. Both men and women can take part.
To be suitable, you need to be experiencing 'motor fluctuations'. This means your current Parkinson's medication does not work consistently throughout the whole day, leading to predictable or sudden periods where your symptoms return before your next dose, or causing troublesome involuntary muscle movements.
Because this is a research study, you will need to undergo standard medical checks to make sure the trial is safe for you. The study doctors will carefully review your general health, medical history, and any other prescription tablets you take before confirming your place.
Could this study suit you?
Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.
- Are you aged 18 or older?
- Have you been diagnosed with Parkinson's disease?
- Does your medication wear off between doses, causing symptoms to return during the day?
- Do you experience involuntary twitches or muscle jerking (dyskinesia)?
- Are you able and willing to keep a daily symptom diary and attend regular clinic visits over 19 weeks?
What does participation involve?
Taking part in this study lasts for at least 19 weeks of treatment, in addition to an initial screening period and follow-up checks. You will be randomly assigned by chance to take either the study medicine (Lu AF28996) or a dummy tablet (placebo). Neither you nor your study doctor will choose or know which one you receive. The dose of the medicine can be adjusted flexibly during the study to find the best amount for you. Throughout the trial, you will attend regular hospital appointments for health checks, blood tests, and movement assessments. You will also be asked to keep a daily diary (the Hauser diary) to record how many hours each day your symptoms are well controlled, and fill out short surveys about your sleep and quality of life.
Potential risks and benefits
Locations (7)
- —UnverifiedCzechia
- —UnverifiedFrance
- —UnverifiedSpain
- —UnverifiedPoland
- —UnverifiedItaly
- —UnverifiedGermany
- —UnverifiedSweden
Common questions
What is a placebo?
A placebo is a dummy pill that looks identical to the real medicine but contains no active ingredients. It helps scientists confirm whether the real drug actually works better than chance.
What does 'Good ON time' mean?
'Good ON time' describes the periods during the day when your Parkinson's medicine is working well, keeping stiffness and tremors away without causing disruptive twitches.
Will I have to pay to take part?
No. The study medication, clinic visits, and trial-related tests are provided free of charge, and travel expenses are usually reimbursed.
Can I carry on taking my current Parkinson's medication?
Yes. The trial drug is generally taken alongside your existing treatment. The study team will check your prescriptions to ensure they are safe to combine.
What happens if I change my mind during the trial?
You can leave the study at any point without giving a reason. Your regular doctor will simply continue your standard Parkinson's care.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Discussion
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