Phase 2, Randomized, Double-Blind, Placebo-Controlled Multicenter Study of CVN424 in Parkinson’s Disease Patients with Motor Complications
Parkinson's disease is a condition that affects movement. Over time, standard medicines can wear off between doses. When this happens, people experience 'OFF time', where tremors, stiffness, and slow movement return. This Phase 2 clinical study is looking at a new tablet called CVN424. Researchers want to find out if taking CVN424 daily can safely reduce daily OFF time over 12 weeks. Participants will be split into two groups by chance: one group will take CVN424, and the other will take an identical dummy pill (a placebo). Neither the participants nor their doctors will know who gets which treatment. Researchers will compare symptom diaries and carry out health checks, like blood tests and heart scans (ECGs), to measure how well the treatment works and check for side effects.
At a glance
What is this study about?
Living with Parkinson's disease can be challenging, especially as symptoms change over time. Many people find that their usual treatments work well at first, but then begin to wear off before the next dose is due. Doctors call these periods 'OFF time'. During OFF time, difficulties such as tremors, muscle stiffness, slowness, and trouble walking can suddenly return or worsen, making daily routines harder to manage.
This clinical study is evaluating a new oral medicine called CVN424. The tablet is designed to help smooth out movement problems and give people more stable symptom control throughout the day. Because this is a Phase 2 trial, researchers are gathering early evidence to see whether the drug works as intended and to explore its safety.
To make sure the results are fair and reliable, this is a double-blind, placebo-controlled study. This means half the participants will take CVN424 and the other half will take a placebo (a dummy pill containing no active medicine). Neither you nor the study team will know which one you are taking until the study ends. Comparing CVN424 directly to a placebo helps scientists prove whether any improvements are truly caused by the new medicine.
Finding new ways to shorten OFF time is an important goal in Parkinson's care. If CVN424 proves successful, it could offer a valuable new treatment option to help people with Parkinson's stay active and independent for longer each day.
Key takeaways
- The trial tests a new daily tablet (CVN424) for Parkinson's disease.
- The main goal is to reduce daily 'OFF time' when movement symptoms return.
- Treatment lasts for 12 weeks and compares CVN424 against a dummy pill (placebo).
- Open to adults aged 18 and over who experience motor complications.
- Participation is completely voluntary and closely supervised by doctors.
Who may be eligible?
This study is open to adults aged 18 and older who have been diagnosed with Parkinson's disease. To take part, you must be experiencing 'motor complications', meaning your regular Parkinson's medications wear off and your movement symptoms return at certain times during the day.
Both men and women may join. You should be able to keep a daily home diary of your symptoms or have a family member or carer who can help you record them.
People with certain other serious medical conditions, or those taking specific medicines that might interfere with the study drug, may not be able to join. The study team will review your full medical history and current prescriptions to make sure it is safe for you to take part.
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.
- I am aged 18 or older.
- I have a confirmed diagnosis of Parkinson's disease.
- My current Parkinson's medication wears off during the day (OFF time).
- I am able (or have help) to complete a daily diary about my movement symptoms.
- I can attend regular clinic appointments over a 12-week period.
What does participation involve?
If you join the study, you will take part for around 12 weeks. You will take a study tablet (either CVN424 or a placebo) once a day by mouth. Throughout the 12 weeks, you will be asked to fill in a simple daily diary during your waking hours to record when your medicine is working well ('ON time') and when symptoms return ('OFF time'). You will also attend regular hospital or clinic visits. During these appointments, the medical team will carry out health checks, including physical examinations, blood tests, blood pressure checks, and heart traces (ECGs), as well as asking questions about your daily quality of life.
Potential risks and benefits
Locations (5)
- —UnverifiedCzechia
- —UnverifiedPoland
- —UnverifiedFrance
- —UnverifiedSpain
- —UnverifiedItaly
Common questions
What is a placebo and why is it used?
A placebo is an inactive tablet that looks exactly like the real medicine. It is used so researchers can compare results and see if changes are truly caused by CVN424.
Will I have to stop taking my normal Parkinson's medications?
In most cases, the study drug is taken alongside your standard Parkinson's treatments. Your study doctor will explain if any small adjustments to your routine are needed.
How long will the study last?
The main treatment period lasts for 12 weeks, though there may also be initial screening visits and a short follow-up visit afterwards.
Does taking part cost anything?
No, the study medicine and all trial-related tests are free. Many trials also help cover travel expenses to and from the clinic.
Can I leave the study early if I change my mind?
Yes. Participation is completely voluntary. You are free to leave the study at any point without giving a reason, and your normal care will continue as usual.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
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