A Phase 2a, Randomized, Double-blind, Placebo-controlled Trial to Evaluate the Safety, Tolerability, and Pharmacokinetics of Multiple Ascending Dosing of Exidavnemab in Patients with Mild to Moderate Parkinson’s Disease on Stable Symptomatic Parkinson’s Disease Medication and in Patients with Multiple System Atrophy
This clinical trial is looking at an experimental medicine called exidavnemab. It is designed for adults living with mild-to-moderate Parkinson's disease or a related condition called multiple system atrophy (MSA). The main goal is to find out if the medicine is safe and well tolerated. Researchers want to see what happens when people receive repeated doses, watch closely for any side effects, and measure how the drug moves through the bloodstream. To ensure fair results, some participants will receive exidavnemab, while others will receive a placebo, which is an inactive salt-water solution. Neither the patients nor the doctors will know who gets which treatment during the study. Regular health checks, including blood tests, heart tracings, and blood pressure checks, will be carried out to keep participants safe throughout.
Överblick
Vad handlar denna studie om?
Parkinson's disease and multiple system atrophy (MSA) are long-term conditions that affect the brain and nervous system. Over time, they can cause problems with movement, balance, muscle stiffness, and daily activities. While current treatments can help manage symptoms, researchers are constantly searching for new medicines that might target these conditions in different ways.
This trial focuses on a new drug named exidavnemab. In this early phase of research, the main aim is not yet to prove whether the drug cures the condition, but to find out if it is safe for people to take. Doctors want to learn how the body breaks down the medicine, what doses are easiest to tolerate, and whether it causes any unwanted side effects.
Taking part in studies like this helps doctors gather vital clues about new treatments. The knowledge gained here will show whether exidavnemab is safe enough to be tested in larger, longer trials in the future, bringing scientists one step closer to better options for people living with these conditions.
Viktiga punkter
- The trial tests the safety of a new medicine called exidavnemab.
- It is open to adults with mild to moderate Parkinson's disease or multiple system atrophy.
- Participants will receive either the study drug or a dummy placebo across four treatment cycles.
- Doctors will closely monitor heart health, blood pressure, and blood tests throughout.
- Taking part is voluntary, and you can stop at any time without losing your regular care.
Vem kan vara berättigad?
This trial is open to adults aged 18 and over who have been diagnosed with either mild to moderate Parkinson's disease or multiple system atrophy. If you have Parkinson's, you will need to be on a stable dose of your usual symptom-relieving medication before joining.
People of any gender can take part, provided they meet the overall health standards required to join safely.
Because this is an early safety trial, people with certain other serious health issues, unstable medical conditions, or specific medication conflicts may not be able to join. The trial team will carry out detailed health checks to make sure taking part is as safe as possible for you.
Kan denna studie passa dig?
Svara på dessa snabba frågor för att se om du kan vara berättigad. Detta är endast en vägledning — forskarteamet fattar det slutgiltiga beslutet.
- I am aged 18 or older.
- I have a confirmed diagnosis of Parkinson's disease (mild to moderate) or multiple system atrophy.
- If I have Parkinson's, my current medications have been stable recently.
- I am willing to attend regular hospital appointments for tests and checks.
- I am happy to receive either the active study medicine or an inactive placebo.
Vad innebär deltagande?
If you take part, you will receive four treatment cycles of either exidavnemab or a placebo, which is an inactive salt-water solution given in the same way. You will have regular clinic visits where the study team will closely monitor your health.
During your visits, staff will measure your vital signs, such as your blood pressure, pulse, and temperature. They will also take blood and urine samples and record heart tracings, known as ECGs, to ensure your heart is working normally. These tests help doctors see how much medicine is in your body and check for any reactions.
You will continue your usual stable Parkinson's medication alongside the study treatment if applicable. The trial team will follow up with you regularly throughout the four cycles and for a period afterwards to monitor your recovery and wellbeing.
Potentiella risker och fördelar
Platser (2)
- —ObekräftadSpanien
- —ObekräftadPolen
Vanliga frågor
Vad är en placebo?
A placebo is a harmless dummy treatment, such as plain salt water, designed to look just like the real medicine. It helps doctors see if changes are truly caused by the drug.
Will I have to stop taking my usual Parkinson's medicine?
No. Participants with Parkinson's disease are expected to remain on their stable, regular symptom medication while taking part in this trial.
Can I choose whether I get the real drug or the placebo?
No. A computer assigns participants at random to either the medicine or the placebo, and neither you nor your doctor will know which one you receive during the study.
Will taking part cure my condition?
No. This trial is designed to check the safety of the medicine and how the body handles it, rather than to provide a cure.
Can I leave the study early if I change my mind?
Yes. You can leave the trial at any time, for any reason. Your regular medical team will continue to support you with your normal care.
Hur du får reda på mer
Prata alltid med din läkare eller specialist innan du bestämmer dig för att delta i en studie.
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Diskussion
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