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Study of CVN424 for Reducing Motor Complications in Parkinson's Disease Patients

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What is this trial about?

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

This clinical trial is focused on studying the effects of a new treatment for Parkinson's Disease, a condition that affects movement and can cause symptoms like tremors, stiffness, and difficulty with balance and coordination. The treatment being tested is a medication called CVN424, which is taken as a tablet. The purpose of the study is to see how effective CVN424 is in reducing the amount of time patients experience motor complications, known as "OFF time," when their usual Parkinson's medications are not working well.

Participants in the study will be randomly assigned to receive either CVN424 or a placebo, which looks like the medication but does not contain the active ingredient. The study will last for 12 weeks, during which participants will take the medication once daily. Throughout the study, participants will keep a diary to record their symptoms and any changes in their condition. The study aims to compare the changes in OFF time between those taking CVN424 and those taking the placebo.

Safety is an important part of the study, and participants will be monitored for any side effects or changes in their health. This will include regular check-ups, physical exams, and tests like ECGs, which measure heart activity. The study will also use questionnaires and scales to assess any improvements in symptoms and overall well-being. The results will help determine if CVN424 is a safe and effective treatment option for people with Parkinson's Disease who experience motor complications.

The research process

The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Beginning of the trial
Upon joining the study, you will be randomly assigned to receive either the study medication, CVN424, or a placebo. A placebo is a substance with no active medication, used to compare the effects of the actual drug.
The study is double-blind, meaning neither you nor the study team will know whether you are receiving CVN424 or the placebo. This helps ensure unbiased results.
Step 2
Medication administration
You will take the study medication in the form of a film-coated tablet. The medication is taken orally, which means you will swallow the tablet.
The dosage for CVN424 is 150 mg, and it is taken once daily. You will continue this daily regimen for a period of 12 weeks.
Step 3
Monitoring and assessments
Throughout the 12-week period, you will be asked to keep a daily diary to record your motor symptoms, specifically noting the amount of time you experience 'OFF' periods. 'OFF' periods are times when your usual Parkinson's medication is not working well, and symptoms return.
You will also undergo regular assessments, which may include physical examinations, vital signs checks, and laboratory tests to monitor your health and any potential side effects of the medication.
Step 4
End of the trial
At the end of the 12-week period, your participation in the study will conclude. You will have a final assessment to evaluate any changes in your condition and to ensure your well-being.
The primary goal of the study is to assess the change in average daily 'OFF' time from the beginning to the end of the study. Secondary assessments will include various questionnaires and scales to evaluate your overall experience and any side effects.

Who can join the trial?

14 criteria

Must be at least 30 years old.
Must have a diagnosis of Parkinson's Disease according to specific medical criteria, which include symptoms like slowness of movement and a good response to the medication levodopa.
Body Mass Index (BMI) must be between 18.0 and 35.0. BMI is a measure of body fat based on height and weight.
Must be in Stage 3 or lower on the Modified Hoehn and Yahr Scale when in the "ON" state. This scale measures the severity of Parkinson's Disease symptoms.
Must be able to walk freely, with or without a walking aid.
Must score at least 24 on the Montreal Cognitive Assessment (MoCA), a test that checks for cognitive impairment.
Parkinson's Disease medications must be stable for at least 4 weeks before the study starts. Medications called MAO-B inhibitors must be stable for at least 12 weeks before the study.
Must take the medication levodopa at least 4 times a day, or 3 times a day if using specific formulations like Rytary or Crexont.
Must have an average of at least 3 hours of "OFF" time per day, as recorded in a home diary. "OFF" time refers to periods when Parkinson's symptoms are not well controlled.
Must be able to correctly identify "ON" (when symptoms are well controlled), "OFF," and dyskinetic (involuntary movements) states in a diary, with more than 80% accuracy.
If female and able to have children, or if male with a female partner who can have children, must agree to use reliable birth control or remain abstinent during the study and for 12 weeks after the last dose of the study drug.
Must be willing to provide written consent to participate and follow the study's schedule and procedures.
Must be approved as a suitable candidate by a special committee.
If taking oral medications for anti-sialorrhea (to reduce saliva), these must be stable for 30 days before the study and not expected to change during the study.

Who cannot join the trial?

7 criteria

Patients who do not have a diagnosis of Parkinson's Disease.
Patients who are not within the specified age range for the study.
Patients who are not able to follow the study procedures or take the study medication as required.
Patients who are pregnant or breastfeeding.
Patients who have a history of allergic reactions to the study medication or similar drugs.
Patients who are currently participating in another clinical trial.
Patients with any other medical condition that the study doctors believe would make it unsafe for them to participate.

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Verified sites

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Axon Clinical s.r.o.
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Prague, Czechia
Azienda Ospedaliera di Padova
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Padua, Italy
Centre Hospitalier Lyon Sud
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Pierre Benite, France

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Investigated drugs

CVN424 is a medication being studied for its potential to help people with Parkinson's Disease who experience motor complications. Parkinson's Disease can cause periods when medications stop working effectively, leading to increased symptoms like stiffness and difficulty moving, known as "OFF time." CVN424 is taken once a day and is being tested to see if it can reduce this "OFF time," helping patients have more control over their movements and improving their quality of life. The study is comparing the effects of CVN424 to a placebo to determine how well it works in managing these symptoms.

1-[2-[4-(2,4-DIFLUOROPHENOXY)PIPERIDIN-1-YL]-3-[[(3R)-OXOLAN-3-YL]AMINO]-7,8-DIHYDRO-5H-PYRIDO[3,4-B]PYRAZIN-6-YL]ETHANONE

What is already known about the treatment

CVN424 – CVN424 is an experimental medication currently being studied for its potential to help people with Parkinson's Disease, particularly those experiencing motor complications. It is taken orally, meaning it is swallowed in pill form. The medication is in the clinical trial phase, specifically a Phase 2 study, which means it is being tested for its effectiveness and safety in patients. CVN424 works by targeting specific pathways in the brain to help reduce the amount of time patients experience "OFF" periods, which are times when their usual Parkinson's medications are not working well. This medication is classified as a treatment for neurological conditions, specifically focusing on improving movement issues associated with Parkinson's Disease.

Investigated diseases

Parkinson Disease – Parkinson Disease is a progressive neurological disorder that affects movement. It is characterized by tremors, stiffness, and difficulty with balance and coordination. The disease progresses gradually, often starting with a barely noticeable tremor in one hand. As it advances, individuals may experience slowness of movement, muscle rigidity, and impaired posture. Over time, the symptoms can become more severe, affecting daily activities and leading to difficulties in walking and talking. The progression of the disease varies from person to person, with some experiencing a slow decline in function while others may have a more rapid progression.