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Study of IPX203 compared to levodopa/carbidopa in patients with advanced Parkinson's disease and motor fluctuations

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What is this trial about?

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

This clinical trial focuses on patients with advanced Parkinson's disease who experience motor fluctuations - periods when movement becomes more difficult as medication wears off. The study tests a new medication called IPX203, which contains two active substances: levodopa and carbidopa. These substances are already used to treat Parkinson's disease, but IPX203 is a new modified-release capsule formulation that may work differently than existing treatments.

The purpose of the study is to compare IPX203 with standard immediate-release levodopa/carbidopa treatment to see if it can better improve the time when patients have good control of their movement symptoms. The medication will be given as capsules that patients take by mouth. The study will look at how well patients' symptoms are controlled throughout the day and how long the medication's effects last.

During the 12-week study, participants will be randomly assigned to receive either IPX203 or standard levodopa/carbidopa treatment. They will need to keep track of their symptoms in a diary and undergo regular evaluations to assess how well the treatment is working. The medication comes in different strength capsules to allow for proper dose adjustment based on individual patient needs.

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
Initial evaluation
You will begin participation in a study comparing two medications for Parkinson's disease: a new medication called IPX203 and standard immediate-release levodopa/carbidopa.
Your current symptoms and medical condition will be assessed to establish a baseline for comparison.
Step 2
Medication assignment
You will be randomly assigned to receive either IPX203 or immediate-release levodopa/carbidopa.
Both medications are taken by mouth.
The immediate-release medication is taken 5 or more times per day, with a minimum total daily dose of 500 mg.
Step 3
12-week treatment period
You will take the assigned medication for 12 weeks.
During this period, you will need to keep a daily diary recording your symptoms.
The diary will track your 'ON time' (periods when medication is working well) and 'OFF time' (periods when symptoms return).
The diary will also record any movement difficulties (dyskinesia) you experience.
Step 4
Final evaluation
After 12 weeks, your condition will be reassessed.
The main focus will be on changes in your 'good ON time' compared to the start of the study.
Other measurements will include changes in OFF time and various types of ON time (with and without movement difficulties).
Clinical assessments will be performed to evaluate your overall condition.

Who can join the trial?

8 criteria

Must be at least 40 years old at the time of providing consent for participation
Must have been diagnosed with Parkinson's disease according to specific diagnostic criteria and currently taking stable doses of immediate-release levodopa/carbidopa medication for at least 6 months before screening
Must have moderate to advanced stage Parkinson's disease (Hoehn and Yahr Stages 2.5 to 4) when medications are working effectively
Must experience daily predictable "wearing-off" episodes (times when medication effects fade and symptoms worsen) for at least 4 weeks before screening
Must have at least 3 hours per day when medications are not working effectively (OFF time) during waking hours
Must be taking levodopa/carbidopa medication at least 5 times per day with a total daily dose of at least 500 mg
If taking levodopa/carbidopa with a COMT inhibitor (a type of medication that helps levodopa work longer), must be taking it 3 to 6 times daily
Can be of any gender identity (male, female, or other)

Who cannot join the trial?

13 criteria

History of brain surgery for Parkinson's disease, including deep brain stimulation (a surgical procedure where electrodes are placed in the brain)
Presence of other significant neurological conditions besides Parkinson's disease
History of psychiatric disorders that could interfere with the study
Significant heart, liver, or kidney disease
Current use of medications that could interact with the study drug
Pregnancy or breastfeeding
Previous adverse reactions to levodopa or carbidopa (medications used to treat Parkinson's disease)
Participation in another clinical trial within the past 30 days
Inability to follow study procedures or attend scheduled visits
Uncontrolled high blood pressure
History of drug or alcohol abuse within the past year
Severe digestive problems that could affect medication absorption
Major surgery planned during the study period

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Verified sites

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Verified
Azienda Ospedaliera di Padova
Padua, Italy
Responsive
Futuremeds Sp. z o.o.
Wroclaw, Poland
Responsive
IRCCS Ospedale Auxologico San Luca
Milan, Italy

Trial locations

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Investigated drugs

IPX203
is an investigational medication designed to treat advanced Parkinson's disease. It is a new formulation that combines levodopa and carbidopa in a way that may provide longer-lasting symptom control for patients with Parkinson's disease who experience motor fluctuations.
Levodopa/Carbidopa immediate-release
is a standard treatment for Parkinson's disease. Levodopa works by being converted to dopamine in the brain, which helps control movement symptoms. Carbidopa prevents levodopa from being broken down before it reaches the brain, allowing more of it to be effective in treating Parkinson's symptoms.

What is already known about the treatment

IPX203
An investigational extended-release oral medication combining levodopa and carbidopa, specifically designed for treating motor fluctuations in advanced Parkinson's disease. This formulation aims to provide more consistent blood levels of levodopa compared to immediate-release versions, potentially offering longer periods of symptom control with fewer daily doses. The medication works by increasing dopamine levels in the brain, with carbidopa preventing the breakdown of levodopa before it reaches the brain, making the treatment more effective.
Levodopa/Carbidopa IR
An immediate-release oral medication that serves as the gold standard treatment for Parkinson's disease symptoms. This combination therapy consists of levodopa, which converts to dopamine in the brain to control motor symptoms, and carbidopa, which prevents levodopa breakdown in the bloodstream before it reaches the brain. The immediate-release formulation provides quick symptom relief but may require more frequent dosing throughout the day to maintain consistent motor function control.

Investigated diseases

Parkinson's Disease - A progressive neurological disorder that affects movement and motor control. The condition develops when nerve cells in the brain that produce dopamine begin to decline or die. Early symptoms include slight tremors, usually starting in the hands, along with stiffness and slowing of movement. As the disease advances, patients experience periods of reduced mobility (OFF time) alternating with periods of better movement control (ON time). Motor fluctuations become more pronounced in advanced stages, where patients may switch between periods of good mobility and periods of significant movement difficulties. Some patients may develop dyskinesia, which causes involuntary, uncontrolled movements, particularly when medication effects peak.