This study is examining Parkinson’s disease, a condition that affects movement and coordination due to a lack of dopamine in the brain. The therapy being investigated includes a solution called ND0612, which contains two active substances: carbidopa and levodopa. These substances are commonly used in treating Parkinson’s disease to help manage symptoms such as tremors and rigidity. In this study, participants may receive ND0612 through a continuous infusion under the skin using an infusion pump system, which aims to provide a steady supply of medication. There are also oral treatments involved, specifically IR-LD/CD tablets, which contain the same active substances for comparison purposes.

The purpose of the study is to determine the effect of the continuous infusion of ND0612 on the daily “ON” time, which is the period when patients experience fewer symptoms, without troublesome dyskinesia, a type of uncontrolled movement. Researchers will be recording the motor function of participants with Parkinson’s disease, who experience fluctuations in their ability to move. Motor fluctuations refer to changes in movement abilities, often alternating between periods where symptoms are well-controlled (“ON” time) and times when symptoms reappear (“OFF” time).

The trial will use a placebo in some of its tests, which is a harmless substance given to some participants to compare against those receiving the actual medication. This helps to ensure that any differences in outcomes are due to the medication itself. The study aims to compare the effectiveness and safety of the subcutaneous infusion versus the oral tablets in providing consistent symptom control for individuals with Parkinson’s disease.