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Study on the Long-Term Safety of ND0612 (Carbidopa, Levodopa) Infusion for Patients with Advanced Parkinson's Disease

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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 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 called ND0612, which is a combination of two substances, carbidopa and levodopa. These substances are delivered continuously under the skin using a special pump system. The purpose of the study is to assess the long-term safety and tolerability of this treatment method.

Participants in the study will receive the treatment as a continuous infusion, which means the medication is delivered steadily over time. The study will last for about 12 months, during which the safety of the treatment will be closely monitored. This includes checking for any side effects and how well participants tolerate the treatment. Some participants may receive a placebo, which is a substance with no active medication, to help compare the effects of the treatment.

Throughout the study, various aspects of the participants' health will be assessed, such as their daily "ON" and "OFF" times, which refer to periods when their symptoms are well-controlled or not, respectively. Other evaluations will include sleepiness, vital signs, and overall physical health. The study aims to provide valuable information on how well ND0612 works over a long period and its impact on the daily lives of those with advanced Parkinson's disease.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the study

    Upon joining the study, the participant will begin a treatment period that involves the use of ND0612, a solution containing levodopa and carbidopa.

    This medication is administered through a continuous subcutaneous infusion, which means it is delivered under the skin using a pump system.

  2. Step 2

    Treatment administration

    The participant will receive the ND0612 infusion continuously over a 12-month period.

    The infusion is designed to provide a steady dose of medication to help manage symptoms of advanced Parkinson's disease.

  3. Step 3

    Monitoring and assessments

    Throughout the study, various assessments will be conducted to monitor safety and effectiveness.

    These assessments include checking vital signs, conducting physical examinations, and evaluating laboratory data such as blood tests and urinalysis.

    Participants will also complete questionnaires to assess changes in daily 'ON' and 'OFF' times, which refer to periods when symptoms are well-controlled or not, respectively.

  4. Step 4

    Safety evaluations

    The study will focus on evaluating the long-term safety and tolerability of the ND0612 infusion.

    This includes monitoring for any potential side effects or complications related to the infusion system.

  5. Step 5

    Completion of the study

    At the end of the 12-month treatment period, a final assessment will be conducted to evaluate the overall impact of the treatment.

    This will include a review of any changes in medication dosage and the participant's response to the treatment.

Who can join the trial?

15 criteria

  • Participants must have **Parkinson's disease**.
  • Participants must be at least 30 years old.
  • Participants must sign an informed consent form approved by an ethics committee.
  • Participants in Cohort 1 must have completed a previous study (ND0612H-006) within one month before joining this study.
  • Participants in Cohort 2 must have a **Parkinson's disease** diagnosis consistent with the UK Brain Bank Criteria.
  • Participants in Cohort 2 must have a **Modified Hoehn & Yahr scale** score of 3 or less in the "ON" state. This scale measures the severity of **Parkinson's disease** symptoms.
  • Participants in Cohort 2 must take at least 4 doses per day of **levodopa/carbidopa** (or at least 3 doses per day of Rytary) and have tried at least one other **Parkinson's disease** treatment for at least 30 days.
  • Participants in Cohort 2 must have stable **Parkinson's disease** medications for at least 30 days before starting the study.
  • Participants in Cohort 2 must have at least 2 hours of "OFF" time per day, with predictable early morning "OFF" periods. "OFF" time refers to periods when **Parkinson's disease** symptoms are not well controlled.
  • Participants in Cohort 2 must have a good response to **levodopa** for treating early morning "OFF" periods, as judged by the study investigator.
  • Participants in Cohort 2 must have a **Mini Mental State Examination (MMSE)** score of 26 or higher. This test measures cognitive function.
  • Participants must not have any significant medical, psychiatric, or laboratory issues that would make participation unsafe or noncompliant, as judged by the study investigator.
  • Female participants must be surgically sterile, postmenopausal, or willing to use effective contraception. They must not be pregnant or breastfeeding and must have a negative pregnancy test at the start of the study.
  • Participants must be willing and able to administer the **subcutaneous (SC) infusion** themselves or with help from a study partner.
  • Participants in Cohort 2 must have a named study partner.

Who cannot join the trial?

10 criteria

  • Patients who do not have Parkinson's disease cannot participate. Parkinson's disease is a condition that affects movement and can cause tremors, stiffness, and difficulty with balance and coordination.
  • Patients who are not within the specified age range cannot participate. The age range for this study is typically defined by the study organizers.
  • Patients who are not part of the specified clinical trial group cannot participate. This group is determined by the study organizers based on specific characteristics.
  • Patients who are not willing to follow the study procedures or take the study medication as directed cannot participate.
  • Patients who have other medical conditions that might interfere with the study or make it unsafe for them to participate cannot join the study.
  • Patients who are pregnant or breastfeeding cannot participate, as the effects of the study medication on unborn babies or infants are not known.
  • Patients who are currently participating in another clinical trial cannot join this study, as it may affect the results or their health.
  • Patients who have a history of allergic reactions to the study medication or similar medications cannot participate.
  • Patients who have a history of substance abuse or addiction that might interfere with the study cannot participate.
  • Patients who have a mental health condition that might interfere with their ability to follow the study procedures cannot participate.
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Investigated drugs

ND0612 is a medication used in this clinical trial. It is a solution containing levodopa and carbidopa, which are commonly used to treat symptoms of Parkinson's Disease. In this study, ND0612 is delivered continuously under the skin using a pump system. The goal is to evaluate the long-term safety and how well patients tolerate this method of delivery for those with advanced Parkinson's Disease.

What is already known about the treatment

ND0612 – ND0612 is a medication designed for the treatment of advanced Parkinson's disease. It is administered as a continuous subcutaneous infusion using a pump system, allowing for a steady delivery of the active ingredients, levodopa and carbidopa. Currently, ND0612 is being studied in clinical trials to evaluate its long-term safety and tolerability. The medication works by increasing dopamine levels in the brain, which helps to improve motor function in individuals with Parkinson's disease. ND0612 falls under the pharmacological classification of dopaminergic agents, which are used to manage symptoms of Parkinson's disease.

Investigated diseases

Parkinson's disease – Parkinson's disease is a progressive neurological disorder that affects movement. It is characterized by tremors, stiffness, and difficulty with balance and coordination. As the disease progresses, individuals may experience slowness of movement and a decrease in facial expressions. Over time, symptoms can worsen, leading to challenges in performing daily activities. The disease is caused by the loss of dopamine-producing neurons in the brain. It typically affects older adults, but symptoms can vary widely among individuals.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IITrial ID2024-513548-27-00Protocol codeND0612H-012Estimated enrolment214 patientsSponsorNeuroderm Ltd.

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On this site, “treatment” means an investigational medicine being studied in a clinical trial. Its safety and efficacy for the use being studied have not yet been confirmed, some participants may receive a placebo or a comparator medicine, and taking part does not guarantee any health benefit. The decision to take part is made by the doctor at the research site. This site is for information only and does not replace medical advice.

This service is not affiliated with the European Commission, the EMA, or the official CTIS system. Most information comes from publicly available international clinical-trial registries, supplemented by data from academic sites, national regulators and commercial sponsors. On this site, “treatment” and “therapy” mean a medicine being tested in a clinical trial. Its safety and effectiveness in the use being studied are not yet confirmed, some participants may receive a placebo or a comparator, and taking part does not guarantee a health benefit. The doctor at the research site decides who can take part. This site provides information, not medical advice. Certain content and visual elements on this website have been generated or enhanced using artificial intelligence (AI).