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Study on the Effectiveness and Safety of ND0612 Infusion vs. Oral Treatment for Parkinson's Disease Patients with Motor Fluctuations

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What is this trial about?

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

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.

The research process

The trial runs in 2 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Participation in the trial

    Upon joining the study, a treatment plan is assigned through a randomized process, meaning the specific treatment type is determined by chance. the study is double-blind, which means neither the person receiving the treatment nor the staff know which specific medication is being used during the study periods.

    The treatment involves a double-dummy method. this means two different types of medication are used at the same time to ensure the experience is identical regardless of the assigned group: one subcutaneous infusion (a liquid delivered under the skin) and one oral capsule (swallowed by mouth).

  2. Step 2

    Maintenance period

    During the maintenance period, which lasts for 12 weeks, the daily routine involves two components to compare the continuous subcutaneous infusion against oral tablets.

    One group receives a continuous subcutaneous infusion of nd0612, which contains carbidopa and levodopa at a dose of 720 mg. this liquid is delivered under the skin through an infusion system. to maintain the double-dummy design, this group also takes a placebo capsule (a pill with no active medicine) by mouth.

    Another group receives oral ir-ld/cd, which are tablets containing carbidopa and levodopa. to maintain the double-dummy design, this group also receives a placebo infusion (a liquid with no active medicine) under the skin.

    Throughout this period, a diary must be used to record daily on/off motor function. on time refers to periods when parkinson's disease symptoms are well-controlled, and off time refers to periods when symptoms return. the records focus on on time without troublesome dyskinesia, which are involuntary, uncontrolled body movements.

Who can join the trial?

13 criteria

  • Participants must be men or women with Parkinson's disease and at least 30 years old.
  • Participants must sign a consent form approved by an ethics committee.
  • Participants and/or their study partners must be able to keep accurate diaries of Parkinson's symptoms, with at least 75% accuracy, including at least one "OFF" assessment.
  • Participants must score 24 or higher on the Mini Mental State Examination (MMSE), a test that checks mental abilities.
  • Participants need approval from an independent committee to join the study.
  • Female participants must be surgically sterile, postmenopausal, or willing to use a highly effective method of birth control. They must not be breastfeeding or pregnant and must have a negative pregnancy test at the start and during the study.
  • Participants must have a named study partner who also signs the consent form.
  • Participants must be willing and able to follow the study's requirements.
  • Participants must have a Parkinson's disease diagnosis that matches the UK Brain Bank Criteria.
  • Participants must have a score of 3 or less on the Modified Hoehn and Yahr scale in the "ON" stage, which measures the severity of Parkinson's disease.
  • Participants must experience motor fluctuations and have at least 2.5 hours daily in the "OFF" state, confirmed by a completed "ON/OFF" diary over 3 days.
  • Participants must be taking at least 4 doses per day of LD/DDI (a type of Parkinson's medication) or at least 3 doses per day of extended-release LD/DDI, and at least 400 mg per day of LD. Their motor fluctuations should not be improved by adjusting their Parkinson's medications, according to the doctor's judgment.
  • Participants and/or their study partners must be able to operate the pump system used in the study.

Who cannot join the trial?

5 criteria

  • Patients who do not have a diagnosis of Parkinson's disease cannot participate.
  • Patients who are not within the specified age range for the study cannot participate.
  • Patients who are not experiencing motor fluctuations related to Parkinson's disease cannot participate.
  • Patients who are unable to complete the "ON/OFF" diary assessments of motor function cannot participate.
  • Patients who are part of a vulnerable population that the study does not include cannot participate.
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Investigated drugs

  • ND0612

    is a medication being tested in this clinical trial. It is administered as a continuous subcutaneous infusion, which means it is delivered under the skin continuously. The purpose of ND0612 is to help manage motor fluctuations in people with Parkinson's disease. Motor fluctuations are changes in the ability to move, often seen in Parkinson's patients, where they experience periods of good movement ("ON" time) and poor movement ("OFF" time). This medication aims to increase the "ON" time without causing troublesome involuntary movements known as dyskinesia.

  • IR-LD/CD

    refers to an oral medication that combines two components: levodopa (LD) and carbidopa (CD). This combination is commonly used to treat symptoms of Parkinson's disease. Levodopa helps replenish dopamine, a chemical in the brain that is low in Parkinson's patients, while carbidopa helps prevent the breakdown of levodopa before it reaches the brain. In this trial, IR-LD/CD is used as a comparison to evaluate the effectiveness of ND0612.

What is already known about the treatment

ND0612 – ND0612 is administered as a continuous subcutaneous infusion and is currently being investigated in clinical trials for its effectiveness in treating Parkinson's disease. The medication is designed to help manage motor fluctuations in patients by increasing "ON" time, which is the period when symptoms are well-controlled. It works by delivering a steady dose of levodopa and carbidopa, which are essential in replenishing dopamine levels in the brain, thus improving motor function. ND0612 falls under the pharmacological classification of dopaminergic agents, which are commonly used to treat symptoms of Parkinson's disease.

Investigated diseases

Parkinson's disease – A progressive neurological disorder that affects movement, causing symptoms such as tremors, stiffness, and difficulty with balance and coordination. It occurs when nerve cells in the brain that produce dopamine become impaired or die. As the disease progresses, individuals may experience a decrease in spontaneous movements, a shuffling gait, and changes in speech and writing. Symptoms often start gradually and worsen over time, affecting both motor and non-motor functions. Non-motor symptoms can include sleep disturbances, mood changes, and cognitive impairment. The progression and severity of symptoms can vary widely among individuals.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-511940-20-00Protocol codeND0612-317Estimated enrolment381 patientsSponsorNeuroderm Ltd.

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