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 study about?

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.

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 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 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 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 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 Study?

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 Study?

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.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country	Status
Medizinische Universitaet Innsbruck	Innsbruck	Austria
Centre Hospitalier Universitaire De Lille	Lille	France

Other Sites

Site Name	City	Country
Centre Hospitalier Universitaire De Poitiers	Poitiers	France
CHU Gabriel-Montpied	Clermont Ferrand	France
Centrum Medyczne Plejady Magdalena Celinska Loewenhoff Michal Zolnowski sp.k.	Cracow	Poland
Krakowska Akademia Neurologii Sp. z o.o.	Cracow	Poland
Centre Hospitalier Du Pays D Aix Centre Hospitalier Intercommunal Aix-Pertuis	Aix En Provence	France
Università degli studi Gabriele D’Annunzio Chieti-Pescara Centro di Studi e tecnologie avanzate	Chieti	Italy
Irccs San Raffaele Roma S.r.l.	Rome	Italy
Hospices Civils De Lyon	Lyon	France
Centre Hospitalier Universitaire Amiens Picardie	Amiens	France
Idmidvnibiag Phbgbvtt Lahpvfkx pjdiy Kkeyxi Rkmkpc	Lublin	Poland
Afmdegbdid Ppvigwup Hpsrgdjp Ds Mbgrqtgvw	Marseille	France

Trial status

Country	Status	Recruitment Start
Austria	Not recruiting	18.10.2016
France	Not recruiting	18.10.2016
Italy	Not recruiting	18.10.2016
Poland	Not recruiting	18.10.2016

Trial locations

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.

Investigated diseases:

Parkinson's disease

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 ID:

2024-513548-27-00

Protocol code:

ND0612H-012

NCT ID:

NCT02726386

Trial Phase:

Therapeutic exploratory (Phase II)

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

What is this study about?

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