A Long Term Safety Study of ND0612 Administered as a Continuous SC Infusion in Advanced Parkinson… (NCT02726386) | Clinical Trial Compass
Active — Not RecruitingPhase 2
A Long Term Safety Study of ND0612 Administered as a Continuous SC Infusion in Advanced Parkinson's Disease
United States, Austria, Czechia214 participantsStarted 2016-05-04
Plain-language summary
This is a multi-center, international, open-label, safety study of ND0612, a solution of levodopa/carbidopa (LD/CD) delivered via a pump system as a continuous SC infusion in subjects with advanced Parkinson's Disease (PD).
Who can participate
Age range
30 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Subject is able to, and has signed an Institutional Review Board/Ethics Committee (IRB/EC)-approved informed consent form (ICF).
. Subject has completed the treatment period of study ND0612H-006 not more than one month prior to enrolling in ND0612H-012.
. Willing and able to administer the SC infusion alone or with the assistance of a study partner and able to comply with the study specific procedures.
. Male and female PD subjects of any race aged at least 30 years who sign an IRB/EC-approved ICF.
. PD diagnosis consistent with the UK Brain Bank Criteria.
. Modified Hoehn \& Yahr scale in "ON" state of stage ≤3.
. Taking at least 4 doses/day of LD/DDI (or at least 3 doses/day of Rytary) and taking, or have attempted to take, at least one other PD treatment for at least 30 days.
. Subjects must be stable on their anti-PD medications for at least 30 days before Day 1.
Exclusion criteria
. Atypical or secondary parkinsonism.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Adverse Events (Long-term Safety)
Timeframe: Baseline to Month 12
2
Percentages of Subjects Who Complete the 12-month Treatment Period or Discontinue Due to AE (Tolerability)
. Acute psychosis or hallucinations in past 6 months.
. Any relevant medical, surgical, or psychiatric condition, laboratory value, or concomitant medication which, in the opinion of the Investigator makes the subject unsuitable for study entry or potentially unable to complete all aspects of the study.
. Any malignancy in the 5 years prior to randomization (excluding basal cell carcinoma of the skin or cervical carcinoma in situ that have been successfully treated).
. Positive serum serology for Hepatitis B Virus (HBV), Hepatitis C Virus (HCV) or Human Immunodeficiency Virus (HIV) at the Screening visit.
. Prior neurosurgical procedure for PD, or Duodopa treatment
. Subjects with a history of drug abuse or alcoholism within the past 12 months.