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ND0612 for Parkinson's Disease (BouNDless Trial)
BouNDless Trial Summary
This trial is testing a new drug to see if it's effective and safe. Subjects will take the drug for a year and then be evaluated.
BouNDless Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowBouNDless Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.BouNDless Trial Design
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Who is running the clinical trial?
Media Library
- You have been diagnosed with Parkinson's disease according to the United Kingdom Brain Bank Criteria.My condition is not typical Parkinson's but a variant or caused by another condition.I haven't used apomorphine injections, sublingual apomorphine, or inhaled levodopa in the last 4 weeks.I experience more than 2.5 hours of symptom worsening during the day.I take 4 or more daily doses of levodopa, totaling 400mg or more.I am using a duodenal levodopa or apomorphine infusion.I have a history of serious skin conditions.I have had brain surgery for Parkinson's disease.You have very severe and disabling uncontrolled movements, as decided by the doctor.I am 30 years old or older.You have taken part in studies involving ND0612 before.My Parkinson's symptoms are mild to moderate when my medication is working.I experience at least 2 hours of 'OFF' time daily.I am 30 years old or older.You have been diagnosed with Parkinson's disease according to the UK Brain Bank Criteria.My Parkinson's disease allows me to walk and stand unassisted.I take 4 or more daily doses of levodopa, totaling at least 400mg.
- Group 1: IR-LD/CD Group
- Group 2: Oral IR-LD/CD Adjustment
- Group 3: ND0612 Conversion
- Group 4: ND0612 Group
- Group 5: Open-Label Extension
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
Could you please list other times when ND0612 Solution has been used in a clinical trial?
"177 studies have completed investigating the effects of ND0612 Solution for SC infusion, which was originally studied in 2014 at Tel Aviv Sourasky Medical Center. Of the 17 ongoing studies, a significant proportion are taking place within Boston, Massachusetts."
Can you tell me how many hospitals are participating in this research project?
"There are a total of 44 hospitals and medical centres currently running this study. In the Northeastern region of the United States, there are locations such as Beth Israel Deaconess Medical Center in Boston and Weill Cornell Medicine in New york. Alternatively, for those on the West Coast, Hawaii Pacific Neuroscience in Honolulu is an option."
Has the Food and Drug Administration cleared ND0612 Solution for SC infusion?
"There is some evidence from previous trials to suggest that ND0612 Solution for SC infusion is effective, and it has been through multiple rounds of testing to ensure safety. Therefore, we have given it a score of 3."
What are the main indications for using ND0612 Solution for SC infusion?
"ND0612 Solution for SC infusion can be used to treat manganese intoxication and other conditions like advanced motor fluctuations, restless legs syndrome (rls), and carbon monoxide intoxication."
Are we still enrolling volunteers for this experiment?
"This study is not recruiting patients at the moment. According to the posting dates (August 27th, 2019 and May 17th, 2022), as well as the last edit date, it seems as if this trial is inactive. There are currently 517 trials searching for patients with Parkinson's disease and 17 trials for ND0612 Solution for SC infusion."
How many people are taking part in this experiment?
"This specific trial is not actively recruiting patients right now, however, there are 517 other clinical trials for parkinson disease and 17 studies enrolling patients for ND0612 Solution for SC infusion."
What are the requirements to participate in this research project?
"381 patients that fit the age demographic of 30-80 and have been diagnosed with parkinson disease are eligible for this trial. There are also certain requirements that applicants must meet, such as being male or female, having an Hoehn & Yahr score of 3 or lower during times when the medication is active, and having at least 2.5 hours of OFF time per day (as confirmed by a patient diary over the course of 3 days)."
Do the requirements for participating in this trial include an age limit?
"According to the specific guidelines for this trial, applicants between the ages of 30 and 80 may be eligible. There are 28 trials involving patients under 18 and 529 trials with senior citizens above 65."
Who else is applying?
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