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Dopamine Precursor
Continuous Subcutaneous Infusion of Levodopa/Carbidopa for Parkinson's Disease (BeyoND Trial)
Phase 2
Waitlist Available
Research Sponsored by NeuroDerm Ltd.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Cohort 2: 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.
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up month 12 to month 102
Awards & highlights
BeyoND Trial Summary
This trial is testing a new way to deliver levodopa/carbidopa, a common Parkinson's treatment, continuously through a pump system under the skin. The study will assess the safety of this new delivery method.
Who is the study for?
This trial is for adults over 30 with advanced Parkinson's Disease who are stable on their current medications, have a mental state score above 26, and can self-administer or get help with the infusion. They need to experience at least 2 hours of 'OFF' time daily and respond well to Levodopa. People with recent drug abuse history, significant heart rhythm problems, liver or kidney issues affecting drug metabolism, psychosis in the past six months, certain other medical conditions or treatments for PD like neurosurgery aren't eligible.Check my eligibility
What is being tested?
The study tests ND0612—a levodopa/carbidopa solution given through a pump as a continuous subcutaneous (under the skin) infusion—to see if it's safe long-term for those with advanced Parkinson's Disease. It’s an open-label international trial where everyone knows they're getting this treatment.See study design
What are the potential side effects?
While specific side effects aren't listed here, typical ones from similar treatments include skin reactions at the infusion site, digestive issues like nausea or constipation, sleep disturbances and potential worsening of some Parkinson's symptoms temporarily.
BeyoND Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am on Parkinson's medication and have tried at least one other treatment for over 30 days.
BeyoND Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ month 12 to month 102
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~month 12 to month 102
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Percentages of Subjects Who Complete the 12-month Treatment Period or Discontinue Due to AE (Tolerability)
Secondary outcome measures
Adverse Events (Long-term Safety)
Other outcome measures
Change in CGI-Severity and CGI-Improvement
Change in ND0612 Total Dose
Change in PDSS-2 Total Score
+12 moreBeyoND Trial Design
2Treatment groups
Experimental Treatment
Group I: 24-hour dosing regimenExperimental Treatment1 Intervention
Continuous SC infusion over 24 hours: fixed day rate of up to 0.64 mL/h for 18 hours, followed by a night rate of 0.08 mL/h for 6 hours to deliver a total daily dose of up to 720/90 mg of levodopa/carbidopa.
All patients who had been previously assigned to the 24-hour group in the prior study continued on this dosing regimen; patients who had previously been assigned to the 14-hour daytime regimen were switched to the 24-hour regimen.
Group II: 16-hour dosing regimenExperimental Treatment1 Intervention
Continuous SC infusion for over 16 hours: fixed rate of 0.75 mL/h to deliver a total infusion dose of 720/90 mg of levodopa/carbidopa over 16 hours.
The device is removed at night and patients in this group also receive a morning oral dose of levodopa/carbidopa upon awakening.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
ND0612
2015
Completed Phase 1
~80
Find a Location
Who is running the clinical trial?
NeuroDerm Ltd.Lead Sponsor
13 Previous Clinical Trials
623 Total Patients Enrolled
Laurence Salin, MDStudy DirectorNeuroDerm Ltd.
1 Previous Clinical Trials
38 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am on Parkinson's medication and have tried at least one other treatment for over 30 days.I am 30 or older with Parkinson's disease and have agreed to participate.My Parkinson's disease is at stage 3 or below when my medication is working.I am on a Parkinson's disease medication regimen and have tried at least one other treatment for over 30 days.My Parkinson's medication has been the same for at least 30 days.My early morning mobility issues improve with Levodopa.You have a Mini Mental State Examination (MMSE) score of more than 26.My condition is diagnosed as atypical or secondary parkinsonism.I have kidney or liver issues that could affect how drugs are processed in my body.I have not had any cancer except for treated skin basal cell carcinoma or cervical carcinoma in situ in the last 5 years.I have Parkinson's and have had brain surgery or Duodopa treatment.I had a bad reaction or couldn't tolerate ND0612 before.I do not have any health issues that would prevent me from completing the study.I have been on the same anti-PD medication for at least 30 days.I stopped using apomorphine injections at least 4 weeks ago.I stopped taking apomorphine at least 4 weeks ago and won't use it during the trial.My Parkinson's disease is at stage 3 or below when my medication is working.I am at least 30 years old with Parkinson's disease and have signed the consent form.I experience clear worsening of my condition in the morning but respond well to medication.I experience at least 2 hours of worsened symptoms daily, especially in the morning.I experience at least 2 hours of 'OFF' time daily with predictable early morning 'OFF' periods.I meet the specific requirements for women regarding surgery, menopause, contraception, pregnancy, and breastfeeding.You have been diagnosed with Parkinson's disease using the UK Brain Bank Criteria.
Timeline:
This trial has the following timeline:- 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
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Has ND0612 been given the necessary clearance by the FDA?
"As this is a Phase 2 trial, with only limited data available to assess the safety of ND0612, it was given a rating of 2."
Answered by AI
How many healthcare locations are conducting this clinical research within the state?
"Presently, 26 different medical centres are accepting participants for this trial. This includes Farmington Hills, Sunrise and Englewood in addition to 23 other sites. If you opt-in for the study it is recommended that you select a facility closeby to reduce travel requirements."
Answered by AI
Are there any slots remaining in this trial to enroll participants?
"According to clinicaltrials.gov, this medical study has ended recruitment; its initial posting was on May 1st 2016 and the latest edit occured on May 3rd 2020. Although no longer enrolling patients in this trial, there are 483 other studies that still require participants."
Answered by AI
Who else is applying?
What state do they live in?
Florida
What portion of applicants met pre-screening criteria?
Did not meet criteria
How many prior treatments have patients received?
1
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