Continuous Subcutaneous Infusion of Levodopa/Carbidopa for Parkinson's Disease
(BeyoND Trial)

Recruiting in Palo Alto (17 mi)

+56 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: NeuroDerm Ltd.

No Placebo Group

Prior Safety Data

Trial Summary

What is the purpose of this trial?This trial tests a pump that delivers medication under the skin for patients with advanced Parkinson's Disease. The treatment aims to improve movement symptoms by increasing dopamine levels in the brain. This method has been used for many years to manage motor complications in advanced Parkinson's Disease.

Eligibility Criteria

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.

Inclusion Criteria

I am on Parkinson's medication and have tried at least one other treatment for over 30 days.

Cohort 2: No clinically significant medical, psychiatric or laboratory abnormalities which the investigator judges would be unsafe or non-compliant in the study.

Cohort 1: Subject is able to, and has signed an Institutional Review Board/Ethics Committee (IRB/EC)-approved informed consent form (ICF).

+13 more

Exclusion Criteria

Cohort 2: Acute psychosis or hallucinations in past 6 months.

My condition is diagnosed as atypical or secondary parkinsonism.

Cohort 2: Clinically significant ECG rhythm abnormalities.

+8 more

Participant Groups

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.

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.