What side effects are associated with this type of intervention?

Common treatments for Parkinson's Disease, such as Levodopa/Carbidopa, including continuous subcutaneous infusion like ND0612, often cause side effects such as nausea, orthostatic hypotension, confusion, and hallucinations. Long-term use can lead to motor complications like dyskinesia and motor fluctuations. Dopamine agonists, another common treatment, can cause similar side effects and additional nonmotor issues like somnolence, edema, and impulse control disorders. Cholinesterase inhibitors used for cognitive symptoms may worsen tremors and cause gastrointestinal issues.

What prior FDA approvals exist?

The FDA has approved several treatments for Parkinson's Disease, including oral formulations of levodopa/carbidopa, which are the mainstay of therapy. Continuous subcutaneous infusion of levodopa/carbidopa, like ND0612, is being studied to provide more stable dopaminergic stimulation and reduce motor complications. Additionally, subcutaneous apomorphine injections have been approved for rescue therapy during 'off' periods. Long-acting formulations of dopamine agonists and extended-release capsules of carbidopa/levodopa have also been developed to manage motor fluctuations and dyskinesia.

What other types of research exist?

Promising alternatives to ND0612 for Parkinson's Disease patients include: 1) Subcutaneous apomorphine infusion, which provides continuous dopaminergic stimulation similar to ND0612. 2) Duodenal levodopa infusion, which bypasses gastric emptying and provides steady plasma levels of levodopa. Both methods aim to reduce motor complications and improve therapeutic outcomes by maintaining consistent dopaminergic delivery.

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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

Must not have

Cohort 2: Atypical or secondary parkinsonism.

Cohort 2: Prior neurosurgical procedure for PD, or Duodopa treatment.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up month 12 to month 102

Awards & highlights

No Placebo-Only Group

Summary

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.

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.

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.

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.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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My condition is diagnosed as atypical or secondary parkinsonism.

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I have Parkinson's and have had brain surgery or Duodopa treatment.

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I had a bad reaction or couldn't tolerate ND0612 before.

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

This trial's timeline: 3 weeks for screening, Varies for treatment, and month 12 to month 102 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Percentages of Subjects Who Complete the 12-month Treatment Period or Discontinue Due to AE (Tolerability)

Secondary study objectives

Adverse Events (Long-term Safety)

Other study objectives

Change in CGI-Severity and CGI-Improvement

Change in ND0612 Total Dose

Change in PDSS-2 Total Score

+12 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

0 / 4Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for Parkinson's Disease focus on dopaminergic therapies, particularly Levodopa combined with Carbidopa. Levodopa is a precursor to dopamine, which replenishes the diminished dopamine levels in the brain, thereby improving motor symptoms. Carbidopa prevents the peripheral breakdown of Levodopa, ensuring more reaches the brain and reducing side effects like nausea. Continuous subcutaneous infusion of Levodopa/Carbidopa, as studied in the ND0612 trial, aims to provide stable dopaminergic stimulation, reducing motor fluctuations and complications associated with oral dosing. This continuous delivery is crucial for advanced Parkinson's patients, as it helps maintain consistent symptom control and improves quality of life.

Effective delivery of apomorphine in the management of Parkinson disease: practical considerations for clinicians and Parkinson nurses.Drug insight: Continuous dopaminergic stimulation in the treatment of Parkinson's disease.