What side effects are associated with this type of intervention?

The most common treatments for Parkinson's Disease, particularly carbidopa-levodopa formulations, can cause several side effects. These include nausea, orthostatic hypotension (a drop in blood pressure when standing up), confusion, and hallucinations. Motor complications such as dyskinesia (involuntary movements) and 'wearing off' phenomena (where the medication's effect diminishes before the next dose) are also common. Adjunctive therapies like dopamine agonists, MAO B inhibitors, and COMT inhibitors can exacerbate these side effects and may also lead to impulse control disorders.

What prior FDA approvals exist?

The FDA has approved several treatments for Parkinson's Disease, focusing on managing motor symptoms and complications. Key treatments include immediate-release (IR) and controlled-release (CR) formulations of carbidopa-levodopa, which are the mainstay of therapy. Nonergot dopamine agonists like pramipexole, ropinirole, and transdermal rotigotine have also been approved and are effective as monotherapy in early disease stages. Newer extended-release (ER) capsules of carbidopa-levodopa show promise in reducing motor complications, although their widespread use is limited by cost and conversion difficulties. These treatments aim to provide continuous dopaminergic stimulation to reduce motor fluctuations and dyskinesia.

What other types of research exist?

Promising novel alternatives for maintaining consistent blood levels of levodopa and carbidopa in Parkinson's Disease patients include: 1) IPX066, an extended-release carbidopa-levodopa preparation that provides rapid attainment and prolonged maintenance of therapeutic LD plasma concentrations. 2) IPX203, another investigational oral extended-release capsule formulation of carbidopa and levodopa, which has shown favorable pharmacodynamics and efficacy. 3) Continuous oral delivery systems of levodopa/carbidopa, which have been associated with reduced motor complications compared to standard intermittent dosing.

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Dopamine Agonist

Sustained Release Levodopa/Carbidopa for Parkinson's Disease

Q: What is the mechanism of action of this treatment?

The most common treatments for Parkinson's Disease (PD) involve the use of levodopa combined with carbidopa. Levodopa is converted to dopamine in the brain, addressing the dopamine deficiency characteristic of PD. Carbidopa inhibits the enzyme that breaks down levodopa before it reaches the brain, enhancing its efficacy and reducing side effects. Sustained-release formulations of carbidopa-levodopa are designed to maintain consistent blood levels of the medication, which helps in reducing motor fluctuations and 'wearing off' periods, thereby providing more stable symptom control and improving the quality of life for PD patients.

Phase < 1

Waitlist Available

Led By Khalaf Bushara, MD,FRCP

Research Sponsored by University of Minnesota

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 5 times, every 60 mins for a total of 6 hours after administration

Awards & highlights

Summary

This trial is testing a new pill that combines two drugs, carbidopa and levodopa, for people with advanced Parkinson's disease. These patients often have trouble with movement control because their current treatments don't keep drug levels steady. The new pill aims to maintain stable drug levels in the blood to help manage these movement problems better. Carbidopa/levodopa is the most effective drug treatment for Parkinson's disease, but long-term use often leads to motor fluctuations.

Who is the study for?

This trial is for people with Parkinson's Disease who have been officially diagnosed and are experiencing motor fluctuations. Participants must be able to give consent and fast before joining the study.

What is being tested?

The study tests three different oral formulations of levodopa/carbidopa (A, B, C) to see which one maintains steady levels in the blood better, aiming to reduce motor issues in Parkinson's patients.

What are the potential side effects?

Levodopa/carbidopa can cause side effects like nausea, dizziness upon standing, involuntary movements, sleepiness during daytime activities, and even hallucinations or psychotic behavior.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 5 times, every 60 mins for a total of 6 hours after administration

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~5 times, every 60 mins for a total of 6 hours after administration

This trial's timeline: 3 weeks for screening, Varies for treatment, and 5 times, every 60 mins for a total of 6 hours after administration for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Carbidopa/levodopa serum level Efficacy of the delivery method

Trial Design

3Treatment groups

Experimental Treatment

Group I: levodopa/carbidopa oral formulation CExperimental Treatment1 Intervention

LD/CD will be delivered using an assembly of nested sachets made of permeable material. The assembly is placed in the oral/buccal cavity (between cheek and gum of lower jaw) and delivers continuous release of CD and LD for both transmucosal and gastrointestinal absorption. Outer sachet contains 50mg CD/200mg LD and inner sachet contains 50mg CD /200mg LD.

Group II: levodopa/carbidopa oral formulation BExperimental Treatment1 Intervention

LD/CD will be delivered using an assembly of nested sachets made of permeable material. The assembly is placed in the oral/buccal cavity (between cheek and gum of lower jaw) and delivers continuous release of CD and LD for both transmucosal and gastrointestinal absorption. Outer sachet contains 100mg CD/0mg LD and inner sachet contains 0mg CD /400mg LD.

Group III: levodopa/carbidopa oral formulation AExperimental Treatment1 Intervention

LD/CD will be delivered using an assembly of nested sachets made of permeable material. The assembly is placed in the oral/buccal cavity (between cheek and gum of lower jaw) and delivers continuous release of CD and LD for both transmucosal and gastrointestinal absorption. Outer sachet contains 100mg CD/100mg LD and inner sachet contains 0mg CD /300mg LD.

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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 (PD) involve the use of levodopa combined with carbidopa. Levodopa is converted to dopamine in the brain, addressing the dopamine deficiency characteristic of PD. Carbidopa inhibits the enzyme that breaks down levodopa before it reaches the brain, enhancing its efficacy and reducing side effects. Sustained-release formulations of carbidopa-levodopa are designed to maintain consistent blood levels of the medication, which helps in reducing motor fluctuations and 'wearing off' periods, thereby providing more stable symptom control and improving the quality of life for PD patients.

Pharmacokinetic model of oral levodopa and role of carbidopa in parkinsonian patients.Continuous versus intermittent oral administration of levodopa in Parkinson's disease patients with motor fluctuations: A pharmacokinetics, safety, and efficacy study.Levodopa/carbidopa microtablets in Parkinson's disease: a study of pharmacokinetics and blinded motor assessment.

Find a Location

Who is running the clinical trial?

University of MinnesotaLead Sponsor

1,413 Previous Clinical Trials

1,561,397 Total Patients Enrolled

Khalaf Bushara, MD,FRCPPrincipal InvestigatorUniversity of Minnesota

Media Library

levodopa/carbidopa oral formulation C (Dopamine Agonist) Clinical Trial Eligibility Overview. Trial Name: NCT05471609 — Phase < 1

Parkinson's Disease Research Study Groups: levodopa/carbidopa oral formulation A, levodopa/carbidopa oral formulation B, levodopa/carbidopa oral formulation C

Parkinson's Disease Clinical Trial 2023: levodopa/carbidopa oral formulation C Highlights & Side Effects. Trial Name: NCT05471609 — Phase < 1

levodopa/carbidopa oral formulation C (Dopamine Agonist) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05471609 — Phase < 1

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