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Dopamine Agonist

Sustained Release Levodopa/Carbidopa for Parkinson's Disease

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 formulation of carbidopa/levodopa to see if it can help Parkinson's patients by achieving a sustained blood level of the medication.

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.Check my eligibility
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.See study design
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 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
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.

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
1,395 Previous Clinical Trials
1,553,319 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
~4 spots leftby Jun 2025