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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
Study 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 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
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.
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Who is running the clinical trial?
University of MinnesotaLead Sponsor
1,378 Previous Clinical Trials
1,588,503 Total Patients Enrolled
Khalaf Bushara, MD,FRCPPrincipal InvestigatorUniversity of Minnesota
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I am unable to give consent for my own medical treatment.I have been diagnosed with Parkinson's disease.I experience changes in my ability to move.
Research Study Groups:
This trial has the following groups:- Group 1: levodopa/carbidopa oral formulation A
- Group 2: levodopa/carbidopa oral formulation B
- Group 3: levodopa/carbidopa oral formulation C
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
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.
Is it possible for me to join this medical experiment?
"This medical trial is searching for 6 individuals aged between 55 and 75 who have been diagnosed with Parkinson's disease."
Answered by AI
Does this research encompass individuals aged 25 and over?
"According to the entry qualifications, adults aged 55 and 75 are eligible for enrollment in this clinical trial."
Answered by AI
Are there any available slots in this research program for participants?
"Per information available on clinicaltrials.gov, the recruitment period for this trial has concluded; it was initially posted on August 1st 2022 and had its last update on July 20th 2022. However, there are 489 other trials actively seeking participants at the present moment."
Answered by AI
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