levodopa/carbidopa oral formulation A for Parkinson Disease

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
University of Minnesota, Minneapolis, MN
Parkinson Disease+1 More
levodopa/carbidopa oral formulation A - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

Achieving sustained blood levels of carbidopa/levodopa has been a challenge in the treatment of PD and although levodopa remains the most commonly used drug, motor fluctuations remain a major disability especially in advanced Parkinson's disease. The aim of this study is to determine the efficacy of a novel oral carbidopa-levodopa formulation in achieving a sustained blood level of levodopa and carbidopa in PD.

Eligible Conditions

  • Parkinson Disease

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

1 Primary · 0 Secondary · Reporting Duration: 5 times, every 60 mins for a total of 6 hours after administration

Hour 6
Carbidopa/levodopa serum level Efficacy of the delivery method

Trial Safety

Safety Progress

1 of 3

Trial Design

3 Treatment Groups

levodopa/carbidopa oral formulation A
1 of 3
levodopa/carbidopa oral formulation B
1 of 3
levodopa/carbidopa oral formulation C
1 of 3
Experimental Treatment

6 Total Participants · 3 Treatment Groups

Primary Treatment: levodopa/carbidopa oral formulation A · No Placebo Group · Phase < 1

levodopa/carbidopa oral formulation A
Drug
Experimental Group · 1 Intervention: levodopa/carbidopa oral formulation A · Intervention Types: Drug
levodopa/carbidopa oral formulation B
Drug
Experimental Group · 1 Intervention: levodopa/carbidopa oral formulation B · Intervention Types: Drug
levodopa/carbidopa oral formulation C
Drug
Experimental Group · 1 Intervention: levodopa/carbidopa oral formulation C · Intervention Types: Drug

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 5 times, every 60 mins for a total of 6 hours after administration
Closest Location: University of Minnesota · Minneapolis, MN
Photo of University of Minnesota  1Photo of University of Minnesota  2Photo of University of Minnesota 3
1993First Recorded Clinical Trial
21 TrialsResearching Parkinson Disease
830 CompletedClinical Trials

Who is running the clinical trial?

University of MinnesotaLead Sponsor
1,227 Previous Clinical Trials
1,454,397 Total Patients Enrolled
18 Trials studying Parkinson Disease
1,118 Patients Enrolled for Parkinson Disease
Khalaf Bushara, MD,FRCPPrincipal InvestigatorUniversity of Minnesota

Eligibility Criteria

Age 18+ · All Participants · 2 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You have idiopathic Parkinson's disease.\n

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.