RecruitingRecruiting
Sustained Release Oral Formulation for Treatment of Parkinson's Disease
NCT05471609 · University of Minnesota
In plain English
Click the button to translate this study into plain language — what it is, who qualifies, and what participation looks like.
About this study
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 normal volunteers.
Eligibility criteria
Inclusion Criteria:
* Normal healthy
* Are 18-65 years of age
* Are not currently taking medications regularly
* Able to fast 6 hours (water allowed)
Exclusion Criteria:
* Pregnancy
* Inability to fast
Study design
Enrollment target: 6 participants
Allocation: randomized
Masking: double
Age groups: adult, older_adult
Timeline
Starts: 2025-06-12
Estimated completion: 2026-06-16
Last updated: 2025-07-10
Interventions
Drug: levodopa/carbidopa oral formulation ADrug: levodopa/carbidopa oral formulation B
Primary outcomes
- • Carbidopa/levodopa serum level Efficacy of the delivery method (4 times, then every 60 mins for a total of 6 hours after administration (total of 9 blood samples))
Sponsor
University of Minnesota · other
Contacts & investigators
ContactResearch Coordinator · contact · umnstudies@gmail.com · 507-339-4093
InvestigatorKhalaf Bushara, MD,FRCP · principal_investigator, University of Minnesota
All locations (1)
University of MinnesotaRecruiting
Minneapolis, Minnesota, United States