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NCT05471609 · ClinicalTrials.gov registry record · Early Phase 1
Sustained Release Oral Formulation for Treatment of Parkinson's Disease
A Early Phase 1 study of Healthy Volunteers, sponsored by University of Minnesota.
- Recruiting
- Registry status
- Early Phase 1
- Development phase
- 6
- Enrollment target
- 1
- Study location
NCT05471609: Recruiting Early Phase 1 study of Healthy Volunteers, sponsored by University of Minnesota.
NCT05471609 is a Early Phase 1 study of Healthy Volunteers that is actively recruiting participants, run by University of Minnesota. The registered enrollment target is 6 participants, below the 482-participant average among 283 other Healthy Volunteers trials with a reported enrollment target (99% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05471609, a Early Phase 1 study of Healthy Volunteers, is actively recruiting participants, sponsored by University of Minnesota.
- RECRUITING
- Registry status
- Early Phase 1
- Development phase
- 6 participants
- Enrollment target
- 1
- Study location
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 normal volunteers.
Primary Outcome
Carbidopa/levodopa serum level
Conditions Studied
Interventions
- DRUG levodopa/carbidopa oral formulation A
- DRUG levodopa/carbidopa oral formulation B
Study Locations (1)
Minnesota
- University of Minnesota - Minneapolis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 6 participants |
| Start Date | 2025-06-12 |
| Est. Completion | 2026-06-16 |
| Phase | Early Phase 1 |
What NCT05471609 shows while recruiting
NCT05471609 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 6 participants, a relatively small participant target, below the 482-participant average among 283 other Healthy Volunteers trials with a reported enrollment target (99% lower).
The record links to 1 condition, with Healthy Volunteers appearing as the primary indexed condition, and to 2 interventions - of which levodopa/carbidopa oral formulation A is the first listed.
NCT05471609 reports a single indexed study location in Minnesota.
Frequently Asked Questions
What is clinical trial NCT05471609 about?
NCT05471609 is a clinical study titled "Sustained Release Oral Formulation for Treatment of Parkinson's Disease". 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...
What is the current status of trial NCT05471609?
This trial is currently recruiting. It is a Early Phase 1 study. The enrollment target is 6 participants. The study started on 2025-06-12. Estimated completion is 2026-06-16.
What conditions does trial NCT05471609 study?
This clinical trial studies the following conditions: Healthy Volunteers.
What interventions are being tested in trial NCT05471609?
The interventions under investigation include: levodopa/carbidopa oral formulation A (DRUG), levodopa/carbidopa oral formulation B (DRUG).
Who is sponsoring clinical trial NCT05471609?
This trial is sponsored by University of Minnesota, which has 966 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05471609 being conducted?
This trial has 1 study location across Minnesota. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Healthy Volunteers
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05471609's enrollment target sits among peer trials
6 279th of 283 higher than 1 of 283 other Healthy Volunteers trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Healthy Volunteers trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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