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NCT05083260 · ClinicalTrials.gov registry record · Phase 1
NE3107 Activity and Safety in Patients With Parkinson's Disease Using Levodopa
A Phase 1 study, sponsored by BioVie.
- Completed
- Registry status
- Phase 1
- Development phase
- 46
- Enrollment target
NCT05083260: Completed Phase 1 study, sponsored by BioVie.
NCT05083260 is a Phase 1 study that has completed, run by BioVie. The registered enrollment target is 46 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (23% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05083260, a Phase 1 study, has completed, sponsored by BioVie.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 46 participants
- Enrollment target
Study Summary
A 28-day phase 2a, double-blind, placebo-controlled (1:1), multi-center study of 20 mg NE3107, twice daily of safety, potential drug-drug interactions, and MDS-UPDRS defined activity in patients with Parkinson's disease . Study will enroll 40 patients that are currently taking immediate release levodopa/ carbidopa (IRLC) and have a practically defined early morning off-state for IRLC. Day one- baseline UPDRS and IRLC PK sampling; day 2- start NE3107 dosing, assess UPDRS during onset and NE3107 PK sampling, rescue meds as needed after 4 hours; day 3 and 14- NE3107 + IRLC UPDRS assessment and PK sampling; day 28- NE3107 + IRLC UPDRS assessments. Optional overnight stays in clinic prior to Day 1-3, 14, and 28.
Primary Outcome
Unified Parkinson's disease rating scale Part III total score is the cumulative score of a 33 question assessment of disease impact on patient's ability to move, with each part scored on a scale of 0-4, with 0 being no effect of disease and 4 being severe disease. a total score of 0 indicates no disease and a total score of 132 indicates the most severe disease
Interventions
- DRUG placebo
- DRUG NE3107
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 46 participants |
| Start Date | 2022-01-04 |
| Est. Completion | 2023-01-04 |
| Phase | Phase 1 |
What the finished NCT05083260 record still lists
NCT05083260 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 46 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (23% lower).
The record links to 0 conditions, and to 2 interventions - of which placebo is the first listed.
NCT05083260 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05083260 about?
NCT05083260 is a clinical study titled "NE3107 Activity and Safety in Patients With Parkinson's Disease Using Levodopa". A 28-day phase 2a, double-blind, placebo-controlled (1:1), multi-center study of 20 mg NE3107, twice daily of safety, potential drug-drug interactions, and MDS-UPDRS defined activity in patients with Parkinson's disease . Study will enroll 40 patients that are currently taking immediate release levo...
What is the current status of trial NCT05083260?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 46 participants. The study started on 2022-01-04. Estimated completion is 2023-01-04.
What interventions are being tested in trial NCT05083260?
The interventions under investigation include: placebo (DRUG), NE3107 (DRUG).
Who is sponsoring clinical trial NCT05083260?
This trial is sponsored by BioVie, which has 6 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05083260's enrollment target sits among peer trials
46 1058th of 2000 higher than 935 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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