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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 is a Phase 1 study that has completed, run by BioVie. The registered enrollment target is 46 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05083260
The ClinicalTrials.gov registry entry for NCT05083260 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 46 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is BioVie, which has 6 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which placebo is the first listed.
NCT05083260 reports 0 study locations.
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.
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