NE3107 Activity and Safety in Patients With Parkinson's Disease Using Levodopa
Public ClinicalTrials.gov record NCT05083260. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Double-Blind, Placebo-Controlled, Safety, Tolerability, and Pharmacokinetics Study in Parkinson's Disease (PD) Participants Treated With Carbidopa/Levodopa and NE3107
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT05083260
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 1, Phase 2
- Enrollment
- 46 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 30 Years to 80 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Jan 3, 2022
- Primary completion
- Nov 20, 2022
- Completion
- Jan 3, 2023
- Last update posted
- Feb 7, 2023
2022 – 2023
United States locations
- U.S. sites
- 16
- U.S. states
- 8
- U.S. cities
- 13
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Rocky Mountain Movement Disorders Center | Englewood | Colorado | 80113 | — |
| Parkinson's Disease & Movement Disorders Center Of Boca Raton | Boca Raton | Florida | 33486 | — |
| Velocity | Hallandale | Florida | 33009 | — |
| Charter Research | Lady Lake | Florida | 32159 | — |
| Premier Clinical Research Institute | Miami | Florida | 33122 | — |
| First Excellent Research Group | Miami | Florida | 33172 | — |
| First Excellent Research | Miami | Florida | 33172 | — |
| EZY Medical Research | Miami | Florida | 33175 | — |
| Charter Research | Winter Park | Florida | 32792 | — |
| Quest Research Institute | Farmington Hills | Michigan | 48334 | — |
| New York Neurology Associates | New York | New York | 10003 | — |
| Duke University | Durham | North Carolina | 27705 | — |
| M3 Wake Research | Raleigh | North Carolina | 27612 | — |
| University of Toledo | Toledo | Ohio | 43614 | — |
| Texas Institute for Neurological Disorders | Sherman | Texas | 75092 | — |
| Inland Northwest Research | Spokane | Washington | 99202 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT05083260, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Feb 7, 2023 · Synced Sep 2, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT05083260 live on ClinicalTrials.gov.