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NCT04476017 · ClinicalTrials.gov registry record · Phase 2
A Study to Evaluate the Safety and Tolerability of SAGE-718 in Participants With Parkinson's Disease Mild Cognitive Impairment (PD-MCI)
A Phase 2 study, sponsored by Supernus Pharmaceuticals.
- Completed
- Registry status
- Phase 2
- Development phase
- 18
- Enrollment target
NCT04476017: Completed Phase 2 study, sponsored by Supernus Pharmaceuticals.
NCT04476017 is a Phase 2 study that has completed, run by Supernus Pharmaceuticals. The registered enrollment target is 18 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (86% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04476017, a Phase 2 study, has completed, sponsored by Supernus Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 18 participants
- Enrollment target
Study Summary
The primary purpose of this two-part study was to evaluate the safety and tolerability of SAGE-718 and its effects on cognitive, neuropsychiatric, and motor symptoms in participants with Parkinson's disease mild cognitive impairment (PD-MCI).
Primary Outcome
An adverse event (AE) was any untoward medical occurrence in a participant administered with a pharmaceutical product and that does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of an IP whether or not related to the product. An AE can include any undesirable medical condition, even if no study treatment has been administered. TEAEs were defined as an AE with an on
Interventions
- DRUG SAGE-718
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 18 participants |
| Start Date | 2020-07-31 |
| Est. Completion | 2022-03-25 |
| Phase | Phase 2 |
What the finished NCT04476017 record still lists
NCT04476017 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 18 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (86% lower).
The record links to 0 conditions, and to 1 intervention - of which SAGE-718 is the first listed.
NCT04476017 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04476017 about?
NCT04476017 is a clinical study titled "A Study to Evaluate the Safety and Tolerability of SAGE-718 in Participants With Parkinson's Disease Mild Cognitive Impairment (PD-MCI)". The primary purpose of this two-part study was to evaluate the safety and tolerability of SAGE-718 and its effects on cognitive, neuropsychiatric, and motor symptoms in participants with Parkinson's disease mild cognitive impairment (PD-MCI).
What is the current status of trial NCT04476017?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 18 participants. The study started on 2020-07-31. Estimated completion is 2022-03-25.
What interventions are being tested in trial NCT04476017?
The interventions under investigation include: SAGE-718 (DRUG).
Who is sponsoring clinical trial NCT04476017?
This trial is sponsored by Supernus Pharmaceuticals, which has 57 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04476017's enrollment target sits among peer trials
18 1898th of 2000 higher than 98 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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