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Brain drug SAGE-718 tested in healthy people – no cure yet

NCT ID NCT03844906

Knowledge-focused Sponsor: Supernus Pharmaceuticals, Inc. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jun 26, 2026

Summary

This early-stage study tested a drug called SAGE-718 in 40 healthy adults. Researchers used a ketamine challenge to see how the drug affects brain electrical activity and safety. The goal was to gather basic information, not to treat any illness. This is a first step toward understanding if SAGE-718 might be useful for brain conditions in the future.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
SAGE-718
What this could lead to
If successful, this could help researchers understand how SAGE-718 affects brain activity, potentially guiding future studies for conditions like Alzheimer's or Parkinson's.
What could go wrong
This is a very early Phase 1 study in only 40 healthy people, not patients. It is designed to test safety and brain effects, not to treat any disease. Results may not lead to a treatment.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

40 people

The number who actually took part.

Started

Dec 2018

Finished

Apr 2019

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 65 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Subject has a body weight ≥50 kg and body mass index (BMI) ≥18.0 and ≤30.0 kg/m2 at screening. 2. Subject is healthy with no history or evidence of clinically relevant medical disorders as determined by the Investigator. Exclusion Criteria: 1. Subject has any clinically significant abnormal value for hematology, clinical chemistry, or urinalysis at screening or admission. 2. Subject has a history or presence of a neurologic disease or condition, including but not limited to epilepsy, closed head trauma with clinically significant sequelae, or a prior seizure. 3. Subject has a positive screening test for alcohol or drugs of abuse (including marijuana) at screening or admission.

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As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Healthy volunteer

Contacts and locations

Locations

  • Sage Investigational Site

    Long Beach, California, 90806, United States

  • Sage Investigational Site

    Berlin, New Jersey, 08009, United States

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