Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
SAGE-904 · 1 trial · 1 indication
AEP variables will include individual amplitudes of N100 and P200 responses and the derived peak-to-peak amplitude of these responses (N100-P200) in microvolts (µV).
MMN is a response to nonmatching sounds in a series of matching sounds. Two tones of the same frequency and sound intensity, but differing in duration, will be sequentially presented to the participant through insert earphones. MMN amplitude will be measured from the peak of a mid-latency negative voltage deflection in the difference waveform representing the response to deviant stimuli in µV.
ASSR is used to assess the integrity of sensory pathways including cortical processing. ASSR will be measured at midline central electrode (Cz) of electroencephalogram (EEG) to assess the response in hertz (Hz). In ASSR, streams of "click" stimuli will be presented at a rate of 40 Hz while the participant will be instructed to fix their gaze on a white cross displayed on a computer monitor.
Improvement of the P300 auditory response time in milliseconds using P300 AEP in a target detection paradigm by an increase in amplitude and/or a decrease in latency will be analyzed. In this paradigm, 2 tones of the same sound intensity, but differing in frequency, are sequentially presented to the participant through insert earphones. The "standard" (low frequency) stimuli will be presented on the majority of trials, with a "target" (high frequency) stimuli presented periodically at random. The participant is told to listen for the "target" stimuli and press a button on the handset as fast as they can. The endpoint variables of P300 amplitude and latency in correlation with the button press reaction time will be used to assess the response time.
| Arm | Type | Description |
|---|---|---|
| SAGE-904 then Placebo | EXPERIMENTAL | SAGE-904 in combination with ketamine, followed by a washout period, followed by placebo in combination with ketamine. |
| Placebo then SAGE-904 | PLACEBO_COMPARATOR | Placebo in combination with ketamine, followed by a washout period, followed by SAGE-904 in combination with ketamine. |
| Name | Type | Description |
|---|---|---|
| SAGE-904 | DRUG | SAGE-904 oral solution. |
| Placebo | DRUG | Placebo oral solution. |
| Ketamine | DRUG | Ketamine intravenous (IV) infusion. |
Inclusion Criteria: 1. Participant is willing and able to provide 2 forms of identification; at least 1 must have a photo 2. Participant has a body weight ≥50 kilograms (kg) and body mass index ≥18.0 and ≤30.0 kilograms per square meter (kg/m\^2) at screening 3. Participant is healthy with no histo...
SAGE-904 is an investigational small molecule drug being developed by Supernus Pharmaceuticals, Inc. It has been studied in a Phase 1 clinical trial in healthy volunteers. Its specific therapeutic indications have not been disclosed.
SAGE-904 is being developed by Supernus Pharmaceuticals, Inc., which trades on the Nasdaq under the ticker symbol SUPN. The company sponsored the Phase 1 study of the compound in healthy participants.
SAGE-904 is in Phase 1 clinical development. One Phase 1 trial has been completed, and no active trials are currently listed. The drug is investigational and has not been approved by the FDA.
SAGE-904 was evaluated in a single Phase 1 trial, NCT05049343, titled a study using a ketamine challenge to evaluate electrophysiology, safety, tolerability, and pharmacokinetics in healthy participants. The trial enrolled 22 participants in the United States and has been completed.
Yes. The completed Phase 1 trial of SAGE-904, NCT05049343, was randomized, double blind, and placebo controlled. It enrolled 22 healthy volunteers aged 21 years and older, with both sexes eligible, and was conducted in the United States.