Recent Updates
Recently added Catalysts

SAGE-217 high dose

Phase 1

Healthy | Small molecule | Other |Biogen Inc.|Last Updated: Nov 29, 2023

Success Probability

Subscribe to view

Market & Valuation

Subscribe to view

Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment45

FDA Designations

No designations recorded

Clinical trial landscape

SAGE-217 high dose · 1 trial · 1 indication

Phase 1 1
NCT03284931A Study to Assess the Pharmacodynamic Effects of SAGE-217 in Healthy Adults Using an Insomnia ModelHealthy
COMPLETED45 Analytics
PHASE1COMPLETED
A Study to Assess the Pharmacodynamic Effects of SAGE-217 in Healthy Adults Using an Insomnia Model
Healthy
NCT0328493145
Unlock trial analytics

Study Endpoints

Primary Endpoints

Sleep efficiency, as determined by polysomnography (PSG)
16 days

Secondary Endpoints

Safety and tolerability, as assessed by adverse events
36 days
Safety and tolerability, as assessed by vital signs
29 days
Safety and tolerability, as assessed by clinical laboratory data
29 days
Unlock Study Endpoints

Study Design & Arms

AllocationRANDOMIZED
MaskingTRIPLE
ModelCROSSOVER
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
SAGE-217 high doseEXPERIMENTALSAGE-217
SAGE-217 low doseEXPERIMENTALSAGE-217
PlaceboPLACEBO_COMPARATORPlacebo

Interventions

NameTypeDescription
SAGE-217 high doseDRUGhigh dose
PlaceboDRUGplacebo
SAGE-217 low doseDRUGlow dose
Unlock Study Design Details

Eligibility Criteria

Age Range18 Years to 64 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Subject is willing and able to participate in the study, including all assessments, planned inpatient stays and all follow-up visits * Subject is a healthy, ambulatory volunteer * Subject meets sleep Qualification criteria Exclusion Criteria: * Subject has a medical history ...

Countries:United States
Unlock Eligibility Criteria

Frequently asked questions about SAGE-217 high dose

What is SAGE-217 high dose used for?

SAGE-217 high dose is an investigational small molecule being studied in healthy adults. It was evaluated in a Phase 1 clinical trial using an insomnia model to assess its pharmacodynamic effects. The drug is not approved and remains in clinical development.

Who makes SAGE-217 high dose?

SAGE-217 high dose is being developed by Biogen Inc., a biopharmaceutical company traded on the NASDAQ under the ticker BIIB. The company sponsored the Phase 1 clinical trial of this investigational small molecule.

What phase is SAGE-217 high dose in?

SAGE-217 high dose is in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities. The Phase 1 trial has been completed.

What clinical trials is SAGE-217 high dose in?

SAGE-217 high dose was studied in one completed Phase 1 clinical trial, NCT03284931, titled 'A Study to Assess the Pharmacodynamic Effects of SAGE-217 in Healthy Adults Using an Insomnia Model.' The trial enrolled 45 participants in the United States.

Is SAGE-217 high dose the same as SAGE-217?

SAGE-217 high dose is a formulation or dosage variant of SAGE-217, the investigational drug being developed by Biogen Inc. The high dose version was specifically evaluated in the Phase 1 trial NCT03284931 for its pharmacodynamic effects in healthy adults.