A Study to Assess the Pharmacodynamic Effects of SAGE-217 in Healthy Adults Using an Insomnia Model

November 27, 2023 updated by: Biogen

A Randomized, Double-Blind, Multiple Dose, 3-way Crossover, Exploratory Study to Assess the Pharmacodynamic Effects of SAGE-217 Capsules in Healthy Adults Using a 5-hour Phase Advance Model of Insomnia

This study will assess the pharmacodynamic effects of SAGE-217 in approximately 42 healthy adult subjects using an insomnia model.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Subjects are expected to complete Treatment Periods 1, 2 and 3, followed by an optional open-label administration of SAGE-217 for pharmacokinetic purposes (Treatment Period 4).

This study was previously posted by Sage Therapeutics. In November 2023, sponsorship of the trial was transferred to Biogen.

Study Type

Interventional

Enrollment (Actual)

45

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • New York, New York, United States, 10019
        • Sage Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 62 years (Adult)

Accepts Healthy Volunteers

Yes

Description

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 of suicidal behavior, epilepsy, eating disorders, sleep disorders, or circadian rhythm disorders
  • Subject has worked a night shift or flown >1 time zone within 30 days prior to Screening

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Drug: Placebo
placebo
Experimental: SAGE-217 high dose
SAGE-217
Drug: SAGE-217 high dose
high dose
Experimental: SAGE-217 low dose
SAGE-217
Drug: SAGE-217 low dose
low dose

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Sleep efficiency, as determined by polysomnography (PSG)
Time Frame: 16 days
16 days

Secondary Outcome Measures

Outcome Measure
Time Frame
Safety and tolerability, as assessed by adverse events
Time Frame: 36 days
36 days
Safety and tolerability, as assessed by vital signs
Time Frame: 29 days
29 days
Safety and tolerability, as assessed by clinical laboratory data
Time Frame: 29 days
29 days
Safety and tolerability, as assessed by ECG
Time Frame: 29 days
29 days
Safety and tolerability, as assessed by Columbia Suicide Severity Rating Scale (C-SSRS)
Time Frame: 29 days
29 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Biogen

Investigators

  • Study Director: Jim Doherty, PhD, Sage Therapeutics

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 14, 2017

Primary Completion (Actual)

December 4, 2017

Study Completion (Actual)

December 18, 2017

Study Registration Dates

First Submitted

September 13, 2017

First Submitted That Met QC Criteria

September 13, 2017

First Posted (Actual)

September 15, 2017

Study Record Updates

Last Update Posted (Actual)

November 29, 2023

Last Update Submitted That Met QC Criteria

November 27, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 217-EXM-101

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

In accordance with Biogen's Clinical Trial Transparency and Data Sharing Policy on https://www.biogentrialtransparency.com/

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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