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

NCT ID: NCT03284931

Last Updated: 2023-11-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

45 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-09-14

Study Completion Date

2017-12-18

Brief Summary

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

Detailed Description

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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.

Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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SAGE-217 high dose

SAGE-217

Group Type EXPERIMENTAL

SAGE-217 high dose

Intervention Type DRUG

high dose

SAGE-217 low dose

SAGE-217

Group Type EXPERIMENTAL

SAGE-217 low dose

Intervention Type DRUG

low dose

Placebo

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

placebo

Interventions

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SAGE-217 high dose

high dose

Intervention Type DRUG

Placebo

placebo

Intervention Type DRUG

SAGE-217 low dose

low dose

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

64 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Biogen

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Sage Investigational Site

New York, New York, United States

Site Status

Countries

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United States

Other Identifiers

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217-EXM-101

Identifier Type: -

Identifier Source: org_study_id