A Study to Evaluate the Efficacy and Safety of SAGE-217 in Participants With Severe Postpartum Depression (PPD)

November 27, 2023 updated by: Biogen

A Randomized, Double-Blind, Placebo-controlled Study Evaluating the Efficacy and Safety of SAGE-217 in the Treatment of Adults With Severe Postpartum Depression

The purpose of this study is to determine if treatment with SAGE-217 reduces depressive symptoms in females with severe postpartum depression (PPD) as compared to placebo.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

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

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
200

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

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

  • Spain
      • Barcelona, Spain, 8003
        • Sage Investigational Site
      • Barcelona, Spain, 8035
        • Sage Investigational Site
      • Barcelona, Spain, 8041
        • Sage Investigational Site
      • Collado-Villalba, Spain, 28040
        • Sage Investigational Site
      • Madrid, Spain, 28031
        • Sage Investigational Site
      • Oviedo, Spain, 33011
        • Sage Investigational Site
      • Sabadell, Spain, 8208
        • Sage Investigational Site
      • Valladolid, Spain, 47012
        • Sage Investigational Site
      • Vigo, Spain, 36213
        • Sage Investigational Site
  • United Kingdom
      • Maidstone, United Kingdom, ME16 9NW
        • Sage Investigational Site
    • Essex
      • Runwell, Essex, United Kingdom, SS11 7XX
        • Sage Investigational Site
    • Lancashire
      • Preston, Lancashire, United Kingdom, PR2 8DW
        • Sage Investigational Site
    • Northumberland
      • Morpeth, Northumberland, United Kingdom, NE61 2NU
        • Sage Investigational Site
    • Oxford
      • Headington, Oxford, United Kingdom, OX3 7JX
        • Sage Investigational Site
  • United States
    • Arizona
      • Scottsdale, Arizona, United States, 85258
        • Sage Investigational Site
    • Arkansas
      • Bentonville, Arkansas, United States, 72712
        • Sage Investigational Site
    • California
      • Anaheim, California, United States, 92805
        • Sage Investigational Site
      • Bellflower, California, United States, 90706
        • Sage Investigational Site
      • Beverly Hills, California, United States, 90212
        • Sage Investigational Site
      • Costa Mesa, California, United States, 92627
        • Sage Investigational Site
      • Imperial, California, United States, 92251
        • Sage Investigational Site
      • Lemon Grove, California, United States, 91945
        • Sage Investigational Site
      • Norwalk, California, United States, 90650
        • Sage Investigational Site
      • Oceanside, California, United States, 92056
        • Sage Investigational Site
      • Orange, California, United States, 92868
        • Sage Investigational Site
      • Orange, California, United States, 92866
        • Sage Investigational Site
      • Redlands, California, United States, 92374
        • Sage Investigational Site
      • San Bernardino, California, United States, 92408
        • Sage Investigational Site
      • Sherman Oaks, California, United States, 91403
        • Sage Investigational Site
      • Torrance, California, United States, 90502
        • Sage Investigational Site
    • Colorado
      • Aurora, Colorado, United States, 80045
        • Sage Investigational Site
    • Connecticut
      • Norwich, Connecticut, United States, 06360
        • Sage Investigational Site
    • Florida
      • Boynton Beach, Florida, United States, 33435
        • Sage Investigational Site
      • Hialeah, Florida, United States, 33012
        • Sage Investigational Site
      • Jacksonville, Florida, United States, 32256
        • Sage Investigational Site
      • Miami, Florida, United States, 33133
        • Sage Investigational Site
      • Miami Springs, Florida, United States, 33166
        • Sage Investigational Site
      • Miramar, Florida, United States, 33029
        • Sage Investigational Site
      • Orlando, Florida, United States, 32807
        • Sage Investigational Site
      • Orlando, Florida, United States, 32801
        • Sage Investigational Site
      • Pensacola, Florida, United States, 35202
        • Sage Investigational Site
      • Pinellas Park, Florida, United States, 33872
        • Sage Investigational Site
      • Pompano Beach, Florida, United States, 33060
        • Sage Investigational Site
    • Georgia
      • Alpharetta, Georgia, United States, 30022
        • Sage Investigational Site
      • Atlanta, Georgia, United States, 30331
        • Sage Investigational Site
      • Decatur, Georgia, United States, 30030
        • Sage Investigational Site
      • Savannah, Georgia, United States, 31405
        • Sage Investigational Site
    • Idaho
      • Idaho Falls, Idaho, United States, 83404
        • Sage Investigational Site
    • Illinois
      • Hoffman Estates, Illinois, United States, 60169
        • Sage Investigational Site
      • Lincolnwood, Illinois, United States, 60712
        • Sage Investigational Site
    • Kansas
      • Wichita, Kansas, United States, 67226
        • Sage Investigational Site
    • Louisiana
      • New Orleans, Louisiana, United States, 70115
        • Sage Investigational Site
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Sage Investigational Site
    • Michigan
      • Detroit, Michigan, United States, 48201
        • Sage Investigational Site
    • Mississippi
      • Flowood, Mississippi, United States, 39232
        • Sage Investigational Site
    • Missouri
      • Saint Charles, Missouri, United States, 63304
        • Sage Investigational Site
      • Saint Louis, Missouri, United States, 63125
        • Sage Investigational Site
      • Saint Louis, Missouri, United States, 63128
        • Sage Investigational Site
    • Nevada
      • Las Vegas, Nevada, United States, 89102
        • Sage Investigational Site
    • New Jersey
      • Marlton, New Jersey, United States, 08053
        • Sage Investigational Site
    • New York
      • Brooklyn, New York, United States, 11229
        • Sage Investigational Site
      • Glen Oaks, New York, United States, 11004
        • Sage Investigational Site
      • New York, New York, United States, 10036
        • Sage Investigational Site
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27599
        • Sage Investigational Site
      • Charlotte, North Carolina, United States, 28211
        • Sage Investigational Site
      • Denver, North Carolina, United States, 28037
        • Sage Investigational Site
    • Ohio
      • Beachwood, Ohio, United States, 44122
        • Sage Investigational Site
      • Mayfield Heights, Ohio, United States, 44124
        • Sage Investigational Site
      • North Canton, Ohio, United States, 44720
        • Sage Investigational Site
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73112
        • Sage Investigational Site
    • Pennsylvania
      • Allentown, Pennsylvania, United States, 18104
        • Sage Investigational Site
      • Moosic, Pennsylvania, United States, 18507
        • Sage Investigational Site
    • Rhode Island
      • Providence, Rhode Island, United States, 02904
        • Sage Investigational Site
    • South Carolina
      • Charleston, South Carolina, United States, 29425
        • Sage Investigational Site
    • Texas
      • Dallas, Texas, United States, 75231
        • Sage Investigational Site
      • Fort Worth, Texas, United States, 76104
        • Sage Investigational Site
      • Houston, Texas, United States, 77058
        • Sage Investigational Site
      • League City, Texas, United States, 77573
        • Sage Investigational Site
      • Richardson, Texas, United States, 75080
        • Sage Investigational Site
      • San Antonio, Texas, United States, 78229
        • Sage Investigational Site
    • Virginia
      • North Chesterfield, Virginia, United States, 23235
        • Sage Investigational Site
    • Washington
      • Bellevue, Washington, United States, 98007
        • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

14 years to 41 years (Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Participant has ceased lactating or agrees not to provide breastmilk to her infant(s) from just prior to receiving the investigational product (IP) on Day 1 until 7 days after the last dose of IP.
  • Participant has had a major depressive episode that began no earlier than the third trimester and no later than the first 4 weeks following delivery, as diagnosed by Structured Clinical Interview for Diagnostic and DSM-5 Clinical Trial Version (SCID-5-CT).
  • Participant is ≤12 months postpartum at screening and Day 1.

Exclusion Criteria:

  • Participant is at significant risk of suicide or has attempted suicide associated with the current episode of PPD.
  • Participant has active psychosis per investigator assessment.
  • Participant has a medical history of nonfebrile seizures.
  • Participant has a medical history of bipolar disorder, schizophrenia, and/or schizoaffective disorder.
  • Participant has a history of sleep apnea.

Note: Other protocol-defined inclusion/exclusion criteria applied.

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: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Placebo Comparator: Placebo
Participants received SAGE-217 matched-placebo capsules, orally, once daily for 14 days.
Drug: Placebo
SAGE-217 matched-placebo oral capsules.
Experimental: SAGE-217 50 mg
Participants received SAGE-217, 50 mg, capsules, orally, once daily for 14 days.
Drug: SAGE-217
SAGE-217 oral capsules.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change From Baseline (CFB) in the 17-item Hamilton Rating Scale for Depression (HAM-D) Total Score at Day 15
Time Frame: Baseline and Day 15
The 17-item HAM-D scale is used to assess the severity of depression. It is comprised of 17 individual items related to the following symptoms: depressed mood (sadness, hopeless, helpless, worthless), feelings of guilt, suicide, insomnia (early, middle, late), work and activities (slowness of thought and speech; impaired ability to concentrate; decreased motor activity), retardation, agitation, anxiety (psychic and somatic), somatic symptoms (gastrointestinal and general), genital symptoms, hypochondriasis, loss of weight, and insight. Individual items are scored on either a 3-point (0 to 2) or a 5-point scale (0 to 4), with 0=none/absent and 4=most severe. The total score is the sum of the 17 individual items, ranges from 0 to 52; where a higher score indicates more depression. Negative change from baseline indicates improvement. Mixed Model for Repeated Measures (MMRM) was used for the analysis.
Baseline and Day 15

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change From Baseline in the 17-item HAM-D Total Score
Time Frame: Baseline, Days 3, 28 and 45
The 17-item HAM-D scale is used to assess the severity of depression. It is comprised of 17 individual items related to the following symptoms: depressed mood (sadness, hopeless, helpless, worthless), feelings of guilt, suicide, insomnia (early, middle, late), work and activities (slowness of thought and speech; impaired ability to concentrate; decreased motor activity), retardation, agitation, anxiety (psychic and somatic), somatic symptoms (gastrointestinal and general), genital symptoms, hypochondriasis, loss of weight, and insight. Individual items are scored on either a 3-point (0 to 2) or a 5-point scale (0 to 4), with 0=none/absent and 4=most severe. The total score is the sum of the 17 individual items, ranges from 0 to 52; where a higher score indicates more depression. Negative change from baseline indicates improvement. MMRM was used for the analysis.
Baseline, Days 3, 28 and 45
Change From Baseline in Clinical Global Impressions - Severity Scale (CGI-S) Score
Time Frame: Baseline and Day 15
The CGI-S is a 7-point Likert scale to rate the severity of the participant's illness at the time of assessment, relative to the clinician's past experience with participants who had the same diagnosis. A participant was assessed on severity of mental illness at the time of rating as 1=normal, not at all ill; 2=borderline mentally ill; 3=mildly ill; 4=moderately ill; 5=markedly ill; 6=severely ill; and 7= extremely ill participants. A lower score indicates a better outcome. A negative change from baseline indicates improvement. MMRM was used for the analysis.
Baseline and Day 15
Percentage of Participants With HAM-D Response
Time Frame: Days 15 and 45
The 17-item HAM-D scale is used to assess the severity of depression. It is comprised of 17 individual items related to the following symptoms: depressed mood (sadness, hopeless, helpless, worthless), feelings of guilt, suicide, insomnia (early, middle, late), work and activities (slowness of thought and speech; impaired ability to concentrate; decreased motor activity), retardation, agitation, anxiety (psychic and somatic), somatic symptoms (gastrointestinal and general), genital symptoms, hypochondriasis, loss of weight, and insight. Individual items are scored on either a 3-point (0 to 2) or a 5-point scale (0 to 4), with 0=none/absent and 4=most severe. The total score is the sum of the 17 individual items, ranges from 0 to 52; where a higher score indicates more depression. Negative change from baseline indicates improvement. HAM-D response was defined as a ≥50% reduction in HAM-D total score from baseline.
Days 15 and 45
Percentage of Participants With HAM-D Remission
Time Frame: Days 15 and 45
The 17-item HAM-D scale is used to assess the severity of depression. It is comprised of 17 individual items related to the following symptoms: depressed mood (sadness, hopeless, helpless, worthless), feelings of guilt, suicide, insomnia (early, middle, late), work and activities (slowness of thought and speech; impaired ability to concentrate; decreased motor activity), retardation, agitation, anxiety (psychic and somatic), somatic symptoms (gastrointestinal and general), genital symptoms, hypochondriasis, loss of weight, and insight. Individual items are scored on either a 3-point (0 to 2) or a 5-point scale (0 to 4), with 0=none/absent and 4=most severe. The total score is the sum of the 17 individual items, ranges from 0 to 52; where a higher score indicates more depression. Negative change from baseline indicates improvement. HAM-D remission was defined as having a HAM-D total score of ≤7.
Days 15 and 45
Percentage of Participants With Clinical Global Impression - Improvement (CGI-I) Response
Time Frame: Day 15
The CGI-I employs a 7-point Likert scale to measure the overall improvement in the participant's condition posttreatment. The investigator rated the participant's total improvement whether or not it is due entirely to drug treatment. Response choices include 1=very much improved, 2=much improved, 3=minimally improved, 4=no change, 5=minimally worse, 6=much worse, and 7=very much worse. The CGI-I was only rated at posttreatment assessments. By definition, all CGI-I assessments are evaluated against baseline conditions. CGI-I response was defined as having a CGI-I score of "very much improved" or "much improved."
Day 15
Change From Baseline in Hamilton Rating Scale for Anxiety (HAM-A) Total Score
Time Frame: Baseline and Day 15
The 14-item HAM-A was used to rate the severity of symptoms of anxiety. Each 14-items were defined by a series of symptoms, and measured both psychic anxiety (mental agitation and psychological distress) and somatic anxiety (physical complaints related to anxiety). The HAM-A total score was calculated as the sum of the 14 individual item scores. The scoring for HAM-A is calculated by assigning scores of 0 (not present) to 4 (very severe), with a total score range of 0 to 56 where <17 indicated mild severity, 18 to 24, mild to moderate severity, and 25 to 30, moderate to severe severity. A negative change from baseline in HAM-A total score indicated improvement.
Baseline and Day 15
Change From Baseline in the Montgomery Åsberg Depression Rating Scale (MADRS) Total Score
Time Frame: Baseline and Day 15
The MADRS is a 10-item diagnostic questionnaire used to measure the severity of depressive episodes in participants with mood disorders. It includes questions on the following symptoms: apparent sadness; reported sadness; inner tension; reduced sleep; reduced appetite; concentration difficulties; lassitude; inability to feel; pessimistic thoughts; and suicidal thoughts. Each item is rated on a 7-point scale from 0 (no symptoms) to 6 (symptoms of maximum severity). The total score ranges from 0 to 60 with a higher score indicating more depression. A negative change from baseline in MADRS total score indicated improvement.
Baseline and Day 15
Change From Baseline in HAM-D Subscale
Time Frame: Baseline and Day 15
17-item HAM-D scale is used for severity of depression. HAM-D subscales: Core subscale(depressed mood, feelings of guilt, suicide, work and activities, and retardation/20x100; Anxiety subscale[anxiety(psychic and somatic), somatic symptoms (gastrointestinal and general), hypochondriasis, and insight loss of weight]/18x100; Bech-6 subscale(depressed mood, feelings of guilt, work and activities, retardation, anxiety psychic, and somatic symptoms general)/22x100; Maier score(depressed mood, feelings of guilt, work and activities, retardation, agitation, and anxiety psychic)/24x100. Each item was scored in range of 0 to 2 or 0 to 4 (0=none to 2 or 4=severe), higher score=more depression. 4 Subscale scores were calculated as sum of individual rating scores related to each subscale, divided by total possible score within subscale, multiplied by 100. Scores were transformed to scale of 0 to 100, with higher scores=more severe depression. Negative CFB=improvement. MMRM was used for analysis.
Baseline and Day 15
Change From Baseline in Self-Reported Measures of Depressive Symptoms, as Assessed by the Edinburgh Postnatal Depression Scale (EPDS) Total Score
Time Frame: Baseline, Days 3, 8,15, 21, 28 and 45
The EPDS is a self-rated depressive symptom severity scale specific to the perinatal period which consists of 10 individual items. Each item is rated on a 4-point scale ranging from 0 to 3 points. The EPDS total score is calculated as the sum of the 10 individual item scores, ranging from 0 points to 30 points with a higher score indicating more depression. A negative change indicates improvement.
Baseline, Days 3, 8,15, 21, 28 and 45
Change From Baseline in Self-Reported Measures of Depressive Symptoms, as Assessed by the 9-item Patient Health Questionnaire (PHQ-9) Score
Time Frame: Baseline, Days 3, 8,15, 21, 28 and 45
The PHQ-9 is a self-rated depressive symptom severity scale to monitor severity over time for newly diagnosed participants or participants in current treatment for depression. Scoring was based on participants responses to 9 specific questions as follows: 0 = not at all; 1 = several days; 2 = more than half the days; and 3 = nearly every day. The score were calculated as the sum of the 9 individual item scores. The PHQ-9 total score was categorized as follows: 1 to 4 = minimal depression, 5 to 9 = mild depression, 10 to 14 = moderate depression, 15 to 19 = moderately severe depression; and 20 to 27 = severe depression. The PHQ-9 total score ranges from 1 to 27 with a higher score indicating more depression. A negative change from baseline indicates reduced depression. MMRM was used for the analysis.
Baseline, Days 3, 8,15, 21, 28 and 45
Percentage of Participants With at Least One Treatment-Emergent Adverse Event (TEAE)
Time Frame: Up to Day 45
An Adverse Event (AE) is any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom or disease temporally associated with the use of a medicinal (investigational) product whether or not related to the medicinal (investigational) product. A TEAE is defined as an AE with onset after the start of IP, or any worsening of a pre-existing medical condition/AE with onset after the start of IP and throughout the study.
Up to Day 45

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Biogen

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 8, 2020

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 15, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 12, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 18, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 18, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 22, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 30, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 27, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 217-PPD-301
  • 2020-001424-34 (EudraCT Number)

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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