Depressive Disorder, MajorPhase 3NCT02951988

A Study of Rapastinel as Adjunctive Therapy in the Prevention of Relapse in Patients With Major Depressive Disorder

A Phase 3 study testing Rapastinel in people with Depressive Disorder, Major, run by Naurex, Inc, an affiliate of Allergan plc at 137 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

This study will evaluate the efficacy, safety and tolerability of rapastinel 450 milligrams (mg) intravenous (IV) once weekly or once every 2 weeks versus placebo as an adjunctive treatment to ongoing anti-depressive therapy (ADT) in the prevention of relapse in participants with Major Depressive Disorder (MDD). Read more about this study

Who is it for?: Ages 18 to 65 years
Conditions the study is for: Depressive Disorder, Major
What is being tested?: Rapastinel
Type of treatment: Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 1,304 participants
Where: 137 sitesUnited States
Study dates: 13 Nov 2016to 22 Feb 2019
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 65 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Meet Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) criteria for MDD
Current major depressive episode of at least 8 weeks and not exceeding 18 months in duration at Screening
Have no more than partial response (< 50% improvement) to ongoing treatment with a protocol-allowed antidepressant
If female of childbearing potential, have a negative serum β-human chorionic gonadotropin (β-hCG) pregnancy test.

Who cannot join

DSM-5-based diagnosis of any disorder other than MDD that was the primary focus of treatment within 6 months before Screening
Lifetime history of meeting DSM-5 criteria for:
Schizophrenia spectrum or other psychotic disorder
Bipolar or related disorder
Major neurocognitive disorder
Neurodevelopmental disorder of greater than mild severity or of a severity that impacts the participant's ability to consent, follow study directions, or otherwise safely participate in the study

Show all 10Show fewer

Dissociative disorder
Posttraumatic stress disorder
MDD with psychotic features
Significant suicide risk, as judged by the Investigator.

Trial locations and contacts

137 sites in 1 country.

City, postcode or hospital

137 sites in 1 country

United States137 sites

Albuquerque Neuroscience, Inc
Albuquerque, New Mexico, 87109
Lehigh Center for Clinical Research
Allentown, Pennsylvania, 18104
Institute for Advanced Medical Research
Alpharetta, Georgia, 30005
California Pharmaceutical Research Institute, Inc
Anaheim, California, 92804
Atlanta Center for Medical Research
Atlanta, Georgia, 30331
Donald J. Garcia, Jr., MD, PA
Austin, Texas, 78737
Community Clinical Research, Inc.
Austin, Texas, 78754
BioBehavioral Research of Austin
Austin, Texas, 78759
Sheppard Pratt Health System
Baltimore, Maryland, 21204
Pharmasite Research, Inc
Baltimore, Maryland, 21208
Houston Clinical Trials, LLC
Bellaire, Texas, 77401
NorthWest Clinical Research Center
Bellevue, Washington, 98007
Hassman Research Institute, LLC
Berlin, New Jersey, 08009
Southern California Research LLC.
Beverly Hills, California, 90036
University of Alabama at Birmingham
Birmingham, Alabama, 35294
Boston Clinical Trials
Boston, Massachusetts, 02131
Pacific Institute of Medical Sciences
Bothell, Washington, 98011
Meridien Research
Bradenton, Florida, 34201
SPRI Clinical Trials, Inc
Brooklyn, New York, 11235
Neuro-Behavioral Clinical Research, Inc
Canton, Ohio, 44718
Carolina Clinical Trials, Inc.
Charleston, South Carolina, 29407
New Hope Clinical Research Inc.
Charlotte, North Carolina, 28211
Department of Psychiatry and Neurobehavioral Sciences, University of Virginia
Charlottesville, Virginia, 22903
Psychiatric Alliance of the Blue Ridge, Inc
Charlottesville, Virginia, 22903
Center for Emotional Fitness
Cherry Hill, New Jersey, 08002
Great Lakes Clinical Trials
Chicago, Illinois, 60640
Patient Priority Clinical Site, LLC
Cincinnati, Ohio, 45215
University of Cincinnati
Cincinnati, Ohio, 45219
MCB Clinical Research Center
Colorado Springs, Colorado, 80910
The Ohio State University Department of Psychiatry
Columbus, Ohio, 43210
ATP Clinical Research Inc.
Costa Mesa, California, 92626
Millennium Psychiatric Associates
Creve Coeur, Missouri, 63141
ProScience Research Group
Culver City, California, 90230
Relaro Medical Trials
Dallas, Texas, 75243
Midwest Clinical Research Center LLC
Dayton, Ohio, 45417
iResearch Atlanta, LLC
Decatur, Georgia, 30030
Harmonex Neuroscience Research
Dothan, Alabama, 36303
El Campo Clinical Trials
El Campo, Texas, 77347
Pharmacology Research Institute
Encino, California, 91316
Eastside Therapeutic Resource
Everett, Washington, 98201
Precise Research Centers
Flowood, Mississippi, 39232
Gulfcoast Clinical Research Center
Fort Myers, Florida, 33912
North Texas Clinical Trials
Fort Worth, Texas, 76104
Sarkis Clinical Trials
Gainesville, Florida, 32607
Collaborative Neuroscience Network, LLC
Garden Grove, California, 92845
Charak Clinical Research Center
Garfield Heights, Ohio, 44125
Behavioral Research Specialists, LLC
Glendale, California, 91206
MD Clinical
Hallandale, Florida, 33009
Reliable Clinical Research
Hialeah, Florida, 33012
Alexian Brothers Center for Psychiatric Research
Hoffman Estates, Illinois, 60169
Advanced Research Institute of Miami
Homestead, Florida, 33030
Earle Research
Houston, Texas, 77058
Red Oak Psychiatry Associates, PA
Houston, Texas, 77090
Sun Valley Research Center
Imperial, California, 92251
Irvine Center for Clinical Research, Inc
Irvine, California, 92614
Clinical Neuroscience Solutions, Inc
Jacksonville, Florida, 32256
Lake Charles Clinical Trials
Lake Charles, Louisiana, 70629
Meridien Research
Lakeland, Florida, 33805
Altea Research
Las Vegas, Nevada, 89102
Innovative Clinical Research, Inc
Lauderhill, Florida, 33319
Synergy Clinical Research Center of Escondido
Lemon Grove, California, 91945
Synergy San Diego
Lemon Grove, California, 91945
Capstone Clinical Research
Libertyville, Illinois, 60048
Alivation Research
Lincoln, Nebraska, 68526
Woodland International Research Group
Little Rock, Arkansas, 72211
Pharmacology Research Institute
Los Alamitos, California, 90720
Northwest Behavioral Research Center
Marietta, Georgia, 30060
Pharmaceutical Research Associates Inc
Marlton, New Jersey, 08053
Lindner Center of Hope
Mason, Ohio, 45040
Professional Psychiatric Services
Mason, Ohio, 45040
Suburban Research Associates
Media, Pennsylvania, 19063
Clinical Neuroscience Solutions, Inc
Memphis, Tennessee, 38119
Research Strategies of Memphis, LLC
Memphis, Tennessee, 38119
ActivMed Practices & Research, Inc.
Methuen, Massachusetts, 01844
Innova Clinical Trials Inc.
Miami, Florida, 33145
International Research Associates, LLC
Miami, Florida, 33183
Bioscience Research
Mount Kisco, New York, 10549
Coastal Carolina Research Center, Inc.
Mt. Pleasant, South Carolina, 29464
AMR - Baber Research, Inc.
Naperville, Illinois, 60563
Healthy Perspectives - Innovative Mental Health Services. PLLC
Nashua, New Hampshire, 03060
BTC of New Bedford
New Bedford, Massachusetts, 02740
Manhattan Behavioral Medicine
New York, New York, 10022
Eastside Comprehensive Medical Center, LLC
New York, New York, 10128
The Medical Research Network, LLC
New York, New York, 10128
Fieve Clinical Research
New York, New York, 10168
Dr. Cherian Verghese
Norristown, Pennsylvania, 20006
Comprehensive Psychiatric Care
Norwich, Connecticut, 06360
Psychiatric Care and Research Center
O'Fallon, Missouri, 63368
Pacific Research Partners; LLC.
Oakland, California, 94607
Research Centers of America
Oakland Park, Florida, 33334
Sarkis Clinical Trials
Ocala, Florida, 34474
Excell Research
Oceanside, California, 92056
IPS Research
Oklahoma City, Oklahoma, 73103
Red River Medical Research Center, LLC
Oklahoma City, Oklahoma, 73112
Sooner Clinical Research, Inc
Oklahoma City, Oklahoma, 73112
Paradigm Research Professionals
Oklahoma City, Oklahoma, 73118
NRC Research Institute
Orange, California, 92868
Medical Research Group of Central Florida
Orange City, Florida, 32763
Clinical Neuroscience Solutions, Inc
Orlando, Florida, 32801
Combined Research Orlando Phase I-IV
Orlando, Florida, 32807
Millenia Psychiatry & Research, Inc
Orlando, Florida, 32839
Psychiatric Associates
Overland Park, Kansas, 66211
Asclepes Research Centers
Panorama City, California, 91402
NoesisPharma
Phoenix, Arizona, 85032
Summit Research Network
Portland, Oregon, 97210
Phoenix Medical Research
Prairie Village, Kansas, 66208
Global Medical Institute, LLC
Princeton, New Jersey, 08540
Richard H. Weisler, MD, PA
Raleigh, North Carolina, 27609
Anderson Clinical Research
Redlands, California, 92374
CITrials
Riverside, California, 92506
Finger Lakes Clinical Research
Rochester, New York, 14618
CBH Health
Rockville, Maryland, 20850
Woodland Research Northwest
Rogers, Arkansas, 72758
St. Charles Psychiatric Associates - Midwest Research Group
Saint Charles, Missouri, 63304
Psychiatric and Behavioral Solutions
Salt Lake City, Utah, 84105
PRA Health Sciences
Salt Lake City, Utah, 84106
Clinical Trials of Texas
San Antonio, Texas, 78229
Artemis Institute for Clinical Research
San Diego, California, 92103
PCSD Feighner Research
San Diego, California, 92108
Artemis Institute for Clinical Research
San Marcos, California, 92078
Thomas M. Shiovitz, M.D., Inc., DBA California Neuroscience Research Medical Group, Inc.,
Sherman Oaks, California, 91403
Louisiana Clinical Research
Shreveport, Louisiana, 71101
J Gary Booker, MD APMC
Shreveport, Louisiana, 71104
IRIS Research
Smyrna, Georgia, 30080
Richmond Behavioral Associates
Staten Island, New York, 10312
Olympian Clinical Research
Tampa, Florida, 33609
The University of South Florida Board of Trustees, A public Body Corporate, for University of South Florida
Tampa, Florida, 33613
Viking Clinical Research
Temecula, California, 92591
Family Psychiatry of The Wood
The Woodlands, Texas, 77381
Bio Behavioral Health
Toms River, New Jersey, 08755
University of Arizona Department of Psychiatry
Tucson, Arizona, 85724
Pacific Clinical Research Medical
Upland, California, 91786
Adams Clinical Trials
Watertown, Massachusetts, 02472
Coastal Research Associates
Weymouth, Massachusetts, 02190
Heartland Research Associates
Wichita, Kansas, 67207
Grayline Clinical Drug Trials
Wichita Falls, Texas, 76309
University of Massachusetts Medical School
Worcester, Massachusetts, 01655

Other trials in United States

About this study

Official title: A Randomized, Double-blind, Placebo-controlled, Multicenter Study of Rapastinel as Adjunctive Therapy in the Prevention of Relapse in Patients With Major Depressive Disorder

Conditions: Depressive Disorder, Major
Being tested: Rapastinel, Placebo-matching Rapastinel
Medical subject headings: Depressive Disorder, Major

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

RapastinelDrug
Rapastinel pre-filled syringes for IV injections.
Placebo-matching RapastinelDrug
Placebo-matching rapastinel pre-filled syringes for weekly IV injections.

Study groups in NCT02951988
Study group	Role	What they receive
Rapastinel 450 mg Weekly	Experimental	Rapastinel 450 milligrams (mg) intravenous (IV) once a week during OLTP followed by rapastinel 450 mg IV once a week during DBTP. Receives: Drug: Rapastinel
Rapastinel 450 mg Every 2 Weeks	Experimental	Rapastinel 450 mg IV once a week during OLTP followed by rapastinel 450 mg IV once every 2 weeks during DBTP. Receives: Drug: Rapastinel
Placebo	Placebo comparator	Rapastinel 450 mg IV once a week during OLTP followed by placebo-matching rapastinel 450 mg IV once a week during DBTP. Receives: Drug: Placebo-matching Rapastinel

What is being measured

The primary outcome is the main question the study is designed to answer.

Time to First Relapse During the First 52 Weeks of the Double-Blind Treatment Period
The time in days to first relapse is defined as the number of days from the date of randomization to the first relapse.
Measured: 52 Weeks
Number of Participants Experiencing Suicidal Ideation or Suicidal Behavior Based on Columbia-Suicide Severity Rating Scale (C-SSRS) Using 5-Point Scales
On the C-SSRS, the 5 types of suicidal ideation are:
Type 1: "Wish to be dead" Type 2: Non-specific active suicidal thoughts Type 3: "Active suicidal ideation with any methods (not plan) without intent to act" Type 4: "Active suicidal ideation with some intent to act, without specific plan" Type 5: "Active suicidal ideation with specific plan and intent"
Measured: 104 Weeks

Secondary outcomes (1)

Time to First Relapse During the Entire Double-Blind Treatment Period
The time in days to first relapse is defined as the number of days from the date of randomization to the first relapse.
Measured: 104 Weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

13 Nov 201622 Feb 2019

First posted1 Nov 2016 (estimated)
Study start13 Nov 2016
Primary completion22 Feb 2019
Study completion22 Feb 2019

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Depressive Disorder, MajorStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind
Who is masked: Participant, Investigator, Outcomes assessor
Enrolment: 1,304 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02951988
Sponsor's protocol ID: RAP-MD-04
Status last verified: Feb 2020
First submitted: 31 Oct 2016
Last updated: 9 Mar 2020
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Recruiting
Targeting Network Dysfunction in Apathy of Late-life Depression Using Digital Therapeutics
Major Depressive Disorder, Apathy
RecruitingPhase 2
Psilocybin With Pimavanserin Compared to Psilocybin Alone for the Treatment of Major Depressive Disorder
Major Depressive Disorder
RecruitingObservational study
Student Precarity and Psychiatry
Depressive Disorder, Major, Generalized Anxiety Disorder
RecruitingPhase 4
Biomarker-Guided Antidepressant Selection
Depression - Major Depressive Disorder, Treatment-resistant Depression (TRD)
Not yet recruiting
Preventive and Personalized Digital Emotion Regulation Skills Intervention to Reduce Depression and Anxiety in Youths With Adverse Childhood Experiences
Adverse Childhood Experience, Depression / Major Depressive Disorder

All Depressive Disorder, Major trials

Study at a glance

From the registry record, last updated by the sponsor on 9 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomized, Double-blind, Placebo-controlled, Multicenter Study of Rapastinel as Adjunctive Therapy in the Prevention of Relapse in Patients With Major Depressive Disorder
ClinicalTrials.gov ID: NCT02951988
Acronym / sponsor ID: RAP-MD-04
Conditions: Depressive Disorder, Major
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 1,304 participants (actual)
Lead sponsor: Naurex, Inc, an affiliate of Allergan plcIndustry (pharma, biotech, devices)
Study start: 13 Nov 2016 (actual)
Primary completion: 22 Feb 2019 (actual)
Study completion: 22 Feb 2019 (actual)
First posted: 1 Nov 2016 (estimated)
Results: Posted 9 Mar 2020

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, investigator, outcomes assessor)
Number of arms: 3

Arm	Type	Receives
Rapastinel 450 mg Weekly	Experimental	Drug: RapastinelRapastinel 450 milligrams (mg) intravenous (IV) once a week during OLTP followed by rapastinel 450 mg IV once a week during DBTP.
Rapastinel 450 mg Every 2 Weeks	Experimental	Drug: RapastinelRapastinel 450 mg IV once a week during OLTP followed by rapastinel 450 mg IV once every 2 weeks during DBTP.
Placebo	Placebo comparator	Drug: Placebo-matching RapastinelRapastinel 450 mg IV once a week during OLTP followed by placebo-matching rapastinel 450 mg IV once a week during DBTP.

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

Meet Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) criteria for MDD
Current major depressive episode of at least 8 weeks and not exceeding 18 months in duration at Screening
Have no more than partial response (< 50% improvement) to ongoing treatment with a protocol-allowed antidepressant
If female of childbearing potential, have a negative serum β-human chorionic gonadotropin (β-hCG) pregnancy test.

Key exclusion criteria (10 listed)

DSM-5-based diagnosis of any disorder other than MDD that was the primary focus of treatment within 6 months before Screening
Lifetime history of meeting DSM-5 criteria for:
Schizophrenia spectrum or other psychotic disorder
Bipolar or related disorder
Major neurocognitive disorder

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
RapastinelRapastinel pre-filled syringes for IV injections.	Drug	Rapastinel 450 mg Every 2 Weeks, Rapastinel 450 mg Weekly
Placebo-matching RapastinelPlacebo-matching rapastinel pre-filled syringes for weekly IV injections.	Drug	Placebo

Primary outcome

Time to First Relapse During the First 52 Weeks of the Double-Blind Treatment Period
Time frame: 52 Weeks
The time in days to first relapse is defined as the number of days from the date of randomization to the first relapse.
Number of Participants Experiencing Suicidal Ideation or Suicidal Behavior Based on Columbia-Suicide Severity Rating Scale (C-SSRS) Using 5-Point Scales
Time frame: 104 Weeks
On the C-SSRS, the 5 types of suicidal ideation are: Type 1: "Wish to be dead" Type 2: Non-specific active suicidal thoughts Type 3: "Active suicidal ideation with any methods (not plan) without intent to act" Type 4: "Active suicidal ideation with some intent to act, without specific plan" Type 5: "Active suicidal ideation with specific plan and intent"

1 secondary outcome

Time to First Relapse During the Entire Double-Blind Treatment Period
Time frame: 104 Weeks

Results and safety

Results posted to the registry on 9 Mar 2020, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
OLTP Rapastinel 450 mg Weekly + ADT	1,304	1,056
DBTP Placebo	0	0
DBTP Rapastinel 450 mg Every 2 Weeks	0	0
DBTP Rapastinel 450 mg Weekly	0	0

Primary outcome: Time to First Relapse During the First 52 Weeks of the Double-Blind Treatment Period

Time frame: 52 Weeks. Median (95% Confidence Interval). Unit: Days

Measure	Placebo n = 202	Rapastinel 450 mg Every 2 Weeks n = 202	Rapastinel 450 mg Weekly n = 200
Value	232 (167 to NA)	225 (127 to 323)	336 (157 to NA)

Placebo vs Rapastinel 450 mg Every 2 Weeks: p = 0.5305, Log Rank
Placebo vs Rapastinel 450 mg Weekly: p = 0.4628, Log Rank

Population analysed: The Double-blind modified Intent-to-Treat Population consists of all patients in the Open-label Safety Population who were randomized to a treatment group during the DBTP of the study and received at least 1 dose of IP during the DBTP.

Primary outcome: Number of Participants Experiencing Suicidal Ideation or Suicidal Behavior Based on Columbia-Suicide Severity Rating Scale (C-SSRS) Using 5-Point Scales

Time frame: 104 Weeks. Count of participants. Unit: Participants

Measure	Placebo n = 202	Rapastinel 450 mg Every 2 Weeks n = 201	Rapastinel 450 mg Weekly n = 200
Suicidal Ideation	17	25	23
Suicidal Behavior	0	0	1

1 secondary outcome is reported in the full results.

Adverse events

Time frame: The study consisted of an 8 to 16 week OLTP; followed by a randomized DBTP of up to 104 weeks; followed by a 2 week safety period.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
OLTP Rapastinel 450 mg Weekly + ADT	26 of 1,304 (2%)	290 of 1,304 (22.2%)	0 of 1,304
DBTP Placebo	6 of 202 (3%)	62 of 202 (30.7%)	1 of 202
DBTP Rapastinel 450 mg Every 2 Weeks	3 of 202 (1.5%)	72 of 202 (35.6%)	0 of 202
DBTP Rapastinel 450 mg Weekly	5 of 200 (2.5%)	66 of 200 (33%)	0 of 200

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 9 Mar 2020.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Depressive Disorder, Major

Recruiting
Targeting Network Dysfunction in Apathy of Late-life Depression Using Digital Therapeutics
Major Depressive Disorder, Apathy
RecruitingPhase 2
Psilocybin With Pimavanserin Compared to Psilocybin Alone for the Treatment of Major Depressive Disorder
Major Depressive Disorder
RecruitingObservational study
Student Precarity and Psychiatry
Depressive Disorder, Major, Generalized Anxiety Disorder
RecruitingPhase 4
Biomarker-Guided Antidepressant Selection
Depression - Major Depressive Disorder, Treatment-resistant Depression (TRD)
Not yet recruiting
Preventive and Personalized Digital Emotion Regulation Skills Intervention to Reduce Depression and Anxiety in Youths With Adverse Childhood Experiences
Adverse Childhood Experience, Depression / Major Depressive Disorder

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Jenna Hoogerheyde study director

Allergan

137 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Rapastinel in people with Depressive Disorder, Major, run by Naurex, Inc, an affiliate of Allergan plc at 137 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 9 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 137 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 9 Mar 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Time to First Relapse During the First 52 Weeks of the Double-Blind Treatment Period (time frame: 52 Weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02951988.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Mar 2020; AzTrials last refreshed its copy on 7 Nov 2026.