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Bipolar DisorderPhase 3NCT01467713

Efficacy and Safety of Ramelteon Sublingual as Adjunctive Therapy for Maintenance Treatment of Bipolar I Disorder

A Phase 3 study testing Ramelteon SL in people with Bipolar Disorder, run by Takeda at 156 sites in 5 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

The purpose of this study is to determine the efficacy and safety of ramelteon, once nightly before bedtime (QHS), sublingual (SL), in the maintenance treatment of Bipolar I Disorder in adult patients. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Bipolar Disorder
What is being tested?
Ramelteon SL
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
642 participants
Where
156 sitesin 5 countries
Study dates
Dec 2011to Mar 2015
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 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • In the opinion of the investigator, the participant is capable of understanding and complying with protocol requirements.
  • The participant or, when applicable, the participant's legally acceptable representative signs and dates a written, informed consent form and any required privacy authorization prior to the initiation of any study procedures.
  • The participant suffers from bipolar I disorder, according to Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV-TR) criteria and is confirmed by the Structured Clinical Interview for DSM Disorders (SCID).
  • The participant is a man or woman aged between 18 and 75 years, inclusive.
  • The participant has an identified caregiver or person responsible (e.g. family member, spouse, case worker or nurse at a residential living (facility) that is considered reliable by the investigator.
  • The most recent mood episode (depression, mania, mixed episode) is within the past 9 months from screening.
Show all 14Show fewer
  • The participant has been in remission in the opinion of the principal investigator (PI) for at least 8 weeks prior to baseline from their most recent mood episode.
  • The participant has a Montgomery-Åsberg Depression Rating Scale (MADRS) total score ≤12 at the Screening and Baseline visits.
  • The participant has a Young Mania Rating Scale (YMRS) score of ≤10 both at the Screening and Baseline visits.
  • The participant has a Clinical Global Impression Scale - Severity (CGI-S) score of ≤2 at the Screening and Baseline visits.
  • Hamilton Rating Scale for Anxiety (HAM-A) score is ≤21 at Screening and Baseline visits.
  • The participant's medications for bipolar I disorder are stable i.e., no dose adjustment has been made for at least 8 weeks prior to the randomization
  • A male participant who is nonsterilized and sexually active with a female partner of childbearing potential agrees to use adequate contraception from signing of informed consent through the duration of the study and for 30 days after the last dose.
  • A female participant of childbearing potential who is sexually active with a non sterilized male partner agrees to use routinely adequate contraception from signing of informed consent throughout the duration of the study and for 30 days after the last dose.

Who cannot join

  • The participant has received any investigational compound <30 days before Screening or 5 half-lives prior to Screening.
  • The participant has ever received ramelteon in a previous clinical study or has ever used ramelteon.
  • The participant is an immediate family member, study site employee, or is in a dependent relationship with a study site employee who is involved in conduct of this study (eg, spouse, parent, child, sibling) or may consent under duress.
  • The participant has one or more of the following:
  • Any current psychiatric disorder which is the primary focus of treatment other than bipolar I disorder as defined in the DSM-IV-TR, as assessed by the SCID.
  • Current or history of: schizophrenia or any other psychotic disorder, including major depression with psychotic features, bipolar depression with psychotic features (with the exception of psychosis associated with a manic or mixed episode), obsessive-compulsive disorder (OCD), mental retardation, organic mental disorders, or mental disorders due to a general medical condition as defined in the DSM-IV-TR.
Show all 34Show fewer
  • Current diagnosis or history of alcohol or other substance abuse (excluding nicotine or caffeine) as defined in the DSM-IV-TR that has not been in full and sustained remission for at three months from the day of screening (Participant must also have negative urine drug screen at Screening and Baseline; only exception is for benzodiazepines and opiates provided the participant has a valid prescription).
  • Current diagnosis or history of alcohol or other substance dependence (excluding nicotine or caffeine) as defined in the DSM-IV-TR that has not been in full and sustained remission for at six months from the day of screening.(Participant must also have negative urine drug screen at Screening and Baseline; only exception is for benzodiazepines and opiates provided the participant has a valid prescription).
  • Presence or history of a clinically significant neurological disorder (including epilepsy) as determined by the investigator.
  • Neurodegenerative disorder (Alzheimer disease, Parkinson disease, multiple sclerosis, Huntington disease, etc).
  • Any Axis II disorder that might compromise the study.
  • History of Rapid Cycling bipolar disorder: Patients who have more than 8 episodes of mood disorder per year.
  • The participant experienced the first episode of mood disorder after the age of 65 years.
  • The participant is on any other medications other than antidepressants (except fluvoxamine), mood stabilizers (lithium, valproate, lamotrigine), or atypical antipsychotics (risperidone, lithium and/or valproate, the levels should be in the specified range: lithium (serum levels up to 1.2 mEq/L); valproate (serum levels up to 125 mcg/ml) at screening.
  • The participant has received electroconvulsive therapy, vagal nerve stimulation, or repetitive transcranial magnetic stimulation within 6 months prior to Screening.
  • The participant has started receiving formal cognitive or behavioral therapy, systematic psychotherapy within 30 days from screening or plans to initiate such therapy during the study (supportive therapy, marital therapy and bereavement counseling are allowed).
  • The participant has a significant risk of suicide according to the investigator's clinical judgment or has a score ≥5 on item 10 (suicidal thoughts) of the MADRS or has made a suicide attempt in the previous 6 months.
  • The participant is required to take excluded medications or it is anticipated that the participant will require treatment with at least 1 of the disallowed concomitant medications during the study.
  • The participant has a clinically significant unstable illness, for example hepatic impairment or renal insufficiency, or a cardiovascular, pulmonary, gastrointestinal, endocrine, neurological, rheumatologic, immunologic, hematological, infectious, dermatological disorder or metabolic disturbance.
  • The participant has a history or current diagnosis of Fibromyalgia, Chronic Fatigue Syndrome, Chronic Pain Syndrome and Sleep apnea.
  • The participant has a previous history of cancer that had been in remission for less than 5 years prior to the first dose of study medication. This criterion does not include those participants with basal cell or stage I squamous cell carcinoma of the skin.
  • The participant has 1 or more laboratory value outside the normal range, based on the blood or urine samples taken at the Screening Visit, that are considered by the investigator to be clinically significant; or the participant has any of the following values at the Screening Visit:
  • A serum creatinine value >1.5 times the upper limits of normal (xULN).
  • A serum total bilirubin value >1.5 xULN.
  • A serum alanine aminotransferase (ALT) or aspartate aminotransferase (AST) value >2 xULN.
  • The participant has glycosylated hemoglobin (HbA1C) ≥7% at screening and no prior diagnosis of diabetes and/or treatment for diabetes. NOTE: Participants with known diabetes are not excluded.
  • The participant has a thyroid stimulating hormone (TSH) value outside the normal range at the Screening Visit that is deemed clinically significant by the investigator. NOTE: T4 will be checked if TSH is out of range. If T4 is abnormal the participant will be excluded.
  • The participant has clinically significant abnormal vital signs as determined by the investigator.
  • The participant has an abnormal electrocardiogram as determined by the central reader and confirmed as clinically significant by the investigator.
  • The participant has a disease or takes medication that, in the opinion of the investigator, could interfere with the assessments of safety, tolerability, or efficacy.
  • The participant has a positive urine drug screen. NOTE: Positive urine drug screens for benzodiazepines and opiates for which the participant has a valid prescription will be allowed.
  • The participant has a disease or takes medication that, in the opinion of the investigator, could interfere with the assessments of safety, tolerability, or efficacy.
  • The participant has a positive urine drug screen. NOTE: Positive urine drug screens for benzodiazepines and opiates for which the participant has a valid prescription will be allowed.
  • The participant, in the opinion of the investigator, is unlikely to comply with the clinical study protocol or is unsuitable for any reason.

Trial locations and contacts

156 sites in 5 countries.

156 sites in 5 countries

United States138 sites

  • Study site

    Albuquerque, New Mexico

  • Study site

    Allentown, Pennsylvania

  • Study site

    Atlanta, Georgia

  • Study site

    Austin, Texas

  • Study site

    Baltimore, Maryland

  • Study site

    Bellaire, Texas

  • Study site

    Bellflower, California

  • Study site

    Birmingham, Alabama

  • Study site

    Bloomfield Hills, Michigan

  • Study site

    Boston, Massachusetts

  • Study site

    Bountiful, Utah

  • Study site

    Brooklyn, New York

  • Study site

    Brownsburg, Indiana

  • Study site

    Cedarhurst, New York

  • Study site

    Charlotte, North Carolina

  • Study site

    Cherry Hill, New Jersey

  • Study site

    Chicago, Illinois, 60610

  • Study site

    Chicago, Illinois

  • Study site

    Cincinnati, Ohio

  • Study site

    Clarksburg, West Virginia

  • Study site

    Clarksville, Tennessee

  • Study site

    Clearwater, Florida

  • Study site

    Cleveland, Ohio

  • Study site

    Colorado Springs, Colorado

  • Study site

    Columbia, South Carolina

  • Study site

    Columbiana, North Carolina

  • Study site

    Coral Gables, Florida

  • Study site

    Coral Springs, Florida

  • Study site

    Corpus Christi, Texas

  • Study site

    Costa Mesa, California

  • Study site

    Dallas, Texas

  • Study site

    Dayton, Ohio

  • Study site

    Denver, Colorado

  • Study site

    Detroit, Michigan

  • Study site

    Dothan, Alabama

  • Study site

    Duncansville, Pennsylvania

  • Study site

    Dunwoody, Georgia

  • Study site

    Durham, North Carolina

  • Study site

    East Point, Georgia

  • Study site

    Edgewater, Florida

  • Study site

    Elizabethtown, Kentucky

  • Study site

    Fall River, Massachusetts

  • Study site

    Fargo, North Dakota

  • Study site

    Flowood, Mississippi

  • Study site

    Franklin, Ohio

  • Study site

    Fresh Meadows, New York

  • Study site

    Garden Grove, California

  • Study site

    Greensboro, North Carolina

  • Study site

    Greer, South Carolina

  • Study site

    Gurnee, Illinois, 60610

  • Study site

    Harbor City, California

  • Study site

    Harleysville, Pennsylvania

  • Study site

    Hazelwood, Missouri

  • Study site

    Hialeah, Florida

  • Study site

    Honolulu, Hawaii

  • Study site

    Huntington Park, California

  • Study site

    Irvine, California

  • Study site

    Irving, Texas

  • Study site

    Jacksonville, Florida

  • Study site

    Kalamazoo, Michigan

  • Study site

    Kirkland, Washington

  • Study site

    Knoxville, Tennessee

  • Study site

    Las Vegas, Nevada

  • Study site

    Leesburg, Florida

  • Study site

    Lexington, Kentucky

  • Study site

    Libertyville, Illinois

  • Study site

    Lincoln, Nebraska

  • Study site

    Lincoln, Rhode Island

  • Study site

    Little Rock, Arkansas

  • Study site

    Lomita, California

  • Study site

    Long Beach, California

  • Study site

    Los Angeles, California

  • Study site

    Mandeville, Louisiana

  • Study site

    Manhattan, Kansas

  • Study site

    McMurray, Pennsylvania

  • Study site

    Media, Pennsylvania

  • Study site

    Memphis, Tennessee

  • Study site

    Metairie, Louisiana

  • Study site

    Miami, Florida

  • Study site

    Miami Beach, Florida

  • Study site

    Miami Lakes, Florida

  • Study site

    Milwaukee, Wisconsin

  • Study site

    Murrieta, California

  • Study site

    Muscle Shoals, Alabama

  • Study site

    Nassau Bay, Texas

  • Study site

    National City, California

  • Study site

    New York, New York

  • Study site

    Newport News, Virginia

  • Study site

    Norfolk, Virginia

  • Study site

    Norwalk, Connecticut

  • Study site

    Oceanside, California

  • Study site

    Oklahoma City, Oklahoma

  • Study site

    Old Point Station, South Carolina

  • Study site

    Orange, California

  • Study site

    Orange City, Florida

  • Study site

    Orlando, Florida

  • Study site

    Paducah, Kentucky

  • Study site

    Paramount, California

  • Study site

    Pembroke Pines, Florida

  • Study site

    Philadelphia, Pennsylvania

  • Study site

    Phoenix, Arizona

  • Study site

    Pittsburgh, Pennsylvania

  • Study site

    Plano, Texas

  • Study site

    Plantation, Florida

  • Study site

    Port Charlotte, Florida

  • Study site

    Portland, Oregon

  • Study site

    Raleigh, North Carolina

  • Study site

    Rancho Cucamonga, California

  • Study site

    Redondo Beach, California

  • Study site

    Richland, Washington

  • Study site

    Richmond, Virginia

  • Study site

    Riverside, California

  • Study site

    Rochester, New York

  • Study site

    Sacramento, California

  • Study site

    Saint Charles, Missouri

  • Study site

    Saint Cloud, Florida

  • Study site

    Salisbury, North Carolina

  • Study site

    San Antonio, Texas

  • Study site

    San Diego, California

  • Study site

    San Jose, California

  • Study site

    San Ramon, California

  • Study site

    Seattle, Washington

  • Study site

    Sherman Oaks, California

  • Study site

    Skokie, Illinois

  • Study site

    Smyrna, Georgia

  • Study site

    St Louis, Missouri

  • Study site

    Staten Island, New York

  • Study site

    Suwanee, Georgia

  • Study site

    Tampa, Florida

  • Study site

    Topeka, Kansas

  • Study site

    Torrance, California

  • Study site

    Vero Beach, Florida

  • Study site

    Virginia Beach, Virginia

  • Study site

    Washington, Missouri

  • Study site

    Washington D.C., District of Columbia

  • Study site

    Wichita, Kansas

  • Study site

    Wildomar, California

  • Study site

    Wilmington, North Carolina

Other trials in United States

Mexico6 sites

  • Study site

    León, Guanajuato

  • Study site

    Mérida, Yucatán

  • Study site

    Mexicali, Estado de Baja California

  • Study site

    México

  • Study site

    Mexico City, Mexico City

  • Study site

    Monterrey, Nuevo León

Other trials in Mexico

Argentina4 sites

  • Study site

    Buenos Aires

  • Study site

    Córdoba

  • Study site

    Mendoza

  • Study site

    Santa Fe

Other trials in Argentina

Chile4 sites

  • Study site

    Antofagasta

  • Study site

    Arauco

  • Study site

    Elqui

  • Study site

    Santiago

Other trials in Chile

Colombia4 sites

  • Study site

    Antioquia

  • Study site

    Barranquilla

  • Study site

    Bello, Antioquia

  • Study site

    Bogotá

Other trials in Colombia

About this study

Official title: A Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study to Evaluate the Efficacy and Safety of Once a Day, TAK-375SL as an Adjunctive Therapy to Treatment-as-Usual in the Maintenance Treatment of Bipolar I Disorder in Adult Patients

The purpose of this study is to determine the efficacy and safety of ramelteon, once nightly before bedtime (QHS), sublingual (SL), in the maintenance treatment of Bipolar I Disorder in adult patients.

Read the detailed description

TAK-375SL (ramelteon sublingual formulation) is being developed by Takeda Pharmaceutical Company Limited as an adjunctive treatment in the maintenance therapy of bipolar I disorder.

Participants will be seen twice a month for the first two months and then once every month up to the end of the 9-month treatment period. Participants who complete the 9-month treatment period will have a follow-up visit approximately seven days after the last visit. A safety followup phone call will be made 30 days after completion of the 9-month treatment period.

Based on the recommendation of the Independent Data Monitoring Committee which determined that the study data had met pre-determined criteria for futility, Takeda has made a decision to terminate the study. No safety concerns were identified by the Independent Data Monitoring Committee

Being tested
Ramelteon SL, Placebo
Keywords
Drug Therapy
Medical subject headings
Bipolar Disorder

What participants receive

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

  • Ramelteon SLDrug

    Also called TAK-375SL

    Ramelteon sublingual (SL) tablets

  • PlaceboDrug

    Ramelteon sublingual (SL) placebo-matching tablets

Study groups in NCT01467713
Study groupRoleWhat they receive
PlaceboPlacebo comparatorRamelteon SL placebo-matching, tablets, sublingual (SL) [dissolved under the tongue], once daily, every night at bedtime for up to 9 months.
Receives: Drug: Placebo
Ramelteon SL 0.1 mgExperimentalRamelteon SL 0.1 mg, tablets, sublingual, once daily, every night at bedtime for up to 9 months.
Receives: Drug: Ramelteon SL
Ramelteon SL 0.4 mgExperimentalRamelteon SL 0.4 mg, tablets, sublingual, once daily, every night at bedtime for up to 9 months.
Receives: Drug: Ramelteon SL
Ramelteon SL 0.8 mgExperimentalRamelteon SL 0.8 mg, tablets, sublingual, once daily, every night at bedtime for up to 9 months.
Receives: Drug: Ramelteon SL

What is being measured

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

  1. Time From Randomization to Any Relapse

    The time from randomization to relapse over 12 months double-blind treatment period as determined by the Principal Investigator (PI) or defined by any of the following criteria: depression [Montgomery-Åsberg Depression Rating Scale (MADRS) score ≥16]; mania/hypomania [Young Mania Rating Scale (YMRS) total score ≥14]; mixed episode [MADRS score ≥16 and YMRS total score ≥16]; or, whether participant receives psychiatric hospitalization for bipolar disorder, electroconvulsive therapy (ECT) or any psychotropic medication change prescribed for the treatment of depression, mania/hypomania or mixed episodes.

    Measured: Randomization to Month 12 double-blind treatment period

Secondary outcomes (10)

  1. Time From Randomization to Relapse Due to Depression

    Relapse due to depression determined by any of the following criteria during the 12-month double-blind treatment period: PI judgment, MADRS ≥16, psychiatry hospitalization, ECT or any psychotropic medication change prescribed for the treatment of depressive episodes.

    Measured: Randomization to Month 12 double-blind treatment period

  2. Time From Randomization to Relapse Due to Mania/Hypomania or Mixed Episode

    Relapse due to mania/hypomania or mixed episode is determined by any of the following criteria: PI judgment, mania/hypomania [YMRS ≥16], mixed episode [MADRS ≥16 and YMRS ≥16], psychiatry hospitalization, ECT or any psychotropic medication change prescribed for the treatment of mania/hypomania or mixed episodes.

    Measured: Randomization to Month 12 double-blind treatment period

  3. Time From Randomization to Relapse Due to Depression From PI Judgement and/or MADRS ≥16

    The time from randomization to relapse event during the 12 month double-blind treatment period due to depression, determined by the PI judgement and/or a MADRS score ≥16. MADRS is a 10-item clinician rated scale to measure overall severity of depressive symptoms (i.e., apparent sadness, reported sadness, inner tension, etc.) rated on a 7-point Likert scale from 0 (normal) to 6 (most abnormal) with a total score range from 0 to 60. Higher scores indicate greater severity of symptoms.

    Measured: Randomization to Month 12 double-blind treatment period

  4. Time From Randomization to Relapse Due to Mania/Hypomania

    Relapse due to mania/hypomania is determined by the primary investigator (PI) judgement and/or a YMRS total score ≥16. YMRS is a 11 item scale with four items scale to assess manic symptoms, rated on a scale from 0 (symptom not present) to 8 (symptom extremely severe), with 7 items rated on a scale from 0 (symptom not present) to 4 (symptom extremely severe) with higher scores reflecting greater levels of mania. The YMRS total score is calculated as the sum of the 11 individual item scores and ranges from 0-60.

    Measured: Randomization to 12 Month double-blind treatment period

  5. Time From Randomization to Relapse Due to Mixed Episode

    Relapse due to Mixed episode is determined by PI judgement and/or MADRS score ≥16 and YMRS total score ≥16. MADRS is a 10-item scale that measures overall severity of depressive symptoms rated on a 7-point Likert scale from 0 (normal) to 6 (most abnormal) with a total score range from 0 to 60. YMRS is a four item scale to assess manic symptoms, rated on a scale from 0 (symptom not present) to 8 (symptom extremely severe), with 7 items rated on a scale from 0 (symptom not present) to 4 (symptom extremely severe). The YMRS total score is calculated as the sum of the 11 individual item scores and ranges from 0-60.

    Measured: Randomization to Month 12 double-blind treatment period

  6. Time From Randomization to Relapse Due to Psychiatric Hospitalization for Bipolar Disorder

    The time from randomization to relapse event during the 12 months double-blind treatment period due to psychiatric hospitalization for bipolar disorder.

    Measured: Randomization to Month 12 double-blind treatment period

  7. Time From Randomization to Relapse Due to Electroconvulsive Therapy (ECT) Administration

    The time from randomization to relapse event during the 12 month double-blind treatment period due to ECT.

    Measured: Randomization to Month 12 double-blind treatment period

  8. Time From Randomization to Relapse Due to Psychotropic Medication Change Prescribed for the Treatment of Depression, Mania/Hypomania or Mixed Episodes

    The time from randomization to relapse event during the 12 month double-blind treatment period due to any psychotropic medication change prescribed for the treatment of depression, mania/hypomania or mixed episode(s).

    Measured: Randomization to Month 12 double-blind treatment period

  9. Time From Randomization to Study Withdrawal for Any Reason

    The time from randomization to study withdrawal during the 12 month double-blind treatment period. Withdrawal includes pretreatment event/adverse event; liver function test abnormalities; major protocol deviation; lost to follow-up; voluntary withdrawal; study termination; pregnancy; lack of efficacy; participant has a depressive, mania/hypomania or mixed episode; is hospitalized for psychiatric reasons; receives electroconvulsive therapy for bipolar disorder; receives any psychotropic medication change prescribed for the treatment of depression, mania/hypomania or mixed episodes; or any other reason.

    Measured: Randomization to Month 12 double-blind treatment period

  10. Quality of Life, Enjoyment and Satisfaction Questionnaire Short Form (Q-LES-Q-SF) Total Score

    Q-LES-Q-SF is a self-administered 16-item questionnaire to assess the degree of enjoyment and satisfaction experienced by patients in various areas of daily functioning. It includes 30 items across five subscales (daily activities, clothing, diet/food habits, relationship, psychological well-being and distress), scored on a 6-point Likert scale with subscale and total score ranging from 0 (none) to 5 (all the time). For reporting purposes, the scores are reversed and higher scores reflect improved quality of life and positive changes relative to baseline indicate improved quality of life.

    Measured: Baseline and Months 1, 2, 3, 4, 5, 6, 7, 8, 10 and 12

Timeline

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

  1. First posted9 Nov 2011 (estimated)
  2. Study startDec 2011
  3. Primary completionMar 2015
  4. Study completionMar 2015

Why it stopped: Business Decision; No Safety Concerns.

Resources

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
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
642 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01467713
Sponsor's protocol ID
TAK-375SL_203
Other IDs
U1111-1124-4675
Status last verified
Apr 2016
First submitted
4 Nov 2011
Last updated
16 May 2016
Data monitoring committee
No

Publications

  • Mahableshwarkar AR, Calabrese JR, Macek TA, Budur K, Adefuye A, Dong X, Hanson E, Sachs GS. Efficacy and safety of sublingual ramelteon as an adjunctive therapy in the maintenance treatment of bipolar I disorder in adults: A phase 3, randomized controlled trial. J Affect Disord. 2017 Oct 15;221:275-282. doi: 10.1016/j.jad.2017.06.044. Epub 2017 Jun 20.

    PubMed 28662460

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Ramelteon SL in people with Bipolar Disorder, run by Takeda at 156 sites in 5 countries.

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 14 inclusion and 34 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: stopped early, as of the sponsor's last update on 16 May 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 156 sites in United States, Mexico, Argentina, Chile, Colombia. 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 16 May 2016). 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 From Randomization to Any Relapse (time frame: Randomization to Month 12 double-blind treatment period). 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 NCT01467713, which also lists 1 linked publication.

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 16 May 2016.

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