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Binge Eating DisorderPhase 3NCT02009163

Evaluate the Maintenance of Efficacy of SPD489 in Adults Aged 18-55 Years With Moderate to Severe Binge Eating Disorder

A Phase 3 study testing Lisdexamfetamine dimesylate in people with Binge Eating Disorder, run by Shire at 53 sites in 5 countries.

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

To evaluate maintenance of efficacy based on time to relapse between SPD489 (50 or 70mg) and placebo, as measured by the number of binge days (defined as days during which at least 1 binge episode occurs) per week as assessed by clinical interview based on subject diary and Clinical Global Impression - Severity… Read more about this study

Who is it for?
Ages 18 to 55 years
Conditions the study is for
Binge Eating Disorder
What is being tested?
Lisdexamfetamine dimesylate
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
418 participants
Where
53 sitesin 5 countries
Study dates
27 Jan 2014to 8 Apr 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 55 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • Subject is between 18-55 years of age, inclusive.
  • Subject meets the following criteria for a diagnosis of BED:
  • Recurrent episodes of binge eating. An episode of binge eating is characterized by both of the following: eating, in a discrete period of time (eg, within a 2-hour period) an amount of food that is definitely larger than most people would eat in a similar period of time under similar conditions, and a sense of lack of control over the eating (eg, a feeling that one cannot stop eating or control what or how much one is eating).
  • The binge eating episodes are associated with at least 3 of the following: eating much more rapidly than normal; eating until uncomfortably full; eating large amounts of food when not feeling physically hungry; eating alone because of being embarrassed by how much one is eating; feeling disgusted with oneself, depressed, or feeling very guilty after overeating.
  • Marked distress regarding binge eating.
  • The binge eating occurs, on average, at least 2 days a week for 6 months.
  • The episodes of binge eating do not occur exclusively during the course of bulimia nervosa or anorexia nervosa.
  • Subject is consistently able to swallow a capsule.

Who cannot join

  • Subject has current diagnosis of bulimia nervosa or anorexia nervosa.
  • Subject is receiving psychotherapy or weight loss support within the past 3 months.
  • Subject has used psychostimulants to facilitate fasting or dieting within the past 6 months.
  • Subject has known history of symptomatic cardiovascular disease, advanced arteriosclerosis, structural cardiac abnormality, cardiomyopathy, serious heart rhythm abnormalities, coronary artery disease.
  • Subject has abnormal thyroid function.
  • Subject initiated treatment with a lipid lowering medication within the past 3 months.
Show all 11Show fewer
  • Subject has a history of moderate or severe hypertension.
  • Subject has a recent history (within the past 6 months) of suspected substance abuse or dependence disorder.
  • Subject has glaucoma.
  • Subject is female and pregnant or nursing.
  • Subjects who have had bariatric surgery, lap bands, duodenal stents, or other procedures for weight loss.

Trial locations and contacts

53 sites in 5 countries.

53 sites in 5 countries

United States39 sites

  • HBSA-Pacific Institute for Research & Evaluation

    Albuquerque, New Mexico, 87102

  • Lehigh Center for Clinical Research

    Allentown, Pennsylvania, 18104

  • Radiant Research, Inc

    Anderson, South Carolina, 29621

  • NeuroTrials Research, Inc

    Atlanta, Georgia, 30342

  • FutureSearch Clinical Trials, LP

    Austin, Texas, 78731

  • Northwest Clinical Research Center

    Bellevue, Washington, 98007

  • McLean Hospital

    Belmont, Massachusetts, 02478

  • Boston Clinical Trials

    Boston, Massachusetts, 02131

  • Brooklyn Medical Institute

    Brooklyn, New York, 11214

  • Patient Priority Clinical Sites, LLC

    Cincinnati, Ohio, 45215

  • Community Research

    Cincinnati, Ohio, 45227

  • FutureSearch Trials of Dallas, LP

    Dallas, Texas, 75231

  • Midwest Clinical Research Center

    Dayton, Ohio, 45417

  • Gulfcoast Clinical Research Center

    Fort Myers, Florida, 33912

  • Radiant Research, Inc

    Greer, South Carolina, 29650

  • Texas Center for Drug Development, Inc

    Houston, Texas, 77081

  • Goldpoint Clinical Research

    Indianapolis, Indiana, 46260

  • Innovative Clinical Research, Inc

    Lauderhill, Florida, 33319

  • Compass Research LLC North Clinic

    Leesburg, Florida, 34748

  • Capstone Clinical Research

    Libertyville, Illinois, 60048

  • Florida Clinical Research Center, LLC

    Maitland, Florida, 32751

  • Linder Center of Hope

    Mason, Ohio, 45040

  • Clinical Neuroscience Solution, Inc

    Memphis, Tennessee, 38119

  • Coastal Carolina Research Center

    Mt. Pleasant, South Carolina, 29464

  • Louisiana Research Associates, Inc

    New Orleans, Louisiana, 70114

  • Scientific Clinical Research, Inc

    North Miami, Florida, 33161

  • Clinical Neuroscience Solutions, Inc

    Orlando, Florida, 32806

  • Research Across America

    Plano, Texas, 75093

  • Oregon Center for Clinical Investigations, Inc (OCCI, Inc)

    Portland, Oregon, 97214

  • Clinical Trials Technology, Inc

    Prairie Village, Kansas, 66206

  • Wake Research Associates, LLC

    Raleigh, North Carolina, 27612

  • Rochester Center for Behavioral Medicine

    Rochester Hills, Michigan, 48307

  • Oregon Center for Clinical Investigations, Inc (OCCI, Inc)

    Salem, Oregon, 97301

  • Radiant Research, Inc

    San Antonio, Texas, 78229

  • Summit Research Network (Seattle) LLC

    Seattle, Washington, 98104

  • Miami Research Associates

    South Miami, Florida, 33143

  • Omega Medical Research

    Warwick, Rhode Island, 02886

  • Adams Clinical Trials, LLC

    Watertown, Massachusetts, 02472

  • Cypress Medical Research Center

    Wichita, Kansas, 67226

Other trials in United States

Germany6 sites

  • Klinische Forschung Berlin-Mitte GmbH

    Berlin, 10117

  • EMOVIS GmbH - Klinische Forschung

    Berlin, 10629

  • Klinische Forschung Dresden GmbH

    Dresden, 01069

  • Klinische Forschung Hannover-Mitte GmbH

    Hanover, 30159

  • Forschung Schwerin GmbH, Friedrichstrasse 1

    Schwerin, 19055

  • Studienzentrum Nordwest

    Westerstede, 26655

Other trials in Germany

Spain3 sites

  • Hospital de la Santa Creu I Sant Pau

    Barcelona, 08025

  • Hospital Universitario Infanta Leonor

    Madrid, 28031

  • Hospital del Henares

    Madrid, 28822

Other trials in Spain

Sweden3 sites

  • Lakarmottagningen Ekdahl & Kronberg

    Malmö, 211 52

  • Sofiahemmet

    Stockholm, 114 86

  • Stockholm Center for Eating Disorders

    Stockholm, 118 50

Other trials in Sweden

Canada2 sites

  • Anxiety and Mood Disorder Center

    Mississauga, Ontario, L5< 4N4

  • Manna Research

    Pointe-Claire, Quebec, H9R 4S3

Other trials in Canada

About this study

Official title: A Phase 3, Multicenter, Double-blind, Placebo-controlled, Randomized-withdrawal Study to Evaluate the Maintenance of Efficacy of SPD489 in Adults Aged 18-55 Years With Moderate to Severe Binge Eating Disorder

To evaluate maintenance of efficacy based on time to relapse between SPD489 (50 or 70mg) and placebo, as measured by the number of binge days (defined as days during which at least 1 binge episode occurs) per week as assessed by clinical interview based on subject diary and Clinical Global Impression - Severity (CGI-S) scores for patients who responded to SPD489 by the end of the Open-label Treatment Phase.

Being tested
Lisdexamfetamine dimesylate, Placebo
Medical subject headings
Binge-Eating Disorder

What participants receive

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

  • Lisdexamfetamine dimesylateDrug

    Also called SPD489, LDX

    SDP489 30, 50, or 70mg capsule once per day (open-label and double-blind periods)

  • PlaceboOther

    Placebo capsule once per day (double-blind period)

Study groups in NCT02009163
Study groupRoleWhat they receive
Lisdexamfetamine dimesylateExperimentalAdminister one capsule (50 or 70 mg) orally daily at approximately 7:00 AM.
Receives: Drug: Lisdexamfetamine dimesylate
PlaceboPlacebo comparatorAdminister one capsule orally daily at approximately 7:00 AM.
Receives: Other: Placebo

What is being measured

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

  1. Time to Relapse From Date of Randomization to Endpoint of The Randomized-withdrawal Period

    Relapse status was assessed during the double-blind treatment phase and was defined as having 2 or more binge days per week for 2 consecutive weeks (14 consecutive days) prior to any visit and having an increase in Clinical Global Impressions-Severity (CGI-S) score of 2 or more points compared to the randomized-withdrawal baseline (date of relapse - date of randomization). Binge eating information was captured via a self-report paper diary. The binge diary captured the number of binges per day, total hours per day spent binging, type of binge (at mealtime or at another time other than mealtime), and a description of the binge (amounts and types of foods). Binge frequency was reviewed by the clinician with the subject to confirm reported binge episodes per day. The CGI-S was performed to rate the severity of a subject's condition using a 7-point scale ranging from 1 (normal, not at all ill) to 7 (among the most extremely ill).

    Measured: Visit 21 (26 weeks after randomization [Week 38] or Early Termination)

Secondary outcomes (16)

  1. Change From Randomized-Withdrawal Baseline in The Number of Binge- Eating Days Per Week During The Randomized-withdrawal Period

    A binge day was defined as days during which at least 1 binge episode occurred. As assessed by clinical interview based on subject binge diary. Binge eating information was captured via a self-report paper diary. The binge diary captured the number of binges per day, total hours per day spent binging, type of binge (at mealtime or at another time other than mealtime), and a description of the binge (amounts and types of foods). Binge frequency was reviewed by the clinician with the subject to confirm reported binge episodes per day. A negative change from Baseline indicates that binge-related behavior decreased. The randomized -withdrawal-baseline was defined as the weekly average number of binge days for the 14 days prior to the Randomization Visit (Visit 8).

    Measured: Randomized--withdrawal baseline (Visit 8; 12 weeks after start of open- label treatment [Week 12]), Visit 21 (26 weeks after randomization [Week 38])

  2. Percent of Participants Within Each Category of The Clinical Global Impression-Severity of Illness (CGI-S) Scale at Endpoint of The Randomized-withdrawal Period

    The CGI-S permits a global evaluation of a subject's condition and severity of symptoms. The CGI-S was performed to rate the severity of a subject's condition based on a 7-point scale ranging from 1 (normal, not at all ill) to 7 (among the most extremely ill).

    Measured: Visit 21 (26 weeks after randomization [Week 38] or Early Termination)

  3. Change From Randomized-Withdrawal Baseline in The Total Score of The Yale-Brown Obsessive Compulsive Scale Modified for Binge Eating (Y-BOCS-BE) During The Randomized-withdrawal Period

    The Y-BOCS-BE measures the obsession of binge eating thoughts and compulsiveness of binge eating behaviors. The scale is a clinician rated, 10-item scale, each item rated from 0 (no symptoms) to 4 (extreme symptoms). The scale includes questions regarding the amount of time spent on obsessions, impairment or distress experienced, and resistance and control over these thoughts. The same types of questions were asked about compulsions (ie, time spent, interference, etc.).Total scores range from 0 to 40. A total score of 0-7 is sub-clinical, 8-15 is mild, 16-23 is moderate, 24-31 is severe, and 32-40 is extreme. A decrease from baseline in Y-BOCS-BE Total Score represents an improvement in obsession with binge-eating thoughts or compulsiveness of binge-eating behaviors.

    Measured: Randomized-withdrawal baseline (Visit 8; 12 weeks after start of open-label treatment [Week 12]), Visit 21 (26 weeks after randomization [Week 38])

  4. Percent of Participants Within Each Category of The EuroQuol Group 5-Dimension 5-Level Self-Report Questionnaire (EQ-5D-5L) For Mobility at Endpoint of The Open-label Period

    The EuroQoL Group 5-Dimension 5-Level Self-Report Questionnaire (EQ-5D-5L) is a health-related quality of life (QoL) measure that assesses mobility, self-care, usual activities, pain/discomfort, and anxiety/depression as well as current overall health. It consists of a 5-item descriptive system that measures 5 dimensions of health, including mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension is represented by a single item with 5 levels of responses, from poor health to good health.

    Measured: Visit 8 (12 weeks after start of open-label treatment [Week 12] or Early Termination)

  5. Percent of Participants Within Each Category of The EuroQuol Group 5--Dimension 5--Level Self--Report Questionnaire (EQ--5D--5L) For Mobility at Endpoint of The Randomized-withdrawal Period

    The EuroQoL Group 5-Dimension 5-Level Self-Report Questionnaire (EQ-5D-5L) is a health-related quality of life (QoL) measure that assesses mobility, self-care, usual activities, pain/discomfort, and anxiety/depression as well as current overall health. It consists of a 5-item descriptive system that measures 5 dimensions of health, including mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension is represented by a single item with 5 levels of responses, from poor health to good health.

    Measured: Visit 21 (26 weeks after randomization [Week 38] or Early Termination)

  6. Percent of Participants Within Each Category of The EuroQuol Group 5-Dimension 5-Level Self-Report Questionnaire (EQ-5D-5L) For Self Care at Endpoint of The Open-label Period

    The EuroQoL Group 5-Dimension 5-Level Self-Report Questionnaire (EQ-5D-5L) is a health-related quality of life (QoL) measure that assesses mobility, self-care, usual activities, pain/discomfort, and anxiety/depression as well as current overall health. It consists of a 5-item descriptive system that measures 5 dimensions of health, including mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension is represented by a single item with 5 levels of responses, from poor health to good health.

    Measured: Visit 8 (12 weeks after start of open-label treatment [Week 12] or Early Termination)

  7. Percent of Participants Within Each Category of The EuroQuol Group 5-Dimension 5-Level Self-Report Questionnaire (EQ-5D-5L) For Self Care at Endpoint of The Randomized-withdrawal Period

    The EuroQoL Group 5-Dimension 5-Level Self-Report Questionnaire (EQ-5D-5L) is a health-related quality of life (QoL) measure that assesses mobility, self-care, usual activities, pain/discomfort, and anxiety/depression as well as current overall health. It consists of a 5-item descriptive system that measures 5 dimensions of health, including mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension is represented by a single item with 5 levels of responses, from poor health to good health.

    Measured: Visit 21 (26 weeks after randomization [Week 38] or Early Termination)

  8. Percent of Participants Within Each Category of The EuroQuol Group 5-Dimension 5-Level Self-Report Questionnaire (EQ-5D-5L) For Usual Activities at Endpoint of The Open-label Period

    The EuroQoL Group 5-Dimension 5-Level Self-Report Questionnaire (EQ-5D-5L) is a health-related quality of life (QoL) measure that assesses mobility, self-care, usual activities, pain/discomfort, and anxiety/depression as well as current overall health. It consists of a 5-item descriptive system that measures 5 dimensions of health, including mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension is represented by a single item with 5 levels of responses, from poor health to good health.

    Measured: Visit 8 (12 weeks after start of open-label treatment [Week 12] or Early Termination)

  9. Percent of Participants Within Each Category of The EuroQuol Group 5-Dimension 5-Level Self-Report Questionnaire (EQ-5D-5L) For Usual Activities at Endpoint of The Randomized-withdrawal Period

    The EuroQoL Group 5-Dimension 5-Level Self-Report Questionnaire (EQ-5D-5L) is a health-related quality of life (QoL) measure that assesses mobility, self-care, usual activities, pain/discomfort, and anxiety/depression as well as current overall health. It consists of a 5-item descriptive system that measures 5 dimensions of health, including mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension is represented by a single item with 5 levels of responses, from poor health to good health.

    Measured: Visit 21 (26 weeks after randomization [Week 38] or Early Termination)

  10. Percent of Participants Within Each Category of The EuroQuol Group 5-Dimension 5-Level Self-Report Questionnaire (EQ-5D-5L) For Pain and Discomfort at Endpoint of The Open-label Period

    The EuroQoL Group 5-Dimension 5-Level Self-Report Questionnaire (EQ-5D-5L) is a health-related quality of life (QoL) measure that assesses mobility, self-care, usual activities, pain/discomfort, and anxiety/depression as well as current overall health. It consists of a 5-item descriptive system that measures 5 dimensions of health, including mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension is represented by a single item with 5 levels of responses, from poor health to good health.

    Measured: Visit 8 (12 weeks after start of open-label treatment [Week 12] or Early Termination)

  11. Percent of Participants Within Each Category of The EuroQuol Group 5-Dimension 5-Level Self-Report Questionnaire (EQ-5D-5L) For Pain and Discomfort at Endpoint of The Randomized-withdrawal Period

    The EuroQoL Group 5-Dimension 5-Level Self-Report Questionnaire (EQ-5D-5L) is a health-related quality of life (QoL) measure that assesses mobility, self-care, usual activities, pain/discomfort, and anxiety/depression as well as current overall health. It consists of a 5-item descriptive system that measures 5 dimensions of health, including mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension is represented by a single item with 5 levels of responses, from poor health to good health.

    Measured: Visit 21 (26 weeks after randomization [Week 38] or Early Termination)

  12. Percent of Participants Within Each Category of The EuroQuol Group 5-Dimension 5-Level Self-Report Questionnaire (EQ-5D-5L) For Anxiety And Depression at Endpoint of The Open-label Period

    The EuroQoL Group 5-Dimension 5-Level Self-Report Questionnaire (EQ-5D-5L) is a health-related quality of life (QoL) measure that assesses mobility, self-care, usual activities, pain/discomfort, and anxiety/depression as well as current overall health. It consists of a 5-item descriptive system that measures 5 dimensions of health, including mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension is represented by a single item with 5 levels of responses, from poor health to good health.

    Measured: Visit 8 (12 weeks after start of open-label treatment [Week 12] or Early Termination)

  13. Percent of Participants Within Each Category of The EuroQuol Group 5-Dimension 5-Level Self-Report Questionnaire (EQ-5D-5L) For Anxiety And Depression at Endpoint of The Randomized-withdrawal Period

    The EuroQoL Group 5-Dimension 5-Level Self-Report Questionnaire (EQ-5D-5L) is a health-related quality of life (QoL) measure that assesses mobility, self-care, usual activities, pain/discomfort, and anxiety/depression as well as current overall health. It consists of a 5-item descriptive system that measures 5 dimensions of health, including mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension is represented by a single item with 5 levels of responses, from poor health to good health.

    Measured: Visit 21 (26 weeks after randomization [Week 38] or Early Termination)

  14. Number of Participants With a Positive Response on The Columbia Suicide Severity Rating Scale (C-SSRS) at Endpoint of The Open-label Period

    The C-SSRS is a semistructured interview that captures the occurrence, severity, and frequency of suicide-related thoughts and behaviors. The interview includes definitions and suggested questions to solicit the type of information needed to determine if a suicide-related thought or behaviour occurred. The interview was initiated with 5 (yes/no) questions, presented in ascending order of severity, about suicidal ideation. The most severe type of ideation was rated for frequency, duration, controllability, deterrents, and reason. If the answer to the first 2 ideation questions was "yes," the clinician asked questions 3-5. Active suicidal ideation included any participant who answered "yes" to questions 2-5. If the answers to ideation questions 1 and 2 were "No," then the clinician proceeded to 5 (yes/no) questions that addressed suicidal behavior, which was categorized as actual attempt, interrupted attempt, aborted attempt, preparatory acts or behaviors, and completed suicide.

    Measured: Visit 8 (12 weeks after start of open-label treatment [Week 12])

  15. Number of Participants With a Positive Response on The Columbia Suicide Severity Rating Scale (C-SSRS) at Endpoint of The Randomized-withdrawal Period

    The C-SSRS is a semistructured interview that captures the occurrence, severity, and frequency of suicide-related thoughts and behaviors. The interview includes definitions and suggested questions to solicit the type of information needed to determine if a suicide-related thought or behaviour occurred. The interview was initiated with 5 (yes/no) questions, presented in ascending order of severity, about suicidal ideation. The most severe type of ideation was rated for frequency, duration, controllability, deterrents, and reason. If the answer to the first 2 ideation questions was "yes," the clinician asked questions 3-5. Active suicidal ideation included any participant who answered "yes" to questions 2-5. If the answers to ideation questions 1 and 2 were "No," then the clinician proceeded to 5 (yes/no) questions that addressed suicidal behavior, which was categorized as actual attempt, interrupted attempt, aborted attempt, preparatory acts or behaviors, and completed suicide.

    Measured: Visit 21 (26 weeks after randomization [Week 38] or Early Termination)

  16. Total Scores For The Amphetamine Cessation Symptom Assessment (ACSA) Scale During Follow-up

    The ACSA was used in this study to assess potential withdrawal symptoms associated with chronic use of SPD489. The ACSA is a self-completed scale used to assess withdrawal symptoms. The scale has 16 symptom items rated on a 5-point scale ranging from 0 (not at all) to 4 (extremely). The ACSA total score ranges from 0-64, where a higher score indicates greater withdrawal symptom severity.

    Measured: Visit 21 (26 weeks after randomization [Week 38] or Early Termination) and Visit 22 (7 days post last dose)

Timeline

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

  1. First posted11 Dec 2013 (estimated)
  2. Study start27 Jan 2014
  3. Primary completion8 Apr 2015
  4. Study completion8 Apr 2015

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
418 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02009163
Sponsor's protocol ID
SPD489-346
Other IDs
2012-004457-88
Status last verified
Jun 2021
First submitted
6 Dec 2013
Last updated
14 Jun 2021
Data monitoring committee
No

Publications

  • Robertson B, Wu J, Fant RV, Schnoll SH, McElroy SL. Assessment of Amphetamine Withdrawal Symptoms of Lisdexamfetamine Dimesylate Treatment for Adults With Binge-Eating Disorder. Prim Care Companion CNS Disord. 2020 Mar 26;22(2):19m02540. doi: 10.4088/PCC.19m02540.

    PubMed 32237290

  • Hudson JI, McElroy SL, Ferreira-Cornwell MC, Radewonuk J, Gasior M. Efficacy of Lisdexamfetamine in Adults With Moderate to Severe Binge-Eating Disorder: A Randomized Clinical Trial. JAMA Psychiatry. 2017 Sep 1;74(9):903-910. doi: 10.1001/jamapsychiatry.2017.1889.

    PubMed 28700805

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Lisdexamfetamine dimesylate in people with Binge Eating Disorder, run by Shire at 53 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 8 inclusion and 11 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 14 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 53 sites in United States, Germany, Spain, Sweden, Canada. 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 1 Apr 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 to Relapse From Date of Randomization to Endpoint of The Randomized-withdrawal Period (time frame: Visit 21 (26 weeks after randomization [Week 38] or Early Termination)). 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 NCT02009163, which also lists 2 linked publications.

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 14 Jun 2021.

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