Bipolar DisorderPhase 4NCT00277212
A Phase IV Study of the Safety and Efficacy of Aripiprazole in Combination With Lamotrigine in the Long-Term Maintenance Treatment of Patients With Bipolar I Disorder With A Recent Manic or Mixed Episode
A Phase 4 study testing Lamotrigine + Aripiprazole in people with Bipolar Disorder, run by Otsuka Pharmaceutical Development & Commercialization, Inc. at 66 sites in 2 countries.
Trial summary
Efficacy of Aripiprazole in Combination with Lamotrigine in the Long-Term Maintenance Treatment of Bipolar I Disorder in Outpatients with Recent Manic or Mixed Episode Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bipolar Disorder
- What is being tested?
- Lamotrigine + Aripiprazole
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 1,169 participants
- Where
- 66 sitesin 2 countries
- Study dates
- 1 Dec 2005to 1 Jul 2009
- Phase
- Phase 4
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Men and women ≥ 18 years of age meeting Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (Text Revision) (DSM-IV-TR) criteria for bipolar I disorder, recently experiencing a manic or mixed episode with a history of one or more manic or mixed episodes of sufficient severity to require treatment with a mood stabilizer or antipsychotic
Who cannot join
- First manic episode
- Current manic or mixed episode with > 2 years duration
- Treated with aripiprazole within the past 3 months
- Allergic, intolerant, hypersensitive or refractory to aripiprazole or lamotrigine
Trial locations and contacts
66 sites in 2 countries.
66 sites in 2 countries
United States62 sites
Lehigh Valley Hospital
Allentown, Pennsylvania, 18103
Lehigh Center For Clinical Research
Allentown, Pennsylvania, 18104
Pravin Kansagra, M.D.
Anaheim, California, 92801
Comprehensive Neuroscience, Inc
Atlanta, Georgia, 30328
Sheppard Pratt Health System
Baltimore, Maryland, 21285
University Of Alabama At Birmingham
Birmingham, Alabama, 35205
Horizon Medical Services
Bismarck, North Dakota, 58501
Health Sciences America, Llc
Boca Raton, Florida, 33432
Pacific Institute Of Medical Sciences
Bothell, Washington, 98011
Buffalo Psychiatric Center
Buffalo, New York, 14213
Neuro Behavioral Clinical Research, Inc.
Canton, Ohio, 44708
University Of Virginia Health System
Charlottesville, Virginia, 22903
University Of Medicine & Dentistry Of New Jersey
Cherry Hill, New Jersey, 08002
Community Research
Cincinnati, Ohio, 45227
Saroj Brar Md, Inc
Cleveland, Ohio, 44113
Cns Clinical Research Group
Coral Springs, Florida, 33065
College Hospital Costa Mesa
Costa Mesa, California, 92627
Act Clinical Research Institute, Llc
Daytona Beach, Florida, 32124
Dubois Regional Medical Center
DuBois, Pennsylvania, 15801
Duke University Medical Center
Durham, North Carolina, 27705
Freimer, Martin
East Stroudsburg, Pennsylvania, 18301
Psychopharmacology Research Corporation
Farmington Hills, Michigan, 48334
Precise Research Centers
Flowood, Mississippi, 39232
Neuropsychiatric Research Center Of Southwest Florida
Fort Myers, Florida, 33912
Clinical Insights
Glen Burnie, Maryland, 21061
Valle Vista Health System
Greenwood, Indiana, 46143
Bayou City Research, Ltd.
Houston, Texas, 77007
University Of Kentucky, Dept. Of Psychiatry
Lexington, Kentucky, 40509
Pacific Institute For Medical Research, Inc.
Los Angeles, California, 90024
Ut Medical Group/Odyssey Research
Memphis, Tennessee, 38105
Aurora-Cuervo Clinical Trials
Miami, Florida, 33143
Aurora Health Care
Milwaukee, Wisconsin, 53233
University Of Minnesota
Minneapolis, Minnesota, 55455
Health Research Center
Morgantown, West Virginia, 26506
Psychiatric Consultants, Pc
Nashville, Tennessee, 37203
Excell Research
Oceanside, California, 92056
University Of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, 73104
Cutting Edge Research
Oklahoma City, Oklahoma, 73116
Owensboro Behavioral Care
Owensboro, Kentucky, 42301
Southern Ca Clinical Research, Inc.
Pasadena, California, 91106
University Of Pennsylvania
Philadelphia, Pennsylvania, 19104
Belmont Center For Comprehensive Treatment
Philadelphia, Pennsylvania, 19131
Cns Research Institute
Philadelphia, Pennsylvania, 19149
Harmony Research, Llc
Piney Flats, Tennessee, 37686
Gulf Coast Medical Research
Port Charlotte, Florida, 33952
Summit Research Network
Portland, Oregon, 97210
Clinical Trials Technology, Inc
Prairie Village, Kansas, 66206
Zarzar Psychiatric Associates, Pllc
Raleigh, North Carolina, 27607
Finger Lakes Clinical Research
Rochester, New York, 14618
Capital Clinical Research Associates
Rockville, Maryland, 20852
Regions Hospital
Saint Paul, Minnesota, 55101
Alamo Superior Research
San Antonio, Texas, 78229
Summit Research Network (Seattle) Llc
Seattle, Washington, 98104
Stanford University
Stanford, California, 94305
Richmond Behavioral Associates
Staten Island, New York, 10312
Clinco
Terre Haute, Indiana, 47802
Los Angeles Biomedical Research Institute
Torrance, California, 90502
Southwest Biomedical Research Foundation
Tucson, Arizona, 85712
Pacific Clinical Research Medical Group
Upland, California, 91786
Windwood Centre
Virginia Beach, Virginia, 23452
Janus Center For Psychiatric Research
West Palm Beach, Florida, 33407
Clinical Research Institute
Wichita, Kansas, 67213
Puerto Rico4 sites
Local Institution
Cabo Rojo, 00623
Local Institution
Ponce, 00731
Local Institution
Rio Piedras, 00926
Local Institution
San Juan, 00918
About this study
Official title: A Multicenter, Double-blind, Study of the Efficacy and Safety of Aripiprazole in Combination With Lamotrigine in the Long-term Maintenance Treatment of Patients With Bipolar I Disorder With a Recent Manic or Mixed Episode
Efficacy of Aripiprazole in Combination with Lamotrigine in the Long-Term Maintenance Treatment of Bipolar I Disorder in Outpatients with Recent Manic or Mixed Episode
- Conditions
- Bipolar Disorder
- Being tested
- Lamotrigine + Aripiprazole, Lamotrigine + Placebo
- Keywords
- Bipolar I Disorder with a recent manic or mixed episode
- Medical subject headings
- Bipolar Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lamotrigine + AripiprazoleDrug
Also called Abilify, BMS-337039
Tablets, Oral, once daily, Phase 1 (all subjects) - up to 24 weeks; Phase 2 - up to 52 weeks
Lamotrigine 100-200 mg/day
Aripiprazole 10-30 mg/day
Lamotrigine + PlaceboDrug
Tablets, Oral, once daily, Phase 2 - up to 52 weeks
Lamotrigine 100-200 mg/day
placebo 0 mg/day
| Study group | Role | What they receive |
|---|---|---|
| A1 | Experimental | Phase 1: Single-Blind Treatment, Lamotrigine + Aripiprazole ; Phase 2 Double-Blind Treatment: Lamotrigine + Aripiprazole Receives: Drug: Lamotrigine + Aripiprazole |
| A2 | Placebo comparator | Phase 2 Double-Blind Treatment: Lamotrigine + Placebo Receives: Drug: Lamotrigine + Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of Participants Not Experiencing Relapse Through Week 52 in the Double-Blind Relapse Assessment Phase (Phase 2)
Time from randomization to relapse to a manic or mixed episode in the Double-Blind Relapse Assessment Phase as measured by the Proportion of Participants without Relapse Through Week 52 (Kaplan-Meier's estimated survival rate).
Measured: Weeks 0, 2, 4, 6, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52
Secondary outcomes (16)
Proportion of Participants Not Experiencing Relapse (Manic, Mixed, Depressive) in the Double-blind Relapse Assessment Phase Phase 2
Proportion of Participants without Relapse Through Week 52 (Kaplan-Meier's estimated survival rate).
Measured: Weeks 0, 2, 4, 6, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52
Proportion of Participants Not Experiencing a Depressive Relapse in the Double-blind Relapse Assessment Phase (Phase 2)
Proportion of Participants without Relapse Through Week 52 (Kaplan-Meier's estimated survival rate).
Measured: Weeks 0, 2, 4, 6, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52
Proportion of Participants Without Discontinuation for Any Reason in the Double-blind Relapse Assessment Phase (Phase 2)
Proportion of Participants without Discontinuation Through Week 52(Kaplan-Meier's estimated survival rate).
Measured: Weeks 0, 2, 4, 6, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52
Deaths, Treatment-Emergent Serious Adverse Events (SAEs), Adverse Events (AEs) Leading to Discontinuation of Study Medication, Treatment-Emergent AEs and Treatment-Emergent Extrapyramidal Syndrome (EPS)-Related AEs
AE is defined as any new untoward medical occurrence or worsening of a pre-existing medical condition. SAE is any untoward medical occurrence that at any dose results in death, is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a cancer, is a congenital anomaly/birth defect, results in the development of drug dependency or drug abuse, is an important medical event.
Measured: Throughout Phase 2 (up to 52 weeks)
Adjusted Mean Change From Baseline in Body Weight, Phase 2
Adjusted for index mood episode and baseline assessment
Measured: Baseline, Week 52
Number of Participants Showing Clinically Relevant Weight Loss by Study Week
Weight Loss of at least a 7% decrease from Baseline.
Measured: Weeks 12, 24, 36, 52
Number of Participants Showing Clinically Relevant Weight Gain by Study Week
Weight gain of at least a 7% increase from Baseline.
Measured: Weeks 12, 24, 36, 52
Adjusted Mean Change From Baseline in BMI by Study Week
Adjusted for index mood episode and baseline assessment.
Measured: Baseline, Weeks 12, 24, 36, 52
Number of Participants With Potentially Clinically Significant Electrocardiogram (ECG) Abnormalities Occurring During Double-Blind Treatment
Abbreviations and further description used in table: Sinus tachycardia, ≥120 beats per minute (bpm) and ↑ ≥15 bpm \& no current diagnosis of supraventricular or ventricular tachycardia/atrial fibrillation (AF)/atrial flutter/ other rhythm abnormality. Sinus bradycardia, ≤ 50 bpm and ↓ 15 bpm \& no current diagnosis of AF/atrial flutter/other rhythm abnormality. Supraventricular premature beat (SPB), Ventricular premature beat (VPB), Atroventricular (A-V). Other intraventricular block, QRS ≥0.12 sec and ↑ ≥0.02 sec \& no current diagnosis of left or right bundle branch block.
Measured: Throughout the study, up to Week 52
Number of Participants With Potentially Clinically Relevant Vital Sign Abnormalities Occurring During Double-Blind Treatment
In order to be identified as clinically relevant abnormal, an on-drug value must meet the Criterion Value (CV) and also represent a change from the patient's pretreatment value of at least the Change Relative to Baseline (CRB) magnitude. Heart Rate CV: 120 beats per minute (bpm), CRB: increase of ≥15 / CV: 50 bpm, CRB: decrease of ≥15. Systolic BP CV: 180 mmHg, CRB: increase of ≥20 / CV: 90 mmHg, CRB: decrease of ≥20. Diastolic BP CV: 105 mmHg, CRB: increase of ≥15 / CV: 50 mmHg, CRB: decrease of ≥15.
Measured: Up to 52 Weeks
Number of Participants With Potentially Clinically Relevant Laboratory Abnormalities Occurring During Double-Blind Treatment (Phase 2)
Chemistry, hematology, and urinalysis abnormalities.Abbreviations used: alanine aminotransferase (ALT), institutional upper limit of normal (ULN), aspartate aminotransferase (AST), alkaline phosphatase (ALP), lactate dehydrogenase (LDH), high density lipoprotein cholesterol (HDL-C), low density lipoprotein cholesterol (LDL-C), baseline (BL)
Measured: Throughout Phase 2 of the study, up to Week 52
Summary of Concomitant Medications, Phase 1
Measured: Phase 1 (9 to 24 Week Single-blind Stabilization Phase)
Summary of Concomitant Medications, Phase 2
Measured: Phase 2 (52 Week Double-blind Relapse Assessment Phase)
Adjusted Mean Change From Baseline in Simpson-Angus Scale (SAS) Total Score
The SAS is a 10-item instrument used to evaluate the presence and severity of parkinsonian symptomatology. The ten items focus on rigidity rather than bradykinesia, and do not assess subjective rigidity or slowness. Items are rated for severity on a 0-4 scale, with definitions given for each anchor point. The total SAS Score has a possible range from 10 to 50. Negative change scores indicate improvement.
Measured: Baseline, Weeks 8, 24, 36, 52
Adjusted Mean Change From Baseline in Abnormal Involuntary Movement Scale (AIMS) Total Score
The AIMS is an assessment of movement dysfunctions. It is a 12-item instrument assessing abnormal involuntary movements associated with antipsychotic drugs and 'spontaneous' motor disturbance related to the illness itself. Scoring the AIMS consists of rating the severity of movement in 3 main anatomic areas (facial/oral, extremities, and trunk), based on a five-point scale (0=none, 4=severe). The AIMS Total Score has a possible range from 0 to 28. Negative change scores indicate improvement in movement dysfunction.
Measured: Baseline, Weeks 8, 24, 36, 52
Adjusted Mean Change From Baseline in Barnes Akathisia Global Clinical Assessment,
The Barnes Akathisia Rating Scale is a 4-item scale to assess presence and severity of drug-induced akathisia, including both objective items and subjective items, together with a global clinical assessment of akathisia. Global assessment is made on a scale of 0 to 5 with comprehensive definitions provided for each anchor point on scale: 0=absent; 1=questionable; 2=mild akathisia; 3=moderate akathisia; 4=marked akathisia; 5=severe akathisia. Score has a possible range from 0 (absent) to 5 (severe akathisia). Negative change scores indicate improvement in akathisia.
Measured: Baseline, Weeks 8, 24, 36, 52
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2006 (estimated)
- Study start1 Dec 2005
- Primary completion1 Jul 2009
- Study completion1 Jul 2009
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 Bipolar DisorderStudies of the same condition, open and under way.
- More trials run by Otsuka Pharmaceutical Development & Commercialization, Inc.The sponsor's other registered studies.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,169 participants (actual)
Sponsor and investigators
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Otsuka America Pharmaceutical
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00277212
- Sponsor's protocol ID
- CN138-392 ST
- Status last verified
- Apr 2026
- First submitted
- 13 Jan 2006
- Last updated
- 13 May 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Double-blind, Study of the Efficacy and Safety of Aripiprazole in Combination With Lamotrigine in the Long-term Maintenance Treatment of Patients With Bipolar I Disorder With a Recent Manic or Mixed Episode
- ClinicalTrials.gov ID
- NCT00277212
- Acronym / sponsor ID
- CN138-392 ST
- Conditions
- Bipolar Disorder
- Keywords
- Bipolar I Disorder with a recent manic or mixed episode
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,169 participants (actual)
- Lead sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Otsuka America Pharmaceutical
- Study start
- 1 Dec 2005 (actual)
- Primary completion
- 1 Jul 2009 (actual)
- Study completion
- 1 Jul 2009 (actual)
- First posted
- 16 Jan 2006 (estimated)
- Results
- Posted 20 Oct 2010
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Efficacy of Aripiprazole in Combination with Lamotrigine in the Long-Term Maintenance Treatment of Bipolar I Disorder in Outpatients with Recent Manic or Mixed Episode
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A1 | Experimental | Drug: Lamotrigine + AripiprazolePhase 1: Single-Blind Treatment, Lamotrigine + Aripiprazole ; Phase 2 Double-Blind Treatment: Lamotrigine + Aripiprazole |
| A2 | Placebo comparator | Drug: Lamotrigine + PlaceboPhase 2 Double-Blind Treatment: Lamotrigine + Placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Men and women ≥ 18 years of age meeting Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (Text Revision) (DSM-IV-TR) criteria for bipolar I disorder, recently experiencing a manic or mixed episode with a history of one or more manic or mixed episodes of sufficient severity to require treatment with a mood stabilizer or antipsychotic
Key exclusion criteria (4 listed)
- First manic episode
- Current manic or mixed episode with > 2 years duration
- Treated with aripiprazole within the past 3 months
- Allergic, intolerant, hypersensitive or refractory to aripiprazole or lamotrigine
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 |
|---|---|---|
| Lamotrigine + AripiprazoleAlso: Abilify, BMS-337039Tablets, Oral, once daily, Phase 1 (all subjects) - up to 24 weeks; Phase 2 - up to 52 weeks Lamotrigine 100-200 mg/day Aripiprazole 10-30 mg/day | Drug | A1 |
| Lamotrigine + PlaceboTablets, Oral, once daily, Phase 2 - up to 52 weeks Lamotrigine 100-200 mg/day placebo 0 mg/day | Drug | A2 |
Primary outcome
Proportion of Participants Not Experiencing Relapse Through Week 52 in the Double-Blind Relapse Assessment Phase (Phase 2)
Time frame: Weeks 0, 2, 4, 6, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52
Time from randomization to relapse to a manic or mixed episode in the Double-Blind Relapse Assessment Phase as measured by the Proportion of Participants without Relapse Through Week 52 (Kaplan-Meier's estimated survival rate).
16 secondary outcomes
Proportion of Participants Not Experiencing Relapse (Manic, Mixed, Depressive) in the Double-blind Relapse Assessment Phase Phase 2
Time frame: Weeks 0, 2, 4, 6, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52
Proportion of Participants Not Experiencing a Depressive Relapse in the Double-blind Relapse Assessment Phase (Phase 2)
Time frame: Weeks 0, 2, 4, 6, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52
Proportion of Participants Without Discontinuation for Any Reason in the Double-blind Relapse Assessment Phase (Phase 2)
Time frame: Weeks 0, 2, 4, 6, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52
Deaths, Treatment-Emergent Serious Adverse Events (SAEs), Adverse Events (AEs) Leading to Discontinuation of Study Medication, Treatment-Emergent AEs and Treatment-Emergent Extrapyramidal Syndrome (EPS)-Related AEs
Time frame: Throughout Phase 2 (up to 52 weeks)
Adjusted Mean Change From Baseline in Body Weight, Phase 2
Time frame: Baseline, Week 52
Number of Participants Showing Clinically Relevant Weight Loss by Study Week
Time frame: Weeks 12, 24, 36, 52
Number of Participants Showing Clinically Relevant Weight Gain by Study Week
Time frame: Weeks 12, 24, 36, 52
Adjusted Mean Change From Baseline in BMI by Study Week
Time frame: Baseline, Weeks 12, 24, 36, 52
Number of Participants With Potentially Clinically Significant Electrocardiogram (ECG) Abnormalities Occurring During Double-Blind Treatment
Time frame: Throughout the study, up to Week 52
Number of Participants With Potentially Clinically Relevant Vital Sign Abnormalities Occurring During Double-Blind Treatment
Time frame: Up to 52 Weeks
Number of Participants With Potentially Clinically Relevant Laboratory Abnormalities Occurring During Double-Blind Treatment (Phase 2)
Time frame: Throughout Phase 2 of the study, up to Week 52
Summary of Concomitant Medications, Phase 1
Time frame: Phase 1 (9 to 24 Week Single-blind Stabilization Phase)
Summary of Concomitant Medications, Phase 2
Time frame: Phase 2 (52 Week Double-blind Relapse Assessment Phase)
Adjusted Mean Change From Baseline in Simpson-Angus Scale (SAS) Total Score
Time frame: Baseline, Weeks 8, 24, 36, 52
Adjusted Mean Change From Baseline in Abnormal Involuntary Movement Scale (AIMS) Total Score
Time frame: Baseline, Weeks 8, 24, 36, 52
Adjusted Mean Change From Baseline in Barnes Akathisia Global Clinical Assessment,
Time frame: Baseline, Weeks 8, 24, 36, 52
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Otsuka Clinical Trial WebsiteLink provided by the sponsor.
- Otsuka Clinical Trial TransparencyLink provided by the sponsor.
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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.
The record lists no contact. Use the official record to reach the sponsor.
66 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Lamotrigine + Aripiprazole in people with Bipolar Disorder, run by Otsuka Pharmaceutical Development & Commercialization, Inc. at 66 sites in 2 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 1 inclusion and 4 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 13 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 66 sites in United States, Puerto Rico. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 20 Oct 2010). 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?
Proportion of Participants Not Experiencing Relapse Through Week 52 in the Double-Blind Relapse Assessment Phase (Phase 2) (time frame: Weeks 0, 2, 4, 6, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 13 May 2026.