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| ID | Type | Description | Link |
|---|---|---|---|
| 2017-002225-38 | EudraCT Number |
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| Name | Class |
|---|---|
| H. Lundbeck A/S | INDUSTRY |
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This study evaluated the safety and evaluate the safety and tolerability of open-label brexpiprazole (2 - 4 mg/day, with a starting dose of 2 mg/day) for the treatment of adult subjects with bipolar I disorder. All participants received a starting dose of brexpiprazole.
While the availability of atypical antipsychotics had increased the therapeutic options available, there remains a need for safer and more effective therapies in the treatment of manic and depressive episodes of bipolar I disorder. Brexpiprazole's specific receptor activity profile likely correlates with its established efficacy in schizophrenia and major depressive disorder, and may prove to be an effective target for the treatment of acute mania of bipolar I disorder.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Brexpiprazole | Experimental | Brexpiprazole was administered in participants orally with flexible dosing from 2 mg/day from Days 1 to 3 regardless of treatment assignment in the previous double-blind trial, followed by titration to 3 mg/day on Day 4. Participants may have been titrated (or re-titrated) to a higher dose of brexpiprazole, up to a maximum of 4 mg/day, based on treatment response and at the investigator's discretion anytime at Day 7 or thereafter. Participants who were unable to tolerate their current dose could have been titrated down to a minimum of 2 mg/day any time after Day 4. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Brexpiprazole | Drug | Brexpiprazole tablets |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With at Least One Treatment Emergent Adverse Event (TEAE) by Severity | An adverse event (AE) was defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (eg, a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, whether or not it is considered related to the drug. A TEAE is defined as an adverse event with an onset that occurs after receiving study drug. AEs severity were graded on a 3-point scale as: 1 = mild; discomfort noticed, but no disruption to daily activity, 2 = moderate; discomfort sufficient to reduce or affect normal daily activity, and 3 = severe; inability to work or perform normal daily activity. | From Day 1 (after dosing) through 29 weeks (26 weeks treatment, 3 weeks safety follow-up) |
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Inclusion Criteria (rollover participants from 331-201-00080 & 331-201-00081 trials)
Exclusion Criteria (rollover participants from 331-201-00080 & 331-201-00081 trials)
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Woodland International Research Group | Little Rock | Arkansas | 72211 | United States | ||
| Woodland Research Northwest, LLC |
Anonymized Individual participant data (IPD) that underlie the results of this study will be shared with researchers to achieve aims pre-specified in a methodologically sound research proposal. Small studies with less than 25 participants are excluded from data sharing.
Data will be available after marketing approval in global markets, or beginning 1-3 years following article publication. There is no end date to the availability of the data.
Otsuka will share data on an Otsuka-owned remotely accessible data sharing platform with Python and R analytical software. Research requests should be directed to clinicaltransparency@Otsuka-us.com
The study included participants who completed 3-week double-blind treatment in studies 331-201-00080 (NCT03259555)/331-201-00081 (NCT03257865) and, who in the investigator's judgment, could potentially benefit to receive brexpiprazole in this study. Data was summarized as per the treatment received in the previous studies.
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| ID | Title | Description |
|---|---|---|
| FG000 | Prior Brexpiprazole | Brexpiprazole was administered in participants orally with flexible dosing from 2 mg/day from Days 1 to 3 regardless of treatment assignment in the previous double-blind trial, followed by titration to 3 mg/day on Day 4. Participants may have been titrated (or re-titrated) to a higher dose of brexpiprazole, up to a maximum of 4 mg/day, based on treatment response and at the investigator's discretion anytime at Day 7 or thereafter. Participants who were unable to tolerate their current dose could have been titrated down to a minimum of 2 mg/day any time after Day 4. Participants who received brexpiprazole in the double-blind treatment period in previous studies were included in this group. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Oct 23, 2017 | Aug 14, 2020 |
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Group composed of eligible rollover participants who completed one of the double-blind, phase 3 efficacy trials (331-201-00080 (NCT03259555) or 331-201-00081 (NCT03257865)).
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| Rogers |
| Arkansas |
| 72758 |
| United States |
| Citrials Inc. | Bellflower | California | 90706 | United States |
| Radiant Research | Cerritos | California | 90703 | United States |
| ProScience Research Group | Culver City | California | 90230 | United States |
| Collaborative Neuroscience Network, LLC | Garden Grove | California | 92845 | United States |
| Behavioral Research Specialists, LLC | Glendale | California | 91206 | United States |
| Apostle Clinical Trials | Long Beach | California | 90813 | United States |
| Pacific Research Partners, LLC | Oakland | California | 94607 | United States |
| NRC Research Institute | Orange | California | 92868 | United States |
| Asclepes Research Centers, PC | Panorama City | California | 91402 | United States |
| CI Trials | Riverside | California | 92705 | United States |
| CNRI-San Diego | San Diego | California | 92102 | United States |
| Artemis Institute for Clinical Research | San Diego | California | 92103 | United States |
| Sharp Mesa Vista Hospital | San Diego | California | 92123 | United States |
| CI Trials | Santa Ana | California | 92705 | United States |
| Collaborative Neuroscience Network, LLC | Torrance | California | 90502 | United States |
| Shreenath Clinical Service | Yorba Linda | California | 92886 | United States |
| Optimus U Corp | Coral Gables | Florida | 33134 | United States |
| Segal Trials | Fort Lauderdale | Florida | 33308 | United States |
| Galiz Research | Hialeah | Florida | 33016 | United States |
| Research Centers of America, LLC | Hollywood | Florida | 33024 | United States |
| Florida Behavioral Medicine | Largo | Florida | 33770 | United States |
| University of South Florida Board of Trustees | Tampa | Florida | 33613 | United States |
| iResearch Atlanta, LLC | Decatur | Georgia | 30030 | United States |
| Alexian Brothers Center for Psychiatric Research | Hoffman Estates | Illinois | 60169 | United States |
| NeuroPsychiatric Research | Winfield | Illinois | 60190 | United States |
| Louisiana Clinical Research | Shreveport | Louisiana | 71101 | United States |
| CBH Health | Gaithersburg | Maryland | 20877 | United States |
| St. Charles Psychiatric Associates | Saint Charles | Missouri | 63304 | United States |
| Arch Clinical Trials, LLC | St Louis | Missouri | 63118 | United States |
| St. Louis Clinical Trials | St Louis | Missouri | 63141 | United States |
| Hassman Research Institute, LLC | Berlin | New Jersey | 08009 | United States |
| Clinical Trials of America-NC, LLC | Hickory | North Carolina | 28601 | United States |
| Richard H Weisler, MD PA Associates | Raleigh | North Carolina | 27609 | United States |
| SP Research PLLC | Oklahoma City | Oklahoma | 73112 | United States |
| Cutting Edge Research Group | Oklahoma City | Oklahoma | 73116 | United States |
| Community Clinical Research, Inc. | Austin | Texas | 78754 | United States |
| InSite Clinical Research | DeSoto | Texas | 75115 | United States |
| North Texas Clinical Trials | Fort Worth | Texas | 76104 | United States |
| Pillar Clinical Research LLC | Garland | Texas | 75042 | United States |
| Pillar Clinical Research, LLC | Richardson | Texas | 75080 | United States |
| Core Clinical Research | Everett | Washington | 98201 | United States |
| Mid Columbia Research | Richland | Washington | 99352 | United States |
| Mental Health Center Prof. Dr. Ivan Temkov - Burgas EOOD, Department for Treatment of Emergency Psychiatric Condition | Burgas | 8000 | Bulgaria |
| State Psychiatry Hospital - Kardzhali,Third Male Department, First Female Department | Kardzhali | 6600 | Bulgaria |
| State Psychiatry Hospital Sv. Ivan Rilski, First Male department, First Female Department | Novi Iskar | 1282 | Bulgaria |
| University Multiprofile Hospital for Active Treatment Sveti Georgi EAD, Clinic of Psychiatry | Plovdiv | 4002 | Bulgaria |
| "Mental Health Centre-Ruse" EOOD, Male department for persons with severe mental disorders, Female department for persons with severe mental disorders | Rousse | 7003 | Bulgaria |
| University Multiprofile Hospital for Active Treatment -Alexandrovska EAD, Clinic of Psychiatry, First Department of Psychiatry | Sofia | 1431 | Bulgaria |
| Multiprofile Hospital for Active Treatment - Targovishte AD, Department of Psychiatry | Targovishte | 7700 | Bulgaria |
| Mental Health Center - Veliko Tarnovo EOOD, Department of Psychiatry for Active Treatment of Persons with Severe Mental Disorders | Veliko Tarnovo | 5000 | Bulgaria |
| Mental Health Center - Vratsa EOOD, Department of Psychiatry | Vratsa | 3000 | Bulgaria |
| CHC Rijeka-Clinic for Psychiatrics | Rijeka | 51000 | Croatia |
| Poliklinika Neuron /Polyclinic Neuron | Zagreb | 10000 | Croatia |
| Indywidualna Specjalistyczna Praktyka Lekarska Wieslaw Jerzy Cubala | Gdansk | 80-438 | Poland |
| NZOZ Prywatna Klinika Psychiatryczna Inventiva | Tuszyn | 95-080 | Poland |
| CHC Dr Dragisa Misovic | Belgrade | 11000 | Serbia |
| Clinic for Psychiatric Disorders, Dr Laza Lazarevic | Belgrade | 11000 | Serbia |
| Clinic for Psychiatry | Belgrade | 11000 | Serbia |
| Specialized Hospital for Psychiatry Diseases Kovin | Kovin | 26220 | Serbia |
| Clinical Center Kragujevac, Clinic of Psychiatry | Kragujevac | 34000 | Serbia |
| Klinika za psihijariju, Klinicki Centar Vojvodine | Novi Sad | 21000 | Serbia |
| Regional Clinical Hospital n.a I.I. Mechnicov | Dnipro | 49005 | Ukraine |
| SI of Neurology Psychiatry and Narcology NAMS | Kharkiv | 61068 | Ukraine |
| Kherson Regional Psychiatric Hospital | Kherson | 73488 | Ukraine |
| Kyiv Regional Medical Incorporation Psychiatry | Kyiv | 04080 | Ukraine |
| CI of LOR Lviv Regional Clinical Psychiatric Hospital, Department #25 | Lviv | 79021 | Ukraine |
| Communal Institution of Lviv Regional Council "Lviv Regional Clinical Psychiatric Hospital", department #20 | Lviv | 79021 | Ukraine |
| Odesa Regional Psychiatric Hospital 2 | Odesa | 67513 | Ukraine |
| Maltsev Regional Clinical Psychiatric Hospital | Poltava | 36013 | Ukraine |
| Ternopil Regional Municipal Clinical Psychoneurological Hospital | Ternopil | 46027 | Ukraine |
| O.I. Yushenko Vinnitsa Regional Clinic | Vinnitsa | 21018 | Ukraine |
| FG001 | Prior Placebo | Brexpiprazole was administered in participants orally with flexible dosing from 2 mg/day from Days 1 to 3 regardless of treatment assignment in the previous double-blind trial, followed by titration to 3 mg/day on Day 4. Participants may have been titrated (or re-titrated) to a higher dose of brexpiprazole, up to a maximum of 4 mg/day, based on treatment response and at the investigator's discretion anytime at Day 7 or thereafter. Participants who were unable to tolerate their current dose could have been titrated down to a minimum of 2 mg/day any time after Day 4. Participants who received placebo in the double-blind treatment period in previous studies were included in this group. |
| Analyzed For Safety (Safety Sample) | Participants who received at least 1 dose of investigational medicinal product (IMP-brexpiprazole). |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
Enrolled Sample included all participants who signed an inform consent form (ICF) for the trial.
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| ID | Title | Description |
|---|---|---|
| BG000 | Prior Brexpiprazole | Brexpiprazole was administered in participants orally with flexible dosing from 2 mg/day from Days 1 to 3 regardless of treatment assignment in the previous double-blind trial, followed by titration to 3 mg/day on Day 4. Participants may have been titrated (or re-titrated) to a higher dose of brexpiprazole, up to a maximum of 4 mg/day, based on treatment response and at the investigator's discretion anytime at Day 7 or thereafter. Participants who were unable to tolerate their current dose could have been titrated down to a minimum of 2 mg/day any time after Day 4. Participants who received brexpiprazole in the double-blind treatment period in previous studies were included in this group. |
| BG001 | Prior Placebo | Brexpiprazole was administered in participants orally with flexible dosing from 2 mg/day from Days 1 to 3 regardless of treatment assignment in the previous double-blind trial, followed by titration to 3 mg/day on Day 4. Participants may have been titrated (or re-titrated) to a higher dose of brexpiprazole, up to a maximum of 4 mg/day, based on treatment response and at the investigator's discretion anytime at Day 7 or thereafter. Participants who were unable to tolerate their current dose could have been titrated down to a minimum of 2 mg/day any time after Day 4. Participants who received placebo in the double-blind treatment period in previous studies were included in this group. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Race/Ethnicity, Customized | Count of Participants | Participants |
| ||||||||||||||||
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants With at Least One Treatment Emergent Adverse Event (TEAE) by Severity | An adverse event (AE) was defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (eg, a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, whether or not it is considered related to the drug. A TEAE is defined as an adverse event with an onset that occurs after receiving study drug. AEs severity were graded on a 3-point scale as: 1 = mild; discomfort noticed, but no disruption to daily activity, 2 = moderate; discomfort sufficient to reduce or affect normal daily activity, and 3 = severe; inability to work or perform normal daily activity. | Safety Sample included all participants who received at least 1 dose of IMP (brexpiprazole). | Posted | Count of Participants | Participants | From Day 1 (after dosing) through 29 weeks (26 weeks treatment, 3 weeks safety follow-up) |
|
|
|
From Day 1 (after dosing) through 29 weeks (26 weeks treatment, 3 weeks safety follow-up)
Safety Sample included all participants who received at least 1 dose of IMP.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Prior Brexpiprazole | Brexpiprazole was administered in participants orally with flexible dosing from 2 mg/day from Days 1 to 3 regardless of treatment assignment in the previous double-blind trial, followed by titration to 3 mg/day on Day 4. Participants may have been titrated (or re-titrated) to a higher dose of brexpiprazole, up to a maximum of 4 mg/day, based on treatment response and at the investigator's discretion anytime at Day 7 or thereafter. Participants who were unable to tolerate their current dose could have been titrated down to a minimum of 2 mg/day any time after Day 4. Participants who received brexpiprazole in the double-blind treatment period in previous studies were included in this group. | 0 | 184 | 11 | 184 | 13 | 184 |
| EG001 | Prior Placebo | Brexpiprazole was administered in participants orally with flexible dosing from 2 mg/day from Days 1 to 3 regardless of treatment assignment in the previous double-blind trial, followed by titration to 3 mg/day on Day 4. Participants may have been titrated (or re-titrated) to a higher dose of brexpiprazole, up to a maximum of 4 mg/day, based on treatment response and at the investigator's discretion anytime at Day 7 or thereafter. Participants who were unable to tolerate their current dose could have been titrated down to a minimum of 2 mg/day any time after Day 4. Participants who received placebo in the double-blind treatment period in previous studies were included in this group. | 0 | 184 | 8 | 184 | 26 | 184 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Acute Myocardial Infarction | Cardiac disorders | MedDRA (22.0) | Systematic Assessment |
| |
| Vertigo Positional | Ear and labyrinth disorders | MedDRA (22.0) | Systematic Assessment |
| |
| Upper Gastrointestinal Haemorrhage | Gastrointestinal disorders | MedDRA (22.0) | Systematic Assessment |
| |
| Chest Pain | General disorders | MedDRA (22.0) | Systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA (22.0) | Systematic Assessment |
| |
| Migraine | Nervous system disorders | MedDRA (22.0) | Systematic Assessment |
| |
| Bipolar Disorder | Psychiatric disorders | MedDRA (22.0) | Systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA (22.0) | Systematic Assessment |
| |
| Mania | Psychiatric disorders | MedDRA (22.0) | Systematic Assessment |
| |
| Suicidal Behaviour | Psychiatric disorders | MedDRA (22.0) | Systematic Assessment |
| |
| Suicidal Ideation | Psychiatric disorders | MedDRA (22.0) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Akathisia | Nervous system disorders | MedDRA (22.0) | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA (22.0) | Systematic Assessment |
|
As predefined in the protocol, there were no primary or secondary efficacy endpoints in this trial.
Sponsor reserves the right to review results publications prior to public release and can delay such publications for a period greater than 60 days but no more than 120 days from the date that the publication is submitted to the Sponsor for review. Sponsor can require changes to the publication to protect Sponsor's intellectual property rights and/or confidential information and reserves the right to limit publication timing and scope of data published based on the number of study locations.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Global Clinical Development | Otsuka Pharmaceutical Development & Commercialization, Inc. | 1-609-524-6788 | clinicaltransparency@otsuka-us.com |
| Prot_002.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jul 17, 2019 | Aug 14, 2020 | SAP_003.pdf |
Not provided
| ID | Term |
|---|---|
| D000087122 | Mania |
| ID | Term |
|---|---|
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| C000591922 | brexpiprazole |
Not provided
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| Male |
|
| Black or African American |
|
| American Indian or Alaska Native |
|
| Asian |
|
| Race-Other |
|
| Not Hispanic or Latino |
|
| Ethnicity-Other |
|
| TEAE, Moderate |
|
| TEAE, Severe |
|