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| ID | Type | Description | Link |
|---|---|---|---|
| JapicCTI-184179 | Other Identifier | Japic |
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To evaluate the safety of brexpiprazole 1 mg or 2 mg after a 14 week treatment regimen for agitation associated with dementia of the Alzheimer's type patients who completed in a double-blind trial, and to investigate the efficacy of brexpiprazole.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Brexpiprazole | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Brexpiprazole | Drug | Brexpiprazole 1mg or 2mg will be orally once daily for 14 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| The Frequency of Subjects With Treatment-Emergent Adverse Events (TEAEs) | This trial enrolled subjects rolled over from Trial 331-102-00088, and the safety of brexpiprazole when administered for a maximum of 24 weeks (including the treatment period of Trial 331-102-00088) was evaluated. | From baseline to week 14 |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Change From Baseline in Cohen-Mansfield Agitation Inventory (CMAI) Score at 14 Weeks After Dosing | The CMAI assessed the frequency of agitated behaviors in elderly persons, such as hitting, cursing, and restlessness. It consisted of 29 items all rated on a 1 to 7 scale with 1 being the "best" rating and 7 being the "worst" rating. The minimum possible CMAI total score was 29, and the maximum possible CMAI total score was 203. A decrease in score indicated improvement in symptoms. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Osamu Sato | Otsuka Pharmaceutical Co., Ltd. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Jisenkai Nanko Psychiatric Institute | Shirakawa | Japan |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40290781 | Derived | Nakamura Y, Adachi J, Hirota N, Iba K, Shimizu K, Nakai M, Mori N, Takahashi K. Long-term safety and tolerability of brexpiprazole for Japanese patients with agitation in Alzheimer's disease dementia: A multicenter, open-label study. J Alzheimers Dis Rep. 2025 Apr 16;9:25424823251334054. doi: 10.1177/25424823251334054. eCollection 2025 Jan-Dec. |
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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.
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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.
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| ID | Title | Description |
|---|---|---|
| FG000 | ROLLOVER BREX | Rollover subjects from the brexpiprazole group in Trial 331-102-00088 |
| FG001 | ROLLOVER PLACEBO | Rollover subjects from the placebo group in Trial 331-102-00088 |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
This trial was conducted in 164 participants in Japan.
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| ID | Title | Description |
|---|---|---|
| BG000 | ROLLOVER BREX | Rollover subjects from the brexpiprazole group in Trial 331-102-00088 |
| BG001 | ROLLOVER PLACEBO | Rollover subjects from the placebo group in Trial 331-102-00088 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of 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 | The Frequency of Subjects With Treatment-Emergent Adverse Events (TEAEs) | This trial enrolled subjects rolled over from Trial 331-102-00088, and the safety of brexpiprazole when administered for a maximum of 24 weeks (including the treatment period of Trial 331-102-00088) was evaluated. | The safety analysis set comprised subjects who have received at least 1 dose of the IMP. | Posted | Number | Percentage of percipitante | From baseline to week 14 |
|
Adverse events were monitored from signing of the informed consent form through 35 days after last dose of study drug (Up to approximately Week 19)
Subjects who received at least one dose of IMP were included in the safety analysis.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | ROLLOVER BREX | Rollover subjects from the brexpiprazole group in Trial 331-102-00088 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Gait disturbance | General disorders | MedDRA version 25.0 | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Dry eye | Eye disorders | MedDRA version 25.0 | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Director of Clinical Trials | Otsuka Pharmaceutical Co., Ltd. | +81363617366 | CL_OPCJ_RDA_Team@otsuka.jp |
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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 | Feb 3, 2021 | Oct 27, 2023 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Feb 4, 2022 | Oct 27, 2023 | SAP_001.pdf |
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| ID | Term |
|---|---|
| C000591922 | brexpiprazole |
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| Baseline and 14 weeks after dosing |
| Mean Change From Baseline in Clinical Global Impression of Severity (CGI-S) Score at 14 Weeks After Dosing. | The CGI-S was used to rate the severity of agitation. Scores were: 0 = not assessed; 1 = normal, not at all ill; 2 = borderline mentally ill; 3 = mildly ill; 4 = moderately ill; 5 = markedly ill; 6 = severely ill; and 7 = among the most extremely ill participants. A decrease in score indicated improvement in symptoms. | Baseline and 14 weeks after dosing. |
| Clinical Global Impression of Improvement (CGI-I) Score at 14 Weeks After Dosing | The CGI-I Scale was clinician-rated scale which assessed the total improvement of the patient's condition compared to that at baseline. Scores range from 0 to 7: 0 = Not assessed, 1= Very much improved, 2 = Much improved, 3= Minimally improved, 4= No change, 5= Minimally worse, 6= Much worse, 7= Very much worse. Higher scores indicate worse condition. | 14 weeks after dosing. |
| Physician Decision |
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| Protocol Violation |
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| Bedridden All Day and Required Full Assistance for Excretion, Meals and Change of Clothes |
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| Withdrawal by Legal Representative |
|
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
| Secondary | Mean Change From Baseline in Cohen-Mansfield Agitation Inventory (CMAI) Score at 14 Weeks After Dosing | The CMAI assessed the frequency of agitated behaviors in elderly persons, such as hitting, cursing, and restlessness. It consisted of 29 items all rated on a 1 to 7 scale with 1 being the "best" rating and 7 being the "worst" rating. The minimum possible CMAI total score was 29, and the maximum possible CMAI total score was 203. A decrease in score indicated improvement in symptoms. | The efficacy analysis set will comprise subjects who have received at least 1 dose of the IMP and from whom CMAI total scores have been obtained at baseline and at least 1 time point after initiation of treatment. | Posted | Mean | Standard Deviation | Units on a scale | Baseline and 14 weeks after dosing |
|
|
|
| Secondary | Mean Change From Baseline in Clinical Global Impression of Severity (CGI-S) Score at 14 Weeks After Dosing. | The CGI-S was used to rate the severity of agitation. Scores were: 0 = not assessed; 1 = normal, not at all ill; 2 = borderline mentally ill; 3 = mildly ill; 4 = moderately ill; 5 = markedly ill; 6 = severely ill; and 7 = among the most extremely ill participants. A decrease in score indicated improvement in symptoms. | The efficacy analysis set will comprise subjects who have received at least 1 dose of the IMP and from whom CMAI total scores have been obtained at baseline and at least 1 time point after initiation of treatment. | Posted | Mean | Standard Deviation | Units on a scale | Baseline and 14 weeks after dosing. |
|
|
|
| Secondary | Clinical Global Impression of Improvement (CGI-I) Score at 14 Weeks After Dosing | The CGI-I Scale was clinician-rated scale which assessed the total improvement of the patient's condition compared to that at baseline. Scores range from 0 to 7: 0 = Not assessed, 1= Very much improved, 2 = Much improved, 3= Minimally improved, 4= No change, 5= Minimally worse, 6= Much worse, 7= Very much worse. Higher scores indicate worse condition. | The efficacy analysis set will comprise subjects who have received at least 1 dose of the IMP and from whom CMAI total scores have been obtained at baseline and at least 1 time point after initiation of treatment. | Posted | Mean | Standard Deviation | Units on a scale | 14 weeks after dosing. |
|
|
|
| 0 |
| 102 |
| 7 |
| 102 |
| 90 |
| 102 |
| EG001 | ROLLOVER PLACEBO | Rollover subjects from the placebo group in Trial 331-102-00088 | 1 | 62 | 4 | 62 | 55 | 62 |
| Pneumonia | Infections and infestations | MedDRA version 25.0 | Non-systematic Assessment |
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| Pneumonia aspiration | Infections and infestations | MedDRA version 25.0 | Non-systematic Assessment |
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| Femoral neck fracture | Injury, poisoning and procedural complications | MedDRA version 25.0 | Non-systematic Assessment |
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| Femur fracture | Injury, poisoning and procedural complications | MedDRA version 25.0 | Non-systematic Assessment |
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| Subdural haematoma | Injury, poisoning and procedural complications | MedDRA version 25.0 | Non-systematic Assessment |
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| Blood creatine phosphokinase increased | Investigations | MedDRA version 25.0 | Non-systematic Assessment |
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| Muscle rigidity | Musculoskeletal and connective tissue disorders | MedDRA version 25.0 | Non-systematic Assessment |
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| Akathisia | Nervous system disorders | MedDRA version 25.0 | Non-systematic Assessment |
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| Bradykinesia | Nervous system disorders | MedDRA version 25.0 | Non-systematic Assessment |
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| Agitation | Psychiatric disorders | MedDRA version 25.0 | Non-systematic Assessment |
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| Pneumothorax | Respiratory, thoracic and mediastinal disorders | MedDRA version 25.0 | Non-systematic Assessment |
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| Constipation | Gastrointestinal disorders | MedDRA version 25.0 | Non-systematic Assessment |
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| Diarrhoea | Gastrointestinal disorders | MedDRA version 25.0 | Non-systematic Assessment |
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| Salivary hypersecretion | Gastrointestinal disorders | MedDRA version 25.0 | Non-systematic Assessment |
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| Vomiting | Gastrointestinal disorders | MedDRA version 25.0 | Non-systematic Assessment |
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| Gait disturbance | General disorders | MedDRA version 25.0 | Non-systematic Assessment |
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| Oedema | General disorders | MedDRA version 25.0 | Non-systematic Assessment |
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| Pyrexia | General disorders | MedDRA version 25.0 | Non-systematic Assessment |
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| Peripheral swelling | General disorders | MedDRA version 25.0 | Non-systematic Assessment |
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| Hepatic function abnormal | Hepatobiliary disorders | MedDRA version 25.0 | Non-systematic Assessment |
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| Conjunctivitis | Infections and infestations | MedDRA version 25.0 | Non-systematic Assessment |
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| Herpes zoster | Infections and infestations | MedDRA version 25.0 | Non-systematic Assessment |
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| Nasopharyngitis | Infections and infestations | MedDRA version 25.0 | Non-systematic Assessment |
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| Tinea pedis | Infections and infestations | MedDRA version 25.0 | Non-systematic Assessment |
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| Urinary tract infection | Infections and infestations | MedDRA version 25.0 | Non-systematic Assessment |
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| Fall | Injury, poisoning and procedural complications | MedDRA version 25.0 | Non-systematic Assessment |
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| Femur fracture | Injury, poisoning and procedural complications | MedDRA version 25.0 | Non-systematic Assessment |
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| Subcutaneous haematoma | Injury, poisoning and procedural complications | MedDRA version 25.0 | Non-systematic Assessment |
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| Contusion | Injury, poisoning and procedural complications | MedDRA version 25.0 | Non-systematic Assessment |
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| Wound | Injury, poisoning and procedural complications | MedDRA version 25.0 | Non-systematic Assessment |
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| Skin laceration | Injury, poisoning and procedural complications | MedDRA version 25.0 | Non-systematic Assessment |
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| Skin abrasion | Injury, poisoning and procedural complications | MedDRA version 25.0 | Non-systematic Assessment |
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| Blood albumin decreased | Investigations | MedDRA version 25.0 | Non-systematic Assessment |
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| Blood creatine phosphokinase increased | Investigations | MedDRA version 25.0 | Non-systematic Assessment |
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| Weight decreased | Investigations | MedDRA version 25.0 | Non-systematic Assessment |
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| Weight increased | Investigations | MedDRA version 25.0 | Non-systematic Assessment |
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| Hepatic enzyme increased | Investigations | MedDRA version 25.0 | Non-systematic Assessment |
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| Hypokalaemia | Metabolism and nutrition disorders | MedDRA version 25.0 | Non-systematic Assessment |
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| Decreased appetite | Metabolism and nutrition disorders | MedDRA version 25.0 | Non-systematic Assessment |
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| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA version 25.0 | Non-systematic Assessment |
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| Back pain | Musculoskeletal and connective tissue disorders | MedDRA version 25.0 | Non-systematic Assessment |
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| Muscle rigidity | Musculoskeletal and connective tissue disorders | MedDRA version 25.0 | Non-systematic Assessment |
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| Akathisia | Nervous system disorders | MedDRA version 25.0 | Non-systematic Assessment |
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| Bradykinesia | Nervous system disorders | MedDRA version 25.0 | Non-systematic Assessment |
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| Dyskinesia | Nervous system disorders | MedDRA version 25.0 | Non-systematic Assessment |
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| Dystonia | Nervous system disorders | MedDRA version 25.0 | Non-systematic Assessment |
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| Extrapyramidal disorder | Nervous system disorders | MedDRA version 25.0 | Non-systematic Assessment |
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| Headache | Nervous system disorders | MedDRA version 25.0 | Non-systematic Assessment |
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| Parkinsonism | Nervous system disorders | MedDRA version 25.0 | Non-systematic Assessment |
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| Seizure | Nervous system disorders | MedDRA version 25.0 | Non-systematic Assessment |
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| Somnolence | Nervous system disorders | MedDRA version 25.0 | Non-systematic Assessment |
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| Tremor | Nervous system disorders | MedDRA version 25.0 | Non-systematic Assessment |
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| Sedation complication | Nervous system disorders | MedDRA version 25.0 | Non-systematic Assessment |
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| Insomnia | Psychiatric disorders | MedDRA version 25.0 | Non-systematic Assessment |
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| Restlessness | Psychiatric disorders | MedDRA version 25.0 | Non-systematic Assessment |
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| Urinary incontinence | Renal and urinary disorders | MedDRA version 25.0 | Non-systematic Assessment |
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| Decubitus ulcer | Skin and subcutaneous tissue disorders | MedDRA version 25.0 | Non-systematic Assessment |
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| Dermatitis contact | Skin and subcutaneous tissue disorders | MedDRA version 25.0 | Non-systematic Assessment |
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| Dry skin | Skin and subcutaneous tissue disorders | MedDRA version 25.0 | Non-systematic Assessment |
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| Erythema | Skin and subcutaneous tissue disorders | MedDRA version 25.0 | Non-systematic Assessment |
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| Skin exfoliation | Skin and subcutaneous tissue disorders | MedDRA version 25.0 | Non-systematic Assessment |
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| Internal haemorrhage | Vascular disorders | MedDRA version 25.0 | Non-systematic Assessment |
|
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