A Phase 2 interventional study of Brexpiprazole and Placebo in Borderline Personality Disorder, sponsored by Otsuka Pharmaceutical Development & Commercialization, Inc.. Completed at 77 sites in 3 countries. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2024-07-18.
Sponsored by Otsuka Pharmaceutical Development & Commercialization, Inc. · Phase 2, Interventional, and Treatment
There are currently no pharmacological treatments approved to treat borderline personality disorder (BPD). This trial will be conducted to evaluate the efficacy and safety of brexpiprazole for the treatment of participants diagnosed with BPD to provide a pharmacological treatment for BPD.
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This study's enrollment of 332 is above the median of 75 across 229 interventional studies indexed under Personality Disorders.
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Exclusion Criteria:
Participants who fulfill the following criteria related to suicide and/or suicidal ideation are excluded:
Participants received brexpiprazole, 2-3 milligrams per day (mg/day) tablets, orally, up to Week 12 during the treatment phase.
Drug: Brexpiprazole
Participants received brexpiprazole-matching placebo tablets, orally, up to Week 12 during the treatment phase.
Other: Placebo
Tablet
Also known as: Rexulti®
Tablet
Change From Baseline in the Zanarini Rating Scale for Borderline Personality Disorder (ZAN-BPD) Total Score
The ZAN-BPD is a clinician-administered scale designed to assess severity of disease symptoms in participants with BPD based on clinician rating on 9 criteria. Each of the 9 criteria for BPD was rated on a 5-point anchored rating scale of 0 to 4. These scores were clustered into 4 sector scores (akin to domains) and a total score. The 4 sector scores added up to provide the overall total score for the ZAN-BPD, which ranged from 0 to 36. A higher score represented a higher severity of disease symptoms. Mixed model repeated measures = MMRM, antidepressant therapy = ADT.
Time frame: Baseline (Day 0) to Week 10
Change From Baseline in the Clinical Global Impression - Severity of Illness (CGI-S) Score
The severity of illness for each participant was rated using the CGI-S. CGI-S is an observer-rated scale with a total score range of 0 to 7 where a higher score represented a worse outcome. The response choices were 0 = not assessed; 1 = normal, not at all ill; 2 = borderline ill; 3 = mildly ill; 4 = moderately ill; 5 = markedly ill; 6 = severely ill; and 7 = among the most extremely ill participants.
Time frame: Baseline (Day 0) to Week 10
Change From Baseline in the Patient's Global Impression of Severity (PGI-S)
PGI-S is a 7-point single-item self-report scale for the participant to rate the severity of symptoms of BPD ranging from 0 to 7 where 1 denoted no symptoms and 7 denoted very severe.
Time frame: Baseline (Day 0), Weeks 2, 4, 6, 8, 10 and 12
Patient's Global Impression of Change (PGI-C) Scale Score
A 7-point single-item self-report scale depicting a participant's rating of overall change in their condition since starting trial medication. Participants answered the question: "Since starting study medication, how much have their symptoms of Borderline Personality Disorder changed?" with a score ranging from 1 to 7 where 1 denoted very much improved and 7 denoted very much worse.
Time frame: Weeks 2, 4, 6, 8,10 and 12
Clinical Global Impression - Improvement (CGI-I) Scale Score
Participant's condition was assessed using CGI-I scale. CGI-I is an observer-rated scale with a total score of 0 to 7 and a higher score represents a worse outcome. The score included the following response choices: 0 = not assessed; 1 = normal, not at all ill; 2 = borderline ill; 3 = mildly ill; 4 = moderately ill; 5 = markedly ill; 6 = severely ill; and 7 = among the most extremely ill participants.
Time frame: Weeks 2, 4, 6, 8, 10 and 12
Number of Participants With Treatment Emergent Adverse Events (TEAEs)
An adverse event (AE) is any untoward medical occurrence in a clinical trial participant administered an IMP and which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product. A TEAE is defined as an AE that started after start of study treatment.
Time frame: From Baseline (Day 0) to 21 days after last dose (Up to Week 15)
Number of Participants With Potentially Clinically Relevant Laboratory Test Values
Laboratory parameters included hematology(Hem), serum chemistry(Che) and urinalysis(Uri). Criterion:Che-Alkaline Phosphatase (Units/liter \[U/L\]):≥3 x ULN, Aspartate Aminotransferase (U/L):≥3 x ULN,Bilirubin (mg/deciliter\[dL\]):≥2.0,Cholesterol(Cho);Cho,fasting(mg/dl):≥240,Creatine Kinase(U/L):≥3 x ULN, Creatinine(mg/dL):≥2.0,Glucose (Glu);Glu,fasting(mg/dL):100,High Density Lipoprotein (HDL) Cho (mg/dL):Male (M) \< 40or Female (F) \<50, Low Density Lipoprotein (LDL) Cho(mg/dL):≥160,Prolactin (nanograms/milliliter \[ng/mL\]):\>1 x ULN,Triglyceride (mg/dL):≥150,Urate(mg/dL): M ≥10.5 or F ≥8.5,Urea Nitrogen (mg/dL):≥30,Hem-Eosinophils (Eosi) (10\^9 L):≥10%,Hematocrit (%): M ≤37% and ≥3 percentage (per) point decrease from baseline or F≤32% and ≥3per point decrease from baseline, Hemaglobin(gram per deciliter \[g/dL\]):M ≤11.5 or F ≤9.5,Leukocytes(10\^9/L):≤2.8 x10\^3/uL,≤16.0 x10\^3/uL,Platelets(10\^9/L):≤75 x10\^3/ uL,≥700 x10\^3/uL,Uri-Glu,urine; Protein,urine:Increase of ≥2U.
Time frame: From first dose of study drug up to Week 12
Number of Participants With Potential Clinical Relevant Laboratory Test Values - Prolactin
New onset (\> 1 x upper limit of normal {ULN}, \> 2 x ULN, 3 X ULN) prolactin means a participant who attains a categorical change during treatment phase but not at baseline. Only those categories with at least one participant with event are reported.
Time frame: Week 12
Number of Participants With Potentially Clinically Relevant Abnormalities in Vital Signs
Vital Signs included orthostatic hypotension, heart rate (HR), systolic and diastolic blood pressure (bp), and weight. Potential clinical relevance criterion: Orthostatic Hypotension:\>= 20 millimeters of mercury (mmhg) decrease in systolic bp and \>= 25 beats per minute (bpm) increase in HR from supine to standing; HR Standing (bpm):\< 50 and decrease \>= 15,\> 120 and increase \>= 15; HR Supine (bpm): \< 50 and decrease \>= 15,\>120 and increase \>= 15; Systolic BP Standing (mmhg):\< 90 and decrease \>=20,\> 180 and increase \>= 20; Systolic BP Supine (mmhg):\< 90 and decrease \>= 20, \>180 and increase \>= 20; Diastolic BP Standing (mmHg): \< 50 and decrease \>= 15,\> 105 and increase \>= 15; Diastolic BP Supine (mmHg):\< 50 and decrease \>= 15, \> 105 and increase \>= 15; Weight (kilograms\[kg\]): Decrease or increase \>= 7%. Only those categories with at least one participant with event are reported.
Time frame: From first dose of study drug up to Week 12
Change From Baseline in Body Weight
Time frame: Baseline (Day 0), Weeks 2, 4, 6, 8, 10, and 12
Change From Baseline in Waist Circumference
Time frame: Baseline (Screening: Day -21 to Day -1), Week 12
Change From Baseline in Body Mass Index (BMI)
BMI is defined as weight in kilograms divided by the square of height in meters.
Time frame: Baseline (Day 0), Weeks 2, 4, 6, 8, 10, and 12
Number of Participants With Potentially Clinically Relevant Abnormalities in 12-Lead Electrocardiogram (ECG) Parameters
ECG parameters analyzed included rhythm, conduction and ST/T morphology. Potential clinical relevance criterion: Rhythm- Supraventricular Premature Beat: not present at baseline and present post baseline, Ventricular Premature Beat: not present at baseline and present post baseline, Conduction- Right Bundle Branch Block: not present at baseline and present post baseline, ST/T Morphology- Symmetrical (Sym) T-Wave Inversion: not present at baseline and present post baseline. Only those categories with at least one participant with event are reported.
Time frame: Week 12
Change From Baseline in Simpson-Angus Scale (SAS) Total Score
The SAS consisted of a list of 10 symptoms of Parkinsonism (gait, arm dropping, shoulder shaking, elbow rigidity, wrist rigidity, head rotation, glabella tap, tremor, salivation, and akathisia). Each item was rated on a 5-point scale, with a score of zero representing the absence of symptoms and a score of 4 representing a severe condition. The SAS total score was the sum of the scores for all 10 items and ranged from 0 to 40. Higher scores indicated worst outcome.
Time frame: Baseline (Day 0), Week 6 and 12
Change From Baseline in Abnormal Involuntary Movement Scale (AIMS) Total Score
AIMS assessment consisted of 10 items describing symptoms of dyskinesia (muscles of facial expression, lips and perioral area, jaw, tongue, upper extremities, lower extremities, neck/shoulders/hips, overall movement severity, incapacitation, participant awareness). Facial and oral movements (items 1 through 4), extremity movements (items 5 and 6), and trunk movements (item 7) were observed unobtrusively while participant was at rest (e.g., in waiting room), and study physician would make global judgments on participant's dyskinesia's (items 8 through 10). Each item was rated on 5-point scale of severity from 0 (none) to 4 (severe) and assessment of problems with teeth or dentures (yes = 1, no = 0) and if the participant normally wears dentures (yes = 1, no = 0). Total score ranged from 0 to 42. Higher scores indicated worst outcome.
Time frame: Baseline (Day 0), Weeks 6 and 12
Change From Baseline in Barnes Akathisia Rating Scale (BARS): Global Clinical Assessment of Akathisia Score
The BARS consisted of 4 items related to akathisia: objective observation of akathisia by the investigator, subjective feelings of restlessness by the participant, subjective distress due to akathisia, and global clinical assessment of akathisia. The global clinical evaluation was made on a 6-point scale, with zero representing absence of symptoms and a score of 5 representing severe akathisia.
Time frame: Baseline (Day 0), Weeks 6 and 12
Number of Participants With Suicidal Behavior and Suicidal Ideation As Assessed by Columbia-Suicide Severity Rating Scale (C-SSRS)
Suicidality was monitored using the C-SSRS. Suicidality was defined as at least one occurrence of suicidal ideation (including wish to be dead, non-specific suicidal thought, suicidal ideation-no intent, ideation with intent, no plan, ideation with plan/intent) or at least one occurrence of suicidal behavior (actual attempt, non-suicidal self-injurious behavior, interrupted attempt, aborted attempt, preparatory acts/behavior, suicidal behavior) for the assessment period.
Time frame: Baseline (Day 0) to Week 12
Participants were enrolled in the study at 62 study centers in the United States, Spain, and Ukraine from 17 October 2019 to 27 Jun 2021.
| Milestone | Brexpiprazole 2-3 Milligrams Per Day | Placebo |
|---|---|---|
| Started | 159 | 165 |
| Safety population | 157 | 165 |
| Full analysis set (fas) for enriched participants | 112 | 111 |
| Completed | 112 | 127 |
| Not completed | 47 | 38 |
| Withdrew: Adverse event | 19 | 7 |
| Withdrew: Lack of efficacy | 0 | 1 |
| Withdrew: Lost to follow-up | 13 | 11 |
| Withdrew: Non-compliance with study drug | 1 | 3 |
| Withdrew: Protocol deviation | 1 | 1 |
| Withdrew: Withdrawal by participant | 13 | 15 |
The ZAN-BPD is a clinician-administered scale designed to assess severity of disease symptoms in participants with BPD based on clinician rating on 9 criteria. Each of the 9 criteria for BPD was rated on a 5-point anchored rating scale of 0 to 4. These scores were clustered into 4 sector scores (akin to domains) and a total score. The 4 sector scores added up to provide the overall total score for the ZAN-BPD, which ranged from 0 to 36. A higher score represented a higher severity of disease symptoms. Mixed model repeated measures = MMRM, antidepressant therapy = ADT.
| score on a scale | Brexpiprazole 2-3 Milligrams Per Day | Placebo |
|---|---|---|
| Change From Baseline in the Zanarini Rating Scale for Borderline Personality Disorder (ZAN-BPD) Total Score | -7.27 ± 0.80 | -6.25 ± 0.76 |
The severity of illness for each participant was rated using the CGI-S. CGI-S is an observer-rated scale with a total score range of 0 to 7 where a higher score represented a worse outcome. The response choices were 0 = not assessed; 1 = normal, not at all ill; 2 = borderline ill; 3 = mildly ill; 4 = moderately ill; 5 = markedly ill; 6 = severely ill; and 7 = among the most extremely ill participants.
| score on a scale | Brexpiprazole 2-3 Milligrams Per Day | Placebo |
|---|---|---|
| Change From Baseline in the Clinical Global Impression - Severity of Illness (CGI-S) Score | -1.13 ± 0.14 | -1.09 ± 0.14 |
PGI-S is a 7-point single-item self-report scale for the participant to rate the severity of symptoms of BPD ranging from 0 to 7 where 1 denoted no symptoms and 7 denoted very severe.
| score on a scale | Brexpiprazole 2-3 Milligrams Per Day | Placebo |
|---|---|---|
| Change from Baseline at Week 2 | -0.33 ± 0.12 | -0.27 ± 0.12 |
| Change from Baseline at Week 4 | -0.60 ± 0.15 | -0.35 ± 0.14 |
| Change from Baseline at Week 6 | -0.91 ± 0.15 | -0.72 ± 0.14 |
| Change from Baseline at Week 8 | -0.99 ± 0.14 | -0.69 ± 0.14 |
| Change from Baseline at Week 10 | -0.90 ± 0.15 | -0.79 ± 0.14 |
| Change from Baseline at Week 12 | -1.00 ± 0.16 | -0.86 ± 0.15 |
A 7-point single-item self-report scale depicting a participant's rating of overall change in their condition since starting trial medication. Participants answered the question: "Since starting study medication, how much have their symptoms of Borderline Personality Disorder changed?" with a score ranging from 1 to 7 where 1 denoted very much improved and 7 denoted very much worse.
| score on a scale | Brexpiprazole 2-3 Milligrams Per Day | Placebo |
|---|---|---|
| Week 2 | 3.38 ± 0.89 | 3.30 ± 0.93 |
| Week 4 | 3.23 ± 1.26 | 3.25 ± 1.22 |
| Week 6 | 2.94 ± 1.14 | 3.15 ± 1.11 |
| Week 8 | 2.94 ± 1.10 | 3.11 ± 1.12 |
| Week 10 | 2.89 ± 1.26 | 2.97 ± 1.20 |
| Week 12 | 2.88 ± 1.19 | 2.96 ± 1.14 |
Participant's condition was assessed using CGI-I scale. CGI-I is an observer-rated scale with a total score of 0 to 7 and a higher score represents a worse outcome. The score included the following response choices: 0 = not assessed; 1 = normal, not at all ill; 2 = borderline ill; 3 = mildly ill; 4 = moderately ill; 5 = markedly ill; 6 = severely ill; and 7 = among the most extremely ill participants.
| score on a scale | Brexpiprazole 2-3 Milligrams Per Day | Placebo |
|---|---|---|
| Week 2 | 2.99 ± 0.96 | 2.99 ± 0.97 |
| Week 4 | 2.89 ± 1.04 | 3.00 ± 1.20 |
| Week 6 | 2.62 ± 1.05 | 2.77 ± 1.21 |
| Week 8 | 2.39 ± 1.06 | 2.79 ± 1.26 |
| Week 10 | 2.45 ± 1.18 | 2.61 ± 1.20 |
| Week 12 | 2.37 ± 1.19 | 2.65 ± 1.17 |
An adverse event (AE) is any untoward medical occurrence in a clinical trial participant administered an IMP and which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product. A TEAE is defined as an AE that started after start of study treatment.
| Participants | Brexpiprazole 2-3 Milligrams Per Day | Placebo |
|---|---|---|
| Number of Participants With Treatment Emergent Adverse Events (TEAEs) | 95 | 79 |
Laboratory parameters included hematology(Hem), serum chemistry(Che) and urinalysis(Uri). Criterion:Che-Alkaline Phosphatase (Units/liter \[U/L\]):≥3 x ULN, Aspartate Aminotransferase (U/L):≥3 x ULN,Bilirubin (mg/deciliter\[dL\]):≥2.0,Cholesterol(Cho);Cho,fasting(mg/dl):≥240,Creatine Kinase(U/L):≥3 x ULN, Creatinine(mg/dL):≥2.0,Glucose (Glu);Glu,fasting(mg/dL):100,High Density Lipoprotein (HDL) Cho (mg/dL):Male (M) \< 40or Female (F) \<50, Low Density Lipoprotein (LDL) Cho(mg/dL):≥160,Prolactin (nanograms/milliliter \[ng/mL\]):\>1 x ULN,Triglyceride (mg/dL):≥150,Urate(mg/dL): M ≥10.5 or F ≥8.5,Urea Nitrogen (mg/dL):≥30,Hem-Eosinophils (Eosi) (10\^9 L):≥10%,Hematocrit (%): M ≤37% and ≥3 percentage (per) point decrease from baseline or F≤32% and ≥3per point decrease from baseline, Hemaglobin(gram per deciliter \[g/dL\]):M ≤11.5 or F ≤9.5,Leukocytes(10\^9/L):≤2.8 x10\^3/uL,≤16.0 x10\^3/uL,Platelets(10\^9/L):≤75 x10\^3/ uL,≥700 x10\^3/uL,Uri-Glu,urine; Protein,urine:Increase of ≥2U.
| Participants | Brexpiprazole 2-3 Milligrams Per Day | Placebo |
|---|---|---|
| Che: Alkaline Phosphatase, High | 1 | 0 |
| Che: Aspartate Aminotransferase, High | 1 | 0 |
| Che: Bilirubin, High | 0 | 2 |
| Che: Cho, High | 2 | 4 |
| Che: Cho Fasting, High | 13 | 7 |
| Che: Creatine Kinase, High | 4 | 3 |
| Che: Creatinine, High | 1 | 0 |
| Che: Glu Fasting, High | 29 | 30 |
| Che: HDL Cho, Fasting, Low | 46 | 42 |
| Che: Low LDL Cho, High | 3 | 4 |
| Che: LDL Cholesterol, Fasting, High | 11 | 8 |
| Che: Prolactin, High | 41 | 7 |
| Che: Triglyceride, Fasting, High | 35 | 25 |
| Che: Urate, High | 1 | 0 |
| Che: Urea Nitrogen, High | 2 | 0 |
| Hem: Eosi/Leukocytes Ratio, High | 4 | 2 |
| Hem: Hematocrit, Low | 2 | 4 |
| Hem: Hemoglobin, Low | 2 | 2 |
| Hematology: Leukocytes, Low | 0 | 1 |
| Hem: Leukocytes, High | 2 | 0 |
| Hem: Platelets, Low | 0 | 2 |
| Uri: Glu, Urine, High | 0 | 1 |
| Uri: Protein, Urine, High | 1 | 0 |
New onset (\> 1 x upper limit of normal {ULN}, \> 2 x ULN, 3 X ULN) prolactin means a participant who attains a categorical change during treatment phase but not at baseline. Only those categories with at least one participant with event are reported.
| Participants | Brexpiprazole 2-3 Milligrams Per Day | Placebo |
|---|---|---|
| Prolactin: >1 x ULN | 37 | 4 |
| Prolactin: >2 x ULN | 1 | 1 |
Vital Signs included orthostatic hypotension, heart rate (HR), systolic and diastolic blood pressure (bp), and weight. Potential clinical relevance criterion: Orthostatic Hypotension:\>= 20 millimeters of mercury (mmhg) decrease in systolic bp and \>= 25 beats per minute (bpm) increase in HR from supine to standing; HR Standing (bpm):\< 50 and decrease \>= 15,\> 120 and increase \>= 15; HR Supine (bpm): \< 50 and decrease \>= 15,\>120 and increase \>= 15; Systolic BP Standing (mmhg):\< 90 and decrease \>=20,\> 180 and increase \>= 20; Systolic BP Supine (mmhg):\< 90 and decrease \>= 20, \>180 and increase \>= 20; Diastolic BP Standing (mmHg): \< 50 and decrease \>= 15,\> 105 and increase \>= 15; Diastolic BP Supine (mmHg):\< 50 and decrease \>= 15, \> 105 and increase \>= 15; Weight (kilograms\[kg\]): Decrease or increase \>= 7%. Only those categories with at least one participant with event are reported.
| Participants | Brexpiprazole 2-3 Milligrams Per Day | Placebo |
|---|---|---|
| Orthostatic Hypotension: Low | 0 | 1 |
| Heart Rate Standing, High | 2 | 0 |
| Heart Rate Supine, Low | 1 | 1 |
| Systolic Blood Pressure Standing, Low | 1 | 1 |
| Systolic Blood Pressure Supine, Low | 1 | 0 |
| Weight, Increase | 5 | 3 |
| Weight, Decrease | 25 | 12 |
| kilogram (kg) | Brexpiprazole 2-3 Milligrams Per Day | Placebo |
|---|---|---|
| Baseline (Day 0) | 78.60 ± 22.15 | 78.85 ± 22.33 |
| Change From Baseline at Week 2 | 0.27 ± 1.15 | 0.09 ± 1.62 |
| Change From Baseline at Week 4 | 1.05 ± 1.92 | -0.05 ± 2.02 |
| Change From Baseline at Week 6 | 1.39 ± 2.25 | 0.20 ± 2.21 |
| Change From Baseline at Week 8 | 1.55 ± 2.75 | -0.03 ± 2.41 |
| Change From Baseline at Week 10 | 2.09 ± 2.96 | 0.37 ± 2.72 |
| Change From Baseline at Week 12 | 1.74 ± 3.09 | 0.30 ± 2.75 |
| centimeter | Brexpiprazole 2-3 Milligrams Per Day | Placebo |
|---|---|---|
| Baseline (Screening: Day -21 to Day -1) | 89.74 ± 17.54 | 90.01 ± 17.25 |
| Change from Baseline at Week 12 | 1.07 ± 5.23 | -0.32 ± 5.76 |
BMI is defined as weight in kilograms divided by the square of height in meters.
| kilograms per square meter (kg/m^2) | Brexpiprazole 2-3 Milligrams Per Day | Placebo |
|---|---|---|
| Baseline (Day 0) | 27.35 ± 7.49 | 28.52 ± 7.69 |
| Change From Baseline at Week 2 | 0.09 ± 0.42 | 0.05 ± 0.62 |
| Change From Baseline at Week 4 | 0.38 ± 0.68 | -0.00 ± 0.75 |
| Change From Baseline at Week 6 | 0.50 ± 0.81 | 0.09 ± 0.83 |
| Change From Baseline at Week 8 | 0.57 ± 1.01 | 0.00 ± 0.89 |
| Change From Baseline at Week 10 | 0.76 ± 1.10 | 0.15 ± 1.00 |
| Change From Baseline at Week 12 | 0.64 ± 1.17 | 0.13 ± 1.01 |
ECG parameters analyzed included rhythm, conduction and ST/T morphology. Potential clinical relevance criterion: Rhythm- Supraventricular Premature Beat: not present at baseline and present post baseline, Ventricular Premature Beat: not present at baseline and present post baseline, Conduction- Right Bundle Branch Block: not present at baseline and present post baseline, ST/T Morphology- Symmetrical (Sym) T-Wave Inversion: not present at baseline and present post baseline. Only those categories with at least one participant with event are reported.
| Participants | Brexpiprazole 2-3 Milligrams Per Day | Placebo |
|---|---|---|
| Rhythm: Supraventricular Premature Beat | 0 | 1 |
| Rhythm: Ventricular Premature Beat | 1 | 0 |
| Conduction: Right Bundle Branch Block | 1 | 0 |
| ST/T Morphology: Symmetrical T-Wave Inversion | 0 | 1 |
The SAS consisted of a list of 10 symptoms of Parkinsonism (gait, arm dropping, shoulder shaking, elbow rigidity, wrist rigidity, head rotation, glabella tap, tremor, salivation, and akathisia). Each item was rated on a 5-point scale, with a score of zero representing the absence of symptoms and a score of 4 representing a severe condition. The SAS total score was the sum of the scores for all 10 items and ranged from 0 to 40. Higher scores indicated worst outcome.
| score on a scale | Brexpiprazole 2-3 Milligrams Per Day | Placebo |
|---|---|---|
| Baseline (Day 0) | 0.18 ± 0.65 | 0.24 ± 0.92 |
| Change from Baseline at Week 6 | 0.04 ± 0.76 | -0.08 ± 0.55 |
| Change from Baseline at Week 12 | 0.04 ± 0.88 | -0.05 ± 0.63 |
AIMS assessment consisted of 10 items describing symptoms of dyskinesia (muscles of facial expression, lips and perioral area, jaw, tongue, upper extremities, lower extremities, neck/shoulders/hips, overall movement severity, incapacitation, participant awareness). Facial and oral movements (items 1 through 4), extremity movements (items 5 and 6), and trunk movements (item 7) were observed unobtrusively while participant was at rest (e.g., in waiting room), and study physician would make global judgments on participant's dyskinesia's (items 8 through 10). Each item was rated on 5-point scale of severity from 0 (none) to 4 (severe) and assessment of problems with teeth or dentures (yes = 1, no = 0) and if the participant normally wears dentures (yes = 1, no = 0). Total score ranged from 0 to 42. Higher scores indicated worst outcome.
| score on a scale | Brexpiprazole 2-3 Milligrams Per Day | Placebo |
|---|---|---|
| Baseline (Day 0) | 0.03 ± 0.20 | 0.04 ± 0.42 |
| Change from Baseline at Week 6 | -0.02 ± 0.25 | 0.09 ± 0.87 |
| Change from Baseline at Week 12 | -0.02 ± 0.27 | 0.07 ± 0.73 |
The BARS consisted of 4 items related to akathisia: objective observation of akathisia by the investigator, subjective feelings of restlessness by the participant, subjective distress due to akathisia, and global clinical assessment of akathisia. The global clinical evaluation was made on a 6-point scale, with zero representing absence of symptoms and a score of 5 representing severe akathisia.
| score on a scale | Brexpiprazole 2-3 Milligrams Per Day | Placebo |
|---|---|---|
| Baseline (Day 0) | 0.08 ± 0.27 | 0.12 ± 0.40 |
| Change from Baseline at Week 6 | 0.15 ± 0.59 | -0.04 ± 0.37 |
| Change from Baseline at Week 12 | 0.06 ± 0.53 | -0.05 ± 0.33 |
Suicidality was monitored using the C-SSRS. Suicidality was defined as at least one occurrence of suicidal ideation (including wish to be dead, non-specific suicidal thought, suicidal ideation-no intent, ideation with intent, no plan, ideation with plan/intent) or at least one occurrence of suicidal behavior (actual attempt, non-suicidal self-injurious behavior, interrupted attempt, aborted attempt, preparatory acts/behavior, suicidal behavior) for the assessment period.
| Participants | Brexpiprazole 2-3 Milligrams Per Day | Placebo |
|---|---|---|
| Suicidal Behavior | 42 | 29 |
| Suicidal Ideation | 78 | 70 |
Collected over From Baseline (Day 0) to 21 days after last dose (up to Week 15). Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Brexpiprazole 2-3 Milligrams Per Day | 0/157 (0%) | 5/157 (3.2%) | 69/157 (43.9%) |
| Placebo | 0/165 (0%) | 2/165 (1.2%) | 45/165 (27.3%) |
| Event | Brexpiprazole 2-3 Milligrams Per Day | Placebo |
|---|---|---|
| Suicide AttemptPsychiatric disorders | 2/157 | 0/165 |
| Cerebrovascular AccidentNervous system disorders | 1/157 | 0/165 |
| Major DepressionPsychiatric disorders | 1/157 | 0/165 |
| Panic AttackPsychiatric disorders | 1/157 | 0/165 |
| GastritisGastrointestinal disorders | 0/157 | 1/165 |
| PneumoniaInfections and infestations | 0/157 | 1/165 |
| DissociationPsychiatric disorders | 0/157 | 1/165 |
| Event | Brexpiprazole 2-3 Milligrams Per Day | Placebo |
|---|---|---|
| AkathisiaNervous system disorders | 22/157 | 2/165 |
| InsomniaPsychiatric disorders | 15/157 | 10/165 |
| AnxietyPsychiatric disorders | 13/157 | 9/165 |
| FatigueGeneral disorders | 12/157 | 6/165 |
| HeadacheNervous system disorders | 8/157 | 12/165 |
| Weight IncreasedInvestigations | 10/157 | 4/165 |
| RestlessnessPsychiatric disorders | 10/157 | 2/165 |
| Increased AppetiteMetabolism and nutrition disorders | 8/157 | 4/165 |
| SomnolenceNervous system disorders | 8/157 | 5/165 |
Randomized population included all participants who were randomized to receive brexpiprazole or matching placebo in the treatment phase.
| Age, Continuous(years) | Brexpiprazole 2 to 3 Milligrams Per Day | Placebo | Total |
|---|---|---|---|
| Mean | 32.0 ± 10.6 | 31.0 ± 10.9 | 31.5 ± 10.7 |
| Sex: Female, Male(Participants) | Brexpiprazole 2 to 3 Milligrams Per Day | Placebo | Total |
|---|---|---|---|
| Female | 129 | 137 | 266 |
| Male | 30 | 28 | 58 |
| Race (NIH/OMB)(Participants) | Brexpiprazole 2 to 3 Milligrams Per Day | Placebo | Total |
|---|---|---|---|
| American Indian or Alaska Native | 3 | 0 | 3 |
| Asian | 7 | 2 | 9 |
| Native Hawaiian or Other Pacific Islander | 1 | 1 | 2 |
| Black or African American | 19 | 22 | 41 |
| White | 123 | 131 | 254 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 6 | 9 | 15 |
| Race/Ethnicity, Customized(Participants) | Brexpiprazole 2 to 3 Milligrams Per Day | Placebo | Total |
|---|---|---|---|
| Ethnicity — Hispanic or Latino | 31 | 33 | 64 |
| Ethnicity — Not Hispanic or Latino | 127 | 131 | 258 |
| Ethnicity — Unknown | 1 | 0 | 1 |
| Ethnicity — Other | 0 | 1 | 1 |
Documents are hosted by the registry — open the source record to download them.
Plan to share: Yes — 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.
Supporting information: Study protocol, Sap, Csr
This study is completed, as verified in Jun 2024. You cannot join it, but the record below documents what was studied.
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Otsuka Pharmaceutical Development & Commercialization, Inc.