ZENITH: Safety and Tolerability Study of Oral OPC-34712 as Maintenance Treatment in Adults With Schizophrenia
Sponsor
Otsuka Pharmaceutical Development & Commercialization, Inc. (Industry)
Overall Status
Completed
CT.gov ID
NCT01397786
Collaborator
(none)
1,044
148
1
52
7.1
0.1
Study Details
Study Description
Brief Summary
The purpose of this study is to assess the long-term safety, tolerability and efficacy of oral OPC-34712 as monotherapy in adults with schizophrenia.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 3 |
Detailed Description
Schizophrenia is a severely debilitating mental illness that affects approximately 1% of the world population. Hallucinations and delusions are the most striking characteristic positive symptoms of schizophrenia; however, more subtle negative symptoms (eg, social withdrawal and lack of emotion, energy, and motivation) may also be present. The first antipsychotics developed for the treatment of schizophrenia were effective against positive symptoms, but showed little efficacy for negative symptoms and were also associated with a high incidence of side effects. Second generation antipsychotics, represent a significant advancement in the treatment of psychotic disorders because they are effective and at the same time exhibit fewer side effects than first generation antipsychotics. Although generally safer than first generation antipsychotics, the second-generation antipsychotics are not devoid of undesirable side effects such as Hyperprolactinemia and weight gain. In addition, the safety of these drugs vary considerably.
Study Design
Study Type:
Interventional
Actual Enrollment
:
1044 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Long-term, Phase 3, Multicenter, Open-label Trial to Evaluate the Safety and Tolerability of Oral OPC-34712 as Maintenance Treatment in Adults With Schizophrenia
Study Start Date
:
Sep 1, 2011
Actual Primary Completion Date
:
Jan 1, 2016
Actual Study Completion Date
:
Jan 1, 2016
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: OPC-34712
|
Drug: OPC-34712
Phase A: 1-2 mgs/day by mouth, max of 4 wks.
Phase B: 1-4 mgs/day by mouth, up to 52 weeks
|
Outcome Measures
Primary Outcome Measures
- Percentage of Participants With Adverse Events (AEs) [From Baseline up to 52 Weeks]
A treatment-emergent adverse event (TEAE) is defined as an AE that started after start of investigational medicinal product (IMP) treatment; or if the event was continuous from baseline and was serious, IMP-related, or resulted in death, discontinuation, interruption or reduction of IMP.
Secondary Outcome Measures
- Mean Change From Baseline in Positive and Negative Syndrome Scale Total Score [From Baseline up to 52 Weeks]
The PANSS consisted of 3 subscales with 30 symptom constructs (positive subscale (7): delusions, conceptual disorganization, hallucinatory behavior, excitement, grandiosity, suspiciousness/perseckion, and hostility; negative subscale (7): blunted affect, emotional withdrawal, poor rapport, passive/apathetic social withdrawal, difficulty in abstract thinking, lack of spontaneity and conversation flow, stereotyped thinking and general psychopathology subscale (16): somatic concern, anxiety, guilt feelings, tension, mannerisms and posturing, depression, motor retardation, uncooperativeness, unusual thought content, disorientation, poor attention, lack of judgment and insight, disturbance of volition, poor impulse control, preoccupation, and active social avoidance). Severity was rated on 7-point scale with scores 1 (absence) & 7 (extremely severe). The PANSS total score was sum of rating scores for 7 positive, 7 negative, and 16 general psychopathology subscale items of PANSS panel.
- Mean Change From Baseline in PANSS Positive Subscale Score [From Baseline up to 52 Weeks]
The PANSS consisted of three subscales that contained a total of 30 symptom constructs. For each symptom construct, severity is rated on a 7-point scale, with a score of 1 indicated the absence of symptoms and a score of 7 indicated extremely severe symptoms. In positive subscale, the 7 positive symptom constructs were: delusions, conceptual disorganization, hallucinatory behavior, excitement, grandiosity, suspiciousness/persecution, and hostility.
- Mean Change From Baseline in PANSS Negative Subscale Score [From Baseline up to 52 Weeks]
The PANSS consisted of three subscales that contained a total of 30 symptom constructs. For each symptom construct, severity was rated on a 7-point scale, with a score of 1 indicated the absence of symptoms and a score of 7 indicated extremely severe symptoms. In negative subscale the severity was rated for the following 7 negative symptom constructs: blunted affect, emotional withdrawal, poor rapport, passive/apathetic social withdrawal, difficulty in abstract thinking, lack of spontaneity and flow of conversation, stereotyped thinking.
- Mean Change From Baseline in Clinical Global Impression - Severity of Illness Scale Score [From Baseline up to 52 Weeks]
The severity of illness for each participant was rated using the CGI-S. To perform this assessment, the investigator were to answer the following question: "Considering your total clinical experience with this particular population, how mentally ill was the participant at that time?" Response choices include: 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.
- Mean Change From Baseline in Personal and Social Performance Scale Total Score [From Baseline up to 52 Weeks]
The PSP was a validated clinician-rated scale that measured personal and social functioning in four domains: socially useful activities (e.g, work and study), personal and social relationships, self-care, and disturbing and aggressive behaviors. Impairment in each of these domains was rated as absent, mild, manifest, marked, severe, or very severe. These ratings were then converted to a total score based on a 100-point scale using algorithms to identify the appropriate 10-point interval, and the rater's judgment that determined the total score within the 10-point interval. Participants with a PSP total score of 71 to 100 were considered to have mild functional difficulty. Scores of 31 to 70 represented manifest disabilities of various degrees and ratings of 1 to 30 indicated minimal functioning that required intense support and/or supervision.
- Mean Clinical Global Impression - Improvement Score [From Baseline up to 52 Weeks]
The efficacy of study medication was rated for each participant using the CGI-I. The investigator rated the participant's total improvement whether or not it was due to the drug treatment. All responses were compared to the participant's condition at Screening/Baseline (i.e, Week 6 visit of Protocol NCT00905307). Response choices included: 0 = not assessed, 1 = very much improved, 2 = much improved, 3 = minimally improved, 4 = no change, 5 = minimally worse, 6 = much worse, and 7 = very much worse.
- Response Rate [From Baseline up to 52 Weeks]
Response rate was defined as a reduction of ≥ 30% from Baseline in PANSS total score or CGI-I score of 1 (very much improved) or 2 (much improved) at the Last Visit.
- Discontinuation Rate for Lack of Efficacy [From Baseline up to 52 Weeks]
Discontinuation rate for the participants who discontinued due to lack of efficacy were examined.
- Mean Change From Baseline in Positive and Negative Syndrome Scale Excited Component Score [From Baseline up to 52 Weeks]
The PEC score consisted of five PANSS items: excitement (P4), hostility (P7), tension (G4), uncooperativeness (G8), and poor impulse control (G14). Each of the items were rated on a scale of 1 (absent) to 7 (extreme). The PEC scores ranged from 5 (not present) to 35 (extremely severe).
- Mean Change From Baseline in PANSS Marder Factor Scores - Positive Symptoms Score [From Baseline up to 52 Weeks]
Retrospective factor analyses have been performed in recent decades using scores for the 30 individual PANSS items to categorize symptoms into 5 dimensions. Collectively, these dimensions are referred to as the PANSS Marder Factor scores and include positive symptoms score, negative symptoms score, thought score, uncontrolled hostility/excitement, anxiety depression score. The positive factor score was the sum of the 8 components (delusions (P1), hallucinatory behavior (P3), grandiosity (P5), suspiciousness/persecution (P6), stereotyped thinking (N7), somatic concern (G1), unusual thought content (G9) and lack of judgment and insight (G12)) of the positive symptoms scale (range: 8 - best possible outcome to 56 - worst possible outcome).
- Mean Change From Baseline in PANSS Marder Factor Scores - Negative Symptoms Score [From Baseline up to 52 Weeks]
Retrospective factor analyses have been performed in recent decades using scores for the 30 individual PANSS items to categorize symptoms into 5 dimensions. Collectively, these dimensions are referred to as the PANSS Marder Factor scores and include positive symptoms score, negative symptoms score, thought score, uncontrolled hostility/excitement, anxiety depression score. The negative factor score is the sum of the 7 items (blunted affect (N1), emotional withdrawal (N2), poor rapport (N3), passive/apathetic social withdrawal (N4), lack of spontaneity and conversation flow (N6), motor retardation (G7) and active social avoidance (G16)) of the negative subscale (range: 8 - best possible outcome to 56 - worst possible outcome).
- Mean Change From Baseline in PANSS Marder Factor Scores - Disorganized Thought Score [From Baseline up to 52 Weeks]
Retrospective factor analyses have been performed in recent decades using scores for the 30 individual PANSS items to categorize symptoms into 5 dimensions. Collectively, these dimensions are referred to as the PANSS Marder Factor scores and include positive symptoms score, negative symptoms score, thought score, uncontrolled hostility/excitement, anxiety depression score. The disorganized thoughts factor score is the sum of score from the 7 items (conceptual disorganization (P2), difficulty in abstract thinking (N5), mannerisms and posturing (G5), disorientation (G10), poor attention (G11), disturbance of volition (G13) and preoccupation (G15)) on the disorganized thoughts subscale (range: 7 - best possible outcome to 49 - worst possible outcome).
- Mean Change From Baseline in PANSS Marder Factor Scores - Hostility/ Excitement Score [From Baseline up to 52 Weeks]
Retrospective factor analyses have been performed in recent decades using scores for the 30 individual PANSS items to categorize symptoms into 5 dimensions. Collectively, these dimensions are referred to as the PANSS Marder Factor scores and include positive symptoms score, negative symptoms score, thought score, uncontrolled hostility/excitement, anxiety depression score. The uncontrolled hostility/excitement factor score is the sum of score from the 4 items (excitement (P4), hostility (P7), uncooperativeness (G8) and poor impulse control (G14)) on the uncontrolled hostility/excitement subscale (range: 4 - best possible outcome to 28 - worst possible outcome).
- Mean Change From Baseline in PANSS Marder Factor Scores - Anxiety/Depression Score [From Baseline up to 52 Weeks]
Retrospective factor analyses have been performed in recent decades using scores for the 30 individual PANSS items to categorize symptoms into 5 dimensions. Collectively, these dimensions are referred to as the PANSS Marder Factor scores and include positive symptoms score, negative symptoms score, thought score, uncontrolled hostility/excitement, anxiety depression score. The anxiety/depression factor score is the sum of score from the 4 items (anxiety (G2), guilt feelings (G3), tension (G4) and depression (G6)) on the anxiety/depression subscale (range: 4 - best possible outcome to 28 - worst possible outcome).
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
to 65 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
-
Male or female subjects between 18 and 65 years of age, with a diagnosis of schizophrenia, as defined by DSM-IV-TR criteria
-
Outpatient status at last visit of Trial 331-10-230 or Trial 331-10-231
-
Willing to discontinue all prohibitive psychotropic medications to meet protocol required washouts prior to and during the trial period.
-
Other protocol specific inclusion criteria may apply.
Exclusion Criteria:
-
Females who are breast-feeding and/or who have a positive pregnancy test result prior to receiving study drug
-
Subjects with a current DSM-IV-TR Axis I diagnosis of:
-
Schizoaffective disorder
-
MDD
-
Bipolar disorder
-
Delirium, dementia, amnestic or other cognitive disorder
-
Borderline, paranoid, histrionic, schizotypal, schizoid or antisocial personality disorder
-
Subjects presenting with a first episode of schizophrenia
-
Other protocol specific exclusion criteria may apply.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Birmingham | Alabama | United States | 35226 | |
| 2 | Little Rock | Arkansas | United States | 72201 | |
| 3 | Little Rock | Arkansas | United States | 72205 | |
| 4 | Springdale | Arkansas | United States | 72764 | |
| 5 | Anaheim | California | United States | 92805 | |
| 6 | Cerritos | California | United States | 90703 | |
| 7 | Escondido | California | United States | 92025 | |
| 8 | Garden Grove | California | United States | 92845 | |
| 9 | Glendale | California | United States | 91206 | |
| 10 | Long Beach | California | United States | 90813 | |
| 11 | National City | California | United States | 91950 | |
| 12 | Oakland | California | United States | 94612 | |
| 13 | Oceanside | California | United States | 92056 | |
| 14 | Pico Rivera | California | United States | 90660 | |
| 15 | San Diego | California | United States | 92102 | |
| 16 | San Diego | California | United States | 92103 | |
| 17 | San Diego | California | United States | 92123 | |
| 18 | Torrance | California | United States | 90502 | |
| 19 | Washington | District of Columbia | United States | 20016 | |
| 20 | Bradenton | Florida | United States | 34208 | |
| 21 | LeesBurg | Florida | United States | 34748 | |
| 22 | Maitland | Florida | United States | 32751 | |
| 23 | Miami Springs | Florida | United States | 33166 | |
| 24 | Miami | Florida | United States | 33143 | |
| 25 | North Miami | Florida | United States | 33162 | |
| 26 | Tampa | Florida | United States | 33613 | |
| 27 | Chicago | Illinois | United States | 60611 | |
| 28 | Hoffman Estates | Illinois | United States | 60169 | |
| 29 | Joliet | Illinois | United States | 60435 | |
| 30 | Oak Brook | Illinois | United States | 60523 | |
| 31 | Overland Park | Kansas | United States | 66212 | |
| 32 | Lake Charles | Louisiana | United States | 70629 | |
| 33 | Shreveport | Louisiana | United States | 71104 | |
| 34 | Flowood | Mississippi | United States | 39232 | |
| 35 | St. Charles | Missouri | United States | 63301 | |
| 36 | St. Louis | Missouri | United States | 63109 | |
| 37 | St. Louis | Missouri | United States | 63141 | |
| 38 | Las Vegas | Nevada | United States | 89102 | |
| 39 | Buffalo | New York | United States | 14215 | |
| 40 | Cedarhurst | New York | United States | 11516 | |
| 41 | Jamaica | New York | United States | 11432 | |
| 42 | Rochester | New York | United States | 14618 | |
| 43 | Staten Island | New York | United States | 10305 | |
| 44 | Staten Island | New York | United States | 10312 | |
| 45 | Dayton | Ohio | United States | 45417 | |
| 46 | Allentown | Pennsylvania | United States | 18104 | |
| 47 | Norristown | Pennsylvania | United States | 19403 | |
| 48 | Charleston | South Carolina | United States | 29407 | |
| 49 | Memphis | Tennessee | United States | 38119 | |
| 50 | Austin | Texas | United States | 78731 | |
| 51 | Austin | Texas | United States | 78754 | |
| 52 | Dallas | Texas | United States | 75231 | |
| 53 | Dallas | Texas | United States | 75243 | |
| 54 | Houston | Texas | United States | 77007 | |
| 55 | Richmond | Virginia | United States | 23230 | |
| 56 | Kirkland | Washington | United States | 98033 | |
| 57 | Burlington | Ontario | Canada | L7R 4E2 | |
| 58 | Chatham | Ontario | Canada | N7M 5L9 | |
| 59 | Barranquilla | Colombia | 00000 | ||
| 60 | Bello | Colombia | 00000 | ||
| 61 | Bogota | Colombia | 00000 | ||
| 62 | Pereira | Colombia | 00000 | ||
| 63 | Rijeka | Croatia | 51000 | ||
| 64 | Zagreb | Croatia | 10090 | ||
| 65 | Fujisawa-shi | Kanagawa-Ken | Japan | 251-8530 | |
| 66 | Kumamoto-shi | Kumamoto-Ken | Japan | 861-8002 | |
| 67 | Kunigami-gun | Okinawa-Ken | Japan | 904-1201 | |
| 68 | Sakai-shi | Osaka-Fu | Japan | 590-0018 | |
| 69 | Incheon | Korea, Republic of | 400-711 | ||
| 70 | Incheon | Korea, Republic of | 405-760 | ||
| 71 | Seoul | Korea, Republic of | 136-705 | ||
| 72 | Seoul | Korea, Republic of | 137-710 | ||
| 73 | Seoul | Korea, Republic of | 143-711 | ||
| 74 | Daugavpils | Latvia | LV-5417 | ||
| 75 | Jelgava | Latvia | LV-3008 | ||
| 76 | Liepaja | Latvia | LV-3401 | ||
| 77 | Riga | Latvia | LV-1005 | ||
| 78 | Strenci | Latvia | LV-4730 | ||
| 79 | Kota Bahru | Kelantan | Malaysia | 15586 | |
| 80 | Kajang | Selangor | Malaysia | 43000 | |
| 81 | Ipoh | Malaysia | 31250 | ||
| 82 | Jalan Greentown | Malaysia | 30450 | ||
| 83 | Kuala Lumpur | Malaysia | 59100 | ||
| 84 | Sabah | Malaysia | 88815 | ||
| 85 | Col. Florida | Distrito Federal | Mexico | 01030 | |
| 86 | Monterrey | Nuevo Leon | Mexico | 64060 | |
| 87 | San Luis Potosi | San Luis Potos | Mexico | 78218 | |
| 88 | Cebu City | Philippines | 6000 | ||
| 89 | Davao City | Philippines | 8000 | ||
| 90 | Manila | Philippines | 1000 | ||
| 91 | Choroszcz | Poland | 16-070 | ||
| 92 | Gdansk | Poland | 80-282 | ||
| 93 | Gdansk | Poland | 80-952 | ||
| 94 | Lodz | Poland | 91-229 | ||
| 95 | San Juan | Puerto Rico | 00918 | ||
| 96 | San Juan | Puerto Rico | 00927 | ||
| 97 | Arad | Romania | 310022 | ||
| 98 | Brasov | Romania | 500123 | ||
| 99 | Bucuresti | Romania | 010825 | ||
| 100 | Bucuresti | Romania | 030442 | ||
| 101 | Bucuresti | Romania | 041914 | ||
| 102 | Cluj-Napoca | Romania | 400012 | ||
| 103 | Craiova | Romania | 200473 | ||
| 104 | Focsani | Romania | 620165 | ||
| 105 | Iasi | Romania | 700282 | ||
| 106 | Pitesti | Romania | 110069 | ||
| 107 | Targoviste | Romania | 130086 | ||
| 108 | Arkhangelsk | Russian Federation | 163530 | ||
| 109 | Moscow Region | Russian Federation | 142601 | ||
| 110 | Moscow | Russian Federation | 117152 | ||
| 111 | Moscow | Russian Federation | 119435 | ||
| 112 | Nizhniy Novgorod | Russian Federation | 603155 | ||
| 113 | Petrozavodsk | Russian Federation | 185000 | ||
| 114 | Samara | Russian Federation | 443016 | ||
| 115 | Saratov | Russian Federation | 410060 | ||
| 116 | St. Petersburg | Russian Federation | 190005 | ||
| 117 | St. Petersburg | Russian Federation | 190121 | ||
| 118 | St. Petersburg | Russian Federation | 192019 | ||
| 119 | St. Petersburg | Russian Federation | 194214 | ||
| 120 | St. Petersburg | Russian Federation | 197341 | ||
| 121 | Tomsk | Russian Federation | 634014 | ||
| 122 | Village Nikolskoe | Russian Federation | 188357 | ||
| 123 | Belgrade | Serbia | 11000 | ||
| 124 | Kragujevac | Serbia | 34000 | ||
| 125 | Novi Knezevac | Serbia | 23330 | ||
| 126 | Novi Sad | Serbia | 21000 | ||
| 127 | Bratislava | Slovakia | 82606 | ||
| 128 | Michalovce | Slovakia | 07101 | ||
| 129 | Rimavska Sobota | Slovakia | 97912 | ||
| 130 | Roznava | Slovakia | 04801 | ||
| 131 | Kashsiung | Taiwan | 802 | ||
| 132 | New Taipei City | Taiwan | 249 | ||
| 133 | Taipei | Taiwan | 110 | ||
| 134 | Taoyuan County | Taiwan | 333 | ||
| 135 | Diyarbakir | Turkey | 21280 | ||
| 136 | Kocaeli | Turkey | 41380 | ||
| 137 | Chernihiv | Ukraine | 14000 | ||
| 138 | Dnipropetrovsk | Ukraine | 49027 | ||
| 139 | Dnipropetrovsk | Ukraine | 49115 | ||
| 140 | Glevakha | Ukraine | 08631 | ||
| 141 | Kharkiv | Ukraine | 61068 | ||
| 142 | Kherson, Vil. Stepanivka | Ukraine | 73488 | ||
| 143 | Kyiv | Ukraine | 02660 | ||
| 144 | Kyiv | Ukraine | 04080 | ||
| 145 | Lviv | Ukraine | 79021 | ||
| 146 | Odesa | Ukraine | 65014 | ||
| 147 | Simferopol | Ukraine | 95006 | ||
| 148 | Vinnytsia | Ukraine | 21005 |
Sponsors and Collaborators
- Otsuka Pharmaceutical Development & Commercialization, Inc.
Investigators
- Study Director: Aleksandar Skuban, M.D., Otsuka Pharmaceutical Development & Commercialization, Inc.
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
Otsuka Pharmaceutical Development & Commercialization, Inc.
ClinicalTrials.gov Identifier:
NCT01397786
Other Study ID Numbers:
- 331-10-237
First Posted:
Jul 20, 2011
Last Update Posted:
May 10, 2017
Last Verified:
Apr 1, 2017
Additional relevant MeSH terms:
Study Results
Participant Flow
| Recruitment Details | This trial was conducted in a total of 1072 participants (1044 of whom entered the open-label treatment phase) at 202 trial sites in the following 18 countries: Japan, Korea, Malaysia, Philippines, Taiwan, Croatia, Latvia, Poland, Romania, Russia, Serbia, Turkey, Ukraine, Columbia, Mexico, Canada, Puerto Rico, and United States of America (USA). |
|---|---|
| Pre-assignment Detail | Enrollment was drawn from eligible participants who could potentially benefit from monotherapy treatment with oral brexpiprazole for schizophrenia and included rollover participants from the double-blind, phase-3 efficacy trials (ie, Trial NCT01393613, Trial NCT01396421, and Trial NCT01668797) and de novo participants from select sites. |
| Arm/Group Title | Prior Brexpiprazole | Prior Placebo | De Novo |
|---|---|---|---|
| Arm/Group Description | Participants who rolled over from, and received blinded brexpiprazole in, one of the randomized, double-blind, placebo-controlled Phase 3 efficacy studies (Vector, NCT01396421; Beacon, NCT01393613; and Equator, NCT01668797); all received 1-4 mg of daily treatment with open label brexpiprazole in trial NCT01397786 . | Participants who rolled over from, and received blinded placebo in, one of the randomized, double-blind, placebo-controlled Phase 3 efficacy studies (Vector, NCT01396421; Beacon, NCT01393613; and Equator, NCT01668797); all received 1-4 mg of daily treatment with open label brexpiprazole in trial NCT01397786. | Participants who had not previously participated in a brexpiprazole clinical study and who received 1-4 mg of daily treatment with open label brexpiprazole in trial NCT01397786. |
| Period Title: Phase A | |||
| STARTED | 12 | 0 | 227 |
| COMPLETED | 12 | 0 | 199 |
| NOT COMPLETED | 0 | 0 | 28 |
| Period Title: Phase A | |||
| STARTED | 611 | 204 | 229 |
| COMPLETED | 308 | 109 | 91 |
| NOT COMPLETED | 303 | 95 | 138 |
Baseline Characteristics
| Arm/Group Title | Prior Brexpiprazole | Prior Placebo | De Novo | Total |
|---|---|---|---|---|
| Arm/Group Description | Participants who rolled over from, and received blinded brexpiprazole in, one of the randomized, double-blind, placebo-controlled Phase 3 efficacy studies (Vector, NCT01396421; Beacon, NCT01393613; and Equator, NCT01668797); all received 1-4 mg of daily treatment with open label brexpiprazole in trial NCT01397786. | Participants who rolled over from, and received blinded placebo in, one of the randomized, double-blind, placebo-controlled Phase 3 efficacy studies (Vector, NCT01396421; Beacon, NCT01393613; and Equator, NCT01668797); all received 1-4 mg of daily treatment with open label brexpiprazole in trial NCT01397786. | Participants who had not previously participated in a brexpiprazole clinical study and who received 1-4 mg of daily treatment with open label brexpiprazole in trial NCT01397786. | Total of all reporting groups |
| Overall Participants | 611 | 204 | 257 | 1072 |
| Age (participants) [Mean (Standard Deviation) ] | ||||
| Mean (Standard Deviation) [participants] |
38.5
(10.8)
6.3%
|
39.6
(10.8)
19.4%
|
44.1
(11.1)
17.2%
|
40.0
(11.1)
3.7%
|
| Sex: Female, Male (Count of Participants) | ||||
| Female |
245
40.1%
|
79
38.7%
|
85
33.1%
|
409
38.2%
|
| Male |
366
59.9%
|
125
61.3%
|
172
66.9%
|
663
61.8%
|
Outcome Measures
| Title | Percentage of Participants With Adverse Events (AEs) |
|---|---|
| Description | A treatment-emergent adverse event (TEAE) is defined as an AE that started after start of investigational medicinal product (IMP) treatment; or if the event was continuous from baseline and was serious, IMP-related, or resulted in death, discontinuation, interruption or reduction of IMP. |
| Time Frame | From Baseline up to 52 Weeks |
Outcome Measure Data
| Analysis Population Description |
|---|
| Safety sample included those participants who had at least one post-baseline efficacy evaluation for Positive and Negative Syndrome Scale (PANSS) total score. |
| Arm/Group Title | Prior Brexpiprazole | Prior Placebo | De Novo | Total |
|---|---|---|---|---|
| Arm/Group Description | Participants who rolled over from, and received blinded brexpiprazole in, one of the randomized, double-blind, placebo-controlled Phase 3 efficacy studies (Vector, NCT01396421; Beacon, NCT01393613; and Equator, NCT01668797); all received 1-4 mg of daily treatment with open label brexpiprazole in trial NCT01397786. | Participants who rolled over from, and received blinded placebo in, one of the randomized, double-blind, placebo-controlled Phase 3 efficacy studies (Vector, NCT01396421; Beacon, NCT01393613; and Equator, NCT01668797); all received 1-4 mg of daily treatment with open label brexpiprazole in trial NCT01397786. | Participants who had not previously participated in a brexpiprazole clinical study and who received 1-4 mg of daily treatment with open label brexpiprazole in trial NCT01397786. | Participants who rolled over from, and received blinded brexpiprazole/placebo in, one of the randomized, double blind, placebo controlled Phase 3 efficacy studies (Vector, NCT01396421;Beacon, NCT01393613; and Equator, NCT01668797); or de novo patients, All received 1-4 mg of daily treatment with open label brexpiprazole in trial NCT01397786. |
| Measure Participants | 605 | 202 | 224 | 1031 |
| With AEs |
60.2
9.9%
|
56.4
27.6%
|
65.2
25.4%
|
60.5
5.6%
|
| With TEAEs |
60.0
9.8%
|
56.4
27.6%
|
65.2
25.4%
|
60.4
5.6%
|
| With SAEs |
14.9
2.4%
|
8.9
4.4%
|
11.2
4.4%
|
12.9
1.2%
|
| Title | Mean Change From Baseline in Positive and Negative Syndrome Scale Total Score |
|---|---|
| Description | The PANSS consisted of 3 subscales with 30 symptom constructs (positive subscale (7): delusions, conceptual disorganization, hallucinatory behavior, excitement, grandiosity, suspiciousness/perseckion, and hostility; negative subscale (7): blunted affect, emotional withdrawal, poor rapport, passive/apathetic social withdrawal, difficulty in abstract thinking, lack of spontaneity and conversation flow, stereotyped thinking and general psychopathology subscale (16): somatic concern, anxiety, guilt feelings, tension, mannerisms and posturing, depression, motor retardation, uncooperativeness, unusual thought content, disorientation, poor attention, lack of judgment and insight, disturbance of volition, poor impulse control, preoccupation, and active social avoidance). Severity was rated on 7-point scale with scores 1 (absence) & 7 (extremely severe). The PANSS total score was sum of rating scores for 7 positive, 7 negative, and 16 general psychopathology subscale items of PANSS panel. |
| Time Frame | From Baseline up to 52 Weeks |
Outcome Measure Data
| Analysis Population Description |
|---|
| The Efficacy Sample included participants in the Safety Sample who had at least 1 post-baseline efficacy evaluation for PANSS Total Score. |
| Arm/Group Title | Prior Brexpiprazole | Prior Placebo | De Novo | Total |
|---|---|---|---|---|
| Arm/Group Description | Participants who rolled over from, and received blinded brexpiprazole in, one of the randomized, double-blind, placebo-controlled Phase 3 efficacy studies (Vector, NCT01396421; Beacon, NCT01393613; and Equator, NCT01668797); all received 1-4 mg of daily treatment with open label brexpiprazole in trial NCT01397786. | Participants who rolled over from, and received blinded placebo in, one of the randomized, double-blind, placebo-controlled Phase 3 efficacy studies (Vector, NCT01396421; Beacon, NCT01393613; and Equator, NCT01668797); all received 1-4 mg of daily treatment with open label brexpiprazole in trial NCT01397786. | Participants who had not previously participated in a brexpiprazole clinical study and who received 1-4 mg of daily treatment with open label brexpiprazole in trial NCT01397786. | Participants who rolled over from, and received blinded brexpiprazole/placebo in, one of the randomized, double blind, placebo controlled Phase 3 efficacy studies (Vector, NCT01396421;Beacon, NCT01393613; and Equator, NCT01668797); or de novo patients, All received 1-4 mg of daily treatment with open label brexpiprazole in trial NCT01397786. |
| Measure Participants | 591 | 198 | 223 | 1012 |
| At Week 26 (Participant count=375,134,123,632) |
-6.90
(12.90)
|
-12.50
(14.90)
|
-6.60
(13.60)
|
-8.00
(13.60)
|
| At Week 52 (Participant count= 226,93,91,410) |
-11.0
(14.40)
|
-18.40
(16.90)
|
-8.80
(12.60)
|
-12.20
(15.00)
|
| At Last Visit (Participant count=591,198,223,1012) |
-3.80
(16.70)
|
-9.70
(18.70)
|
-3.50
(14.30)
|
-4.90
(16.80)
|
| Title | Mean Change From Baseline in PANSS Positive Subscale Score |
|---|---|
| Description | The PANSS consisted of three subscales that contained a total of 30 symptom constructs. For each symptom construct, severity is rated on a 7-point scale, with a score of 1 indicated the absence of symptoms and a score of 7 indicated extremely severe symptoms. In positive subscale, the 7 positive symptom constructs were: delusions, conceptual disorganization, hallucinatory behavior, excitement, grandiosity, suspiciousness/persecution, and hostility. |
| Time Frame | From Baseline up to 52 Weeks |
Outcome Measure Data
| Analysis Population Description |
|---|
| The Efficacy Sample included participants in the Safety Sample who had at least 1 post-baseline efficacy evaluation for PANSS Total Score. |
| Arm/Group Title | Prior Brexpiprazole | Prior Placebo | De Novo | Total |
|---|---|---|---|---|
| Arm/Group Description | Participants who rolled over from, and received blinded brexpiprazole in, one of the randomized, double-blind, placebo-controlled Phase 3 efficacy studies (Vector, NCT01396421; Beacon, NCT01393613; and Equator, NCT01668797); all received 1-4 mg of daily treatment with open label brexpiprazole in trial NCT01397786. | Participants who rolled over from, and received blinded placebo in, one of the randomized, double-blind, placebo-controlled Phase 3 efficacy studies (Vector, NCT01396421; Beacon, NCT01393613; and Equator, NCT01668797); all received 1-4 mg of daily treatment with open label brexpiprazole in trial NCT01397786. | Participants who had not previously participated in a brexpiprazole clinical study and who received 1-4 mg of daily treatment with open label brexpiprazole in trial NCT01397786. | Participants who rolled over from, and received blinded brexpiprazole/placebo in, one of the randomized, double blind, placebo controlled Phase 3 efficacy studies (Vector, NCT01396421;Beacon, NCT01393613; and Equator, NCT01668797); or de novo patients, All received 1-4 mg of daily treatment with open label brexpiprazole in trial NCT01397786. |
| Measure Participants | 591 | 198 | 123 | 1012 |
| At Week 26 (Participant count=375,134,123,632) |
-2.10
(4.50)
|
-4.10
(5.40)
|
-1.70
(4.30)
|
-2.40
(4.70)
|
| At Week 52 (Participant count=226,93,91,410) |
-3.20
(4.60)
|
-5.80
(5.20)
|
-2.30
(4.10)
|
-3.60
(4.80)
|
| At Last Visit (Participant count=591,198,223,1012) |
-0.90
(5.90)
|
-2.80
(6.40)
|
-1.00
(4.90)
|
-1.30
(5.80)
|
| Title | Mean Change From Baseline in PANSS Negative Subscale Score |
|---|---|
| Description | The PANSS consisted of three subscales that contained a total of 30 symptom constructs. For each symptom construct, severity was rated on a 7-point scale, with a score of 1 indicated the absence of symptoms and a score of 7 indicated extremely severe symptoms. In negative subscale the severity was rated for the following 7 negative symptom constructs: blunted affect, emotional withdrawal, poor rapport, passive/apathetic social withdrawal, difficulty in abstract thinking, lack of spontaneity and flow of conversation, stereotyped thinking. |
| Time Frame | From Baseline up to 52 Weeks |
Outcome Measure Data
| Analysis Population Description |
|---|
| The Efficacy Sample included participants in the Safety Sample who had at least 1 post-baseline efficacy evaluation for PANSS Total Score. |
| Arm/Group Title | Prior Brexpiprazole | Prior Placebo | De Novo | Total |
|---|---|---|---|---|
| Arm/Group Description | Participants who rolled over from, and received blinded brexpiprazole in, one of the randomized, double-blind, placebo-controlled Phase 3 efficacy studies (Vector, NCT01396421; Beacon, NCT01393613; and Equator, NCT01668797); all received 1-4 mg of daily treatment with open label brexpiprazole in trial NCT01397786. | Participants who rolled over from, and received blinded placebo in, one of the randomized, double-blind, placebo-controlled Phase 3 efficacy studies (Vector, NCT01396421; Beacon, NCT01393613; and Equator, NCT01668797); all received 1-4 mg of daily treatment with open label brexpiprazole in trial NCT01397786. | Participants who had not previously participated in a brexpiprazole clinical study and who received 1-4 mg of daily treatment with open label brexpiprazole in trial NCT01397786. | Participants who rolled over from, and received blinded brexpiprazole/placebo in, one of the randomized, double blind, placebo controlled Phase 3 efficacy studies (Vector, NCT01396421;Beacon, NCT01393613; and Equator, NCT01668797); or de novo patients, All received 1-4 mg of daily treatment with open label brexpiprazole in trial NCT01397786. |
| Measure Participants | 591 | 198 | 223 | 1012 |
| At Week 26 (Participant count=375,134,123,632) |
-1.40
(3.70)
|
-2.40
(4.30)
|
-1.30
(3.80)
|
-1.60
(3.90)
|
| At Week 52 (Participant count=226,93,91,410) |
-2.70
(4.50)
|
-3.70
(5.40)
|
-2.00
(3.70)
|
-2.80
(4.60)
|
| At Last Visit (Participant count=591,198,223,1012) |
-1.00
(4.10)
|
-2.40
(5.00)
|
-0.60
(4.20)
|
-1.20
(4.30)
|
| Title | Mean Change From Baseline in Clinical Global Impression - Severity of Illness Scale Score |
|---|---|
| Description | The severity of illness for each participant was rated using the CGI-S. To perform this assessment, the investigator were to answer the following question: "Considering your total clinical experience with this particular population, how mentally ill was the participant at that time?" Response choices include: 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. |
| Time Frame | From Baseline up to 52 Weeks |
Outcome Measure Data
| Analysis Population Description |
|---|
| The Efficacy Sample included participants in the Safety Sample who had at least 1 post-baseline efficacy evaluation for PANSS Total Score. |
| Arm/Group Title | Prior Brexpiprazole | Prior Placebo | De Novo | Total |
|---|---|---|---|---|
| Arm/Group Description | Participants who rolled over from, and received blinded brexpiprazole in, one of the randomized, double-blind, placebo-controlled Phase 3 efficacy studies (Vector, NCT01396421; Beacon, NCT01393613; and Equator, NCT01668797); all received 1-4 mg of daily treatment with open label brexpiprazole in trial NCT01397786. | Participants who rolled over from, and received blinded placebo in, one of the randomized, double-blind, placebo-controlled Phase 3 efficacy studies (Vector, NCT01396421; Beacon, NCT01393613; and Equator, NCT01668797); all received 1-4 mg of daily treatment with open label brexpiprazole in trial NCT01397786. | Participants who had not previously participated in a brexpiprazole clinical study and who received 1-4 mg of daily treatment with open label brexpiprazole in trial NCT01397786. | Participants who rolled over from, and received blinded brexpiprazole/placebo in, one of the randomized, double blind, placebo controlled Phase 3 efficacy studies (Vector, NCT01396421;Beacon, NCT01393613; and Equator, NCT01668797); or de novo patients, All received 1-4 mg of daily treatment with open label brexpiprazole in trial NCT01397786. |
| Measure Participants | 591 | 198 | 223 | 1012 |
| At at Week 26 (Participant count=375,134,123,632) |
-0.35
(0.79)
|
-0.60
(0.98)
|
-0.24
(0.88)
|
-0.38
(0.86)
|
| At Week 52 (Participant count=226,93,91,410) |
-0.55
(0.86)
|
-0.97
(0.98)
|
-0.48
(0.86)
|
-0.63
(0.91)
|
| At Last Visit (Participant count=591,198,223,1012) |
-0.14
(1.04)
|
-0.46
(1.12)
|
-0.17
(0.88)
|
-0.21
(1.03)
|
| Title | Mean Change From Baseline in Personal and Social Performance Scale Total Score |
|---|---|
| Description | The PSP was a validated clinician-rated scale that measured personal and social functioning in four domains: socially useful activities (e.g, work and study), personal and social relationships, self-care, and disturbing and aggressive behaviors. Impairment in each of these domains was rated as absent, mild, manifest, marked, severe, or very severe. These ratings were then converted to a total score based on a 100-point scale using algorithms to identify the appropriate 10-point interval, and the rater's judgment that determined the total score within the 10-point interval. Participants with a PSP total score of 71 to 100 were considered to have mild functional difficulty. Scores of 31 to 70 represented manifest disabilities of various degrees and ratings of 1 to 30 indicated minimal functioning that required intense support and/or supervision. |
| Time Frame | From Baseline up to 52 Weeks |
Outcome Measure Data
| Analysis Population Description |
|---|
| The Efficacy Sample included participants in the Safety Sample who had at least 1 post-baseline efficacy evaluation for PANSS Total Score. |
| Arm/Group Title | Prior Brexpiprazole | Prior Placebo | De Novo | Total |
|---|---|---|---|---|
| Arm/Group Description | Participants who rolled over from, and received blinded brexpiprazole in, one of the randomized, double-blind, placebo-controlled Phase 3 efficacy studies (Vector, NCT01396421; Beacon, NCT01393613; and Equator, NCT01668797); all received 1-4 mg of daily treatment with open label brexpiprazole in trial NCT01397786. | Participants who rolled over from, and received blinded placebo in, one of the randomized, double-blind, placebo-controlled Phase 3 efficacy studies (Vector, NCT01396421; Beacon, NCT01393613; and Equator, NCT01668797); all received 1-4 mg of daily treatment with open label brexpiprazole in trial NCT01397786. | Participants who had not previously participated in a brexpiprazole clinical study and who received 1-4 mg of daily treatment with open label brexpiprazole in trial NCT01397786. | Participants who rolled over from, and received blinded brexpiprazole/placebo in, one of the randomized, double blind, placebo controlled Phase 3 efficacy studies (Vector, NCT01396421;Beacon, NCT01393613; and Equator, NCT01668797); or de novo patients, All received 1-4 mg of daily treatment with open label brexpiprazole in trial NCT01397786. |
| Measure Participants | 591 | 198 | 123 | 1012 |
| At Week 26 (Participant count=366,134,123,623) |
4.50
(9.70)
|
6.50
(11.30)
|
4.50
(9.00)
|
4.90
(10.00)
|
| At Week 52 (Participant count=223,93,91,407) |
7.00
(10.60)
|
9.60
(11.90)
|
7.60
(10.80)
|
7.70
(11.00)
|
| At Last Visit (Participant count=569,196,219,984) |
1.80
(12.40)
|
5.10
(12.80)
|
2.70
(11.00)
|
2.70
(12.20)
|
| Title | Mean Clinical Global Impression - Improvement Score |
|---|---|
| Description | The efficacy of study medication was rated for each participant using the CGI-I. The investigator rated the participant's total improvement whether or not it was due to the drug treatment. All responses were compared to the participant's condition at Screening/Baseline (i.e, Week 6 visit of Protocol NCT00905307). Response choices included: 0 = not assessed, 1 = very much improved, 2 = much improved, 3 = minimally improved, 4 = no change, 5 = minimally worse, 6 = much worse, and 7 = very much worse. |
| Time Frame | From Baseline up to 52 Weeks |
Outcome Measure Data
| Analysis Population Description |
|---|
| The Efficacy Sample included participants in the Safety Sample who had at least 1 post-baseline efficacy evaluation for PANSS Total Score. |
| Arm/Group Title | Prior Brexpiprazole | Prior Placebo | De Novo | Total |
|---|---|---|---|---|
| Arm/Group Description | Participants who rolled over from, and received blinded brexpiprazole in, one of the randomized, double-blind, placebo-controlled Phase 3 efficacy studies (Vector, NCT01396421; Beacon, NCT01393613; and Equator, NCT01668797); all received 1-4 mg of daily treatment with open label brexpiprazole in trial NCT01397786. | Participants who rolled over from, and received blinded placebo in, one of the randomized, double-blind, placebo-controlled Phase 3 efficacy studies (Vector, NCT01396421; Beacon, NCT01393613; and Equator, NCT01668797); all received 1-4 mg of daily treatment with open label brexpiprazole in trial NCT01397786. | Participants who had not previously participated in a brexpiprazole clinical study and who received 1-4 mg of daily treatment with open label brexpiprazole in trial NCT01397786. | Participants who rolled over from, and received blinded brexpiprazole/placebo in, one of the randomized, double blind, placebo controlled Phase 3 efficacy studies (Vector, NCT01396421;Beacon, NCT01393613; and Equator, NCT01668797); or de novo patients, All received 1-4 mg of daily treatment with open label brexpiprazole in trial NCT01397786. |
| Measure Participants | 598 | 198 | 123 | 1012 |
| At Week 26 (Participant count=381,134,123,638) |
3.00
(1.13)
|
2.77
(0.99)
|
3.00
(1.13)
|
2.95
(1.10)
|
| At Week 52 (Participant count=226,93,91,410) |
2.66
(1.13)
|
2.26
(0.97)
|
2.76
(1.09)
|
2.59
(1.10)
|
| At Last Visit (Participant count=598,198,223,1019) |
3.31
(1.43)
|
2.96
(1.33)
|
3.30
(1.27)
|
3.24
(1.38)
|
| Title | Response Rate |
|---|---|
| Description | Response rate was defined as a reduction of ≥ 30% from Baseline in PANSS total score or CGI-I score of 1 (very much improved) or 2 (much improved) at the Last Visit. |
| Time Frame | From Baseline up to 52 Weeks |
Outcome Measure Data
| Analysis Population Description |
|---|
| The Efficacy Sample included participants in the Safety Sample who had at least 1 post-baseline efficacy evaluation for PANSS Total Score. |
| Arm/Group Title | Prior Brexpiprazole | Prior Placebo | De Novo | Total |
|---|---|---|---|---|
| Arm/Group Description | Participants who rolled over from, and received blinded brexpiprazole in, one of the randomized, double-blind, placebo-controlled Phase 3 efficacy studies (Vector, NCT01396421; Beacon, NCT01393613; and Equator, NCT01668797); all received 1-4 mg of daily treatment with open label brexpiprazole in trial NCT01397786. | Participants who rolled over from, and received blinded placebo in, one of the randomized, double-blind, placebo-controlled Phase 3 efficacy studies (Vector, NCT01396421; Beacon, NCT01393613; and Equator, NCT01668797); all received 1-4 mg of daily treatment with open label brexpiprazole in trial NCT01397786. | Participants who had not previously participated in a brexpiprazole clinical study and who received 1-4 mg of daily treatment with open label brexpiprazole in trial NCT01397786. | Participants who rolled over from, and received blinded brexpiprazole/placebo in, one of the randomized, double blind, placebo controlled Phase 3 efficacy studies (Vector, NCT01396421;Beacon, NCT01393613; and Equator, NCT01668797); or de novo patients, All received 1-4 mg of daily treatment with open label brexpiprazole in trial NCT01397786. |
| Measure Participants | 605 | 202 | 224 | 1031 |
| Number [percentage of participants] |
34.2
5.6%
|
42.6
20.9%
|
27.2
10.6%
|
34.3
3.2%
|
| Title | Discontinuation Rate for Lack of Efficacy |
|---|---|
| Description | Discontinuation rate for the participants who discontinued due to lack of efficacy were examined. |
| Time Frame | From Baseline up to 52 Weeks |
Outcome Measure Data
| Analysis Population Description |
|---|
| The Efficacy Sample included participants in the Safety Sample who had at least 1 post-baseline efficacy evaluation for PANSS Total Score. |
| Arm/Group Title | Prior Brexpiprazole | Prior Placebo | De Novo | Total |
|---|---|---|---|---|
| Arm/Group Description | Participants who rolled over from, and received blinded brexpiprazole in, one of the randomized, double-blind, placebo-controlled Phase 3 efficacy studies (Vector, NCT01396421; Beacon, NCT01393613; and Equator, NCT01668797); all received 1-4 mg of daily treatment with open label brexpiprazole in trial NCT01397786. | Participants who rolled over from, and received blinded placebo in, one of the randomized, double-blind, placebo-controlled Phase 3 efficacy studies (Vector, NCT01396421; Beacon, NCT01393613; and Equator, NCT01668797); all received 1-4 mg of daily treatment with open label brexpiprazole in trial NCT01397786. | Participants who had not previously participated in a brexpiprazole clinical study and who received 1-4 mg of daily treatment with open label brexpiprazole in trial NCT01397786. | Participants who rolled over from, and received blinded brexpiprazole/placebo in, one of the randomized, double blind, placebo controlled Phase 3 efficacy studies (Vector, NCT01396421;Beacon, NCT01393613; and Equator, NCT01668797); or de novo patients, All received 1-4 mg of daily treatment with open label brexpiprazole in trial NCT01397786. |
| Measure Participants | 605 | 202 | 224 | 1031 |
| Number [percentage of participants] |
3.6
0.6%
|
3.5
1.7%
|
6.3
2.5%
|
4.2
0.4%
|
| Title | Mean Change From Baseline in Positive and Negative Syndrome Scale Excited Component Score |
|---|---|
| Description | The PEC score consisted of five PANSS items: excitement (P4), hostility (P7), tension (G4), uncooperativeness (G8), and poor impulse control (G14). Each of the items were rated on a scale of 1 (absent) to 7 (extreme). The PEC scores ranged from 5 (not present) to 35 (extremely severe). |
| Time Frame | From Baseline up to 52 Weeks |
Outcome Measure Data
| Analysis Population Description |
|---|
| The Efficacy Sample included participants in the Safety Sample who had at least 1 post-baseline efficacy evaluation for PANSS Total Score. |
| Arm/Group Title | Prior Brexpiprazole | Prior Placebo | De Novo | Total |
|---|---|---|---|---|
| Arm/Group Description | Participants who rolled over from, and received blinded brexpiprazole in, one of the randomized, double-blind, placebo-controlled Phase 3 efficacy studies (Vector, NCT01396421; Beacon, NCT01393613; and Equator, NCT01668797); all received 1-4 mg of daily treatment with open label brexpiprazole in trial NCT01397786. | Participants who rolled over from, and received blinded placebo in, one of the randomized, double-blind, placebo-controlled Phase 3 efficacy studies (Vector, NCT01396421; Beacon, NCT01393613; and Equator, NCT01668797); all received 1-4 mg of daily treatment with open label brexpiprazole in trial NCT01397786. | Participants who had not previously participated in a brexpiprazole clinical study and who received 1-4 mg of daily treatment with open label brexpiprazole in trial NCT01397786. | Participants who rolled over from, and received blinded brexpiprazole/placebo in, one of the randomized, double blind, placebo controlled Phase 3 efficacy studies (Vector, NCT01396421;Beacon, NCT01393613; and Equator, NCT01668797); or de novo patients, All received 1-4 mg of daily treatment with open label brexpiprazole in trial NCT01397786. |
| Measure Participants | 591 | 198 | 123 | 1012 |
| At Week 26 (Participant count=375,134,123,632) |
-0.60
(3.10)
|
-1.80
(3.70)
|
-0.70
(3.10)
|
-0.90
(3.30)
|
| At Week 52 (Participant count=226,93,91,410) |
-1.20
(3.20)
|
-2.60
(3.40)
|
-1.00
(2.90)
|
-1.50
(3.20)
|
| At Last Visit (Participant count=591,198,223,1012) |
0.10
(4.10)
|
-0.90
(4.20)
|
-0.30
(3.50)
|
-0.20
(4.00)
|
| Title | Mean Change From Baseline in PANSS Marder Factor Scores - Positive Symptoms Score |
|---|---|
| Description | Retrospective factor analyses have been performed in recent decades using scores for the 30 individual PANSS items to categorize symptoms into 5 dimensions. Collectively, these dimensions are referred to as the PANSS Marder Factor scores and include positive symptoms score, negative symptoms score, thought score, uncontrolled hostility/excitement, anxiety depression score. The positive factor score was the sum of the 8 components (delusions (P1), hallucinatory behavior (P3), grandiosity (P5), suspiciousness/persecution (P6), stereotyped thinking (N7), somatic concern (G1), unusual thought content (G9) and lack of judgment and insight (G12)) of the positive symptoms scale (range: 8 - best possible outcome to 56 - worst possible outcome). |
| Time Frame | From Baseline up to 52 Weeks |
Outcome Measure Data
| Analysis Population Description |
|---|
| The Efficacy Sample included participants in the Safety Sample who had at least 1 post-baseline efficacy evaluation for PANSS Total Score. |
| Arm/Group Title | Prior Brexpiprazole | Prior Placebo | De Novo | Total |
|---|---|---|---|---|
| Arm/Group Description | Participants who rolled over from, and received blinded brexpiprazole in, one of the randomized, double-blind, placebo-controlled Phase 3 efficacy studies (Vector, NCT01396421; Beacon, NCT01393613; and Equator, NCT01668797); all received 1-4 mg of daily treatment with open label brexpiprazole in trial NCT01397786. | Participants who rolled over from, and received blinded brexpiprazole in, one of the randomized, double-blind, placebo-controlled Phase 3 efficacy studies (Vector, NCT01396421; Beacon, NCT01393613; and Equator, NCT01668797); all received 1-4 mg of daily treatment with open label brexpiprazole in trial NCT01397786. | Participants who rolled over from, and received blinded brexpiprazole in, one of the randomized, double-blind, placebo-controlled Phase 3 efficacy studies (Vector, NCT01396421; Beacon, NCT01393613; and Equator, NCT01668797); all received 1-4 mg of daily treatment with open label brexpiprazole in trial NCT01397786. | Participants who rolled over from, and received blinded brexpiprazole/placebo in, one of the randomized, double blind, placebo controlled Phase 3 efficacy studies (Vector, NCT01396421;Beacon, NCT01393613; and Equator, NCT01668797); or de novo patients, All received 1-4 mg of daily treatment with open label brexpiprazole in trial NCT01397786. |
| Measure Participants | 591 | 198 | 123 | 1012 |
| At Week 26 (Participant count=375,134,123,632) |
-2.60
(4.80)
|
-4.70
(5.50)
|
-2.00
(5.20)
|
-2.90
(5.10)
|
| At Week 52 (Participant count=226,93,91,410) |
-3.90
(5.20)
|
-6.60
(5.70)
|
-2.60
(4.80)
|
-4.20
(5.40)
|
| At Last Visit (Participant count=591,198,223,1012) |
-1.60
(5.90)
|
-3.50
(6.50)
|
-1.30
(5.00)
|
-1.90
(5.90)
|
| Title | Mean Change From Baseline in PANSS Marder Factor Scores - Negative Symptoms Score |
|---|---|
| Description | Retrospective factor analyses have been performed in recent decades using scores for the 30 individual PANSS items to categorize symptoms into 5 dimensions. Collectively, these dimensions are referred to as the PANSS Marder Factor scores and include positive symptoms score, negative symptoms score, thought score, uncontrolled hostility/excitement, anxiety depression score. The negative factor score is the sum of the 7 items (blunted affect (N1), emotional withdrawal (N2), poor rapport (N3), passive/apathetic social withdrawal (N4), lack of spontaneity and conversation flow (N6), motor retardation (G7) and active social avoidance (G16)) of the negative subscale (range: 8 - best possible outcome to 56 - worst possible outcome). |
| Time Frame | From Baseline up to 52 Weeks |
Outcome Measure Data
| Analysis Population Description |
|---|
| The Efficacy Sample included participants in the Safety Sample who had at least 1 post-baseline efficacy evaluation for PANSS Total Score. |
| Arm/Group Title | Prior Brexpiprazole | Prior Placebo | De Novo | Total |
|---|---|---|---|---|
| Arm/Group Description | Participants who rolled over from, and received blinded brexpiprazole in, one of the randomized, double-blind, placebo-controlled Phase 3 efficacy studies (Vector, NCT01396421; Beacon, NCT01393613; and Equator, NCT01668797); all received 1-4 mg of daily treatment with open label brexpiprazole in trial NCT01397786. | Participants who rolled over from, and received blinded placebo in, one of the randomized, double-blind, placebo-controlled Phase 3 efficacy studies (Vector, NCT01396421; Beacon, NCT01393613; and Equator, NCT01668797); all received 1-4 mg of daily treatment with open label brexpiprazole in trial NCT01397786. | Participants who had not previously participated in a brexpiprazole clinical study and who received 1-4 mg of daily treatment with open label brexpiprazole in trial NCT01397786. | Participants who rolled over from, and received blinded brexpiprazole/placebo in, one of the randomized, double blind, placebo controlled Phase 3 efficacy studies (Vector, NCT01396421;Beacon, NCT01393613; and Equator, NCT01668797); or de novo patients, All received 1-4 mg of daily treatment with open label brexpiprazole in trial NCT01397786. |
| Measure Participants | 591 | 198 | 123 | 1012 |
| At Week 26 (Participant count=375,134,123,632) |
-1.50
(3.60)
|
-2.20
(4.00)
|
-1.70
(4.10)
|
-1.70
(3.80)
|
| At Week 52 (Participant count=226,93,91,410) |
-2.60
(4.30)
|
-3.90
(5.00)
|
-2.20
(3.80)
|
-2.80
(4.40)
|
| At Last Visit (Participant count=591,198,223,1012) |
-1.00
(4.10)
|
-2.30
(5.10)
|
-0.70
(4.10)
|
-1.20
(4.40)
|
| Title | Mean Change From Baseline in PANSS Marder Factor Scores - Disorganized Thought Score |
|---|---|
| Description | Retrospective factor analyses have been performed in recent decades using scores for the 30 individual PANSS items to categorize symptoms into 5 dimensions. Collectively, these dimensions are referred to as the PANSS Marder Factor scores and include positive symptoms score, negative symptoms score, thought score, uncontrolled hostility/excitement, anxiety depression score. The disorganized thoughts factor score is the sum of score from the 7 items (conceptual disorganization (P2), difficulty in abstract thinking (N5), mannerisms and posturing (G5), disorientation (G10), poor attention (G11), disturbance of volition (G13) and preoccupation (G15)) on the disorganized thoughts subscale (range: 7 - best possible outcome to 49 - worst possible outcome). |
| Time Frame | From Baseline up to 52 Weeks |
Outcome Measure Data
| Analysis Population Description |
|---|
| The Efficacy Sample included participants in the Safety Sample who had at least 1 post-baseline efficacy evaluation for PANSS Total Score. |
| Arm/Group Title | Prior Brexpiprazole | Prior Placebo | De Novo | Total |
|---|---|---|---|---|
| Arm/Group Description | Participants who rolled over from, and received blinded brexpiprazole in, one of the randomized, double-blind, placebo-controlled Phase 3 efficacy studies (Vector, NCT01396421; Beacon, NCT01393613; and Equator, NCT01668797); all received 1-4 mg of daily treatment with open label brexpiprazole in trial NCT01397786. | Participants who rolled over from, and received blinded placebo in, one of the randomized, double-blind, placebo-controlled Phase 3 efficacy studies (Vector, NCT01396421; Beacon, NCT01393613; and Equator, NCT01668797); all received 1-4 mg of daily treatment with open label brexpiprazole in trial NCT01397786. | Participants who had not previously participated in a brexpiprazole clinical study and who received 1-4 mg of daily treatment with open label brexpiprazole in trial NCT01397786. | Participants who rolled over from, and received blinded brexpiprazole/placebo in, one of the randomized, double blind, placebo controlled Phase 3 efficacy studies (Vector, NCT01396421;Beacon, NCT01393613; and Equator, NCT01668797); or de novo patients, All received 1-4 mg of daily treatment with open label brexpiprazole in trial NCT01397786. |
| Measure Participants | 591 | 198 | 123 | 1012 |
| At Week 26 (Participant count=375,134,123,632) |
-1.70
(3.30)
|
-2.60
(3.50)
|
-1.70
(3.50)
|
-1.90
(3.40)
|
| At Week 52 (Participant count=226,93,91,410) |
-2.90
(3.70)
|
-3.70
(4.60)
|
-2.30
(3.70)
|
-2.90
(4.00)
|
| At Last Visit (Participant count=591,198,223,1012) |
-1.20
(4.20)
|
-2.20
(4.50)
|
-0.90
(4.00)
|
-1.40
(4.20)
|
| Title | Mean Change From Baseline in PANSS Marder Factor Scores - Hostility/ Excitement Score |
|---|---|
| Description | Retrospective factor analyses have been performed in recent decades using scores for the 30 individual PANSS items to categorize symptoms into 5 dimensions. Collectively, these dimensions are referred to as the PANSS Marder Factor scores and include positive symptoms score, negative symptoms score, thought score, uncontrolled hostility/excitement, anxiety depression score. The uncontrolled hostility/excitement factor score is the sum of score from the 4 items (excitement (P4), hostility (P7), uncooperativeness (G8) and poor impulse control (G14)) on the uncontrolled hostility/excitement subscale (range: 4 - best possible outcome to 28 - worst possible outcome). |
| Time Frame | From Baseline up to 52 Weeks |
Outcome Measure Data
| Analysis Population Description |
|---|
| The Efficacy Sample included participants in the Safety Sample who had at least 1 post-baseline efficacy evaluation for PANSS Total Score. |
| Arm/Group Title | Prior Brexpiprazole | Prior Placebo | De Novo | Total |
|---|---|---|---|---|
| Arm/Group Description | Participants who rolled over from, and received blinded brexpiprazole in, one of the randomized, double-blind, placebo-controlled Phase 3 efficacy studies (Vector, NCT01396421; Beacon, NCT01393613; and Equator, NCT01668797); all received 1-4 mg of daily treatment with open label brexpiprazole in trial NCT01397786. | Participants who rolled over from, and received blinded placebo in, one of the randomized, double-blind, placebo-controlled Phase 3 efficacy studies (Vector, NCT01396421; Beacon, NCT01393613; and Equator, NCT01668797); all received 1-4 mg of daily treatment with open label brexpiprazole in trial NCT01397786. | Participants who had not previously participated in a brexpiprazole clinical study and who received 1-4 mg of daily treatment with open label brexpiprazole in trial NCT01397786. | Participants who rolled over from, and received blinded brexpiprazole/placebo in, one of the randomized, double blind, placebo controlled Phase 3 efficacy studies (Vector, NCT01396421;Beacon, NCT01393613; and Equator, NCT01668797); or de novo patients, All received 1-4 mg of daily treatment with open label brexpiprazole in trial NCT01397786. |
| Measure Participants | 591 | 198 | 123 | 1012 |
| At Week 26 (Participant count=375,134,123,632) |
-0.40
(2.70)
|
-1.40
(3.10)
|
-0.60
(2.60)
|
-0.60
(2.80)
|
| At Week 52 (Participant count=226,93,91,410) |
-0.80
(2.70)
|
-1.90
(2.90)
|
-0.90
(2.30)
|
-1.10
(2.70)
|
| At Last Visit (Participant count=591,198,223,1012) |
0.20
(3.40)
|
-0.70
(3.50)
|
-0.30
(3.00)
|
-0.10
(3.40)
|
| Title | Mean Change From Baseline in PANSS Marder Factor Scores - Anxiety/Depression Score |
|---|---|
| Description | Retrospective factor analyses have been performed in recent decades using scores for the 30 individual PANSS items to categorize symptoms into 5 dimensions. Collectively, these dimensions are referred to as the PANSS Marder Factor scores and include positive symptoms score, negative symptoms score, thought score, uncontrolled hostility/excitement, anxiety depression score. The anxiety/depression factor score is the sum of score from the 4 items (anxiety (G2), guilt feelings (G3), tension (G4) and depression (G6)) on the anxiety/depression subscale (range: 4 - best possible outcome to 28 - worst possible outcome). |
| Time Frame | From Baseline up to 52 Weeks |
Outcome Measure Data
| Analysis Population Description |
|---|
| The Efficacy Sample included participants in the Safety Sample who had at least 1 post-baseline efficacy evaluation for PANSS Total Score. |
| Arm/Group Title | Prior Brexpiprazole | Prior Placebo | De Novo | Total |
|---|---|---|---|---|
| Arm/Group Description | Participants who rolled over from, and received blinded brexpiprazole in, one of the randomized, double-blind, placebo-controlled Phase 3 efficacy studies (Vector, NCT01396421; Beacon, NCT01393613; and Equator, NCT01668797); all received 1-4 mg of daily treatment with open label brexpiprazole in trial NCT01397786. | Participants who rolled over from, and received blinded placebo in, one of the randomized, double-blind, placebo-controlled Phase 3 efficacy studies (Vector, NCT01396421; Beacon, NCT01393613; and Equator, NCT01668797); all received 1-4 mg of daily treatment with open label brexpiprazole in trial NCT01397786. | Participants who had not previously participated in a brexpiprazole clinical study and who received 1-4 mg of daily treatment with open label brexpiprazole in trial NCT01397786. | Participants who rolled over from, and received blinded brexpiprazole/placebo in, one of the randomized, double blind, placebo controlled Phase 3 efficacy studies (Vector, NCT01396421;Beacon, NCT01393613; and Equator, NCT01668797); or de novo patients, All received 1-4 mg of daily treatment with open label brexpiprazole in trial NCT01397786. |
| Measure Participants | 591 | 198 | 123 | 1012 |
| At Week 26 (Participant count=375,134,123,632) |
-0.70
(2.60)
|
-1.50
(3.00)
|
-0.70
(3.40)
|
-0.90
(2.90)
|
| At Week 52 (Participant count=226,93,91,410) |
-0.90
(2.50)
|
-2.40
(2.90)
|
-0.80
(3.50)
|
-1.20
(2.90)
|
| At Last Visit (Participant count=591,198,223,1012) |
-0.20
(3.20)
|
-0.90
(3.40)
|
-0.40
(3.80)
|
-0.40
(3.40)
|
Adverse Events
| Time Frame | The trial required that participants be actively monitored for AEs up to 30 (+2) days after the last dose of study drug, up to 52 weeks. | |||||||
|---|---|---|---|---|---|---|---|---|
| Adverse Event Reporting Description | An adverse event (AE) was defined as any untoward medical occurrence associated with use of a drug in humans, whether or not considered drug related. Serious adverse event (SAE) includes any AE that meets the either one or more seriousness criteria mentioned in the study protocol. An immediately Reportable Event (IRE) was defined as any SAE, AE/pregnancy cases that necessitates discontinuation of IMP/potential Hy's Law cases. Included participants who received at least 1 dose of open-label IMP. | |||||||
| Arm/Group Title | De Novo (Phase A) | Prior Brexpiprazole (Phase B) | Prior Placebo (Phase B) | De Novo (Phase B) | ||||
| Arm/Group Description | Participants underwent cross-titration to oral brexpiprazole for 4 weeks in Phase A. DeNovo participants in Phase A received brexpiprazole monotherapy starting dose of 2 mg daily at the conversion Week 4 visit (baseline visit of Phase B). Participants who received at least 1 dose of study drug were included in this phase. NOTE: 12 participants from the trial P33110232 were excluded in this analysis. | Participants who rolled over from, and received blinded brexpiprazole in, one of the randomized, double-blind, placebo-controlled Phase 3 efficacy studies (Vector, NCT01396421; Beacon, NCT01393613; and Equator, NCT01668797); all received 1-4 mg of daily treatment with open label brexpiprazole in trial NCT01397786. Participants who received at least 1 dose of study drug were included in this phase. NOTE: Six participants from the trial P33110231 were excluded in this analysis. | Participants who rolled over from, and received blinded placebo in, one of the randomized, double-blind, placebo-controlled Phase 3 efficacy studies (Vector, NCT01396421; Beacon, NCT01393613; and Equator, NCT01668797); all received 1-4 mg of daily treatment with open label brexpiprazole in trial NCT01397786. Participants who received at least 1 dose of study drug were included in this phase. NOTE: One participant each from the trials P33110230 and P33110231 were excluded in this analysis. | Participants who had not previously participated in a brexpiprazole clinical study and who received 1-4 mg of daily treatment with open label brexpiprazole in trial NCT01397786. Participants who received at least 1 dose of study drug were included in this phase. NOTE: Five participants from Phase B - Denovo were excluded in this analysis. | ||||
All Cause Mortality |
||||||||
| De Novo (Phase A) | Prior Brexpiprazole (Phase B) | Prior Placebo (Phase B) | De Novo (Phase B) | |||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | / (NaN) | / (NaN) | / (NaN) | / (NaN) | ||||
Serious Adverse Events |
||||||||
| De Novo (Phase A) | Prior Brexpiprazole (Phase B) | Prior Placebo (Phase B) | De Novo (Phase B) | |||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 4/226 (1.8%) | 90/605 (14.9%) | 18/202 (8.9%) | 25/224 (11.2%) | ||||
| Cardiac disorders | ||||||||
| Cardiac failure | 0/226 (0%) | 1/605 (0.2%) | 0/202 (0%) | 0/224 (0%) | ||||
| Cardiac failure congestive | 0/226 (0%) | 0/605 (0%) | 0/202 (0%) | 1/224 (0.4%) | ||||
| Coronary artery disease | 0/226 (0%) | 0/605 (0%) | 0/202 (0%) | 1/224 (0.4%) | ||||
| Gastrointestinal disorders | ||||||||
| Abdominal hernia | 0/226 (0%) | 0/605 (0%) | 0/202 (0%) | 1/224 (0.4%) | ||||
| Duodenal ulcer perforation | 0/226 (0%) | 0/605 (0%) | 0/202 (0%) | 1/224 (0.4%) | ||||
| Gastric ulcer perforation | 0/226 (0%) | 1/605 (0.2%) | 0/202 (0%) | 0/224 (0%) | ||||
| General disorders | ||||||||
| Asthenia | 0/226 (0%) | 1/605 (0.2%) | 0/202 (0%) | 1/224 (0.4%) | ||||
| Infections and infestations | ||||||||
| Appendicitis | 0/226 (0%) | 2/605 (0.3%) | 0/202 (0%) | 0/224 (0%) | ||||
| Peritonitis | 0/226 (0%) | 2/605 (0.3%) | 0/202 (0%) | 0/224 (0%) | ||||
| Pneumonia | 0/226 (0%) | 0/605 (0%) | 0/202 (0%) | 1/224 (0.4%) | ||||
| Sepsis | 0/226 (0%) | 1/605 (0.2%) | 0/202 (0%) | 0/224 (0%) | ||||
| Septic shock | 0/226 (0%) | 0/605 (0%) | 0/202 (0%) | 1/224 (0.4%) | ||||
| Injury, poisoning and procedural complications | ||||||||
| Rib fracture | 0/226 (0%) | 1/605 (0.2%) | 0/202 (0%) | 0/224 (0%) | ||||
| Toxicity to various agents | 0/226 (0%) | 0/605 (0%) | 0/202 (0%) | 1/224 (0.4%) | ||||
| Metabolism and nutrition disorders | ||||||||
| Diabetic ketoacidosis | 0/226 (0%) | 1/605 (0.2%) | 0/202 (0%) | 0/224 (0%) | ||||
| Neoplasms benign, malignant and unspecified (incl cysts and polyps) | ||||||||
| Endometrial cancer | 0/226 (0%) | 1/605 (0.2%) | 0/202 (0%) | 0/224 (0%) | ||||
| Uterine cancer | 0/226 (0%) | 0/605 (0%) | 1/202 (0.5%) | 0/224 (0%) | ||||
| Nervous system disorders | ||||||||
| Akathisia | 0/226 (0%) | 2/605 (0.3%) | 0/202 (0%) | 0/224 (0%) | ||||
| Cerebrovascular accident | 0/226 (0%) | 1/605 (0.2%) | 0/202 (0%) | 0/224 (0%) | ||||
| Seizure | 0/226 (0%) | 1/605 (0.2%) | 0/202 (0%) | 0/224 (0%) | ||||
| Somnolence | 0/226 (0%) | 1/605 (0.2%) | 0/202 (0%) | 0/224 (0%) | ||||
| Psychiatric disorders | ||||||||
| Schizophrenia | 2/226 (0.9%) | 68/605 (11.2%) | 12/202 (5.9%) | 10/224 (4.5%) | ||||
| Psychotic disorder | 1/226 (0.4%) | 7/605 (1.2%) | 3/202 (1.5%) | 4/224 (1.8%) | ||||
| Agitation | 0/226 (0%) | 1/605 (0.2%) | 0/202 (0%) | 1/224 (0.4%) | ||||
| Anxiety | 0/226 (0%) | 0/605 (0%) | 0/202 (0%) | 2/224 (0.9%) | ||||
| Schizophrenia, Paranoid type | 0/226 (0%) | 1/605 (0.2%) | 1/202 (0.5%) | 0/224 (0%) | ||||
| Acute psychosis | 0/226 (0%) | 1/605 (0.2%) | 0/202 (0%) | 0/224 (0%) | ||||
| Completed suicide | 0/226 (0%) | 0/605 (0%) | 1/202 (0.5%) | 0/224 (0%) | ||||
| Emotional disorder | 0/226 (0%) | 0/605 (0%) | 1/202 (0.5%) | 0/224 (0%) | ||||
| Hallucination, auditory | 0/226 (0%) | 1/605 (0.2%) | 0/202 (0%) | 0/224 (0%) | ||||
| Suicidal ideation | 0/226 (0%) | 1/605 (0.2%) | 0/202 (0%) | 0/224 (0%) | ||||
| Suicide attempt | 0/226 (0%) | 1/605 (0.2%) | 0/202 (0%) | 0/224 (0%) | ||||
| Suicidal behaviour | 1/226 (0.4%) | 0/605 (0%) | 0/202 (0%) | 0/224 (0%) | ||||
| Respiratory, thoracic and mediastinal disorders | ||||||||
| Chronic obstructive pulmonary disease | 0/226 (0%) | 0/605 (0%) | 0/202 (0%) | 1/224 (0.4%) | ||||
Other (Not Including Serious) Adverse Events |
||||||||
| De Novo (Phase A) | Prior Brexpiprazole (Phase B) | Prior Placebo (Phase B) | De Novo (Phase B) | |||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/226 (0%) | 166/605 (27.4%) | 53/202 (26.2%) | 95/256 (37.1%) | ||||
| Investigations | ||||||||
| Weight increased | 0/226 (0%) | 47/605 (7.8%) | 15/202 (7.4%) | 23/256 (9%) | ||||
| Nervous system disorders | ||||||||
| Akathisia | 0/226 (0%) | 22/605 (3.6%) | 14/202 (6.9%) | 14/256 (5.5%) | ||||
| Headache | 0/226 (0%) | 42/605 (6.9%) | 14/202 (6.9%) | 24/256 (9.4%) | ||||
| Psychiatric disorders | ||||||||
| Agitation | 0/226 (0%) | 30/605 (5%) | 7/202 (3.5%) | 23/256 (9%) | ||||
| Insomnia | 0/226 (0%) | 51/605 (8.4%) | 17/202 (8.4%) | 32/256 (12.5%) | ||||
| Vascular disorders | ||||||||
| Hypertension | 0/226 (0%) | 10/605 (1.7%) | 2/202 (1%) | 20/256 (7.8%) | ||||
Limitations/Caveats
[Not Specified]
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days from the time submitted to the sponsor for review. The sponsor cannot require changes to the communication and cannot extend the embargo.
Results Point of Contact
| Name/Title | Global Medical Affairs |
|---|---|
| Organization | Otsuka Pharmaceutical Development and Commercialization, Inc. |
| Phone | 800 562-3974 |
Responsible Party:
Otsuka Pharmaceutical Development & Commercialization, Inc.
ClinicalTrials.gov Identifier:
NCT01397786
Other Study ID Numbers:
- 331-10-237
First Posted:
Jul 20, 2011
Last Update Posted:
May 10, 2017
Last Verified:
Apr 1, 2017