| Primary | Change From Baseline to Week 24 in MATRICS Consensus Cognitive Battery (MCCB) Neurocognitive Composite Score | The MCCB is a cognitive battery to assess 7 domains recommended by the MATRICS initiative (i.e., working memory, verbal learning, speed of processing, attention/vigilance, visual learning, social cognition, reasoning and problem solving). The MCCB neurocognitive composite T-score is a standardized mean of the six domain scores (excluding social cognition). Raw scores are converted to age and sex adjusted t-scores which are standardized to normative data, and have a mean of 50 and standard deviation of 10 in the general healthy population. A higher composite T-score represents lower impairment. | The EAP2 Population was defined as all participants in the Efficacy Analysis Population (EAP) who were randomized to placebo or 240mg Basmisanil (excluded participants randomized to 80mg Basmisanil due to the results of a futility analysis which meant that enrolment into the 80mg Basmisanil arm was discontinued). Data presented below is only for participants that were included in the actual analysis. | Posted | | Mean | Standard Deviation | Composite T-Score | | Baseline up to Week 24 | | | | ID | Title | Description |
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| OG000 | Placebo | Participants received matching Placebo to Basmisanil orally twice daily for 24 weeks. | | OG001 | Basmisanil 240mg BID | Participants received Basmisanil 240 mg orally twice daily (BID) for 24 weeks. |
| | | Title | Denominators | Categories |
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| Baseline | - ParticipantsOG00076
- ParticipantsOG00177
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| | Group IDs | Group Description | Statistical Method | Statistical Comment | P-Value | P-Value Comment | Parameter Type | Parameter Value | Dispersion Type | Dispersion Value | Confidence Interval Sides | Confidence Interval % | CI Lower Limit | CI Upper Limit | CI Lower Limit Comment | CI Upper Limit Comment | Estimate Comment | Tested Non-Inferiority | Non-Inferiority Type | Non-Inferiority Comment | Other Analysis Description |
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| | Mixed Models Analysis | | 0.730 | | Treatment Difference | -0.36 | | | 2-Sided | 90 | -2.11 | 1.38 | | | | | Superiority | | | | | Mixed Models Analysis |
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| Secondary | Change From Baseline to Week 24 in MCCB Cognitive Domain Scores | The MCCB is a cognitive battery to assess 7 domains recommended by the MATRICS initiative (i.e., working memory, verbal learning, speed of processing, attention/vigilance, visual learning, social cognition, reasoning and problem solving). Raw scores are converted to age and sex adjusted t-scores which are standardized to normative data, and have a mean of 50 and standard deviation of 10 in the general healthy population. A higher T-score represents lower impairment. | The EAP2 Population was defined as all participants in the Efficacy Analysis Population (EAP) who were randomized to placebo or 240mg Basmisanil (excluded participants randomized to 80mg Basmisanil due to the results of a futility analysis which meant that enrolment into the 80mg Basmisanil arm was discontinued). Data presented below is only for participants that were included in the actual analysis. | Posted | | Mean | Standard Deviation | T-score | | Baseline up to Week 24 | | | | ID | Title | Description |
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| OG000 | Placebo | Participants received matching Placebo to Basmisanil orally twice daily for 24 weeks. | | OG001 | Basmisanil 240mg BID | Participants received Basmisanil 240 mg orally twice daily (BID) for 24 weeks. |
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| Secondary | Change From Baseline to Week 24 in Wechsler Memory Scale Fourth Edition, Verbal Paired Associates (WMS IV-PAL) Score | The Paired Associates Learning (PAL I and II) of the WMS-IV (Wechsler Memory Scale Fourth edition) is a test of verbal learning and memory that requires the participant to learn novel word pairs. The participant learns the word pairs across learning trials and is asked to recall them immediately (PAL I) or after a 30-minute delay (PAL II). Data is presented here for 3 Scores: VPA I total raw score, VPA II total raw score and VPA II Recognition total raw score. The total raw score ranges for these 3 Scores are 0 to 56, 0 to 14 and 0 to 40 respectively, with larger total raw scores indicating better performance. | The EAP2 Population was defined as all participants in the Efficacy Analysis Population (EAP) who were randomized to placebo or 240mg Basmisanil (excluded participants randomized to 80mg Basmisanil due to the results of a futility analysis which meant that enrolment into the 80mg Basmisanil arm was discontinued). Data presented below is only for participants that were included in the actual analysis. | Posted | | Mean | Standard Deviation | Scores on a Scale | | Baseline up to Week 24 | | | | ID | Title | Description |
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| OG000 | Placebo | Participants received matching Placebo to Basmisanil orally twice daily for 24 weeks. | | OG001 | Basmisanil 240mg BID | Participants received Basmisanil 240 mg orally twice daily (BID) for 24 weeks. |
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| Secondary | Change From Baseline to Week 24 in Wechsler Memory Scale Fourth Edition, Logical Memory Test (WMS IV-LM) Score | Logical memory (LM) assesses narrative memory under free-recall conditions. Two short stories are presented orally. The examinee is asked to retell each story from memory immediately after hearing it (LM I). In the delayed condition (LM II), the examinee is asked to retell both stories from the immediate condition (delayed free recall). Data is presented here for 2 Scores: LM I total raw score and LM II total raw score. The total raw score range is from 0 to 50 with larger total raw scores indicating better performance. | The EAP2 Population was defined as all participants in the Efficacy Analysis Population (EAP) who were randomized to placebo or 240mg Basmisanil (excluded participants randomized to 80mg Basmisanil due to the results of a futility analysis which meant that enrolment into the 80mg Basmisanil arm was discontinued). Data presented below is only for participants that were included in the actual analysis. | Posted | | Mean | Standard Deviation | Scores on a Scale | | Baseline up to Week 24 | | | | ID | Title | Description |
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| OG000 | Placebo | Participants received matching Placebo to Basmisanil orally twice daily for 24 weeks. | | OG001 | Basmisanil 240mg BID | Participants received Basmisanil 240 mg orally twice daily (BID) for 24 weeks. |
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| Secondary | Change From Baseline to Week 24 in Ratio Between Trail Making Test (TMT)- Part B and TMT- Part A Scores | The TMT consists of two parts: Trail Making Part A, which is a part of the standard MCCB and Trail Making Part B additionally included in this study. Circles containing numbers (Part A) or both numbers and letters (Part B) must be sequentially connected. The difference (ratio) in performance between Part A and Part B reflects executive processes and will be used to assess executive functioning including cognitive set shifting abilities and data for this ratio is presented here. Smaller ratio values, hence decreases from baseline (TMT-B/TMT-A ratio values below 1) indicate higher executive functioning capabilities. | The EAP2 Population was defined as all participants in the Efficacy Analysis Population (EAP) who were randomized to placebo or 240mg Basmisanil (excluded participants randomized to 80mg Basmisanil due to the results of a futility analysis which meant that enrolment into the 80mg Basmisanil arm was discontinued). Data presented below is only for participants that were included in the actual analysis. | Posted | | Mean | Standard Deviation | Ratio | | Baseline up to Week 24 | | | | ID | Title | Description |
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| OG000 | Placebo | Participants received matching Placebo to Basmisanil orally twice daily for 24 weeks. | | OG001 | Basmisanil 240mg BID | Participants received Basmisanil 240 mg orally twice daily (BID) for 24 weeks. |
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| Secondary | Change From Baseline to Week 24 in Personal and Social Performance (PSP) Total Score | The PSP Total Score is an integer result in the range of 0 to 100. Larger values, hence increases from baseline in the PSP total score, indicate higher social and personal functioning. | The EAP2 Population was defined as all participants in the Efficacy Analysis Population (EAP) who were randomized to placebo or 240mg Basmisanil (excluded participants randomized to 80mg Basmisanil due to the results of a futility analysis which meant that enrolment into the 80mg Basmisanil arm was discontinued). Data presented below is only for participants that were included in the actual analysis. | Posted | | Mean | Standard Deviation | Scores on a Scale | | Baseline up to Week 24 | | | | ID | Title | Description |
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| OG000 | Placebo | Participants received matching Placebo to Basmisanil orally twice daily for 24 weeks. | | OG001 | Basmisanil 240mg BID | Participants received Basmisanil 240 mg orally twice daily (BID) for 24 weeks. |
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| Secondary | Change From Baseline to Week 24 in Schizophrenia Cognition Rating Scale (SCoRS) Total Score | The main parameter of interest for the Schizophrenia Cognition Rating Scale (SCoRS) is the SCoRS 'Total Score'. The total score range is from 0 to 80 with lower scores indicating better day-to-day functioning. | The EAP2 Population was defined as all participants in the Efficacy Analysis Population (EAP) who were randomized to placebo or 240mg Basmisanil (excluded participants randomized to 80mg Basmisanil due to the results of a futility analysis which meant that enrolment into the 80mg Basmisanil arm was discontinued). Data presented below is only for participants that were included in the actual analysis. | Posted | | Mean | Standard Deviation | Scores on a Scale | | Baseline up to Week 24 | | | | ID | Title | Description |
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| OG000 | Placebo | Participants received matching Placebo to Basmisanil orally twice daily for 24 weeks. | | OG001 | Basmisanil 240mg BID | Participants received Basmisanil 240 mg orally twice daily (BID) for 24 weeks. |
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| Secondary | Change From Baseline to Week 24 in Clinical Global Impression Severity (CGI-S) Rating | Values for the CGI-S Scale are encoded by the numerical values from 1 to 7 respectively. Higher numerical values represent greater impairment. | The EAP2 Population was defined as all participants in the Efficacy Analysis Population (EAP) who were randomized to placebo or 240mg Basmisanil (excluded participants randomized to 80mg Basmisanil due to the results of a futility analysis which meant that enrolment into the 80mg Basmisanil arm was discontinued). Data presented below is only for participants that were included in the actual analysis. | Posted | | Mean | Standard Deviation | Scores on a Scale | | Baseline up to Week 24 | | | | ID | Title | Description |
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| OG000 | Placebo | Participants received matching Placebo to Basmisanil orally twice daily for 24 weeks. | | OG001 | Basmisanil 240mg BID | Participants received Basmisanil 240 mg orally twice daily (BID) for 24 weeks. |
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| Secondary | Change From Baseline to Week 24 in Clinical Global Impression Improvement (CGI-I) Rating | Values for the CGI-I Scale are encoded by the numerical values from 1 to 7 respectively. Higher numerical values represent greater impairment. | The EAP2 Population was defined as all participants in the Efficacy Analysis Population (EAP) who were randomized to placebo or 240mg Basmisanil (excluded participants randomized to 80mg Basmisanil due to the results of a futility analysis which meant that enrolment into the 80mg Basmisanil arm was discontinued). Data presented below is only for participants that were included in the actual analysis. | Posted | | Mean | Standard Deviation | Scores on a Scale | | Baseline up to Week 24 | | | | ID | Title | Description |
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| OG000 | Placebo | Participants received matching Placebo to Basmisanil orally twice daily for 24 weeks. | | OG001 | Basmisanil 240mg BID | Participants received Basmisanil 240 mg orally twice daily (BID) for 24 weeks. |
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| Secondary | Change From Baseline to Week 24 in Schizophrenia Quality of Life Scale (SQLS) | The SQLS is a patient reported scale consisting of 33 items: 2 domain scores (Cognition & Vitality Score [SQLS-CV] and Psycho-social Score [SQLS-P]) as well as a Total score (SQLS-T) are derived. The overall score range is from 0 to 100. On all scales, higher scores represent a lower quality of life. | The EAP2 Population was defined as all participants in the Efficacy Analysis Population (EAP) who were randomized to placebo or 240mg Basmisanil (excluded participants randomized to 80mg Basmisanil due to the results of a futility analysis which meant that enrolment into the 80mg Basmisanil arm was discontinued). Data presented below is only for participants that were included in the actual analysis. | Posted | | Mean | Standard Deviation | Scores on a Scale | | Baseline up to Week 24 | | | | ID | Title | Description |
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| OG000 | Placebo | Participants received matching Placebo to Basmisanil orally twice daily for 24 weeks. | | OG001 | Basmisanil 240mg BID | Participants received Basmisanil 240 mg orally twice daily (BID) for 24 weeks. |
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| Secondary | Percentage of Participants With Adverse Events (AEs) | An Adverse Event (AE) is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An Adverse Event can therefore be any unfavorable and unintended sign (including abnormal laboratory values or abnormal clinical test results), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Preexisting conditions which worsen during a study are also considered as Adverse Events. | The Safety-evaluable population was defined as all participants who received at least one dose of study medication, whether prematurely withdrawn from the study or not. Data are summarized according to actual treatment arm participants were randomized to. | Posted | | Number | | Percentage of Participants | | Baseline up to 4 weeks after the last dose of study drug (up to 28 weeks) | | | | ID | Title | Description |
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| OG000 | Placebo | Participants received matching Placebo to Basmisanil orally twice daily for 24 weeks. | | OG001 | Basmisanil 80mg BID | Participants received Basmisanil 80 mg orally twice daily (BID) for 24 weeks. | | OG002 | Basmisanil 240mg BID |
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| Secondary | Apparent Clearance of Basmisanil at Steady State (CL/F,ss) | Population PK model estimated apparent oral clearance of Basmisanil at steady-state. | Please note that for this Outcome Measure, incomplete PK data was collected as a result of early termination of the study which meant that data for the (CL/F,ss) parameter could not be generated via the Population PK model. | Posted | | | | | | Pre-dose (hour 0) in Days 7, 14, 42, 84, 168 | | | | ID | Title | Description |
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| OG000 | Basmisanil 80mg BID | Participants received Basmisanil 80 mg orally twice daily (BID) for 24 weeks. | | OG001 | Basmisanil 240mg BID | Participants received Basmisanil 240 mg orally twice daily (BID) for 24 weeks. |
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| Secondary | Apparent Volume of Distribution of Basmisanil at Steady State (Vz/F,ss) | Population PK model estimated apparent volume of distribution of Basmisanil at steady-state. | Please note that for this Outcome Measure, incomplete PK data was collected as a result of early termination of the study which meant that data for the (Vz/F,ss) parameter could not be generated via the Population PK model. | Posted | | | | | | Pre-dose (hour 0) in Days 7, 14, 42, 84, 168 | | | | ID | Title | Description |
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| OG000 | Basmisanil 80mg BID | Participants received Basmisanil 80 mg orally twice daily (BID) for 24 weeks. | | OG001 | Basmisanil 240mg BID | Participants received Basmisanil 240 mg orally twice daily (BID) for 24 weeks. |
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| Secondary | Area Under the Curve of Basmisanil at Steady State (AUC,ss) | Population PK model estimated AUC of Basmisanil at steady-state. | The Safety-evaluable population was defined as all participants who received at least one dose of study medication, whether prematurely withdrawn from the study or not. Data are summarized according to actual treatment arm participants were randomized to. Data presented below is only for participants included in the actual analysis. | Posted | | Median | Full Range | ng*mL/hr | | Pre-dose (hour 0) in Days 7, 14, 42, 84, 168 | | | | ID | Title | Description |
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| OG000 | Basmisanil 80mg BID | Participants received Basmisanil 80 mg orally twice daily (BID) for 24 weeks. | | OG001 | Basmisanil 240mg BID | Participants received Basmisanil 240 mg orally twice daily (BID) for 24 weeks. |
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| Secondary | Maximum Plasma Concentration of Basmisanil at Steady State (Cmax,ss) | Population PK model estimated maximum plasma concentration of Basmisanil at steady-state (ss). | The Safety-evaluable population was defined as all participants who received at least one dose of study medication, whether prematurely withdrawn from the study or not. Data are summarized according to actual treatment arm participants were randomized to. Data presented below is only for participants included in the actual analysis. | Posted | | Median | Full Range | ng/mL | | Pre-dose (hour 0) in Days 7, 14, 42, 84, 168 | | | | ID | Title | Description |
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| OG000 | Basmisanil 80mg BID | Participants received Basmisanil 80 mg orally twice daily (BID) for 24 weeks. | | OG001 | Basmisanil 240mg BID | Participants received Basmisanil 240 mg orally twice daily (BID) for 24 weeks. |
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