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| ID | Type | Description | Link |
|---|---|---|---|
| 2018-003825-27 | EudraCT Number |
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The primary objective of the study is to evaluate the efficacy of BIIB104 in participants with CIAS, using the Working Memory Domain of the MATRICS Consensus Cognitive Battery (MCCB).
The secondary objectives of this study are to evaluate the safety and tolerability of BIIB104 in participants with CIAS, and to evaluate the efficacy of BIIB104 in participants with CIAS on measures of cognition, functioning, and psychiatric symptomology.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BIIB104 0.5 mg | Experimental | Participants will receive 0.5 mg of BIIB104 twice a day, orally, for 12 weeks. |
|
| BIIB104 0.15 mg | Experimental | Participants will receive 0.15 mg of BIIB104 twice a day, orally, for 12 weeks. |
|
| Matching Placebo | Placebo Comparator | Participants will receive matching placebo twice a day, orally, for 12 weeks. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BIIB104 | Drug | Administered as specified in the treatment arm |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Change From Baseline in Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) Consensus Cognitive Battery (MCCB) Working Memory Domain Score at Week 12 | The MCCB is a cognitive battery that assesses 7 domains recommended by the MATRICS initiative (i.e., Working Memory, Verbal Learning, Speed of Processing, Attention/Vigilance, Visual Learning, Social Cognition, and Reasoning and Problem Solving). MCCB was administered via laptop computer and paper-and-pencil assessments. T-scores for the individual tests were calculated according to the developer's recommended scoring algorithms. MCCB composite T scores are between 40 and 60 (normal range). Higher scores indicate better cognitive functioning. The working memory domain score of the MCCB is reported in this outcome measure. | Baseline and Week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | An AE is any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment. An SAE is any untoward medical occurrence that at any dose results in death, places the participant at immediate risk of death, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, results in a congenital anomaly/birth defect, or is a medically important event. |
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Key Inclusion Criteria:
Key Exclusion Criteria:
NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Biogen | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pillar Clinical Research, LLC | Bentonville | Arkansas | 72712 | United States | ||
| ProScience Research Group |
A total of 554 participants were screened out of which, 195 participants were randomized and dosed to receive BIIB104 or placebo.
Participants took part in the study at 53 investigative sites in the United States, Japan, Spain, Germany, and the United Kingdom from 15 Nov 2018 to 07 April 2022.
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | Participants received BIIB104 matching placebo capsules, twice a day (BID), orally for 12 weeks. |
| FG001 | BIIB104 0.15 mg | Participants received 0.15 milligrams (mg) capsules of BIIB104, BID, orally for 12 weeks. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Oct 30, 2019 | Mar 23, 2023 |
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| Placebo | Other | Administered as specified in the treatment arm |
|
| From first dose of study drug through end of the study (up to Week 14) |
| Mean Total Score Assessed by Scale for the Assessment and Rating of Ataxia (SARA) | The SARA is a clinical scale that is based on a semiquantitative assessment of cerebellar ataxia on an impairment level and complements the brief neurological examination. The SARA scale is an eight-item clinical rating scale (gait, stance, sitting, speech, finger-chase test, nose-finger test, fast alternating movements, and heel-shin test) with a total score range of 0-40, where 0 is the best neurological status and 40 is the worst neurological status. | Baseline, Weeks 2, 6, 12 and safety follow-up (Week 14) |
| Number of Participants With at Least One Event of Suicidal Ideation and/or Suicidal Behavior as Assessed by Columbia-Suicide Severity Rating Scale (C-SSRS) Score | The C-SSRS is an interview-based rating scale to systematically assess suicidal ideation and suicidal behavior. Suicidal ideation is classified on a 5-item scale: 1 (wish to be dead), 2 (nonspecific active suicidal thoughts), 3 (active suicidal ideation with any methods [not plan] without intent to act), 4 (active suicidal ideation with some intent to act, without specific plan), and 5 (active suicidal ideation with specific plan and intent). Suicidal behavior is classified on a 6-item scale: 1 (actual attempt), 2 (interrupted attempt), 3 (aborted attempt), 4 (preparatory acts or behavior), 5 (suicidal behavior), and 6 (suicide). The data analyzed signifies the participants with at least one event of suicidal ideation and/or suicidal behavior. | Up to Week 14 |
| Change From Baseline in University of California, San Diego Performance Based Skills Assessment-Brief International Version (UPSA-Bi) Assessment at Week 12 | The UPSA-Bi, international version, an abbreviated version of the UPSA-Validation of Intermediate Measures, is a measure of functional capacity and assesses skills used in community tasks. This assessment measures 2 general skills that were previously identified as essential to functioning in the community: financial skills and communication skills. The UPSA-Bi assessment is scored from 0-100, higher scores indicating higher functional status. | Baseline and Week 12 |
| Change From Baseline in Schizophrenia Cognition Rating Scale (SCoRS) Assessment Score at Week 12 | The SCoRS is an interview-based assessment of cognition that involves interviews with participants and informants. The SCoRS includes 20 items designed to specifically assess aspects of cognitive functioning found in each of the seven MCCB cognitive domains including the following: Memory: 4 items; Learning: 2 items; Attention: 3 items; Working memory: 2 items; Problem solving: 3 items; Processing/motor speed: 2 items; Social cognition: 3 items; Language: 1 item. Total score range is 20-80, lower scores indicating higher functional status. The data reported in this outcome measure are for global rating score. | Baseline and Week 12 |
| Change From Baseline in MCCB Neurocognitive Composite Scores at Week 12 | The MCCB is a cognitive battery that assesses 7 domains recommended by the MATRICS initiative (i.e., Working Memory, Verbal Learning, Speed of Processing, Attention/Vigilance, Visual Learning, Social Cognition, and Reasoning and Problem Solving). MCCB was administered via laptop computer and paper-and-pencil assessments. T-scores for the individual tests were calculated according to the developer's recommended scoring algorithms. MCCB composite T scores are between 40 and 60 (normal range). Higher scores indicate better cognitive functioning. The MCCB composite score contains all of the tests and domains of the MCCB. | Baseline and Week 12 |
| Change From Baseline in MCCB Individual Domain Scores (Excluding Working Memory Domain) at Week 12 | The MCCB is a cognitive battery that assesses 7 domains recommended by the MATRICS initiative (i.e., working memory, verbal learning, speed of processing, attention/vigilance, visual learning, social cognition, and reasoning and problem solving). MCCB was administered via laptop computer and paper-and-pencil assessments. T-scores for the individual tests were calculated according to the developer's recommended scoring algorithms. MCCB composite T scores are between 40 and 60 (normal range). Higher scores indicate better cognitive functioning. All the domain scores of the MCCB are reported in this outcome measure with the exception of working memory domain. | Baseline and Week 12 |
| Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score, Positive Subscale, and Negative Subscale Scores at Week 12 | The PANSS includes 3 subscales and 30 items: 7 items that make up the Positive subscale (e.g., delusions, conceptual disorganization, hallucinatory behaviour); 7 items that make up the Negative subscale (e.g., blunted affect, emotional withdrawal, poor rapport, passive/apathetic social withdrawal); and 16 items that make up the General Psychopathology subscale (e.g., somatic concern, anxiety, guilt feelings, mannerisms and posturing, motor retardation, uncooperativeness, disorientation, poor impulse control, preoccupation). Each item on the positive, negative and general psychopathology subscale is rated from 1 (absent) to 7 (extreme). The score range is 7-49 for positive and negative subscales, score range is 16-112 for the general psychopathology subscale. Total PANSS score (positive+ negative + general psychopathology subscale scores) range from 30 to 210. Higher scores represent more severity in symptoms. | Baseline and Week 12 |
| Change From Baseline in Clinical Global Impression-Severity (CGI-S) Scores at Week 12 | The CGI-S consists of a single 7-point rating score of illness severity. The following question: "Considering your total clinical experience with this particular population, how mentally ill is your participant at this time?" is rated with a score from 1 to 7- 1: Normal, not ill at all; 2: Borderline mentally ill; 3: Mildly ill; 4: Moderately ill; 5: Markedly ill; 6: Severely ill; or 7: Among the most severely ill participants. Lower scores indicate less severity of illness. | Baseline and Week 12 |
| Number of Participants With Response on Clinical Global Impression-Improvement (CGI-I) Scale at Week 12 | The CGI-I consists of a single 7-point rating score total improvement, regardless of whether or not the change is due entirely to drug treatment. The following question: "Compared to your participant's condition at the beginning of treatment, how much has your participant changed?" is rated with a score from 1 to 7- 1: Very much improved; 2: Much improved; 3: Minimally improved; 4: No change; 5: Minimally worse; 6: Much worse; or 7: Very much worse. Lower scores indicate greater improvement. | Week 12 |
| Culver City |
| California |
| 90230 |
| United States |
| Collaborative Neuroscience Network, LLC | Garden Grove | California | 92845 | United States |
| Synergy San Diego | Lemon Grove | California | 91945 | United States |
| Research Site | Long Beach | California | 90807 | United States |
| Catalina Research Institute, LLC | Montclair | California | 91763 | United States |
| Excell Research | Oceanside | California | 92056 | United States |
| Research Site | Pico Rivera | California | 90660 | United States |
| CNRI - San Diego, LLC | San Diego | California | 92102 | United States |
| Artemis Institute for Clinical Research | San Diego | California | 92103 | United States |
| Research Site | San Diego | California | 92123 | United States |
| Research Site | San Rafael | California | 94901 | United States |
| Research Site | Torrance | California | 90502 | United States |
| Yale University, Department of Psychiatry | New Haven | Connecticut | 06519 | United States |
| Research Site | Lauderhill | Florida | 33319 | United States |
| Premier Clinical Research Institute, Inc. | Miami | Florida | 33122 | United States |
| Stedman Clinical Trials | Tampa | Florida | 33613 | United States |
| Atlanta Center for Medical Research | Atlanta | Georgia | 30331 | United States |
| Augusta University | Augusta | Georgia | 30912 | United States |
| Research Site | Decatur | Georgia | 30030 | United States |
| Research Site | Chicago | Illinois | 60611 | United States |
| Alexian Brothers Hospital Network | Hoffman Estates | Illinois | 60169 | United States |
| Southern Illinois University, School of Medicine | Springfield | Illinois | 62702 | United States |
| Research Site | Gaithersburg | Maryland | 20877 | United States |
| Cherry Health | Grand Rapids | Michigan | 49503 | United States |
| Research Site | Flowood | Mississippi | 39232 | United States |
| Research Site | St Louis | Missouri | 63128 | United States |
| St. Louis Clinical Trials, LC | St Louis | Missouri | 63141 | United States |
| Hassman Research Institute | Berlin | New Jersey | 08009 | United States |
| UB Department Psychiatry | Buffalo | New York | 104051 | United States |
| Neurobehavioral Research, Inc. | Cedarhurst | New York | 11516 | United States |
| Finger Lakes Clinical Research | Rochester | New York | 14618 | United States |
| The Ohio State University Department of Psychiatry | Columbus | Ohio | 43210 | United States |
| Research Site | North Canton | Ohio | 44720 | United States |
| Research Site | Richardson | Texas | 75080 | United States |
| The University of Texas Health Science Center at San Antonio | San Antonio | Texas | 78207 | United States |
| Research Site | Kirkland | Washington | 98033 | United States |
| Zentrum für klinische Forschung Dr. med. I. Schöll | Bad Homburg | Hesse | 61348 | Germany |
| Clinic for Psychiatrie | Frankfurt am Main | Hesse | 60528 | Germany |
| Universitätsmedizin Göttingen, Klinik für Psychiatrie und Psychotherapie | Westerstede | Lower Saxony | 26655 | Germany |
| Dpt of Psychiatry and Psychotherapy, University of Leipzig | Leipzig | Saxony | 04103 | Germany |
| Research Site | Anan-shi | Japan |
| Research Site | Ichikawa-shi | Japan |
| Research Site | Kashihara-shi | Japan |
| Research Site | Kawasaki-shi | Japan |
| Research Site | Kita-gun | Japan |
| Research Site | Kodaira-shi | Japan |
| Research Site | Kumagaya-shi | Japan |
| Research Site | Takasaki-shi | Japan |
| Research Site | Yokosuka-shi | Japan |
| Hospital Universitario Marques Valdecilla | Santander | Cantabria | 39008 | Spain |
| Research Site | Majadahonda | Madrid | 28222 | Spain |
| Research Site | Oviedo | Principality of Asturias | 33011 | Spain |
| Hospital Clinic de Barcelona | Barcelona | 08036 | Spain |
| Hospital Universitario 12 de Octubre | Madrid | 28040 | Spain |
| Unidad Neurociencias CS San Juan | Salamanca | 37005 | Spain |
| Research Site | Seville | 41013 | Spain |
| Oxford Health NHS Foundation Trust | Oxford | Oxfordshire | OX3 7JX | United Kingdom |
| Abraham Cowley Unit | Lyne | Surrey | KT16 0AE | United Kingdom |
| Research Site | London | SE5 8AZ | United Kingdom |
| FG002 | BIIB104 0.5 mg | Participants received 0.5 mg capsules of BIIB104, BID, orally for 12 weeks. |
| Safety Analysis Set | The safety population included all randomized participants who received at least 1 dose of study treatment(BIIB104 or placebo). One participant randomized to placebo, inadvertently received one or more doses of active treatment. |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
Intent-to-treat (ITT) population included all randomized participants who received at least one dose of study treatment (BIIB104 or placebo).
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | Participants received BIIB104 matching placebo capsules, BID, orally for 12 weeks. |
| BG001 | BIIB104 0.15 mg | Participants received 0.15 mg capsules of BIIB104, BID, orally for 12 weeks. |
| BG002 | BIIB104 0.5 mg | Participants received 0.5 mg capsules of BIIB104, BID, orally for 12 weeks. |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
| ||||||||||||||||
| MATRICS Consensus Cognitive Battery (MCCB) Working Memory Domain Score | The MCCB is a cognitive battery that assesses 7 domains recommended by the Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) initiative (i.e., Working Memory, Verbal Learning, Speed of Processing, Attention/Vigilance, Visual Learning, Social Cognition, and Reasoning and Problem Solving). MCCB was administered via laptop computer and paper-and-pencil assessments. MCCB composite T scores are between 40 and 60 (normal range). Higher scores indicate better cognitive functioning. The working memory domain score of the MCCB is reported. | Mean | Full Range | score on a scale |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Primary | Change From Baseline in Change From Baseline in Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) Consensus Cognitive Battery (MCCB) Working Memory Domain Score at Week 12 | The MCCB is a cognitive battery that assesses 7 domains recommended by the MATRICS initiative (i.e., Working Memory, Verbal Learning, Speed of Processing, Attention/Vigilance, Visual Learning, Social Cognition, and Reasoning and Problem Solving). MCCB was administered via laptop computer and paper-and-pencil assessments. T-scores for the individual tests were calculated according to the developer's recommended scoring algorithms. MCCB composite T scores are between 40 and 60 (normal range). Higher scores indicate better cognitive functioning. The working memory domain score of the MCCB is reported in this outcome measure. | ITT population included all randomized participants who received at least one dose of study treatment (BIIB104 or placebo). Here, "Overall Number of Participants Analyzed" signifies the number of participants analyzed in this outcome measure. | Posted | Least Squares Mean | Standard Error | score on a scale | Baseline and Week 12 |
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| Secondary | Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | An AE is any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment. An SAE is any untoward medical occurrence that at any dose results in death, places the participant at immediate risk of death, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, results in a congenital anomaly/birth defect, or is a medically important event. | The safety population included all randomized participants who received at least 1 dose of study treatment (BIIB104 or placebo). | Posted | Count of Participants | Participants | From first dose of study drug through end of the study (up to Week 14) |
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| Secondary | Mean Total Score Assessed by Scale for the Assessment and Rating of Ataxia (SARA) | The SARA is a clinical scale that is based on a semiquantitative assessment of cerebellar ataxia on an impairment level and complements the brief neurological examination. The SARA scale is an eight-item clinical rating scale (gait, stance, sitting, speech, finger-chase test, nose-finger test, fast alternating movements, and heel-shin test) with a total score range of 0-40, where 0 is the best neurological status and 40 is the worst neurological status. | The safety population included all randomized participants who received at least 1 dose of study treatment (BIIB104 or placebo). Here, "Overall number of participants analyzed" signifies the number of participants analyzed in this outcome measure and "number analyzed" signifies the number of participants analyzed at specified time-point. | Posted | Mean | Standard Deviation | score on a scale | Baseline, Weeks 2, 6, 12 and safety follow-up (Week 14) |
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| Secondary | Number of Participants With at Least One Event of Suicidal Ideation and/or Suicidal Behavior as Assessed by Columbia-Suicide Severity Rating Scale (C-SSRS) Score | The C-SSRS is an interview-based rating scale to systematically assess suicidal ideation and suicidal behavior. Suicidal ideation is classified on a 5-item scale: 1 (wish to be dead), 2 (nonspecific active suicidal thoughts), 3 (active suicidal ideation with any methods [not plan] without intent to act), 4 (active suicidal ideation with some intent to act, without specific plan), and 5 (active suicidal ideation with specific plan and intent). Suicidal behavior is classified on a 6-item scale: 1 (actual attempt), 2 (interrupted attempt), 3 (aborted attempt), 4 (preparatory acts or behavior), 5 (suicidal behavior), and 6 (suicide). The data analyzed signifies the participants with at least one event of suicidal ideation and/or suicidal behavior. | The safety population included all randomized participants who received at least 1 dose of study treatment (BIIB104 or placebo). Here, "Overall Number of Participants Analyzed" signifies the number of participants analyzed in this outcome measure. | Posted | Count of Participants | Participants | Up to Week 14 |
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| Secondary | Change From Baseline in University of California, San Diego Performance Based Skills Assessment-Brief International Version (UPSA-Bi) Assessment at Week 12 | The UPSA-Bi, international version, an abbreviated version of the UPSA-Validation of Intermediate Measures, is a measure of functional capacity and assesses skills used in community tasks. This assessment measures 2 general skills that were previously identified as essential to functioning in the community: financial skills and communication skills. The UPSA-Bi assessment is scored from 0-100, higher scores indicating higher functional status. | ITT population included all randomized participants who received at least one dose of study treatment (BIIB104 or placebo). Here, "Overall Number of Participants Analyzed" signifies the number of participants analyzed in this outcome measure. | Posted | Least Squares Mean | Standard Error | score on a scale | Baseline and Week 12 |
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| Secondary | Change From Baseline in Schizophrenia Cognition Rating Scale (SCoRS) Assessment Score at Week 12 | The SCoRS is an interview-based assessment of cognition that involves interviews with participants and informants. The SCoRS includes 20 items designed to specifically assess aspects of cognitive functioning found in each of the seven MCCB cognitive domains including the following: Memory: 4 items; Learning: 2 items; Attention: 3 items; Working memory: 2 items; Problem solving: 3 items; Processing/motor speed: 2 items; Social cognition: 3 items; Language: 1 item. Total score range is 20-80, lower scores indicating higher functional status. The data reported in this outcome measure are for global rating score. | ITT population included all randomized participants who received at least one dose of study treatment (BIIB104 or placebo). Here, "Overall Number of Participants Analyzed" signifies the number of participants analyzed in this outcome measure. | Posted | Least Squares Mean | Standard Error | score on a scale | Baseline and Week 12 |
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| Secondary | Change From Baseline in MCCB Neurocognitive Composite Scores at Week 12 | The MCCB is a cognitive battery that assesses 7 domains recommended by the MATRICS initiative (i.e., Working Memory, Verbal Learning, Speed of Processing, Attention/Vigilance, Visual Learning, Social Cognition, and Reasoning and Problem Solving). MCCB was administered via laptop computer and paper-and-pencil assessments. T-scores for the individual tests were calculated according to the developer's recommended scoring algorithms. MCCB composite T scores are between 40 and 60 (normal range). Higher scores indicate better cognitive functioning. The MCCB composite score contains all of the tests and domains of the MCCB. | ITT population included all randomized participants who received at least one dose of study treatment (BIIB104 or placebo). Here, "Overall Number of Participants Analyzed" signifies the number of participants analyzed in this outcome measure. | Posted | Least Squares Mean | Standard Error | score on a scale | Baseline and Week 12 |
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| Secondary | Change From Baseline in MCCB Individual Domain Scores (Excluding Working Memory Domain) at Week 12 | The MCCB is a cognitive battery that assesses 7 domains recommended by the MATRICS initiative (i.e., working memory, verbal learning, speed of processing, attention/vigilance, visual learning, social cognition, and reasoning and problem solving). MCCB was administered via laptop computer and paper-and-pencil assessments. T-scores for the individual tests were calculated according to the developer's recommended scoring algorithms. MCCB composite T scores are between 40 and 60 (normal range). Higher scores indicate better cognitive functioning. All the domain scores of the MCCB are reported in this outcome measure with the exception of working memory domain. | ITT population included all randomized participants who received at least one dose of study treatment (BIIB104 or placebo). Here, "Overall Number of Participants Analyzed" signifies the number of participants analyzed in this outcome measure. | Posted | Least Squares Mean | Standard Error | score on a scale | Baseline and Week 12 |
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| Secondary | Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score, Positive Subscale, and Negative Subscale Scores at Week 12 | The PANSS includes 3 subscales and 30 items: 7 items that make up the Positive subscale (e.g., delusions, conceptual disorganization, hallucinatory behaviour); 7 items that make up the Negative subscale (e.g., blunted affect, emotional withdrawal, poor rapport, passive/apathetic social withdrawal); and 16 items that make up the General Psychopathology subscale (e.g., somatic concern, anxiety, guilt feelings, mannerisms and posturing, motor retardation, uncooperativeness, disorientation, poor impulse control, preoccupation). Each item on the positive, negative and general psychopathology subscale is rated from 1 (absent) to 7 (extreme). The score range is 7-49 for positive and negative subscales, score range is 16-112 for the general psychopathology subscale. Total PANSS score (positive+ negative + general psychopathology subscale scores) range from 30 to 210. Higher scores represent more severity in symptoms. | ITT population included all randomized participants who received at least one dose of study treatment (BIIB104 or placebo). Here, "Overall Number of Participants Analyzed" signifies the number of participants analyzed in this outcome measure. | Posted | Least Squares Mean | Standard Error | score on a scale | Baseline and Week 12 |
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| Secondary | Change From Baseline in Clinical Global Impression-Severity (CGI-S) Scores at Week 12 | The CGI-S consists of a single 7-point rating score of illness severity. The following question: "Considering your total clinical experience with this particular population, how mentally ill is your participant at this time?" is rated with a score from 1 to 7- 1: Normal, not ill at all; 2: Borderline mentally ill; 3: Mildly ill; 4: Moderately ill; 5: Markedly ill; 6: Severely ill; or 7: Among the most severely ill participants. Lower scores indicate less severity of illness. | ITT population included all randomized participants who received at least one dose of study treatment (BIIB104 or placebo). Here, "Overall Number of Participants Analyzed" signifies the number of participants analyzed in this outcome measure. | Posted | Least Squares Mean | Standard Error | score on a scale | Baseline and Week 12 |
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| Secondary | Number of Participants With Response on Clinical Global Impression-Improvement (CGI-I) Scale at Week 12 | The CGI-I consists of a single 7-point rating score total improvement, regardless of whether or not the change is due entirely to drug treatment. The following question: "Compared to your participant's condition at the beginning of treatment, how much has your participant changed?" is rated with a score from 1 to 7- 1: Very much improved; 2: Much improved; 3: Minimally improved; 4: No change; 5: Minimally worse; 6: Much worse; or 7: Very much worse. Lower scores indicate greater improvement. | ITT population included all randomized participants who received at least one dose of study treatment (BIIB104 or placebo). Here, "Overall Number of Participants Analyzed" signifies the number of participants analyzed in this outcome measure. | Posted | Count of Participants | Participants | Week 12 |
|
From first dose of study drug through end of the study (up to Week 14)
The safety population included all randomized participants who received at least 1 dose of study treatment(BIIB104 or placebo).One participant randomized to placebo,inadvertently received one or more doses of active treatment. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Placebo | Participants received BIIB104 matching placebo capsules, BID, orally for 12 weeks. | 0 | 63 | 1 | 63 | 2 | 63 |
| EG001 | BIIB104 0.15 mg | Participants received 0.15 mg capsules of BIIB104, BID, orally for 12 weeks. | 0 | 66 | 1 | 66 | 2 | 66 |
| EG002 | BIIB104 0.5 mg | Participants received 0.5 mg capsules of BIIB104, BID, orally for 12 weeks. | 0 | 66 | 2 | 66 | 8 | 66 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Appendicitis | Infections and infestations | MedDRA25.0 | Systematic Assessment |
| |
| Schizophrenia | Psychiatric disorders | MedDRA25.0 | Systematic Assessment |
| |
| Psychiatric decompensation | Psychiatric disorders | MedDRA25.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Headache | Nervous system disorders | MedDRA25.0 | Systematic Assessment |
| |
| Schizophrenia | Psychiatric disorders | MedDRA25.0 | Systematic Assessment |
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Our agreement is subject to confidentiality but generally the PI can publish, for non-commercial purposes only, results and methods of the trial, but no other Sponsor Confidential Information. PI must give Sponsor no less than 60 days to review any manuscript for a proposed publication and must delay publication for up to an additional 90 days thereafter if Sponsor needs to file any patent application to protect any of Sponsor's intellectual property contained in the proposed publication.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| US Biogen Clinical Trial Center | Biogen | 866-633-4636 | clinicaltrials@biogen.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Mar 30, 2022 | Mar 23, 2023 | SAP_001.pdf |
| ID | Term |
|---|---|
| C000600968 | PF-04958242 |
Not provided
Not provided
Not provided
| Male |
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| Not Hispanic or Latino |
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| Unknown or Not Reported |
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| Black or African American |
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| Native Hawaiian or Other Pacific Islander |
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| White |
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| Other |
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| Unknown |
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A MMRM model was used to analyze the change from baseline of the OM of interest, using fixed effects of treatment group, region, study visit, study visit-by-treatment interaction, baseline value of OM, baseline-by-visit interaction. |
| MMRM |
| =0.8053 |
| LS Mean Difference |
| -0.33 |
| Standard Error of the Mean |
| 1.323 |
| 2-Sided |
| 95 |
| -2.94 |
| 2.29 |
| Superiority |
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Participants received 0.5 mg capsules of BIIB104, BID, orally for 12 weeks.
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| OG002 | BIIB104 0.5 mg | Participants received 0.5 mg capsules of BIIB104, BID, orally for 12 weeks. |
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Participants received 0.5 mg capsules of BIIB104, BID, orally for 12 weeks. |
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Participants received 0.5 mg capsules of BIIB104, BID, orally for 12 weeks. |
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| BIIB104 0.5 mg |
Participants received 0.5 mg capsules of BIIB104, BID, orally for 12 weeks. |
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Participants received 0.15 mg capsules of BIIB104, BID, orally for 12 weeks. |
| OG002 | BIIB104 0.5 mg | Participants received 0.5 mg capsules of BIIB104, BID, orally for 12 weeks. |
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