Trial · NCT03745820
A Study to Evaluate the Safety and Efficacy of BIIB104 in Participants With Cognitive Impairment Associated With Schizophrenia (CIAS)
NCT03745820, Phase 2, Completed, Biogen; results first posted 2023-04-18
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Study to Evaluate the Safety and Efficacy of BIIB104 in Participants With Cognitive Impairment Associated With Schizophrenia (CIAS). Trials, record NCT03745820. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03745820
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study to Evaluate the Safety and Efficacy of BIIB104 in Participants With Cognitive Impairment Associated With Schizophrenia (CIAS)
- NCT number
- NCT03745820
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 195 participants, actual
- Lead sponsor
- Biogen
- Conditions
- Cognitive Impairment Associated With Schizophrenia
- Interventions
- BIIB104, Placebo
- First posted
- 2018-11-19
- Last updated
- 2023-04-18
- Other registries' IDs
- eudract:2018-003825-27
- Results first posted
- 2023-04-18
Source ClinicalTrials.gov
Registered outcomes11
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| 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 | Baseline and 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. |
| Secondary | Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | From first dose of study drug through end of the study (up to Week 14) | 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. |
| Secondary | Mean Total Score Assessed by Scale for the Assessment and Rating of Ataxia (SARA) | Baseline, Weeks 2, 6, 12 and safety follow-up (Week 14) | 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. |
| 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 | Up to Week 14 | 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. |
| Secondary | Change From Baseline in University of California, San Diego Performance Based Skills Assessment-Brief International Version (UPSA-Bi) Assessment at Week 12 | Baseline and 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. |
| Secondary | Change From Baseline in Schizophrenia Cognition Rating Scale (SCoRS) Assessment Score at Week 12 | Baseline and 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. |
| Secondary | Change From Baseline in MCCB Neurocognitive Composite Scores at Week 12 | Baseline and 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. |
| Secondary | Change From Baseline in MCCB Individual Domain Scores (Excluding Working Memory Domain) at Week 12 | Baseline and 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. |
| Secondary | Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score, Positive Subscale, and Negative Subscale Scores at Week 12 | Baseline and 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. |
| Secondary | Change From Baseline in Clinical Global Impression-Severity (CGI-S) Scores at Week 12 | Baseline and 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. |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 registered outcomesOutcomes11
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| 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 | Baseline and Week 12 | 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. | score on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | 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). | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Mean Total Score Assessed by Scale for the Assessment and Rating of Ataxia (SARA) | Baseline, Weeks 2, 6, 12 and safety follow-up (Week 14) | 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. | score on a scale | MEAN |
| 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 | Up to Week 14 | 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. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Change From Baseline in University of California, San Diego Performance Based Skills Assessment-Brief International Version (UPSA-Bi) Assessment at Week 12 | Baseline and Week 12 | 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. | score on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Schizophrenia Cognition Rating Scale (SCoRS) Assessment Score at Week 12 | Baseline and Week 12 | 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. | score on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in MCCB Neurocognitive Composite Scores at Week 12 | Baseline and Week 12 | 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. | score on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in MCCB Individual Domain Scores (Excluding Working Memory Domain) at Week 12 | Baseline and Week 12 | 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. | score on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score, Positive Subscale, and Negative Subscale Scores at Week 12 | Baseline and Week 12 | 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. | score on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Clinical Global Impression-Severity (CGI-S) Scores at Week 12 | Baseline and Week 12 | 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. | score on a scale | LEAST_SQUARES_MEAN |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 outcomesResults by group87
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
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 | Placebo | 1.17 | Standard Error 0.939 | score on a scale | |
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 | BIIB104 0.15 mg | 0.91 | Standard Error 0.936 | score on a scale | |
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 | BIIB104 0.5 mg | 0.84 | Standard Error 0.934 | score on a scale | |
| Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | Placebo | AEs | 28 | Participants | |
| Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | BIIB104 0.15 mg | AEs | 32 | Participants | |
| Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | BIIB104 0.5 mg | AEs | 28 | Participants | |
| Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | Placebo | SAEs | 1 | Participants | |
| Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | BIIB104 0.15 mg | SAEs | 1 | Participants | |
| Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | BIIB104 0.5 mg | SAEs | 2 | Participants | |
| Mean Total Score Assessed by Scale for the Assessment and Rating of Ataxia (SARA) | Placebo | Baseline | 0.5 | Standard Deviation 1.03 | score on a scale |
1 to 10 of 87Source ClinicalTrials.gov
See all 87 results by groupParticipant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Placebo | 64 | |
| Overall Study | STARTED | BIIB104 0.15 mg | 66 | |
| Overall Study | STARTED | BIIB104 0.5 mg | 65 | |
| Overall Study | Safety Analysis Set | Placebo | 63 | |
| Overall Study | Safety Analysis Set | BIIB104 0.15 mg | 66 | |
| Overall Study | Safety Analysis Set | BIIB104 0.5 mg | 66 | |
| Overall Study | COMPLETED | Placebo | 52 | |
| Overall Study | COMPLETED | BIIB104 0.15 mg | 52 | |
| Overall Study | COMPLETED | BIIB104 0.5 mg | 51 | |
| Overall Study | NOT COMPLETED | Placebo | 12 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events15
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Headache | Nervous system disorders | Placebo | 1 | 63 | 1 |
| other | Headache | Nervous system disorders | BIIB104 0.15 mg | 1 | 66 | 1 |
| other | Headache | Nervous system disorders | BIIB104 0.5 mg | 4 | 66 | 4 |
| other | Schizophrenia | Psychiatric disorders | Placebo | 1 | 63 | 1 |
| other | Schizophrenia | Psychiatric disorders | BIIB104 0.15 mg | 1 | 66 | 1 |
| other | Schizophrenia | Psychiatric disorders | BIIB104 0.5 mg | 4 | 66 | 4 |
| serious | Appendicitis | Infections and infestations | Placebo | 1 | 63 | 1 |
| serious | Appendicitis | Infections and infestations | BIIB104 0.15 mg | 0 | 66 | 0 |
| serious | Appendicitis | Infections and infestations | BIIB104 0.5 mg | 0 | 66 | 0 |
| serious | Schizophrenia | Psychiatric disorders | Placebo | 0 | 63 | 0 |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Placebo | 0 | 63 |
| Total, all-cause mortality | BIIB104 0.15 mg | 0 | 66 |
| Total, all-cause mortality | BIIB104 0.5 mg | 0 | 66 |
| Total, other adverse events | Placebo | 2 | 63 |
| Total, other adverse events | BIIB104 0.15 mg | 2 | 66 |
| Total, other adverse events | BIIB104 0.5 mg | 8 | 66 |
| Total, serious adverse events | Placebo | 1 | 63 |
| Total, serious adverse events | BIIB104 0.15 mg | 1 | 66 |
| Total, serious adverse events | BIIB104 0.5 mg | 2 | 66 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT03745820
GET https://conductscience.org/api/trials/v1/NCT03745820/results?page=2