Trial · NCT03745820
Outcomes11
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 11 of 11
Download this page as JSON| 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 |
| SECONDARY | Number of Participants With Response on Clinical Global Impression-Improvement (CGI-I) Scale at Week 12 | 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. | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
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 list from software.
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GET https://conductscience.org/api/trials/v1/NCT03745820/outcomes