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NCT03745820 · ClinicalTrials.gov registry record · Phase 2
A Study to Evaluate the Safety and Efficacy of BIIB104 in Participants With Cognitive Impairment Associated With Schizophrenia (CIAS)
A Phase 2 study, sponsored by Biogen.
- Completed
- Registry status
- Phase 2
- Development phase
- 195
- Enrollment target
NCT03745820: Completed Phase 2 study, sponsored by Biogen.
NCT03745820 is a Phase 2 study that has completed, run by Biogen. The registered enrollment target is 195 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (47% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03745820, a Phase 2 study, has completed, sponsored by Biogen.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 195 participants
- Enrollment target
Study Summary
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.
Primary Outcome
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). High
Interventions
- OTHER Placebo
- DRUG BIIB104
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 195 participants |
| Start Date | 2018-11-15 |
| Est. Completion | 2022-04-07 |
| Phase | Phase 2 |
What the finished NCT03745820 record still lists
NCT03745820 is an interventional study that assigns participants to a tested intervention. The registered 195 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (47% higher).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT03745820 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03745820 about?
NCT03745820 is a clinical study titled "A Study to Evaluate the Safety and Efficacy of BIIB104 in Participants With Cognitive Impairment Associated With Schizophrenia (CIAS)". 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 ...
What is the current status of trial NCT03745820?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 195 participants. The study started on 2018-11-15. Estimated completion is 2022-04-07.
What interventions are being tested in trial NCT03745820?
The interventions under investigation include: Placebo (OTHER), BIIB104 (DRUG).
Who is sponsoring clinical trial NCT03745820?
This trial is sponsored by Biogen, which has 334 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03745820's enrollment target sits among peer trials
195 350th of 2000 higher than 1,649 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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