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NCT03557931 · ClinicalTrials.gov registry record · Phase 2
A Study to Assess the Safety and Efficacy of ASP4345 as Add-on Treatment for Cognitive Impairment in Subjects With Schizophrenia on Stable Doses of Antipsychotic Medication
A Phase 2 study, sponsored by Astellas Pharma Global Development.
- Completed
- Registry status
- Phase 2
- Development phase
- 233
- Enrollment target
NCT03557931: Completed Phase 2 study, sponsored by Astellas Pharma Global Development.
NCT03557931 is a Phase 2 study that has completed, run by Astellas Pharma Global Development. The registered enrollment target is 233 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (75% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03557931, a Phase 2 study, has completed, sponsored by Astellas Pharma Global Development.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 233 participants
- Enrollment target
Study Summary
The purpose of this study was to evaluate the efficacy of ASP4345 on cognitive impairment compared to placebo using change from baseline in MATRICS Consensus Cognitive Battery (MCCB) neurocognitive composite score (excluding social cognition domain). The primary estimand used a Hypothetical Strategy and compared participants as though the participant had continued on the assigned treatment and to evaluate the safety and tolerability of ASP4345 compared to placebo. This study also evaluated the effects of ASP4345 compared to placebo on functional capacity using the University of California San Diego Performance-based Skills Assessment-2 Extended Range (UPSA-2-ER) total score and evaluated the pharmacokinetic profile of ASP4345.
Primary Outcome
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 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 deviatio
Interventions
- DRUG placebo
- DRUG risperidone
- DRUG olanzapine
- DRUG quetiapine
- DRUG ASP4345
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 233 participants |
| Start Date | 2018-07-13 |
| Est. Completion | 2019-10-21 |
| Phase | Phase 2 |
What the finished NCT03557931 record still lists
NCT03557931 is an interventional study that assigns participants to a tested intervention. The registered 233 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 (75% higher).
The record links to 0 conditions, and to 5 interventions - of which placebo is the first listed.
NCT03557931 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03557931 about?
NCT03557931 is a clinical study titled "A Study to Assess the Safety and Efficacy of ASP4345 as Add-on Treatment for Cognitive Impairment in Subjects With Schizophrenia on Stable Doses of Antipsychotic Medication". The purpose of this study was to evaluate the efficacy of ASP4345 on cognitive impairment compared to placebo using change from baseline in MATRICS Consensus Cognitive Battery (MCCB) neurocognitive composite score (excluding social cognition domain). The primary estimand used a Hypothetical Strategy...
What is the current status of trial NCT03557931?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 233 participants. The study started on 2018-07-13. Estimated completion is 2019-10-21.
What interventions are being tested in trial NCT03557931?
The interventions under investigation include: placebo (DRUG), risperidone (DRUG), olanzapine (DRUG), quetiapine (DRUG), ASP4345 (DRUG).
Who is sponsoring clinical trial NCT03557931?
This trial is sponsored by Astellas Pharma Global Development, which has 168 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03557931's enrollment target sits among peer trials
233 256th of 2000 higher than 1,745 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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