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NCT04109950 · ClinicalTrials.gov registry record · Phase 3
A Clinical Study to Evaluate the Long-term Safety and Tolerability of an Investigational Drug in People With Schizophrenia
A Phase 3 study, sponsored by Otsuka Pharmaceutical Development & Commercialization.
- Terminated
- Registry status
- Phase 3
- Development phase
- 463
- Enrollment target
NCT04109950: Clinical Trial Phase 3 study, sponsored by Otsuka Pharmaceutical Development & Commercialization.
NCT04109950 is a Phase 3 study that was terminated before completion, run by Otsuka Pharmaceutical Development & Commercialization. The registered enrollment target is 463 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (40% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04109950, a Phase 3 study, was terminated before completion, sponsored by Otsuka Pharmaceutical Development & Commercialization.
- TERMINATED
- Registry status
- Phase 3
- Development phase
- 463 participants
- Enrollment target
Study Summary
This is a clinical trial to determine the long-term safety and tolerability of an investigational drug in people with schizophrenia. Participants in the study will receive the drug being studied. This study is accepting male and female participants between 13 and 65 years old who have been diagnosed with schizophrenia and have completed Study SEP361-301 (NCT04072354) or Study SEP361-302 (NCT04092686). This study will be conducted in approximately 80 study centers worldwide. The treatment duration for this study is one (1) year.
Interventions
- DRUG SEP-363856
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 463 participants |
| Start Date | 2019-11-20 |
| Est. Completion | 2023-11-09 |
| Phase | Phase 3 |
Why NCT04109950 stopped before completion
NCT04109950 is an interventional study that assigns participants to a tested intervention. The registered 463 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (40% lower).
The record links to 0 conditions, and to 1 intervention - of which SEP-363856 is the first listed.
NCT04109950 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04109950 about?
NCT04109950 is a clinical study titled "A Clinical Study to Evaluate the Long-term Safety and Tolerability of an Investigational Drug in People With Schizophrenia". This is a clinical trial to determine the long-term safety and tolerability of an investigational drug in people with schizophrenia. Participants in the study will receive the drug being studied. This study is accepting male and female participants between 13 and 65 years old who have been diagnosed...
What is the current status of trial NCT04109950?
This trial is currently terminated. It is a Phase 3 study. The enrollment target is 463 participants. The study started on 2019-11-20. Estimated completion is 2023-11-09.
What interventions are being tested in trial NCT04109950?
The interventions under investigation include: SEP-363856 (DRUG).
Who is sponsoring clinical trial NCT04109950?
This trial is sponsored by Otsuka Pharmaceutical Development & Commercialization, which has 221 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04109950's enrollment target sits among peer trials
463 821st of 2000 higher than 1,180 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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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