Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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 is a Phase 3 study that was terminated before completion, run by Otsuka Pharmaceutical Development & Commercialization. The registered enrollment target is 463 participants.
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04109950
The ClinicalTrials.gov registry entry for NCT04109950 describes a study currently listed as terminated, categorized as Phase 3. The registered enrollment target is 463 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Otsuka Pharmaceutical Development & Commercialization, which has 221 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which SEP-363856 is the first listed.
NCT04109950 reports 0 study locations.
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
Explore more on PlainTrial
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.