trial

A Clinical Trial to Evaluate the Efficacy and Safety of SEP-363856 in Acutely Psychotic People With Schizophrenia, Followed by an Open-label Extension Phase

NCTId NCT04825860
as of 2026-07-01
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at a glance
Phase 2, Phase 3 · Terminated
Enrollment 83 (actual)
Sponsored by Sumitomo Pharmaceuticals America
Primary completion 2023-10-12
Synthesized from structured facts only — each point cited above.

Design & status

Phase
Phase 2, Phase 3
Status
Terminated
Enrollment
83 (actual)
Study type
Interventional
Allocation
Randomized
Model
Parallel
Masking
Quadruple
Start
2021-03-29
Primary completion
2023-10-12
Eligibility
ALL · 18 Years · 65 Years

Interventions & indications

Drugs
Ulotaront

Sponsors

Sumitomo Pharmaceuticals AmericaLead Sponsor

Sites

54 total
Beijing, ChinaBeijing, ChinaGuangzhou, ChinaChangsha, ChinaJining, ChinaShanghai, ChinaXian, ChinaTianjin, ChinaKōnan, JapanToyoake, JapanHachinohe, JapanIchikawa, Japan

Linked catalysts

1
A Clinical Trial to Evaluate the Efficacy and Safety of SEP-363856 in Acutely Ps — primary completion2023-10-12

Facts & assertions

4 sourced
Enrollment
83
Phase
PHASE2,PHASE3
Primary Completion Date
2023-10-12
Status
TERMINATED
relationships
The graph out of here
drug
Ulotaront
drug
lead_sponsor
Sumitomo Pharmaceuticals America
company
indication
Schizophrenia
indication
Schizophrenia
indication