trial

An Extension Study to a Clinical Study That Will Continue to Evaluate the Effectiveness and Safety of SEP-363856 in People With Schizophrenia That Switch to SEP-363856 From Their From Their Current Antipsychotic Medication

NCTId NCT05741528
as of 2026-07-01
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at a glance
Phase 3 · Completed
Enrollment 75 (actual)
Sponsored by Otsuka Pharmaceutical Development & Commercialization, Inc.
Primary completion 2024-09-23
Synthesized from structured facts only — each point cited above.

Design & status

Phase
Phase 3
Status
Completed
Enrollment
75 (actual)
Study type
Interventional
Allocation
Na
Model
Single Group
Masking
None
Start
2023-03-31
Primary completion
2024-09-23
Eligibility
ALL · 18 Years · 65 Years

Interventions & indications

Drugs
Ulotaront

Sponsors

Otsuka Pharmaceutical Development & Commercialization, Inc.Lead Sponsor

Sites

16 total
Anaheim, United StatesBellflower, United StatesGarden Grove, United StatesLemon Grove, United StatesSantee, United StatesTorrance, United StatesHollywood, United StatesMiami, United StatesAtlanta, United StatesAtlanta, United StatesChicago, United StatesGaithersburg, United States

Linked catalysts

1
An Extension Study to a Clinical Study That Will Continue to Evaluate the Effect — primary completion2024-09-23

Facts & assertions

4 sourced
Enrollment
75
Phase
PHASE3
Primary Completion Date
2024-09-23
Status
COMPLETED
relationships
The graph out of here
drug
Ulotaront
drug
lead_sponsor
Otsuka Pharmaceutical Development & Commercialization, Inc.
company
indication
Schizophrenia
indication
Schizophrenia
indication