Autopsy report · NCT04109950

A Clinical Study to Evaluate the Long-term Safety and Tolerability of an Investigational Drug in People With Schizophrenia

“Study terminated early, main goals achieved”

The sponsor’s own words in the registry.

Life of this trial

• Registered 2 months before it started.
• Ran for about 4 years before it stopped.
• 463 participants enrolled.
• No results are posted on the registry.

Vital statistics

Status

Terminated

Phase

Phase 3

Sponsor

Otsuka Pharmaceutical Development & Commercialization, Inc.

Sponsor type

Industry

Conditions

Schizophrenia

Interventions

SEP-363856

Participants

463

Sites

78

Countries

Bulgaria, Colombia, Croatia, Latvia, Russia, Serbia, Ukraine, United States

Trials that died the same way

• Safety, Pharmacokinetics and Efficacy Study of QCC374 in PAH Patients
  “Study was terminated early for strategic reasons. Only Part I of the study was completed.” (85% match in meaning)
• An Efficacy and Safety of Flomoxef Versus Cefepime in the Treatment of Participants With Urinary Tract Infections
  “Study was prematurely terminated due to administrative and strategic reasons” (79% match in meaning)
• PFC Sigma Fixed and Mobile Knee Study
  “The study was terminated at the point the primary endpoint and early milestones were reached and because long term outcomes were available from other sources” (78% match in meaning)
• An Evaluation of a Novel Food Product in Adults Residing in an Area Endemic for Helminths
  “Due to a business decision to stop the project, the study was terminated early.” (77% match in meaning)
• Safety of Buprenorphine Transdermal Patch (BTDS) in Osteoarthritis Pain: a 52-Week Extension Phase
  “This study was terminated early for administrative reasons.” (77% match in meaning)

Look deeper

• The official registry record (the source of truth)
• Record history: every change the sponsor made
• Open it in the database

Everything here comes from the current ClinicalTrials.gov record. The timeline uses the record’s dates; dates marked planned are the sponsor’s plans. The cause of death is an automatic, unverified label. This is research information, not medical advice.