Autopsy report · NCT04572243

A Study of Lorcaserin as Adjunctive Treatment in Participants With Dravet Syndrome

“The study was terminated by Sponsor and the decision was not due to any safety or efficacy reasons.”

The sponsor’s own words in the registry.

Life of this trial

• Ran for about 3 years 11 months before it stopped.
• 22 participants enrolled.
• Results were posted on the registry 1 year 2 months after it ended.

Vital statistics

Status

Terminated

Phase

Phase 3

Sponsor

Eisai Inc.

Sponsor type

Industry

Conditions

Epilepsies, Myoclonic

Interventions

Placebo; Lorcaserin

Participants

22

Sites

30

Countries

Canada, United States

Trials that died the same way

• Study of Obeldesivir to Treat Children With Respiratory Syncytial Virus (RSV) Infection
  “Study was terminated by Sponsor; the decision was not due to any safety findings.” (97% match in meaning)
• Colorectal Lesion Evaluation and Appropriate Resolution (CLEAR) Study
  “Study terminated per sponsor decision due to operational reasons. The termination was not a result of any participant safety concerns.” (91% match in meaning)
• A Study of ARRY-371797 (PF-07265803) in Patients With Symptomatic Dilated Cardiomyopathy Due to a Lamin A/C Gene Mutation
  “The Sponsor terminated the study due to futility. The decision to stop the study was not based on safety concerns.” (90% match in meaning)
• Study of Ataluren (PTC124) in Hemophilia A and B
  “Study was terminated early due to Sponsor decision and not reflective of adverse safety findings.” (88% match in meaning)
• An Evaluation of the Erchonia Laser As a Non-Invasive Treatment to Improve the Appearance of Skin Laxity
  “The study was terminated early due to sponsor decision unrelated to safety or efficacy findings” (88% 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.