Autopsy report · NCT06422377

A Study Evaluating Soticlestat in Participants With Dravet Syndrome or Lennox-Gastaut Syndrome Who Have Been Exposed to Fenfluramine

“Business decision unrelated to patient safety.”

The sponsor’s own words in the registry.

Life of this trial

• Ran for about 4 months before it stopped.
• 1 participant enrolled.
• Results were posted on the registry 7 months after it ended.

Vital statistics

Status

Terminated

Phase

Phase 3

Sponsor

Takeda

Sponsor type

Industry

Conditions

Dravet Syndrome (DS); Lennox-Gastaut Syndrome (LGS)

Interventions

Soticlestat

Participants

1

Sites

1

Countries

Denmark

Trials that died the same way

• Treatment of Impulsive Aggression (IA) in Adolescent With ADHD in Conjunction With Standard ADHD Treatment
  “Business decision, not related to safety” (76% match in meaning)
• Study of Human Central Nervous System (CNS) Stem Cell Transplantation in Cervical Spinal Cord Injury
  “Based on a business decision unrelated to any safety concerns.” (75% match in meaning)
• A Study to Assess AMG 701 Montherapy, or in Combination With Pomalidomide, With or Without, Dexamethasone in Subjects With Relapsed or Refractory Multiple Myeloma
  “business decision, not safety reasons.” (72% match in meaning)
• Efficacy and Safety of Azilsartan Medoxomil Used in Combination With Metformin in Participants With Hypertension and Diabetes
  “Business Decision; No Safety Or Efficacy Concerns. (See below)” (68% match in meaning)
• Efficacy, Safety, Tolerability and Pharmacokinetics of SUN13837 to Treat Acute Stroke
  “study was stopped for business/administrative reasons and not for patient safety concerns” (68% 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.