Autopsy report · NCT03635073
A Study of Soticlestat in Adults and Children With Rare Epilepsies
Cause of deathFutility
“Due to negative results from phase 3 SKYLINE and SKYWAY studies and unrelated to patient safety it has been determined that supplementary data from TAK-935-18-001 study is no longer necessary. Therefore, Takeda has made a decision to close this study”
Life of this trial
- Ran for about 7 years before it stopped.
- 156 participants enrolled.
- Results were posted on the registry 8 months after it ended.
Vital statistics
- Status
- Terminated
- Phase
- Phase 2
- Sponsor
- Takeda
- Sponsor type
- Industry
- Conditions
- Epilepsy; Dravet Syndrome (DS); Lennox-Gastaut Syndrome (LGS)
- Interventions
- Soticlestat
- Participants
- 156
- Sites
- 59
- Countries
- Australia, Canada, China, Israel, Poland, Portugal, Spain, United States
Trials that died the same way
- Dose-Finding Study To Evaluate Safety, Tolerability, and Efficacy of E2609 in Participants With Mild Cognitive Impairment Due to Alzheimer's Disease (Prodromal Alzheimer's Disease) and Mild to Moderate Dementia Due to Alzheimer's Disease
“This study was terminated early by the sponsor on the recommendation of an independent data safety monitoring board following review of unblinded data from the Phase 3 studies E2609-G000-301 (NCT02956486) and E2609-G000-302 (NCT03036280).”
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.