Autopsy report · NCT03107052

A Study to Explore the Long-Term Safety and Efficacy of Fremanezumab (TEV-48125) for the Prevention of Cluster Headache

“The study was terminated after the episodic cluster study was terminated due to a pre specified futility analyses”

The sponsor’s own words in the registry.

Life of this trial

• Registered 1 month before it started.
• Ran for about 2 years 1 month before it stopped.
• 275 participants enrolled.
• Results were posted on the registry 11 months after it ended.

Vital statistics

Status

Terminated

Phase

Phase 3

Sponsor

Teva Branded Pharmaceutical Products R&D, Inc.

Sponsor type

Industry

Conditions

Cluster Headache

Interventions

Fremanezumab

Participants

275

Sites

83

Countries

Australia, Canada, Finland, Germany, Israel, Italy, Netherlands, Poland, Spain, Sweden, United Kingdom, United States

Trials that died the same way

• CONvalescent Plasma for Hospitalized Adults With COVID-19 Respiratory Illness (CONCOR-1)
  “Study was terminated after the planned interim analysis as the pre-defined futility threshold was met” (77% match in meaning)
• Minocycline for the Treatment of Decreased Mental Function in HIV-Infected Adults
  “This study was terminated early due to futility.” (76% match in meaning)
• Tissue Adhesive vs. Sterile Strips After Cesarean Delivery
  “Based on results of an interim analysis, the study was halted for futility” (73% match in meaning)
• Trial Investigating the Efficacy and Safety of SCH 900435 (Org 25935) in Relapse Prevention in Participants With Alcohol Dependence (P05718)
  “Based on the outcome of a planned interim analysis, the study was stopped early due to futility.” (72% match in meaning)
• Removal Versus Retention of Cerclage in Preterm Premature Rupture of Membranes (PPROM)
  “This trial was terminated following a futility analysis confirming futility of continuing the study” (72% 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.