Autopsy report · NCT02193074

A Study to Assess the Efficacy and Safety of Nusinersen (ISIS 396443) in Infants With Spinal Muscular Atrophy

“After a positive interim analysis, the decision was made to terminate the study early to allow for participants to enroll into an open label study”

The sponsor’s own words in the registry.

Life of this trial

• Registered 1 month before it started.
• Ran for about 2 years 3 months before it stopped.
• 122 participants enrolled.
• Results were posted on the registry 8 months after it ended.

Vital statistics

Status

Terminated

Phase

Phase 3

Sponsor

Biogen

Sponsor type

Industry

Conditions

Spinal Muscular Atrophy

Interventions

nusinersen; Sham procedure

Participants

122

Sites

31

Countries

Australia, Belgium, Canada, France, Germany, Italy, Japan, South Korea, Spain, Sweden, Turkey (Türkiye), United Kingdom and more

Trials that died the same way

• Adherence to Antidepressant Treatment in Subjects With Depression
  “The study was terminated early based on the planned interim analysis that did not meet criteria for continuation.” (69% match in meaning)
• A Comparison of Surgical Preparations and Wound Infection Rates for Elective Cesarean Sections
  “Study was stopped following interim analysis.” (68% match in meaning)
• A Clinical Study to Evaluate the Efficacy and Safety of Aramchol in Subjects With NASH (ARMOR)
  “Interim analysis results from the open-label part of the study. The double blind portion of the study will be resumed once the study will continue.” (68% match in meaning)
• A Study to Assess the Long-term Safety and Efficacy of a Subcutaneous Formulation of Efgartigimod PH20 SC in Adults With Pemphigus (Vulgaris or Foliaceus)
  “Based on the lack of observed efficacy in the primary study ARGX-113-1904, the sponsor decided to discontinue the open-label extension study.” (68% match in meaning)
• 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.” (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.