Autopsy report · NCT03783923

A Study of Deflazacort (Emflaza®) in Participants With Limb-Girdle Muscular Dystrophy 2I (LGMD2I)

“The study was terminated early due to low enrollment and missing efficacy assessment data due to missed visits related to COVID-19.”

The sponsor’s own words in the registry.

Life of this trial

• Registered 10 months before it started.
• Ran for about 1 year 2 months before it stopped.
• 11 participants enrolled.
• Results were posted on the registry 1 year 6 months after it ended.

Vital statistics

Status

Terminated

Phase

Phase 3

Sponsor

PTC Therapeutics

Sponsor type

Industry

Conditions

Limb-Girdle Muscular Dystrophy

Interventions

Deflazacort

Participants

11

Sites

18

Countries

Canada, Denmark, France, Germany, Norway, Russia, Sweden, United States

Trials that died the same way

• Evaluating Emetine for Viral Outbreaks (EVOLVE)
  “The study was terminated due to insufficient participant enrollment resulting from a lower-than-expected number of COVID-19 cases” (85% match in meaning)
• Threshold Response of Lumbar Selective Nerve Root Block in Predicting Good Outcome Following Lumbar Foraminotomy
  “The study was terminated early due to a number of concurrent issues: low enrollment, limited data and COVID-19.” (85% match in meaning)
• Peripheral Nerve Stimulation for Back
  “Due to COVID-19 and other factors this study was terminated early and the patients currently enrolled are being used as a small pilot study.” (82% match in meaning)
• Anti-RSV Study in Chinese Patients (ASCENT)
  “The study was terminated early due to COVID-19-related enrollment disruptions, not as a result of any product safety concerns.” (79% match in meaning)
• Treatment Resistance Following Anti-cancer Therapies
  “Study terminated due to lack of enrollment that has been compounded by the global COVID-19 pandemic. There were no safety and/or efficacy concerns involved in the decision to stop enrollment.” (77% 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.