Autopsy report · NCT00545597

A Phase III Trial of Lorenzo's Oil in Adrenomyeloneuropathy

“Upon recommendation of DSMB”

The sponsor’s own words in the registry.

Life of this trial

• Registered 2 years 7 months after it had already started.
• Ran for about 2 years 7 months before it stopped.
• 240 participants planned (an estimate, not an actual count).
• No results are posted on the registry.

Vital statistics

Status

Terminated

Phase

Phase 3

Sponsor

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Sponsor type

US National Institutes of Health

Conditions

Adrenomyeloneuropathy; Adrenoleukodystrophy

Interventions

Lorenzo's oil

Participants

240 (planned, not actual)

Sites

1

Countries

United States

Trials that died the same way

• Study of Immune Modulatory Drugs and Other Treatments in COVID-19 Patients: Sarilumab, Azithromycin, Hydroxychloroquine Trial - CORIMUNO-19 - VIRO
  “DSMB recommendation (futility)” (87% match in meaning)
• Preventing Adverse Incisional Outcomes at Cesarean Multicenter Trial
  “DSMB recommendation following interim analysis” (80% match in meaning)
• Helping HIV Infected Patients in South Africa Adhere to Drug Regimens
  “DSMB stopped trial for futility” (71% match in meaning)
• Efficacy and Safety Study of Drugs for Treatment of Visceral Leishmaniasis in Brazil
  “DSMB recommendation based on programmed interim analysis.” (71% match in meaning)
• Efficacy and Safety of Novel Treatment Options for Adults With COVID-19 Pneumonia
  “DSMB advise due to high probability of futility” (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.