Autopsy report · NCT00997672

Lithium in Multiple System Atrophy

“Data Monitoring Committee decision on 22nd August 2011 for safety issues”

The sponsor’s own words in the registry.

Life of this trial

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

Vital statistics

Status

Terminated

Phase

Phase 2

Sponsor

Federico II University

Sponsor type

University, hospital or other

Conditions

Multiple System Atrophy

Interventions

Lithium Carbonate; Placebo

Participants

10

Sites

1

Countries

Italy

Trials that died the same way

• The Efficacy of Enteric-coated Mycophenolate Sodium (EC-MPS) (Myfortic) in The Treatment of Relapse or Resistant Proliferative Lupus Nephritis
  “Data Safety Monitoring Board concerning of the participants' safety” (77% match in meaning)
• High Resolution Imaging of Cerebral Vasculature by Functional Micro-Doppler Sonography During Brain Surgery
  “recommandation of the Data Safety monitoring Board” (76% match in meaning)
• Non-vitamin K Antagonist Oral Anticoagulants in Patients With Atrial High Rate Episodes
  “following a recommendation from the data safety and monitoring board due to safety concerns and a tendency towards futility.” (69% match in meaning)
• The Efficacy and Safety of REX-001 to Treat Ischemic Ulcers in Subjects With CLI Rutherford Category 5 and DM
  “Independent Data Monitoring Committee recommendation to stop due to futility” (67% match in meaning)
• To Assess The Efficacy and Safety Of Oral Sildenafil in the Treatment of Pulmonary Arterial Hypertension.
  “This study was terminated at the recommendation of an independent Data Monitoring Committee. The decision was not based on any safety concerns.” (62% 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.