Autopsy report · NCT00818389

Study to Investigate the Safety and Efficacy of Lithium in Volunteers With Amyotrophic Lateral Sclerosis (ALS)

“NINDS DSMB recommended trial be terminated for futility after reviewing an interim analysis of 84 subjects.”

The sponsor’s own words in the registry.

Life of this trial

• Ran for about 9 months before it stopped.
• 84 participants enrolled.
• Results were posted on the registry 1 year 6 months after it ended.

Vital statistics

Status

Terminated

Phase

Phase 2, Phase 3

Sponsor

Massachusetts General Hospital

Sponsor type

University, hospital or other

Conditions

Amyotrophic Lateral Sclerosis

Interventions

Lithium Carbonate; Riluzole; placebo

Participants

84

Sites

37

Countries

Canada, United States

Trials that died the same way

• Direct Lysis of Staph Aureus Resistant Pathogen Trial of Exebacase
  “The independent DSMB recommended that the study be stopped for futility following interim efficacy analysis.” (76% match in meaning)
• Interventional Management of Stroke (IMS) III Trial
  “NINDS/NIH-DSMB recommended halting trial due to futility, no safety concerns.” (76% match in meaning)
• High Dose Chemotherapy With Amifostine and Autologous Stem Cell Transplantation for High Risk Relapsed Pediatric Solid Tumors and Brain Tumors
  “The study was terminated as recommended by the DSMB due to inability to meet enrollment goals within the time frame allotted (target of 25 patients over 5 years).” (73% match in meaning)
• ATG Plus Low-dose PT-Cy for GVHD Prevention
  “DSMB recommended halting the study owing to futility after the first interim analysis in August 2024.” (73% match in meaning)
• Estrogen Replacement to Reduce Risk of Neurologic Injury After Coronary Artery Bypass Graft Surgery
  “DSMB stopped the study based on conclusion of likely futility of treatment on the primary outcome.” (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.