Autopsy report · NCT01363882

Polysomnography-directed Noninvasive Ventilation in Amyotrophic Lateral Sclerosis (ALS)

“Insufficient enrollment \& high rate of failure to complete protocol”

The sponsor’s own words in the registry.

Life of this trial

• Registered 3 years 1 month after it had already started.
• Ran for about 2 years 5 months before it stopped.
• 25 participants enrolled.
• No results are posted on the registry.

Vital statistics

Status

Terminated

Phase

Na

Sponsor

Columbia University

Sponsor type

University, hospital or other

Conditions

Amyotrophic Lateral Sclerosis (ALS)

Interventions

Sleep study-guided adjustment of NIV; Standard initiation of NIV

Participants

25

Sites

1

Countries

United States

Trials that died the same way

• Cellular Immunotherapy Treatment Antigen-Directed for EBV Lymphoma
  “Insufficient enrollment rate” (78% match in meaning)
• Comparison of Oral Morphine Versus Nasal Ketamine Spray With Chitosan in Cancer Pain Outpatients
  “insufficient enrollment” (77% match in meaning)
• Glucagon Receptor Inhibition to Enable Breast Cancer Patients to Benefit From PI3K Inhibitor Therapy (REMD-477)
  “Lack of enrollment” (75% 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.