Autopsy report · NCT03705390

A Safety and Tolerability Study of ILB® in Patients With Amyotrophic Lateral Sclerosis (ALS)

“Study initially suspended due to COVID-19 Pandemic- treatment stopped - never reopened to recruitment..”

The sponsor’s own words in the registry.

Life of this trial

• Registered 7 months before it started.
• Ran for about 2 years 4 months before it stopped.
• 11 participants enrolled.
• Results were posted on the registry 3 years 11 months after it ended.

Vital statistics

Status

Terminated

Phase

Phase 2

Sponsor

University of Birmingham

Sponsor type

University, hospital or other

Conditions

Amyotrophic Lateral Sclerosis; Motor Neuron Disease

Interventions

ILB®

Participants

11

Sites

1

Countries

United Kingdom

Trials that died the same way

• Lifestyle, Exercise and Diet: The LEAD Study
  “Due to COVID-19, recruitment and enrollment was suspended and never resumed. COVID-related changes have been made to the clinical program which houses our intervention, and we could not compare new participants with our previous cohort.” (85% match in meaning)
• A Study of Pleiotropic Pioglitazone Effects on the Alcoholic Lung (APPEAL Study)
  “Study was suspended in 2020 due to COVID-19 pandemic as a result of recruitment challenges and the inability to conduct all study procedures (e.g., bronchoscopy) per protocol. In late 2021 the decision was made to not re-open the study.” (85% match in meaning)
• Improving Health Behaviors for Pediatric Cancer Survivors
  “Study recruitment of new participants was suspended during 2020 due to the Covid-19 pandemic.” (83% match in meaning)
• rTMS Brain Stimulation and Cognition
  “Recruitment and enrollment were suspended due to COVID-19 and ultimately the study was withdrawn due trained personnel moving on to new projects.” (81% match in meaning)
• Intranasal Insulin for the Treatment of HAND
  “On 3/15/2020 study visits were suspended due to COVID-19 pandemic. With safety concerns surrounding COVID-19 and difficulty recruiting, the investigators decided to close enrollment 10/16/2020 after interim data were reviewed by the DSMB and NIH.” (80% 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.