Autopsy report · NCT03540485

Safety and Efficacy of Melatonin in Patients With Multiple Progressive Primary Sclerosis

“Early termination due to operational feasibility reasons, resulting from a slow recruitment rate and logistical and financial difficulties that prevent reaching the planned sample size within the study schedule.”

The sponsor’s own words in the registry.

Life of this trial

• Registered 1 year 7 months before it started.
• Ran for about 6 years 3 months before it stopped.
• 25 participants enrolled.
• No results are posted on the registry.

Vital statistics

Status

Terminated

Phase

Phase 1, Phase 2

Sponsor

Fundación Pública Andaluza para la gestión de la Investigación en Sevilla

Sponsor type

University, hospital or other

Conditions

Sclerosis, Multiple; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Autoimmune Diseases

Interventions

Melatonin; Placebo

Participants

25

Sites

3

Countries

Spain

Trials that died the same way

• Intestinal Lavage to Promote Enteral Feeding and Prevent Necrotizing Enterocolitis in Extremely Preterm Infants
  “Recruitment was terminated early because of staffing limitations affecting delivery of the intervention, expiration of study funding, and slower-than-anticipated recruitment, which made completion of the planned sample size infeasible.” (81% match in meaning)
• Improving Surgical Safety of Seniors Through Preoperative Cognitive Screening
  “This study was terminated prior to its planned enrollment due to low recruitment rates at the time that the funding for the study was completed.” (75% match in meaning)
• Certolizumab Pegol for Treatment of Adult Greek Patients With Moderate to Severe Crohn's Disease Who Failed Infliximab
  “Study was terminated early because of slow recruitment” (74% match in meaning)
• A Double Blind Randomised Placebo-controlled Trial to Assess the Role of Iron Repletion in Glucose Homeostasis.
  “The reason for early termination is difficulties recruiting that caused a premature ending of financial resources ensuring protected time for research.” (74% match in meaning)
• Alfuzosin Versus Placebo in Acute Urinary Retention
  “The study was early terminated due to slow and difficult recruitment” (73% 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.