Autopsy report · NCT04700046

Study to Investigate the Efficacy and Safety of Mexiletine in Patients With Myotonic Dystrophy Type 1 and Type 2

“Assessing novel alternative study designs and regulatory pathways”

The sponsor’s own words in the registry.

Life of this trial

• Withdrawn before it enrolled anyone. Its dates are the sponsor's plans, not events that happened.

Vital statistics

Status

Withdrawn

Phase

Phase 3

Sponsor

Lupin Ltd.

Sponsor type

Industry

Conditions

Myotonic Dystrophy Type 1 and Type 2

Interventions

Mexiletine 167 mg; Placebo

Participants

0

Trials that died the same way

• Effects of Whole Food, Plant-Based Nutrition on Chronic Kidney Disease With Proteinuria
  “Substantially redesigning study protocol and opening a new study in the future.” (64% match in meaning)
• A Safety and Efficacy Study to Determine if Giving Intravenous Fish Oil Helps Children With Liver Disease
  “study intervention was approved by the FDA” (63% match in meaning)
• The CONNECT Program: Testing a Telephone-Based Mental Health Intervention for Older Adults
  “Change in study design was implemented and the study design no longer follows a pilot randomized controlled trial.” (61% match in meaning)
• A Study in Patients With Advanced Parkinson's Disease to Assess the Relative Bioavailability of Levodopa Administered as ND0612 Subcutaneous Infusion Versus Levodopa Administered as Carbidopa-Levodopa Enteral Suspension
  “Decision to change the study design” (61% match in meaning)
• Safety and Pharmacokinetics of Orodispersible BT-11 in Active Eosinophilic Esophagitis
  “The closure of the study is driven by the decision to redesign the study protocol for future studies.” (61% 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.