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A Prospective, Randomized, Double-Blind, Placebo-Controlled, Single-Center Study of Oral Epalrestat Therapy in Pediatric Subjects With Phosphomannomutase 2-congenital Disorder of Glycosylation (PMM2-CDG)

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Trial Profile

A Prospective, Randomized, Double-Blind, Placebo-Controlled, Single-Center Study of Oral Epalrestat Therapy in Pediatric Subjects With Phosphomannomutase 2-congenital Disorder of Glycosylation (PMM2-CDG)

Status: Active, no longer recruiting
Phase of Trial: Phase III

Latest Information Update: 06 Jun 2024

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At a glance

  • Drugs Epalrestat (Primary)
  • Indications Congenital disorder of glycosylation type 1A
  • Focus Therapeutic Use
  • Most Recent Events

    • 06 Jun 2024 Last checked against ClinicalTrials.gov: US National Institutes of Health record.
    • 30 May 2024 Planned primary completion date changed from 28 Feb 2024 to 28 Feb 2025.
    • 18 Mar 2024 According to Maggie's Pearl media release, In December 2021, the Food and Drug Administration notified Maggie's Pearl that the Phase III clinical trial in 40 patients with PMM2-CDG could proceed. The trial recruited 38 study subjects and closed enrollment in November 2023. The first 29 participants will complete their 15-month visits over the next 2-3 months.
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