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Study of Sodium Phenylbutyrate (ACER-001) for the Treatment of Pediatric and Adults Patients With Medium Chain Acyl-CoA Dehydrogenase Deficiency (MCADD)

StatusRecruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗

Record History

See every version on ClinicalTrials.gov ↗

  1. Re-verified, no change to tracked fieldsv6
  2. Primary completion date: Nov 2026 to Jan 2027
    • Study completion date: Feb 2027 to Jul 2027
    • Start date changed from estimate of Jul 2025 to Jun 30, 2025
    v5
  3. Start date: Apr 2025 to Jul 2025
    • Primary completion date: Sep 2026 to Nov 2026
    • Study completion date: Jan 2027 to Feb 2027
    • Site contact updated
    v4
  4. Start date: Feb 2025 to Apr 2025
    • Primary completion date: Apr 2026 to Sep 2026
    • Study completion date: Jul 2026 to Jan 2027
    v3
  5. Secondary endpoints: details revised at 3 of 3 entries
    • Site contact updated
    • Study description expanded, about 1 word
    v2
  6. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
This is a medical research study to test a medication in patients 4 years of age and older with a disease called medium-chain acyl-CoA dehydrogenase deficiency (MCADD) caused by the common ACADM c.985 A\>G (K304E) mutation. The medication is sodium phenylbutyrate (ACER-001), which is currently FDA approved for the treatment of Urea Cyle Disorders. Previous research suggests that sodium phenylbutyrate may also be effective in the treatment MCADD. This study will investigate the safety and efficacy (how well it works) of sodium phenylbutyrate in patients with MCADD.
Trial Details
NCT Number NCT06773026
Lead Sponsor Jerry Vockley, MD, PhD
Collaborators: Zevra Therapeutics
Conditions
(from sponsor)		 Medium-chain Acyl-CoA Dehydrogenase Deficiency
Related terms Medium chain acyl CoA dehydrogenase deficiency
Enrollment 24 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov