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Rocket Study: A Study to Characterize Biomarkers and Disease Progression in Participants With Pelizaeus-Merzbacher Disease

StatusRecruiting
PhaseNot specified
Started
View on ClinicalTrials.gov ↗

Record History

  1. Study sites: 8 to 10
  2. Study sites: 9 to 8 Eligibility criteria expanded, about 7 words Show 1 more changeShow less
    • Eligibility criteria expanded, about 7 words
  3. Site details revised at 2 of 9 sitesv12
  4. Study sites: 8 to 9v11
  5. Study sites: 7 to 8v10
Show 8 earlier versionsHide 8 earlier versions
  1. Study sites: 5 to 7v9
  2. Study sites: 4 to 5v8
  3. Study sites: 6 to 4v7
  4. Enrollment target: 20 to 32 Primary and study completion dates: Aug 2025 to Mar 2029 · Study description revised · Eligibility criteria shortened, about 1 word · 1 morev6 Show 4 more changesShow less
    • Primary and study completion dates: Aug 2025 to Mar 2029
    • Study description revised
    • Eligibility criteria shortened, about 1 word
    • Study title expanded, about 2 words

    See this version in full on ClinicalTrials.gov ↗

  5. 2 versions Re-verified since Mar 26, 2024, no change to tracked fieldsv4-v5
  6. Study sites: 5 to 6v3
  7. Study sites revised (5)v2 See this version in full on ClinicalTrials.gov ↗
  1. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
The purpose of the study is to prospectively assess longitudinal changes in proteolipid protein 1 (PLP1) protein, disease-related biomarkers in cerebral spinal fluid (CSF) and blood, neuroimaging parameters relevant to Pelizaeus-Merzbacher disease (PMD) and longitudinal changes in performance on clinical, participant, and caregiver-reported outcome assessments to inform the development of therapies for PMD.
Trial Details
NCT Number NCT05659901
Lead Sponsor Ionis Pharmaceuticals, Inc.
Conditions Pelizaeus-Merzbacher Disease
Enrollment 32 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov