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Melpida: Recombinant Adeno-associated Virus (Serotype 9) Encoding a Codon Optimized Human AP4M1 Transgene (hAP4M1opt)

StatusRecruiting
PhasePhase 1/2
Started
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Record History

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  1. Study Identification, Study Status, Oversight, Contacts/Locationsv10
  2. Lead sponsor: University of Texas Southwestern Medical Center to Elpida Therapeutics SPCv9 Show 5 more changesShow less
    • Enrollment target: 2 to 4
    • Study description revised
    • Site contact updated
    • Collaborator revised
    • Eligibility criteria expanded, about 1 word
  3. 4 versions Re-verified since Apr 29, 2023, no change to tracked fieldsv5-v8
  4. Trial status: Not Yet Recruiting to Recruiting
    • Start date: Jan 15, 2023 to Feb 15, 2023
    • Study sites: 0 to 1
    v4
  5. Start date: Oct 1, 2022 to Jan 15, 2023v3
  6. Study description shortened, about 37 words
    • Collaborator revised
    v2
  7. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
MELPIDA is proposed for the treatment of subjects with SPG50 and targets neuronal cells to deliver a fully functional human AP4M1 cDNA copy via intrathecal injection to counter the associated neuronal loss. Outcomes will evaluate the safety and tolerability of a single dose of MELPIDA, which will be measured by the treatment-associated adverse events (AEs) and serious adverse events (SAEs). Secondarily, the trial will explore efficacy in terms of disease burden assessments.
Trial Details
NCT Number NCT05518188
Lead Sponsor Elpida Therapeutics SPC
Collaborators: University of Texas Southwestern Medical Center
Conditions
(from sponsor)		 Spasticity, Muscle, Microcephaly, Intellectual Deficiency, Growth Retardation, SPG50, Spastic Paraplegia
Related terms Microcephaly, Muscle Spasticity, Paraplegia
Enrollment 4 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov