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NCT05518188 · ClinicalTrials.gov registry record · Phase 1
Melpida: Recombinant Adeno-associated Virus (serotype 9) Encoding a Codon Optimized Human AP4M1 Transgene (hAP4M1opt)
A Phase 1 study of Spasticity, Muscle and Microcephaly, sponsored by Elpida Therapeutics SPC.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 4
- Enrollment target
- 1
- Study location
NCT05518188 is a Phase 1 study of Spasticity, Muscle and Microcephaly that is actively recruiting participants, run by Elpida Therapeutics SPC. The registered enrollment target is 4 participants, below the 80-participant average among 11 other Spasticity, Muscle trials with a reported enrollment target (95% lower). The trial reports 1 study location across 1 state.
The verdict
NCT05518188, a Phase 1 study of Spasticity, Muscle and Microcephaly, is actively recruiting participants, sponsored by Elpida Therapeutics SPC.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 4 participants
- Enrollment target
- 1
- Study location
Study Summary
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.
Conditions Studied
Interventions
- BIOLOGICAL MELPIDA
Study Locations (1)
Texas
- Children's Medical Center Dallas - Dallas
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 4 participants |
| Start Date | 2023-02-15 |
| Est. Completion | 2030-10-01 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05518188
The ClinicalTrials.gov registry entry for NCT05518188 describes a study currently listed as recruiting, categorized as Phase 1. The registered enrollment target is 4 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 80-participant average among 11 other Spasticity, Muscle trials with a reported enrollment target (95% lower). The listed sponsor is Elpida Therapeutics SPC, which has 4 total studies on file at ClinicalTrials.gov.
The record links to 6 conditions, with Spasticity, Muscle appearing as the primary indexed condition, and to 1 intervention - of which MELPIDA is the first listed.
NCT05518188 reports 1 study location spanning 1 distinct geographic area - top geographies include Texas.
Frequently Asked Questions
What is clinical trial NCT05518188 about?
NCT05518188 is a clinical study titled "Melpida: Recombinant Adeno-associated Virus (serotype 9) Encoding a Codon Optimized Human AP4M1 Transgene (hAP4M1opt)". 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...
What is the current status of trial NCT05518188?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 4 participants. The study started on 2023-02-15. Estimated completion is 2030-10-01.
What conditions does trial NCT05518188 study?
This clinical trial studies the following conditions: Spasticity, Muscle, Microcephaly, Spastic Paraplegia, SPG50, Growth Retardation.
What interventions are being tested in trial NCT05518188?
The interventions under investigation include: MELPIDA (BIOLOGICAL).
Who is sponsoring clinical trial NCT05518188?
This trial is sponsored by Elpida Therapeutics SPC, which has 4 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05518188 being conducted?
This trial has 1 study location across Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.