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Phase 3 Efficacy Study With Concurrent Control of IT MELPIDA in SPG50.Concurrent Controls.

NCT06692712 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2026-04-20

No results posted yet for this study

Summary

Phase 3, open-label study to assess the efficacy and safety of a single lumbar intrathecal administration of MELPIDA in individuals with Hereditary Spastic Paraplegia Type 50 (SPG50).

Conditions

  • Hereditary Spastic Paraplegia Type 50

Interventions

GENETIC

MELPIDA

Gene Therapy agent

Sponsors & Collaborators

  • University of Texas Southwestern Medical Center

    collaborator OTHER

  • Hospital Sant Joan de Deu

    collaborator OTHER

  • Elpida Therapeutics SPC

    lead INDUSTRY

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
4 Months
Max Age
72 Months
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-04-01
Primary Completion
2032-02-28
Completion
2032-06-01
FDA Drug
Yes

Countries

  • United States
  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06692712 on ClinicalTrials.gov