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A Study to Assess Nomlabofusp in Adolescents and Children With Friedreich's Ataxia

NCT06681766 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 18

Last updated 2026-01-28

No results posted yet for this study

Summary

The goal of this clinical trial is to evaluate the safety and tolerability of nomlabofusp (CTI-1601) in adolescents and children with Friedreich's ataxia (FRDA).

Conditions

  • Friedreich Ataxia

Interventions

DRUG

Nomlabofusp

Nomlabofusp is a recombinant fusion protein provided in a sterile, preservative-free buffered solution for subcutaneous injection intended to deliver human frataxin, the protein deficient in Friedreich's ataxia.

DRUG

Placebo

The placebo is a sterile, preservative-free, clear liquid for subcutaneous injection.

Sponsors & Collaborators

  • Larimar Therapeutics, Inc.

    lead INDUSTRY

Principal Investigators

  • Larimar Therapeutics, Inc. · Larimar Therapeutics, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
2 Years
Max Age
17 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-12-06
Primary Completion
2025-04-28
Completion
2025-04-28
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

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 NCT06681766 on ClinicalTrials.gov