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FUNCtion ALS: Aiming to Restore UNC13A Function in People Living With ALS

NCT07674667 · Status: RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2026-08-05

No results posted yet for this study

Summary

The FUNCtion Amyotrophic Lateral Sclerosis (ALS) trial is a randomized, double-blind, placebo-controlled Phase 1/2 trial to evaluate the safety and tolerability of TRCN-1023 in adults living with ALS. TRCN-1023 is an investigational medicine given as a single injection into the fluid surrounding the spine (intrathecal injection). The trial will also assess how the body processes the drug and whether it shows early signs of benefit over 24 weeks.

Conditions

Interventions

DRUG

TRCN-1023

TRCN-1023 administered as an intrathecal injection.

OTHER

Placebo

Intrathecal injection of artificial cerebrospinal fluid (aCSF).

Sponsors & Collaborators

  • Trace Neuroscience, Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-08-31
Primary Completion
2027-09-30
Completion
2027-09-30
FDA Drug
Yes

Countries

  • Germany
  • Netherlands

Study Locations

More Related Trials

Entities

Diseases

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 NCT07674667 on ClinicalTrials.gov