RecruitingPhase 1Phase 2NCT07674667

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

A Randomized, Double-Blind, Placebo-Controlled, Phase 1 / 2 Trial Evaluating the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Exploratory Efficacy of TRCN-1023 Administered by Intrathecal Injections to Adult People Living With Amyotrophic Lateral Sclerosis


Sponsor

Trace Neuroscience, Inc.

Enrollment

30 participants

Start Date

Aug 20, 2026

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying Placebo and a drug called TRCN-1023 for people with amyotrophic lateral sclerosis. The study is currently recruiting participants at 2 locations. People eligible for this study include aged 18 Years to 75 Years.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGTRCN-1023

TRCN-1023 administered as an intrathecal injection.

OTHERPlacebo

Intrathecal injection of artificial cerebrospinal fluid (aCSF).


Locations(4)

TUM Klinikum Rechts der Isar

Munich, Germany

University Medical Center Rostock

Rostock, Germany

University Medical Center Utrecht

Utrecht, Netherlands

University of Sheffield

Sheffield, United Kingdom

View Full Details on ClinicalTrials.gov

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NCT07674667


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