Tests TRCN-1023 injection in adults living with ALS
Tests TRCN-1023, a spinal fluid injection, in adults with ALS.
Plain-language title generated from the registry record
Registry title: FUNCtion ALS: Aiming to Restore UNC13A Function in People Living With ALS
Key facts
- Where
- Lübeck, Munich, and Rostock, GermanySee the 3 sites
- Phase
- Phase 1/2
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 75 years old?
Source: NCT07674667, who can take part
Where in Germany
- Universitätsklinikum Schleswig-HolsteinLübeck, GermanyTaking people
- Tum Klinikum Rechts Der IsarMunich, GermanyTaking people
- University Medical Center RostockRostock, GermanyTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Trace Neuroscience, Inc.
- Trial code
- NCT07674667
- Record updated
- 14 October 2026
- Original description
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.Read full original descriptionShow less
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
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.
Inclusion: Adults aged 18 to 75 years; Diagnosis of ALS (clinically definite, clinically probable, or clinically probable laboratory supported); ALS symptoms began within the past 24 months; Able to perform breathing tests: slow vital capacity (SVC) with consistent results, with breathing capacity of at least 60% of the expected value; Able and willing to meet all study requirements, including travel to the study site, brain magnetic resonance imaging (MRI) scans, lumbar punctures, and blood draws; Able and willing to use wearable sensors and complete speech assessments at home; On a stable dose of approved ALS medication for at least 4 weeks prior to screening; Capable of providing informed consent.
Exclusion: Has a tracheostomy or requires continuous assisted ventilation more than 22 hours per day during the preceding 3 months before the first Screening Visit; Has a contraindication to brain MRI (e.g., pacemaker, metal implants); Is currently enrolled in another clinical trial or has received an investigational treatment within the past 4 weeks; Has previously received gene therapy, stem cell therapy, or another Antisense oligonucleotide (ASO) treatment; Has a contraindication to lumbar puncture or spinal injection (e.g., blood clotting disorders, certain blood thinners, signs of increased pressure in the brain); Has a clinically significant condition other than ALS that could interfere with study participation; Carries a confirmed SOD1 or FUS gene mutation; Has significant abnormal liver, kidney, or blood test results.