NCT07674667RecruitingPhase 1/2
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
Source: ClinicalTrials.gov · Last updated 14 Oct 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 1/2
- Study type
- Interventional
- Enrollment
- 30 (estimated)
- First submitted
- 21 Jun 2026
- Start date
- Aug 2026
- Primary completion date
- Sept 2027
- Lead sponsor
- Trace Neuroscience, Inc.
- Diseases
- ALS (motor neurone disease)
- NCT number
- NCT07674667
- EudraCT number
- 2025-523111-11
What you commit to
- Study type: Interventional · Phase 1/2
- Planned participants: 30
- From Aug 2026 to the primary completion date, Sept 2027
- 6 sites in 3 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
Other illness
- 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
Other
- Carries a confirmed SOD1 or FUS gene mutation
- Has significant abnormal liver, kidney, or blood test results
Who the study is looking for
- 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
Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers
Sites (6)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Universitätsklinikum Schleswig-Holstein Coordinator of this site? Confirm its status | Lübeck | Germany | Recruiting |
| Tum Klinikum Rechts Der Isar Coordinator of this site? Confirm its status | Munich | Germany | Recruiting |
| University Medical Center Rostock Coordinator of this site? Confirm its status | Rostock | Germany | Recruiting |
| University College London Coordinator of this site? Confirm its status | London | United Kingdom | Recruiting |
| University of Sheffield Coordinator of this site? Confirm its status | Sheffield | United Kingdom | Recruiting |
| University Medical Center Utrecht Coordinator of this site? Confirm its status | Utrecht | Netherlands | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.