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Spinal injection aims to slow ALS in early trial

NCT ID NCT07674667

Disease control Sponsor: Trace Neuroscience, Inc. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 29, 2026 · Last updated Sep 10, 2026 · Updated 9 times

Summary

This study tests a single injection of TRCN-1023 into the spinal fluid of adults with ALS. The goal is to see if it is safe and shows early signs of slowing the disease over 24 weeks. Participants are randomly assigned to receive the drug or a placebo, and neither they nor their doctors know which they get.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
TRCN-1023
What this could lead to
If successful, this could point toward a new treatment that slows or stops the progression of ALS.
What could go wrong
This is an early-phase trial with only 30 participants, so results may not apply to all ALS patients. The drug may not show benefit or could cause side effects.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

About 30 people

The number the study aims to enrol. It can still change while the study runs.

Started

Aug 2026

Expected to finish

Sep 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 75 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Key Inclusion Criteria: * 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 Key Exclusion Criteria: * Carries a confirmed SOD1 or FUS gene mutation * 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) * 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 significant abnormal liver, kidney, or blood test results * 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 clinically significant condition other than ALS that could interfere with study participation

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Conditions

The condition(s) this trial relates to.

amyotrophic lateral sclerosis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Amyotrophic lateral sclerosis

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    4 sites in 3 countries. The list below names each one and where it is.

  3. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  4. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • TUM Klinikum Rechts der Isar

    RECRUITING

    Munich, Germany

  • University Medical Center Rostock

    RECRUITING

    Rostock, 18147, Germany

  • University Medical Center Utrecht

    RECRUITING

    Utrecht, 3508 GA, Netherlands

    Contact Email: •••••@•••••

  • University of Sheffield

    RECRUITING

    Sheffield, S10 2HQ, United Kingdom

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