Not medical advice. This website is not medical advice, a diagnosis, a match to a trial, or a recommendation to join a study. Listings are plain-English rewrites of public ClinicalTrials.gov records. Whether a site is still enrolling, and whether you qualify, can only be confirmed by the study team and your clinician. Source registry: ClinicalTrials.gov. Editorial rules: methodology.
PlainTrials
RecruitingPhase 1 / Phase 2interventionalRules rewrite

Phase 1 / Phase 2: testing TRCN-1023 for Amyotrophic Lateral Sclerosis

The FUNCtion Amyotrophic Lateral Sclerosis (ALS) trial is a randomly assigned, neither you nor the study doctors know who gets the real treatment, compared with a dummy treatment Phase 1/2 trial to measure the whether it is safe and how hard side effects are to live with 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).

Official registry: https://clinicaltrials.gov/study/NCT07674667 · Trace Neuroscience, Inc. · enrollment listed as 30

What this phase means

Phase 2: researchers already know a roughly safe dose (from phase 1). This stage asks whether the treatment actually helps the condition, and watches side effects more closely.

Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

What the registry says happens

If you join, the listed intervention(s) are TRCN-1023, or Placebo. The registry lists allocation as randomized. The FUNCtion Amyotrophic Lateral Sclerosis (ALS) trial is a randomly assigned, neither you nor the study doctors know who gets the real treatment, compared with a dummy treatment Phase 1/2 trial to measure the whether it is safe and how hard side effects are to live with of TRCN-1023 in adults living with ALS.

They plan to enroll about 30 people at 6 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.

Official title (unrewritten)

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

Interventions: TRCN-1023, Placebo

Primary outcome (registry wording): Frequency of Adverse Events

Who it is for (from inclusion criteria)

  • Ages 18 Years to 75 Years
  • 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

Public study contact (from the registry)

Trace Neuroscience Clinical Trials

+1 415-390-9509

Clinicaltrials@traceneuro.com

Published on ClinicalTrials.gov. Contact them as a possible participant. They decide eligibility.

Sites listed on ClinicalTrials.gov

6 listed

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FAQ about this NCT record

Is NCT07674667 still recruiting?

The sponsor posted status “Recruiting” on ClinicalTrials.gov at last ingest. Sites can pause independently. Confirm with the official record and the listed contact.

What phase is NCT07674667?

Phase 1 / Phase 2. Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

Can PlainTrials tell me if I qualify for NCT07674667?

No. The inclusion and exclusion lists on this page are readable extracts of the public eligibility block. Only the study team can screen you.

How to read a ClinicalTrials.gov record · Questions to ask the coordinator · Glossary