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

Sponsor
Trace Neuroscience, Inc.
Study ID
NCT07674667
Phase
PHASE1/PHASE2
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • TRCN-1023 — DRUG
    TRCN-1023 administered as an intrathecal injection.
  • Placebo — OTHER
    Intrathecal injection of artificial cerebrospinal fluid (aCSF).

Study Details

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.

Key Dates

First listed
Jun 29, 2026
Start date
Aug 31, 2026
Status verified
Jun 2026
Primary completion
Sep 30, 2027
Completion
Sep 30, 2027

Study Design

Enrollment
30 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: TRCN-1023
    Antisense oligonucleotide (ASO) administered by intrathecal injection
  • Placebo Comparator: Placebo
    Matching Placebo Comparator

Primary Outcome Measure

Frequency of Adverse Events [ Time Frame: 24 Weeks ]

Central Contacts

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