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AMX0114 in Adult Participants With Amyotrophic Lateral Sclerosis

Study acronym: LUMINA
StatusRecruiting
PhasePhase 1
Started
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Record History

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  1. Eligibility criteria revised
    • Site contacts updated at 6 of 14 sites
    v11
  2. Study sites: 13 to 14v10
  3. Study sites: 11 to 13v9
  4. Study sites: 9 to 11v8
  5. Study sites: 7 to 9v7
Show 5 earlier versionsHide 5 earlier versions
  1. Site details revised at 1 of 7 sitesv6
  2. Study sites: 1 to 7
    • Primary completion date: Jul 2027 to Feb 2027
    • Study completion date: Dec 2027 to Oct 2027
    • Eligibility criteria shortened, about 151 words
    v5
  3. Primary completion date: Feb 2027 to Jul 2027
    • Study completion date: Oct 2027 to Dec 2027
    • Start date changed from estimate of Feb 2025 to Apr 7, 2025
    • Eligibility criteria expanded, about 165 words
    v4
  4. Trial status: Not Yet Recruiting to Recruiting
    • Start date: Dec 2024 to Feb 2025
    • Study sites: 0 to 1
    • Study completion date: Dec 2027 to Oct 2027
    v3
  5. Re-verified, no change to tracked fieldsv2
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
This study is a placebo-controlled Phase I study to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of the antisense oligonucleotide (ASO) AMX0114 in adult participants with amyotrophic lateral sclerosis (ALS).
Trial Details
NCT Number NCT06665165
Lead Sponsor Amylyx Pharmaceuticals Inc.
Conditions
(from sponsor)		 ALS
Related terms Amyotrophic Lateral Sclerosis, Motor Neuron Disease
Enrollment 48 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov