SEALS // A double-blind, randomized, placebo-controlled, multicentric, phase II study in adult patients with amyotrophic lateral sclerosis (ALS) to assess efficacy, safety, tolerability and pharmacokinetics of multiple intravenous infusions of NX210c.

Topic / Pathology

  • ALS
  • Phase 2

Objectives

To assess the effect of NX210c on blood neurofilament light chain (NfL) or on a blood and cerebrospinal fluid (CSF) biomarker of BBB integrity at 6-week follow-up. 

Learn more about : https://clinicaltrials.gov/study/NCT06365216 

Sponsor

AXOLTIS Pharma

Investigator

National coordinator : Dr Emilien Bernard

Partnership(s) with patients association(s)

Critères d'inclusion

  • Aged ≥ 18 years, inclusive at screening.
  • Patients diagnosed as having possible, probable, probable laboratory-supported, or definite ALS according to El Escorial Revised criteria.
  • King's Clinical Staging Stage ≤3, disease duration of ≤ 36 calendar months

Critères de non-inclusion

  • Patients with any cognitive or psychological disorder, intellectual disability or other significant impairment that would result in an inability to understand and sign the informed consent.
  • History of any clinically significant or unstable medical, neurological, psychiatric condition, disorder or disease (other than ALS) or social circumstances that, based on the investigator's judgment, would interfere with the conduct of the study or pose a risk to the patient if they were to participate.

Status

Follow-Up (recruiting ended)

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Updated on 16 December 2025