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Investigating NX210c for treating ALS

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

Phase 2 Interventional Axoltis Pharma · NCT06365216

This study is testing a new treatment called NX210c to see if it can help people with ALS by improving their brain and nerve function.

Quick facts

PhasePhase 2
Study typeInterventional
Enrollment80 (estimated)
Ages18 Years and up
SexAll
SponsorAxoltis Pharma Industry-sponsored
Locations12 sites (Angers and 11 other locations)
Trial IDNCT06365216 on ClinicalTrials.gov

What this trial studies

This study evaluates the efficacy, safety, tolerability, and pharmacokinetics of NX210c through multiple intravenous infusions in patients with Amyotrophic Lateral Sclerosis (ALS). ALS is a severe neurodegenerative disease that leads to muscle atrophy and paralysis, with limited treatment options currently available. The study aims to restore blood-brain barrier integrity and enhance neurotransmission, based on promising preclinical data. Participants will receive either NX210c or a placebo, and the study will assess the drug's effects over time.

Who should consider this trial

Good fit: Ideal candidates include adults aged 18 and older diagnosed with ALS at an early stage and with a disease duration of less than 36 months.

Not a fit: Patients with significant cognitive or psychological disorders or other unstable medical conditions may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new therapeutic option for patients suffering from ALS.

How similar studies have performed: While this approach is based on promising preclinical data, the specific application of NX210c in ALS is novel and has not been extensively tested in prior studies.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

* 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

Exclusion Criteria:

* 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.

Where this trial is running

Angers and 11 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Amyotrophic Lateral SclerosisALS
Last reviewed 2026-06-09 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.