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ALS Phase II Study of NX210c

Active Not RecruitingPhase 2

Sponsor: Axoltis Pharma

Conditions: Amyotrophic Lateral Sclerosis

Interventions: NX210c, Placebo

Countries: France

This study will investigate the efficacy, safety, tolerability and pharmacokinetics (PK) of multiple intravenous infusions of NX210c, at two dose levels, in patients with Amyotrophic lateral sclerosis (ALS).

Eligibility overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility 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.

Locations (16)

Brest, France, France
Caen, France, France
Marseille, France, France
Nancy, France, France
Angers, France
Bordeaux, France
Bron, France
Clermont-Ferrand, France
Lille, France
Limoges, France
Montpellier, France
Nantes, France
Nice, France
Paris, France
Rennes, France
Tours, France