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ALS Phase II Study of NX210c
Sponsor: Axoltis Pharma
Summary
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).
Official title: 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
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
80
Start Date
2024-10-25
Completion Date
2026-09-30
Last Updated
2025-12-24
Healthy Volunteers
No
Conditions
Interventions
NX210c
3 times a week, for 4 weeks
Placebo
3 times a week, for 4 weeks
Locations (16)
Centre Hospitalier Regional Et Universitaire De Brest
Brest, France, France
Centre Hospitalier Universitaire De Caen Normandie
Caen, France, France
Hôpital La Timone - APHM
Marseille, France, France
CHRU De Nancy
Nancy, France, France
Centre Hospitalier Universitaire d'Angers
Angers, France
Centre Hospitalier Universitaire De Bordeaux
Bordeaux, France
CHU de Lyon HCL
Bron, France
Centre Hospitalier Universitaire de Clermont-Ferrand - Hôpital Gabriel Montpied
Clermont-Ferrand, France
Centre Hospitalier Universitaire de Lille
Lille, France
Centre Hospitalier Et Universitaire de Limoges
Limoges, France
Centre Hospitalier Universitaire de Montpellier
Montpellier, France
Centre Hospitalier Universitaire de Nantes - Hôpital Nord Laennec
Nantes, France
Centre Hospitalier Universitaire de Nice
Nice, France
Hôpital de la Pitié Salpêtrière
Paris, France
Centre Hospitalier Universitaire de Rennes
Rennes, France
Centre Hospitalier Regional Universitaire de Tours
Tours, France