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
Trial ID: NCT06365216
Interventional - Phase 2 - Active, not recruiting
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).
Conditions
- Amyotrophic Lateral Sclerosis
Interventions
Eligibility
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.
Sponsor
Axoltis Pharma, ACT4ALS network
Source: ClinicalTrials.gov
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