Efficacy and Safety of Plasma Exchange With Albutein® 5% in Participants With Amyotrophic Lateral Sclerosis

Inclusion Criteria

• Signed informed consent
• Subjects over 18 years of age and less than 70 years old
• Subjects with a possible, probable-lab supported, probable, or definite diagnosis of Amyotrophic Lateral Sclerosis (ALS), according to the revised El Escorial criteria
• Subjects having experienced their first ALS symptoms within 18 months prior to recruitment/consent
• Forced Vital Capacity > 70%
• Subjects must be medically suitable for study participation and willing to comply with all planned aspects of the protocol, including blood sampling, at the time of inclusion in the study.

Exclusion Criteria

• Subjects with pre-existing clinically significant lung disease not attributable to ALS
• Subjects diagnosed with other neurodegenerative diseases or diseases associated with other motor neuron dysfunction
• Participation in another investigational product study within one month prior to screening
• Females who are pregnant, breastfeeding, or, if of child-bearing potential, unwilling to practice a highly effective method of contraception (oral, injectable or implanted hormonal methods of contraception, placement of an intrauterine device or intrauterine system, condom or occlusive cap with spermicidal foam/ gel/ film/ cream/ suppository, male sterilization, or true abstinence) throughout the study
• Difficult or problematic peripheral vein access and inability to implant a central catheter which would make continuous Plasma exchange (PE) not feasible as per the visit protocol
• Contraindication to undergo PE or subject has abnormal coagulation parameters at the discretion of the Outpatient Apheresis Unit team, including but not limited to:
• Thrombocytopenia (platelets 1.5
• Beta-blocker treatment and bradycardia 2 milligram per deciliter (mg/dL)
• Presence of heart disease that contraindicates PE treatment, including ischemic cardiopathy and congestive heart failure
• Presence of prior behavioural disorders requiring pharmacological intervention with less than 3 months of stable treatment
• Mentally challenged subject who cannot give independent informed consent
• Any condition that would complicate compliance with the study protocol (i.e., illness with the expectation of less than one year survival, abuse of drugs or alcohol, etc.)