Safety, Tolerability, and Activity Study of ISIS SOD1Rx to Treat Familial Amyotrophic Lateral Sclerosis (ALS) Caused by SOD1 Gene Mutations

Exclusion criteria

• ✕. Drug abuse or alcoholism within one year of the Screening visit.
• ✕. Unstable cardiac, pulmonary, renal, hepatic, endocrine, hematologic function, or active infectious disease.
• ✕. Documented history of HIV infection.
• ✕. Unstable psychiatric illness defined as psychosis or untreated major depression within 90 days of the Screening Visit.
• ✕. History of structural spinal disease including tumors and hyperplasia.
• ✕. Presence of an implanted shunt for the drainage of CSF or an implanted CNS catheter.
• ✕. Clinically significant abnormalities in hematology or clinical chemistry parameters as assessed by the Site Investigator during the Screening visit.
• ✕. Ongoing medical condition that according to the Site Investigator would interfere with the conduct and assessments of the study. Examples are medical disability (e.g., severe degenerative arthritis, compromised nutritional state, peripheral neuropathy) that would interfere with the assessment of safety and efficacy of study material or device performance, or would compromise the ability of the patient to undergo study procedures.