Enoxacin for Amyotrophic Lateral Sclerosis (ALS)

Prior treatment

• Currently enrolled in another clinical trial involving an experimental drug or device

Other illness

• Hypersensitivity/allergy to fluoroquinolones
• Diagnosed with another neurodegenerative disease
• Significant pulmonary disorder not attributed to ALS, central nervous system disorder associated with seizures, myasthenia gravis, active rheumatologic disease, tendinopathy, or any severe uncontrolled medical condition (other than ALS)
• Severe renal impairment or impaired liver function

Lab values

• Baseline prolongation of QT interval/corrected QT interval (QTc) at screening, treatment with any agent that may prolong Qt/QTc interval, or history of any other at-risk other cardiac condition

• Diagnosis of familial or sporadic ALS
• FVC of ≥ 50 percent predicted
• If female, is not breastfeeding and is not pregnant
• Has been on a stable dose of riluzole, or has not taken riluzole, for at least 30 days prior to screening
• If taking concomitant edaravone at study entry, must have completed at least one cycle of edaravone therapy prior to screening
• Not currently taking and has not taken for at least 30 days prior to screening any Theophylline containing medications, clozapine, or duloxetine
• No active infection in the 30 days prior to randomization
• Has not taken any fluoroquinolone antibiotics for at least 30 days prior to screening