Open Label, Off Label Study to Evaluate the Safety, Tolerability and Preliminary Efficacy of Ciprofloxacin/Celecoxib Combination in Patients With ALS
This is an open label, off label study, to provide interested ALS patients with Ciprofloxacin/Celecoxib fixed dose combination, while assessing safety and tolerability, routine disease progression measures (ALSFRS-R and Vital Capacity).
• Able to comprehend and willing to sign an Informed Consent Form (ICF)
• Males or females between the ages of 18 and 75 years of age, inclusive
• Diagnosis of familial or sporadic ALS (defined as meeting the possible, laboratory-supported probable, probable, or definite criteria for a diagnosis of ALS according to the World Federation of Neurology El Escorial criteria) less than 5 years prior to baseline
• Patients may be on Riluzole and/or Edaravone; 30 days of stable use is required to make safety assessments more reliable
• Upright Forced Vital Capacity (FVC) ≥ 50% of predicted for age, height and sex at screening
• Patient is able to swallow tablets/ capsules
• A caregiver (if one is needed)
• Female patients must be post-menopausal (≥ 1 year) OR sterilized, OR if of childbearing potential (i.e., females who have had their first period unless they are anatomically and physiologically incapable to become pregnant), must have a negative pregnancy test, and agree to use contraceptive drugs or devices (e.g., diaphragm plus spermicide, or oral contraceptives) for the duration of the study and 10 weeks after the last treatment dose AND require male partners to use a condom during sexual intercourse