Open Label Study to Evaluate Ciprofloxacin/Celecoxib Combination in Patients With ALS

Exclusion Criteria

• •1. A past history of adverse reaction/hypersensitivity to either NSAIDs, celecoxib or fluoroquinolones, ciprofloxacin
• •2. Any known clinically significant abnormal gastric mucosal erosion, ulcer or tumor or/and GI disorder
• •3. Known history of clinically significant impairment of renal function (creatinine ≥ 1.5)
• •4. Known or suspected congestive heart and/or coronary heart disease, previous history of myocardial infarction, uncontrolled arterial hypertension, or rhythm abnormalities requiring permanent treatment
• •5. Known history of QT/QTc prolongation, Torsade de pointes (TdP) (e.g. heart failure, hypokalemia, family history of Long QT syndrome) and the use of concomitant medications that prolong the QT/QTc interval
• •6. Known or suspected diagnosis or family history of epilepsy
• •7. Presence at screening of any medically significant cardiac, pulmonary, musculoskeletal, or psychiatric illness that might interfere with the patient's ability to comply with study procedures or that might confound the interpretation of clinical safety data, including, but not limited to:
• •1. Mean systolic blood pressure \>180 mm Hg; mean diastolic blood pressure \>100 mm Hg (measurements taken after few min rest) that persist on 3 successive measurements taken at least 2 minutes apart
• •2. NYHA Class II or greater congestive heart failure
• •3. Chronic obstructive pulmonary disease or asthma requiring daily use of bronchodilator medications
• •4. Poorly controlled or brittle diabetes mellitus
• •5. Cognitive impairment, related to ALS or otherwise, sufficient to impair patient's ability to understand and/or comply with study procedures and provide informed consent
• •8. Patient who is treated with chronic aspirin or NSAIDs, and is at risk if stopped. Clopidogrel is allowed and can replace Aspirin.
• •9. Female who is pregnant or breastfeeding or with intention of becoming pregnant during the course of the study
• •10. Any impairment or social circumstance that, in the opinion of the Investigator, would render the patient not suitable to participate in the study
• •11. Patient, patient's parent(s), or patient's legal guardian(s) is/are unable to understand the nature, scope, and possible consequences of the study
• •12. Patient is participating in (or plans to participate in) any other investigational drug trial, or plans to be exposed to any other investigational agent, device and/or procedure, from 30 days prior to Screening through study completion