Status and phase
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About
This is an open label, off label study, to provide interested ALS patients with Ciprofloxacin/Celecoxib fixed dose combination, while assessing safety and tolerability and routine disease progression measures (ALSFRS-R and Vital Capacity).
Full description
Patients will be prescribed a fixed dose combination of Ciprofloxacin and Celecoxib to be taken thrice daily, and will be monitored for safety and tolerability. Additionally, routine disease progression measures will be assessed.
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
Exclusion criteria
A past history of adverse reaction/hypersensitivity to either NSAIDs, celecoxib or fluoroquinolones, ciprofloxacin
Any known clinically significant abnormal gastric mucosal erosion, ulcer or tumor or/and GI disorder
Known history of clinically significant impairment of renal function (creatinine ≥ 1.5)
Known or suspected congestive heart and/or coronary heart disease, previous history of myocardial infarction, uncontrolled arterial hypertension, or rhythm abnormalities requiring permanent treatment
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
Known or suspected diagnosis or family history of epilepsy
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:
Patient who is treated with chronic aspirin or NSAIDs, and is at risk if stopped. Clopidogrel is allowed and can replace Aspirin.
Female who is pregnant or breastfeeding or with intention of becoming pregnant during the course of the study
Any impairment or social circumstance that, in the opinion of the Investigator, would render the patient not suitable to participate in the study
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
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
Primary purpose
Allocation
Interventional model
Masking
16 participants in 1 patient group
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Data sourced from clinicaltrials.gov
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