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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).
Patients will be prescribed a fixed dose combination of Ciprofloxacin and Celecoxib to be taken twice daily, and will be monitored for safety and tolerability. Additionally, routine progression measures will be assessed.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Fixed dose Ciprofloxacin and Celecoxib | Experimental | Fixed dose Ciprofloxacin and Celecoxib capsule to be taken twice daily, total dose 748mg/day |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fixed dose combination Ciprofloxacin/Celecoxib | Drug | Fixed dose Ciprofloxacin and Celecoxib capsule to be taken twice daily, total dose 748mg/day |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with one or more treatment-emergent adverse events | Treatment emergent adverse event is any medical event associated with the drug | 15 months |
| Number of patients who discontinued treatment prematurely | Number of patients whose treatment is stopped prematurely for any reason | 15 months |
| Number of patients who discontinued treatment prematurely due to adverse events | Number of patients whose treatment is stopped prematurely specifically due to adverse events | 15 months |
| Number of patients with significant abnormal laboratory values | 15 months |
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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 initial gastroscopic of an erosion, ulcer or tumor or/and GI disorder
Known history of impaired renal function.
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:
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
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| Name | Affiliation | Role |
|---|---|---|
| Jeremy Shefner, MD, PhD | Barrow Neurological Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Barrow Neurological Institute | Phoenix | Arizona | 85013 | United States |
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| ID | Term |
|---|---|
| D000690 | Amyotrophic Lateral Sclerosis |
| ID | Term |
|---|---|
| D013118 | Spinal Cord Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D016472 | Motor Neuron Disease |
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| ID | Term |
|---|---|
| D000068579 | Celecoxib |
| ID | Term |
|---|---|
| D000096926 | Benzenesulfonamides |
| D013449 | Sulfonamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
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|
| D019636 | Neurodegenerative Diseases |
| D057177 | TDP-43 Proteinopathies |
| D009468 | Neuromuscular Diseases |
| D057165 | Proteostasis Deficiencies |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D001555 |
| Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D013450 | Sulfones |
| D013457 | Sulfur Compounds |
| D011720 | Pyrazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |