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Ciprofloxacin/Celecoxib Combination in Patients With ALS

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ClinicalTrials.gov Identifier: NCT04090684
Recruitment Status : Not yet recruiting
First Posted : September 16, 2019
Last Update Posted : September 16, 2019
Sponsor:
Information provided by (Responsible Party):
NeuroSense Therapeutics Ltd.

Brief Summary:
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) and change in serum pNFH.

Condition or disease Intervention/treatment Phase
ALS (Amyotrophic Lateral Sclerosis) Drug: Fixed dose combination Ciprofloxacin/Celecoxib Phase 1

Detailed Description:
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, as well as change in serum pNFH.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Open Label, Off Label Study to Evaluate the Safety, Tolerability and Preliminary Efficacy of Ciprofloxacin/Celecoxib Combination in Patients With ALS
Estimated Study Start Date : September 2019
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : March 2021


Arm Intervention/treatment
Experimental: Fixed dose Ciprofloxacin and Celecoxib
Fixed dose Ciprofloxacin and Celecoxib capsule to be taken twice daily, total dose 748mg/day
Drug: Fixed dose combination Ciprofloxacin/Celecoxib
Fixed dose Ciprofloxacin and Celecoxib capsule to be taken twice daily, total dose 748mg/day
Other Name: PrimeC




Primary Outcome Measures :
  1. Number of participants with one or more treatment-emergent adverse events [ Time Frame: 15 months ]
    Treatment emergent adverse event is any medical event associated with the drug

  2. Number of patients who discontinued treatment prematurely [ Time Frame: 15 months ]
    Number of patients whose treatment is stopped prematurely for any reason

  3. Number of patients who discontinued treatment prematurely due to adverse events [ Time Frame: 15 months ]
    Number of patients whose treatment is stopped prematurely specifically due to adverse events

  4. Number of patients with significant abnormal laboratory values [ Time Frame: 15 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Able to comprehend and willing to sign an Informed Consent Form (ICF)
  2. Males or females between the ages of 18 and 75 years of age, inclusive
  3. 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
  4. Patients may be on Riluzole and/or Edaravone; 30 days of stable use is required to make safety assessments more reliable
  5. Upright Forced Vital Capacity (FVC) ≥ 50% of predicted for age, height and sex at screening
  6. Patient is able to swallow tablets/ capsules
  7. A caregiver (if one is needed)
  8. 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

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 initial gastroscopic of an erosion, ulcer or tumor or/and GI disorder
  3. Known history of impaired renal function.
  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 the patient's ability to understand and/or comply with study procedures and provide informed consent
  8. Female who is pregnant or breastfeeding or with intention of becoming pregnant during the course of the study
  9. Any impairment or social circumstance that, in the opinion of the Investigator, would render the patient not suitable to participate in the study
  10. 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
  11. 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04090684


Contacts
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Contact: Avital Pushett, MSc, CRA +972-9-9531142 info@neurosense-tx.com

Locations
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United States, Arizona
Barrow Neurological Institute Active, not recruiting
Phoenix, Arizona, United States, 85013
United States, New York
The Neurological Institute, Columbia University Active, not recruiting
New York, New York, United States, 10032
Sponsors and Collaborators
NeuroSense Therapeutics Ltd.
Investigators
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Principal Investigator: Jeremy Shefner, MD, PhD Barrow Neurological Institute
Principal Investigator: Jinsy Andrews, MD, MSc Columbia University

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Responsible Party: NeuroSense Therapeutics Ltd.
ClinicalTrials.gov Identifier: NCT04090684     History of Changes
Other Study ID Numbers: NST001
First Posted: September 16, 2019    Key Record Dates
Last Update Posted: September 16, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Celecoxib
Motor Neuron Disease
Amyotrophic Lateral Sclerosis
Neurodegenerative Diseases
Nervous System Diseases
Neuromuscular Diseases
Spinal Cord Diseases
Central Nervous System Diseases
TDP-43 Proteinopathies
Proteostasis Deficiencies
Metabolic Diseases
Ciprofloxacin
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase 2 Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Bacterial Agents
Anti-Infective Agents
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Antineoplastic Agents
Cytochrome P-450 CYP1A2 Inhibitors