Open Label, Off Label Study to Evaluate the Safety, Tolerability and Preliminary Efficacy of Ciprofloxacin/Celecoxib Combination in Patients With ALS

Study Purpose:

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.

Disease:

Amyotrophic Lateral Sclerosis (ALS),  Familial ALS,  Sporadic ALS

Study Type:

Interventional Trial

Study Category:

Drug Trial

Study Status:

Enrolling

Phase:

Phase I

Study Chair(s)/Principal Investigator(s):

Jeremy Shefner, MD, PhD Barrow Neurological Institute
Jinsy Andrews, MD, MSc Columbia University

Clinicaltrials.gov ID (11 digit #):

NCT04090684

Neals Affiliated?

No

Coordinating Center Contact Information


Avital Pushett, MSc, CRA / .(JavaScript must be enabled to view this email address)
.(JavaScript must be enabled to view this email address) United States

Full Study Summary:

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.

Study Sponsor:

NeuroSense Therapeutics Ltd.

Participant Duration:

Estimated Enrollment:

30

Estimated Study Start Date:

12/09/2019

Estimated Study Completion Date:

03/31/2021

Posting Last Modified Date:

01/27/2020

Date Study Added to alsconsortium.org:

09/17/2019
  • Eligibility Criteria

    Gender:

    Female, Male

    Minimum Age:

    18

    Maximum Age:

    75

    Min Vital Capacity (% predicted normal):

    50

    Time since Symptom Onset:

    Time since Diagnosis:

    Can participants use Riluzole?

    Yes


    Inclusion Criteria:

    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

    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:

    • 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
    • NYHA Class II or greater congestive heart failure
    • Chronic obstructive pulmonary disease or asthma requiring daily use of bronchodilator medications
    • Poorly controlled or brittle diabetes mellitus
    • 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

    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

  • Site Contact Information

    Barrow Neurological Institute
    Jessie Duncan, MS / .(JavaScript must be enabled to view this email address) / 602-406-1466
    Phoenix , Arizona 85013
    United States

    Columbia University
    New York, New York 10032
    United States