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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04165850
Recruitment Status : Recruiting
First Posted : November 18, 2019
Last Update Posted : November 26, 2019
Sponsor:
Information provided by (Responsible Party):
NeuroSense Therapeutics Ltd.

Tracking Information
First Submitted Date  ICMJE November 13, 2019
First Posted Date  ICMJE November 18, 2019
Last Update Posted Date November 26, 2019
Actual Study Start Date  ICMJE November 25, 2019
Estimated Primary Completion Date February 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 13, 2019)
  • 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
  • Number of patients who discontinued treatment prematurely [ Time Frame: 15 months ]
    Number of patients whose treatment is stopped prematurely for any reason
  • 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
  • Number of patients with significant abnormal laboratory values [ Time Frame: 15 months ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT04165850 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Open Label Study to Evaluate Ciprofloxacin/Celecoxib Combination in Patients With ALS
Official Title  ICMJE Open Label Study to Evaluate the Safety, Tolerability and Preliminary Efficacy of Ciprofloxacin/Celecoxib Combination in Patients With ALS
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 and routine disease progression measures (ALSFRS-R and Vital Capacity).
Detailed 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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Amyotrophic Lateral Sclerosis
  • ALS
Intervention  ICMJE Drug: Fixed dose combination Ciprofloxacin/Celecoxib
Fixed dose Ciprofloxacin and Celecoxib capsule to be taken thrice daily, total dose 909mg/day
Other Name: PrimeC
Study Arms  ICMJE Experimental: Fixed dose Ciprofloxacin and Celecoxib
Fixed dose Ciprofloxacin and Celecoxib capsule to be taken thrice daily, total dose 909mg/day
Intervention: Drug: Fixed dose combination Ciprofloxacin/Celecoxib
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: November 13, 2019)
15
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE May 2021
Estimated Primary Completion Date February 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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 laboratory-supported probable, probable, or definite criteria for a diagnosis of ALS according to the World Federation of Neurology El Escorial criteria)
  4. Disease duration after first symptom less than 3 years prior to baseline
  5. Patients may be treated in parallel with Riluzole and/or Edaravone; 30 days of stable use prior to enrollment is required
  6. Upright forced vital capacity (FVC) ≥ 50% of predicted for age, height, weight and sex at screening
  7. Patient is able to swallow tablets/ capsules
  8. A caregiver (if one is needed)
  9. 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 or 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 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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Avital Pushett, MSc, CRA +972-9-9531142 info@neurosense-tx.com
Listed Location Countries  ICMJE Israel
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04165850
Other Study ID Numbers  ICMJE NST002
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party NeuroSense Therapeutics Ltd.
Study Sponsor  ICMJE NeuroSense Therapeutics Ltd.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Vivian Drory, MD Sourasky Medical Center
PRS Account NeuroSense Therapeutics Ltd.
Verification Date November 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP