Ciprofloxacin/Celecoxib Combination in Patients With ALS

• Register: ClinicalTrials.gov
• Last refreshed on: 7 February 2022
• Main ID: NCT04090684
• Date of registration: 29/08/2019
• Prospective Registration: Yes
• Primary sponsor: NeuroSense Therapeutics Ltd.
• Public title: Ciprofloxacin/Celecoxib Combination in Patients With ALS
• Scientific title: Open Label, Off Label Study to Evaluate the Safety, Tolerability and Preliminary Efficacy of Ciprofloxacin/Celecoxib Combination in Patients With ALS
• Date of first enrolment: December 9, 2019
• Target sample size: 10
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT04090684
• Study type: Interventional
• Study design: Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 1

Countries of recruitment

United States

Contacts

• Name: Jeremy Shefner, MD, PhD
• Affiliation: Barrow Neurological Institute

Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: 75 Years
Gender: All

Health Condition(s) or Problem(s) studied

ALS (Amyotrophic Lateral Sclerosis)

Intervention(s)

Drug: Fixed dose combination Ciprofloxacin/Celecoxib

Primary Outcome(s)

Number of participants with one or more treatment-emergent adverse events [Time Frame: 15 months]

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

Number of patients who discontinued treatment prematurely [Time Frame: 15 months]

Number of patients who discontinued treatment prematurely due to adverse events [Time Frame: 15 months]

Secondary ID(s)

NST001

Source(s) of Monetary Support

Please refer to primary and secondary sponsors