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

NCT04165850 | Completed Phase 2

• 1 other identifier: NST002
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

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).

Conditions

Amyotrophic Lateral Sclerosis; ALS

Outcome Measures

Primary Outcomes (4)

• 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

Study Arms (1)

Fixed dose Ciprofloxacin and Celecoxib

EXPERIMENTAL

Fixed dose Ciprofloxacin and Celecoxib capsule to be taken thrice daily, total dose 909mg/day

Drug: Fixed dose combination Ciprofloxacin/Celecoxib

Interventions

Fixed dose combination Ciprofloxacin/Celecoxib DRUG

Fixed dose Ciprofloxacin and Celecoxib capsule to be taken thrice daily, total dose 909mg/day

Also known as: PrimeC

Fixed dose Ciprofloxacin and Celecoxib

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 laboratory-supported probable, probable, or definite criteria for a diagnosis of ALS according to the World Federation of Neurology El Escorial criteria)
• Disease duration after first symptom less than 3 years prior to baseline
• Patients may be treated in parallel with Riluzole and/or Edaravone; 30 days of stable use prior to enrollment is required
• Upright forced vital capacity (FVC) ≥ 50% of predicted for age, height, weight 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 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

You may not qualify if:

• A past history of adverse reaction/hypersensitivity to either NSAIDs, celecoxib or fluoroquinolones, ciprofloxacin
• Any known clinically significant abnormal gastric mucosal erosion, ulcer or tumor or/and GI disorder
• Known history of clinically significant impairment of renal function (creatinine ≥ 1.5)
• 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 patient's ability to understand and/or comply with study procedures and provide informed consent
• Patient who is treated with chronic aspirin or NSAIDs, and is at risk if stopped. Clopidogrel is allowed and can replace Aspirin.
• 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

Sponsors & Collaborators

• NeuroSense Therapeutics Ltd.: lead

Study Sites (1)

Sourasky Medical Center

Tel Aviv, Israel

Location

MeSH Terms

Conditions

Amyotrophic Lateral Sclerosis

Interventions

Celecoxib

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Motor Neuron Disease; Neurodegenerative Diseases; TDP-43 Proteinopathies; Neuromuscular Diseases; Proteostasis Deficiencies; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Benzenesulfonamides; Sulfonamides; Amides; Organic Chemicals; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Sulfones; Sulfur Compounds; Pyrazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Vivian Drory, MD

  Sourasky Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 13, 2019
• First Posted: November 18, 2019
• Study Start: November 25, 2019
• Primary Completion: January 19, 2021
• Study Completion: January 19, 2021
• Last Updated: March 3, 2021

Record last verified: 2019-11

Data Sharing

• IPD Sharing: Will not share

Locations

IL (1)