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Fixed dose combination Ciprofloxacin/Celecoxib

Phase 2

Amyotrophic Lateral Sclerosis | Small molecule | Neurology |NeuroSense Therapeutics Ltd.|Last Updated: Feb 1, 2022

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLED
Total Trials1
Total Enrollment16

FDA Designations

No designations recorded

Clinical trial landscape

Fixed dose combination Ciprofloxacin/Celecoxib · 2 trials · 3 indications

Phase 2 1Phase 1 1
NCT04165850Open Label Study to Evaluate Ciprofloxacin/Celecoxib Combination in Patients With ALSAmyotrophic Lateral Sclerosis
COMPLETED16 Analytics
PHASE2COMPLETED
Open Label Study to Evaluate Ciprofloxacin/Celecoxib Combination in Patients With ALS
Amyotrophic Lateral SclerosisUnlock trial analytics

Study Endpoints

Primary Endpoints

Number of participants with one or more treatment-emergent adverse events
15 months

Treatment emergent adverse event is any medical event associated with the drug

Number of patients who discontinued treatment prematurely
15 months

Number of patients whose treatment is stopped prematurely for any reason

Number of patients who discontinued treatment prematurely due to adverse events
15 months

Number of patients whose treatment is stopped prematurely specifically due to adverse events

Number of patients with significant abnormal laboratory values
15 months
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Study Design & Arms

AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

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

Interventions

NameTypeDescription
Fixed dose combination Ciprofloxacin/CelecoxibDRUGFixed dose Ciprofloxacin and Celecoxib capsule to be taken thrice daily, total dose 909mg/day
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Eligibility Criteria

Age Range18 Years to 75 Years
SexALL
Healthy VolunteersNo
Study Sites1

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...

Countries:IsraelUnited States
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Frequently asked questions about Fixed dose combination Ciprofloxacin/Celecoxib

What is the fixed dose combination Ciprofloxacin/Celecoxib used for?

The fixed dose combination Ciprofloxacin/Celecoxib is being developed for the treatment of Amyotrophic Lateral Sclerosis (ALS), a progressive neurodegenerative disease. It is an investigational small molecule combination therapy intended to address this neurological condition.

Who is developing the fixed dose combination Ciprofloxacin/Celecoxib?

NeuroSense Therapeutics Ltd. (NASDAQ: NRSN) is developing the fixed dose combination of Ciprofloxacin and Celecoxib for ALS. The company is conducting clinical trials to evaluate this combination therapy in patients with the disease.

What phase is the fixed dose combination Ciprofloxacin/Celecoxib in?

The fixed dose combination Ciprofloxacin/Celecoxib is in clinical development, with completed Phase 1 and Phase 2 trials for ALS. It remains investigational and has not been approved by regulatory authorities.

What clinical trials is the fixed dose combination Ciprofloxacin/Celecoxib in?

Two clinical trials have been completed for this combination in ALS: NCT04090684, a Phase 1 study in the United States with 10 participants, and NCT04165850, a Phase 2 open-label study in Israel with 16 participants. Both enrolled adults aged 18 and older.

Is the fixed dose combination Ciprofloxacin/Celecoxib the same as Ciprofloxacin or Celecoxib alone?

No, the fixed dose combination Ciprofloxacin/Celecoxib is a specific combination of the two drugs, Ciprofloxacin and Celecoxib, formulated together as a single therapy for ALS. It is distinct from using either drug alone.