Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as PrimeC
Fixed dose combination Ciprofloxacin/Celecoxib · 3 trials · 3 indications
Treatment emergent adverse event is any medical event associated with the drug
Number of subjects whose treatment is stopped prematurely for any reason
Number of patients whose treatment is stopped prematurely specifically due to adverse events
Treatment emergent adverse event is any medical event associated with the drug
Number of patients whose treatment is stopped prematurely for any reason
| Arm | Type | Description |
|---|---|---|
| PrimeC | ACTIVE_COMPARATOR | 2 tablets of PrimeC administered twice daily (4 tablets a day), at a daily dose of 1496 mg |
| Placebo | PLACEBO_COMPARATOR | 2 tablets of Placebo administered twice daily (4 tablets a day). Placebo tablets are matched in size, color and taste. |
| Fixed dose Ciprofloxacin and Celecoxib | EXPERIMENTAL | Fixed dose Ciprofloxacin and Celecoxib capsule to be taken thrice daily, total dose 909mg/day |
| Name | Type | Description |
|---|---|---|
| PrimeC | DRUG | Ciprofloxacin and celecoxib combination extended release formulation |
| Placebo | DRUG | Placebo matches active drug in size, color and taste |
| Fixed dose combination Ciprofloxacin/Celecoxib | DRUG | Fixed dose Ciprofloxacin and Celecoxib capsule to be taken thrice daily, total dose 909mg/day |
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...
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 under evaluation in clinical trials for patients with ALS.
NeuroSense Therapeutics Ltd. (NASDAQ: NRSN) is developing the fixed dose combination Ciprofloxacin/Celecoxib. The company is conducting clinical trials to evaluate this combination therapy for the treatment of Amyotrophic Lateral Sclerosis (ALS).
The fixed dose combination Ciprofloxacin/Celecoxib has completed Phase 1 and Phase 2 clinical trials for ALS. It remains an investigational drug and is not yet approved by regulatory authorities. The completed trials include a Phase 1 study and a Phase 2 open-label study.
The fixed dose combination Ciprofloxacin/Celecoxib has been evaluated in two completed trials: 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 trials enrolled adult patients with ALS.