NCT04090684

Ciprofloxacin/Celecoxib Combination in Patients With ALS

Open Label, Off Label Study to Evaluate the Safety, Tolerability and Preliminary Efficacy of Ciprofloxacin/Celecoxib Combination in Patients With ALS

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 10 (actual)
• Sponsor: NeuroSense Therapeutics Ltd. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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, 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 twice daily, and will be monitored for safety and tolerability. Additionally, routine progression measures will be assessed.

Conditions

• ALS (Amyotrophic Lateral Sclerosis)

Interventions

Type	Name	Description
DRUG	Fixed dose combination Ciprofloxacin/Celecoxib	Fixed dose Ciprofloxacin and Celecoxib capsule to be taken twice daily, total dose 748mg/day

Timeline

• Start date: 2019-12-09
• Primary completion: 2021-09-27
• Completion: 2022-01-20
• First posted: 2019-09-16
• Last updated: 2022-02-01

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study