drugset / Trial / NCT04125927

Cystadrops in Pediatric Cystinosis Patients From Six Months to Less Than Two Years Old (SCOB2)

NCT04125927

Phase 3 Completed 5 enrolled RECORDATI GROUP
NaSingle-groupOpen-labelTreatment

Summary

Cystadrops® is currently indicated in adults and children from 2 years of age diagnosed with cystinosis with corneal crystal accumulation observed. However administration of Cystadrops® in patients below 2 years old could be of value for these patients and prevent the crystal deposit. It is the reason why as part of the Cystadrops® pediatric investigational plan (PIP), RECORDATI Rare Diseases committed to conduct a clinical study to assess Cystadrops® safety and efficacy in the pediatric population from 6 months to less than 2 years old.

Timeline

Start
2020-09-01
Primary completion
2022-12-23
Completion
2022-12-23

Drugs

EvaluationDrugModalityDoseRoute
Subject Cysteamine Unknown Other

Indications