NCT01805024

Congenital Muscular Dystrophy Ascending Multiple Dose Cohort Study Analyzing Pharmacokinetics at Three Dose Levels In Children and Adolescents With Assessment of Safety and Tolerability of Omigapil (CALLISTO)

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: Santhera Pharmaceuticals · Industry
• Sex: All
• Age: 5 Years – 16 Years
• Healthy volunteers: Not accepted

Summary

The purpose of the study is to establish the pharmacokinetic profile of omigapil in paediatric and adolescent patients with CMD and to evaluate the safety and tolerability of omigapil. Funding source - FDA OOPD

Conditions

• Congenital Muscular Dystrophy

Interventions

Type	Name	Description
DRUG	Omigapil	Cohort 1 0.02 mg/kg/day Cohort 2 0.08 mg/kg/day Cohort 3a 0.04 mg/kg/day Cohort 3b 0.06 mg/kg/day

Timeline

• Start date: 2014-12-01
• Primary completion: 2017-12-05
• Completion: 2018-01-29
• First posted: 2013-03-05
• Last updated: 2021-09-24
• Results posted: 2019-09-20

Locations

1 site across 1 country: United States