At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 20 enrolled
Drug / intervention
Omigapildrug
Likely dose
Omigapil 0.02 mg/kgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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)
In Brief
A Phase 1 clinical trial evaluating Omigapil for Congenital Muscular Dystrophy. Completed, enrolled 20 participants across 1 site.
Detailed 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
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCongenital Muscular Dystrophy
CountriesUnited States
Collaborators--
Timeline
Phase 1CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedMar 2013
Enrollment StartDec 2014
Primary CompletionDec 2017
Study CompletionJan 2018
TodayJul 2026
First PostedMar 5, 2013
Enrollment StartDec 1, 2014
Primary CompletionDec 5, 2017
Study CompletionJan 29, 2018
TodayJul 2, 2026
Enrollment to primary: 3.0 yearsPosted 13.3 years ago
Interventions
Omigapildrug
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