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NCT01805024 · ClinicalTrials.gov registry record · Phase 1
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)
A Phase 1 study, sponsored by Santhera Pharmaceuticals.
- Completed
- Registry status
- Phase 1
- Development phase
- 20
- Enrollment target
NCT01805024: Completed Phase 1 study, sponsored by Santhera Pharmaceuticals.
NCT01805024 is a Phase 1 study that has completed, run by Santhera Pharmaceuticals. The registered enrollment target is 20 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (67% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01805024, a Phase 1 study, has completed, sponsored by Santhera Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 20 participants
- Enrollment target
Study 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
Interventions
- DRUG Omigapil
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2014-12 |
| Est. Completion | 2018-01-29 |
| Phase | Phase 1 |
What the finished NCT01805024 record still lists
NCT01805024 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 20 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (67% lower).
The record links to 0 conditions, and to 1 intervention - of which Omigapil is the first listed.
NCT01805024 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01805024 about?
NCT01805024 is a clinical study titled "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)". 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
What is the current status of trial NCT01805024?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 20 participants. The study started on 2014-12. Estimated completion is 2018-01-29.
What interventions are being tested in trial NCT01805024?
The interventions under investigation include: Omigapil (DRUG).
Who is sponsoring clinical trial NCT01805024?
This trial is sponsored by Santhera Pharmaceuticals, which has 7 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01805024's enrollment target sits among peer trials
20 1629th of 2000 higher than 285 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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