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NCT01458119 · ClinicalTrials.gov registry record · Phase 3
Open-Label Phase 3 Long-Term Safety Study of Migalastat
A Phase 3 study, sponsored by Amicus Therapeutics.
- Terminated
- Registry status
- Phase 3
- Development phase
- 85
- Enrollment target
NCT01458119: Clinical Trial Phase 3 study, sponsored by Amicus Therapeutics.
NCT01458119 is a Phase 3 study that was terminated before completion, run by Amicus Therapeutics. The registered enrollment target is 85 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (89% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01458119, a Phase 3 study, was terminated before completion, sponsored by Amicus Therapeutics.
- TERMINATED
- Registry status
- Phase 3
- Development phase
- 85 participants
- Enrollment target
Study Summary
This was a long-term, open-label study of migalastat (123 milligrams \[mg\] of migalastat \[equivalent to 150 mg of migalastat hydrochloride\]) (migalastat) in participants with Fabry disease who completed treatment in a previous monotherapy trial with migalastat.
Primary Outcome
An adverse event (AE) was defined as any untoward medical occurrence in a participant administered migalastat that did not necessarily have a causal relationship with the treatment. Each AE was recorded at the time of reporting; visits typically occurred every 6 months. A TEAE was defined as an AE starting on or after the first study drug administration date. Serious AEs were life-threatening or resulted in death, persistent or significant incapacitation, inpatient or prolonged hospitalization,
Interventions
- DRUG migalastat hydrochloride
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 85 participants |
| Start Date | 2011-10-14 |
| Est. Completion | 2016-02-17 |
| Phase | Phase 3 |
Why NCT01458119 stopped before completion
NCT01458119 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 85 participants, a relatively small participant target, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (89% lower).
The record links to 0 conditions, and to 1 intervention - of which migalastat hydrochloride is the first listed.
NCT01458119 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01458119 about?
NCT01458119 is a clinical study titled "Open-Label Phase 3 Long-Term Safety Study of Migalastat". This was a long-term, open-label study of migalastat (123 milligrams \[mg\] of migalastat \[equivalent to 150 mg of migalastat hydrochloride\]) (migalastat) in participants with Fabry disease who completed treatment in a previous monotherapy trial with migalastat.
What is the current status of trial NCT01458119?
This trial is currently terminated. It is a Phase 3 study. The enrollment target is 85 participants. The study started on 2011-10-14. Estimated completion is 2016-02-17.
What interventions are being tested in trial NCT01458119?
The interventions under investigation include: migalastat hydrochloride (DRUG).
Who is sponsoring clinical trial NCT01458119?
This trial is sponsored by Amicus Therapeutics, which has 34 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01458119's enrollment target sits among peer trials
85 1747th of 2000 higher than 252 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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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