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NCT02194985 · ClinicalTrials.gov registry record · Phase 3
Open-Label Extension Study of the Long-Term Effects of Migalastat HCL in Patients With Fabry Disease
A Phase 3 study, sponsored by Amicus Therapeutics.
- Completed
- Registry status
- Phase 3
- Development phase
- 84
- Enrollment target
NCT02194985: Completed Phase 3 study, sponsored by Amicus Therapeutics.
NCT02194985 is a Phase 3 study that has completed, run by Amicus Therapeutics. The registered enrollment target is 84 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
NCT02194985, a Phase 3 study, has completed, sponsored by Amicus Therapeutics.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 84 participants
- Enrollment target
Study Summary
This is an open-label extension study intended to provide continued treatment with migalastat hydrochloride (HCl) for participants with Fabry disease who completed treatment of a previous migalastat HCl study. The study assessed the long-term safety and effectiveness of migalastat HCl.
Primary Outcome
An 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 time of reporting; visits typically occurred every 6 months. Serious AEs were life threatening or resulted in death, resulted in disability/incapacity, hospitalization or prolonged hospitalization, or a congenital anomaly. The criteria for AE severity were: Mild: awareness of sign or symptom, does not interfe
Interventions
- DRUG migalastat HCl 150 mg
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 84 participants |
| Start Date | 2015-03-14 |
| Est. Completion | 2019-10-23 |
| Phase | Phase 3 |
What the finished NCT02194985 record still lists
NCT02194985 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 84 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 HCl 150 mg is the first listed.
NCT02194985 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02194985 about?
NCT02194985 is a clinical study titled "Open-Label Extension Study of the Long-Term Effects of Migalastat HCL in Patients With Fabry Disease". This is an open-label extension study intended to provide continued treatment with migalastat hydrochloride (HCl) for participants with Fabry disease who completed treatment of a previous migalastat HCl study. The study assessed the long-term safety and effectiveness of migalastat HCl.
What is the current status of trial NCT02194985?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 84 participants. The study started on 2015-03-14. Estimated completion is 2019-10-23.
What interventions are being tested in trial NCT02194985?
The interventions under investigation include: migalastat HCl 150 mg (DRUG).
Who is sponsoring clinical trial NCT02194985?
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 NCT02194985's enrollment target sits among peer trials
84 1749th of 2000 higher than 250 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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