Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT03500094 · ClinicalTrials.gov registry record · Phase 3
Safety, Pharmacokinetics, Pharmacodynamics, and Efficacy of Migalastat in Pediatric Subjects (Aged 12 to <18 Years)
A Phase 3 study, sponsored by Amicus Therapeutics.
- Completed
- Registry status
- Phase 3
- Development phase
- 22
- Enrollment target
NCT03500094 is a Phase 3 study that has completed, run by Amicus Therapeutics. The registered enrollment target is 22 participants.
The verdict
NCT03500094, a Phase 3 study, has completed, sponsored by Amicus Therapeutics.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 22 participants
- Enrollment target
Study Summary
This was an open-label study to evaluate the safety, pharmacokinetics (PK), pharmacodynamics (PD), and efficacy of migalastat treatment in pediatric participants 12 to \<18 years of age with Fabry disease and amenable gene encoding α-galactosidase A (GLA) variants.
Interventions
- DRUG Migalastat HCl 150 mg
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 22 participants |
| Start Date | 2018-09-27 |
| Est. Completion | 2021-02-06 |
| Phase | Phase 3 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03500094
The ClinicalTrials.gov registry entry for NCT03500094 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 22 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Amicus Therapeutics, which has 34 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Migalastat HCl 150 mg is the first listed.
NCT03500094 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03500094 about?
NCT03500094 is a clinical study titled "Safety, Pharmacokinetics, Pharmacodynamics, and Efficacy of Migalastat in Pediatric Subjects (Aged 12 to <18 Years)". This was an open-label study to evaluate the safety, pharmacokinetics (PK), pharmacodynamics (PD), and efficacy of migalastat treatment in pediatric participants 12 to \<18 years of age with Fabry disease and amenable gene encoding α-galactosidase A (GLA) variants.
What is the current status of trial NCT03500094?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 22 participants. The study started on 2018-09-27. Estimated completion is 2021-02-06.
What interventions are being tested in trial NCT03500094?
The interventions under investigation include: Migalastat HCl 150 mg (DRUG).
Who is sponsoring clinical trial NCT03500094?
This trial is sponsored by Amicus Therapeutics, which has 34 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
Explore more on PlainTrial
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.