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NCT00304512 · ClinicalTrials.gov registry record · Phase 2
A 12-Week Safety and Pharmacodynamic Study of AT1001 (Migalastat Hydrochloride) in Female Participants With Fabry Disease
A Phase 2 study, sponsored by Amicus Therapeutics.
- Completed
- Registry status
- Phase 2
- Development phase
- 9
- Enrollment target
NCT00304512: Completed Phase 2 study, sponsored by Amicus Therapeutics.
NCT00304512 is a Phase 2 study that has completed, run by Amicus Therapeutics. The registered enrollment target is 9 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (93% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00304512, a Phase 2 study, has completed, sponsored by Amicus Therapeutics.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 9 participants
- Enrollment target
Study Summary
Study to evaluate the safety, tolerability, and pharmacodynamics of migalastat hydrochloride (HCl) (migalastat) in participants with Fabry disease.
Primary Outcome
TEAEs were defined as any adverse event with start date on or after administration of study drug or pre-existing conditions that worsened on or after the start of the first study drug administration (on Day 1). A severe adverse event was defined as an adverse event that was incapacitating and required medical intervention. The number of participants who experienced one or more severe TEAEs after dosing on Day 1 through Week 48 is presented. A summary of serious and all other non-serious adverse
Interventions
- DRUG migalastat HCl
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 9 participants |
| Start Date | 2006-09-07 |
| Est. Completion | 2008-05-09 |
| Phase | Phase 2 |
What the finished NCT00304512 record still lists
NCT00304512 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 9 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (93% lower).
The record links to 0 conditions, and to 1 intervention - of which migalastat HCl is the first listed.
NCT00304512 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00304512 about?
NCT00304512 is a clinical study titled "A 12-Week Safety and Pharmacodynamic Study of AT1001 (Migalastat Hydrochloride) in Female Participants With Fabry Disease". Study to evaluate the safety, tolerability, and pharmacodynamics of migalastat hydrochloride (HCl) (migalastat) in participants with Fabry disease.
What is the current status of trial NCT00304512?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 9 participants. The study started on 2006-09-07. Estimated completion is 2008-05-09.
What interventions are being tested in trial NCT00304512?
The interventions under investigation include: migalastat HCl (DRUG).
Who is sponsoring clinical trial NCT00304512?
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 NCT00304512's enrollment target sits among peer trials
9 1989th of 2000 higher than 11 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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