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NCT03425539 · ClinicalTrials.gov registry record · Phase 3
Efficacy and Safety of Lucerastat Oral Monotherapy in Adult Subjects With Fabry Disease
A Phase 3 study, sponsored by Idorsia Pharmaceuticals.
- Completed
- Registry status
- Phase 3
- Development phase
- 118
- Enrollment target
NCT03425539: Completed Phase 3 study, sponsored by Idorsia Pharmaceuticals.
NCT03425539 is a Phase 3 study that has completed, run by Idorsia Pharmaceuticals. The registered enrollment target is 118 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (85% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03425539, a Phase 3 study, has completed, sponsored by Idorsia Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 118 participants
- Enrollment target
Study Summary
This study aimed to determine the efficacy and safety of lucerastat oral monotherapy in adult subjects with Fabry disease.
Primary Outcome
Neuropathic pain on the modified BPI-SF3: subjects rated their neuropathic pain intensity ("neuropathic pain at its worst in the last 24 hours") on an 11-point scale, from 0 (no neuropathic pain) to 10 (worst imaginable neuropathic pain).
Interventions
- DRUG Placebo
- DRUG Lucerastat
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 118 participants |
| Start Date | 2018-06-21 |
| Est. Completion | 2021-09-02 |
| Phase | Phase 3 |
What the finished NCT03425539 record still lists
NCT03425539 is an interventional study that assigns participants to a tested intervention. The registered 118 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (85% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT03425539 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03425539 about?
NCT03425539 is a clinical study titled "Efficacy and Safety of Lucerastat Oral Monotherapy in Adult Subjects With Fabry Disease". This study aimed to determine the efficacy and safety of lucerastat oral monotherapy in adult subjects with Fabry disease.
What is the current status of trial NCT03425539?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 118 participants. The study started on 2018-06-21. Estimated completion is 2021-09-02.
What interventions are being tested in trial NCT03425539?
The interventions under investigation include: Placebo (DRUG), Lucerastat (DRUG).
Who is sponsoring clinical trial NCT03425539?
This trial is sponsored by Idorsia Pharmaceuticals, which has 34 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03425539's enrollment target sits among peer trials
118 1641st of 2000 higher than 359 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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