At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 118 enrolled
Drug / intervention
Lucerastat +1 moredrug
Likely dose
Lucerastat 250 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Multicenter, dOuble-blind, ranDomized, Placebo-controlled, Parallel-group Study to Determine the effIcacy and Safety of Lucerastat Oral Monotherapy in Adult Subjects With FabrY Disease
In Brief
A Phase 3 clinical trial evaluating Lucerastat and Placebo for Fabry Disease. Completed, enrolled 118 participants across 49 sites in 14 countries.
Detailed Summary
This study aimed to determine the efficacy and safety of lucerastat oral monotherapy in adult subjects with Fabry disease.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsFabry Disease
CountriesAustralia, Austria, Belgium, Canada, Germany, Ireland, Italy, Netherlands, Norway, Poland, Spain, Switzerland, United Kingdom, United States
Collaborators--
Timeline
Phase 3CompletedFinished
201820192020202120222023202420252026
First PostedFeb 2018
Enrollment StartJun 2018
Primary CompletionAug 2021
Study CompletionSep 2021
TodayJul 2026
First PostedFeb 7, 2018
Enrollment StartJun 21, 2018
Primary CompletionAug 17, 2021
Study CompletionSep 2, 2021
TodayJul 2, 2026
Enrollment to primary: 3.2 yearsPosted 8.4 years ago
Interventions
Lucerastatdrug
Hard gelatin capsules containing 250 mg of lucerastat and inactive excipients; 1000 mg (4 capsules) twice daily (b.i.d.); dose adjusted for renal function.
Placebodrug
Placebo capsules are identical in appearance to the lucerastat capsules, and contain inactive excipients; 4 capsules b.i.d.; dose adjusted for renal function.