At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 194 enrolled
Drug / intervention
Emixustat +1 moredrug
Likely dose
Not stated in 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 Phase 3 Multicenter, Randomized, Double-Masked Study Comparing the Efficacy and Safety of Emixustat Hydrochloride With Placebo for the Treatment of Macular Atrophy Secondary to Stargardt Disease
In Brief
A Phase 3 clinical trial evaluating Emixustat and Placebo for Stargardt Disease. Completed, enrolled 194 participants across 29 sites in 11 countries.
Detailed Summary
The purpose of this study is to determine if emixustat hydrochloride reduces the rate of progression of macular atrophy compared to placebo in subjects with Stargardt disease. Funding Source -- FDA OOPD
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsStargardt Disease
CountriesBrazil, Canada, Denmark, France, Germany, Italy, Netherlands, South Africa, Spain, United Kingdom, United States
CollaboratorsFood and Drug Administration (FDA)
Timeline
Phase 3CompletedFinished
20192020202120222023202420252026
First PostedDec 2018
Enrollment StartJan 2019
Primary CompletionJun 2022
Study CompletionJun 2022
TodayJul 2026
First PostedDec 11, 2018
Enrollment StartJan 7, 2019
Primary CompletionJun 13, 2022
Study CompletionJun 23, 2022
TodayJul 2, 2026
Enrollment to primary: 3.4 yearsPosted 7.6 years ago
Interventions
Emixustatdrug
Once daily oral tablet taken for 24 months
Placebodrug
Once daily oral tablet taken for 24 months