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Safety and Efficacy of Emixustat in Stargardt Disease

NCT03772665 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 194

Last updated 2024-05-30

Study results available
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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

Conditions

Interventions

DRUG

Emixustat

Once daily oral tablet taken for 24 months

DRUG

Placebo

Once daily oral tablet taken for 24 months

Sponsors & Collaborators

  • Food and Drug Administration (FDA)

    collaborator FED

  • Kubota Vision Inc.

    lead INDUSTRY

Principal Investigators

  • Jeff Gregory, MD · VP of Clinical Development, Acucela

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
16 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-01-07
Primary Completion
2022-06-13
Completion
2022-06-23
FDA Drug
Yes

Countries

  • United States
  • Brazil
  • Canada
  • Denmark
  • France
  • Germany
  • Italy
  • Netherlands
  • South Africa
  • Spain
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03772665 on ClinicalTrials.gov