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Phase 2 Tolerability and Effects of ALK-001 on Stargardt Disease

NCT02402660 · Status: ENROLLING_BY_INVITATION · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 160

Last updated 2025-04-27

No results posted yet for this study

Summary

The purpose of this study is to determine the long term safety and tolerability of ALK-001 (C20-D3-retinyl acetate), and to explore the effects of ALK-001 on the progression of Stargardt disease in patients between the ages of 8 and 70 years old.

Funding Source - FDA OOPD

Conditions

  • Stargardt Disease
  • Stargardt Macular Degeneration
  • Stargardt Macular Dystrophy
  • Autosomal Recessive Stargardt Disease 1 (ABCA4-related)

Interventions

DRUG

ALK-001

Daily, oral administration for 24 months

DRUG

Placebo

Daily, oral administration for 24 months

Sponsors & Collaborators

  • Alkeus Pharmaceuticals, Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
8 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-08-31
Primary Completion
2026-06-30
Completion
2026-11-30
FDA Drug
Yes

Countries

  • United States

Study Locations

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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 NCT02402660 on ClinicalTrials.gov