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

Part of paid clinical trials in Phoenix, Arizona.

Sponsor
Alkeus Pharmaceuticals, Inc.
Study ID
NCT02402660
Phase
PHASE2
Status
Enrolling By Invitation

Conditions

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

Eligibility Criteria

Sex
ALL
Age
8 Years - 70 Years
Healthy Volunteers
Not accepted

Interventions

  • ALK-001 — DRUG
    Daily, oral administration for 24 months
  • Placebo — DRUG
    Daily, oral administration for 24 months

Study Details

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

Key Dates

Start date
Aug 31, 2015
Status verified
Apr 2025
Primary completion
Jun 30, 2026
Completion
Nov 30, 2026

Study Design

Enrollment
160 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: ALK-001
    Daily, oral administration of one capsule. See details below.
  • Placebo Comparator: Placebo
    Daily, oral administration of one capsule. See details below.

Primary Outcome Measure

Safety and tolerability of 24 months of daily dosing of ALK-001 assessed by incidence and/or clinically significant changes of a combination of ocular and non-ocular adverse events [ Time Frame: From baseline to 24 months ]

Locations (14)

FacilityCityStateZIPSite coordinators
Alkeus SitePhoenixArizona85020-
Alkeus SiteLos AngelesCalifornia90095-
Alkeus SiteAuroraColorado80045-
Alkeus SiteGainesvilleFlorida32601-
Alkeus SiteMiamiFlorida33136-
Alkeus SiteIndianapolisIndiana46202-
Alkeus SiteBaltimoreMaryland21287-
Alkeus SiteGrand RapidsMichigan49546-
Alkeus SiteNew YorkNew York10032-
Alkeus SiteWestburyNew York11590-
Alkeus SiteHoustonTexas77025-
Alkeus SiteSalt Lake CityUtah84132-
Alkeus SiteSilverdaleWashington98383-
Alkeus SiteMilwaukeeWisconsin53226-

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