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230 Participants NeededMy employer runs this trial

ALK-001 for Stargardt Disease

(NORTHSTAR Trial)

Recruiting at 2 trial locations
Ft
Overseen ByFor trial questions: trials@alkeuspharma.com or 877-255-7476
Age: < 65
Sex: Any
Trial Phase: Phase 3
Sponsor: Alkeus Pharmaceuticals, Inc.
Must not be taking: Vitamin A, Beta-carotene, Retinoids
Disqualifiers: Pregnancy, Gene therapy, Drug study, others
Pivotal Trial (Near Approval)This treatment is in the last trial phase before FDA approval
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

This study evaluates the efficacy and safety of investigational study drug ALK-001 in participants 8 to 45 years of age, inclusive, with symptoms and signs of autosomal recessive Stargardt disease (STGD)

Are You a Good Fit for This Trial?

Inclusion Criteria

Have signed and dated the informed consent forms (ICFs; or assent as appropriate) to participate
I am willing to use birth control as required during and after the study.
I have been diagnosed with typical autosomal recessive Stargardt macular dystrophy.
See 2 more

Exclusion Criteria

I have not taken vitamin A, beta-carotene, liver products, or oral retinoids recently.
I am pregnant, breastfeeding, or planning to have a child during the study.
I have not had gene, cell, or device therapy for STGD, and no drug study in the past 6 months.
See 2 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive ALK-001 or placebo to evaluate efficacy and safety in Stargardt disease

24 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • ALK-001

How Is the Trial Designed?

2

Treatment groups

Active Control

Placebo Group

Group I: ActiveActive Control1 Intervention
Group II: PlaceboPlacebo Group1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Alkeus Pharmaceuticals, Inc.

Lead Sponsor

Trials
4
Recruited
520+

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