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New treatment option for Stargardt Disease
Official title Study of ALK-001 on the Progression of Stargardt Disease
ClinicalTrials.gov ID: NCT07419334
What this study is testing
What is ALK-001?
ALK-001 is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for stargardt disease.
Also referred to as Gildeuretinol acetate.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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)
- Phase 3: a large, late-stage study
- You might receive a placebo (an inactive treatment) instead of the study drug.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 8 to 45
You may be able to join if
- Male or female, 8 to 45 years of age (inclusive) on the day of screening.
- Female participants of childbearing potential, as well as fertile male participants with female partners of childbearing potential, must be willing...
- Have a clinical diagnosis of typical autosomal recessive STGD macular dystrophy
- Have provided a genetic report by any regional accredited organization that provides certified testing indicating the presence of disease-causing...
- Have signed and dated the informed consent forms (ICFs; or assent as appropriate) to participate.
You likely can't join if
- Has taken disallowed items (supplements containing vitamin A or beta-carotene, liver-based products, or prescription oral retinoid medications)...
- Is lactating, pregnant, or has a positive serum or urine pregnancy test at screening or at randomization, or is planning to become pregnant during...
- Has ever participated in any gene therapy, cell therapy, or device study to treat STGD, unless documented confirmation of participation in the...
- Has participated in any drug study to treat any other condition within 5 half-lives of the investigational drug prior to screening, unless documented...
- Anticipates participating in any other drug or device study within the duration of the study.
The study team makes the final eligibility decision.
Where it's taking place
- Phoenix, Arizona, United States
- Gainesville, Florida, United States
- Erie, Pennsylvania, United States
- Dallas, Texas, United States
- Fort Worth, Texas, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 8 years to 45 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Phoenix, Arizona, United States; Gainesville, Florida, United States; Erie, Pennsylvania, United States; Dallas, Texas, United States; Fort Worth, Texas, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.