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ALK-001 for Stargardt Disease (TEASE Trial)
TEASE Trial Summary
This trial is exploring the long term safety and effectiveness of a treatment for Stargardt disease, a genetic disorder that causes vision loss. The treatment, ALK-001 (C20-D3-retinyl acetate), is being given to patients 8 to 70 years old to see if it slows the progression of the disease. The trial is funded by the FDA's Office of Orphan Products Development.
TEASE Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTEASE Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.TEASE Trial Design
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Who is running the clinical trial?
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- I have not taken vitamin A, beta-carotene supplements, liver products, or oral retinoids in the last 30 days.I have a current or past liver condition.I am between 8 and 70 years old and my ability to see is not limited.I have been diagnosed with Stargardt disease.I am aware of the birth defect risks and contraception requirements.I have a genetic report showing two mutations linked to my condition.I have not had eye surgery or injections in my main eye within the last 3 months.I'm sorry, "Main" is not a clinical trial exclusion criterion. Can you please provide a specific criterion for me to summarize?I have a report showing two or more ABCA4 mutations.I have had eye problems or surgeries that could affect my retina's health.My eyes can be clearly imaged and I'm not allergic to dilation drops.
- Group 1: ALK-001
- Group 2: Placebo
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
What risks should be considered when using ALK-001?
"Despite there being no evidence of ALK-001's efficacy, the drug has been assigned a safety score of 2 owing to existing clinical data."
What afflictions can ALK-001 be employed to ameliorate?
"ALK-001 is typically used to address vitamin d deficiencies, but it may also be prescribed for diseases related to vitamin A deficiency and nutritional supplementation."
What is the current number of participants in this clinical trial?
"This trial necessitates 140 properly qualified candidates, who can be sourced from multiple locations including the University of California Los Angeles - Jules Stein Eye Institute in LA and Columbia University Medical Center - Harkness Eye Institute located in NYC."
How many sites are actively administering this research?
"This research project is being conducted at 4 different medical sites, which include Los Angeles, New york and Gainesville. For the convenience of those interested in enrolling, it's crucial to select a clinic close by thus reducing travel time."
Is this experimental medical investigation unique and original?
"Alkeus Pharmaceuticals, Inc. first began researching ALK-001 in 2015 and conducted a clinical trial with 140 participants that year; it was subsequently granted Phase 2 drug approval. Currently, 8 distinct studies on ALK-001 are ongoing across 10 cities spread over two countries."
Are there any analogous experiments involving ALK-001?
"As of now, 8 clinical trials for ALK-001 are active with 2 being in Phase 3. Primarily based in Somerville, MA, 13 different sites across the country have studies involving this drug."
Is the target demographic of this research investigation inclusive of individuals over 20 years old?
"This research initiative seeks participants aged 8 and above, but below the age of 70."
Do I possess the necessary qualifications to partake in this clinical study?
"Individuals with stargardt disease who are between 8 and 70 years old have the opportunity to apply for this trial. A total of 140 applicants will be accepted."
Is this research project available for participants at the moment?
"Affirmative, clinicaltrials.gov attests that this medical trial is recruiting volunteers for participation. Initially posted on August 1st 2015 and most recently updated on February 15th 2022, the experiment intends to enlist 140 individuals from 4 separate sites."
Who else is applying?
What state do they live in?
How old are they?
What site did they apply to?
What portion of applicants met pre-screening criteria?
How many prior treatments have patients received?
Why did patients apply to this trial?
What questions have other patients asked about this trial?
How responsive is this trial?
Most responsive sites:
- University of California Los Angeles - Jules Stein Eye Institute: < 48 hours
Average response time
- < 2 Days
Typically responds via
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