Open-Label Extension: Tolerability and Effects of ALK-001 on Stargardt Disease (TEASE)
Public ClinicalTrials.gov record NCT04239625. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Phase 2 Multicenter, Double-Masked, Randomized, Placebo-Controlled Study to Investigate the Long Term Safety, Tolerability, Pharmacokinetics and Effects of ALK-001 on the Progression of Stargardt Disease
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
The purpose of this open-label, multicenter study is to determine the long-term safety, pharmacokinetics and effects of ALK-001 (C20-D3-retinyl acetate) on the progression of Stargardt disease. This study is an extension of NCT02402660 and enrolls participants who are at least 8 years old. Enrollment is by invitation only. Funding Source - FDA OOPD
Study identification
- NCT ID
- NCT04239625
- Recruitment status
- Active, not recruiting
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 200 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 8 Years to 70 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Dec 20, 2019 (Actual)
- Primary completion
- Dec 2028 (Estimated)
- Completion
- Dec 2029 (Estimated)
- Last update posted
- Sep 21, 2026
2019 – 2029
United States locations
- U.S. sites
- 8
- U.S. states
- 8
- U.S. cities
- 8
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Alkeus Site | Phoenix | Arizona | 85020 | — |
| Alkeus Site | Los Angeles | California | 90095 | — |
| Alkeus Site | Aurora | Colorado | 80045 | — |
| Alkeus Site | Gainesville | Florida | 32601 | — |
| Alkeus Site | Indianapolis | Indiana | 46202 | — |
| Alkeus Site | Grand Rapids | Michigan | 49456 | — |
| Alkeus Site | Westbury | New York | 11590 | — |
| Alkeus Site | Silverdale | Washington | 98383 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT04239625, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Sep 21, 2026 · Synced Oct 24, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT04239625 live on ClinicalTrials.gov.