Trial · NCT02402660
Phase 2 Tolerability and Effects of ALK-001 on Stargardt Disease
NCT02402660, Phase 2, Active not recruiting, Alkeus Pharmaceuticals, Inc.
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Phase 2 Tolerability and Effects of ALK-001 on Stargardt Disease. Trials, record NCT02402660. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02402660
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Phase 2 Tolerability and Effects of ALK-001 on Stargardt Disease
- NCT number
- NCT02402660
- Status
- Active not recruiting
- Phases
- Phase 2
- Enrollment
- 160 participants, estimated
- Lead sponsor
- Alkeus Pharmaceuticals, Inc.
- Conditions
- Stargardt Disease, Stargardt Macular Degeneration, Stargardt Macular Dystrophy, Autosomal Recessive Stargardt Disease 1 (ABCA4-related)
- Interventions
- ALK-001, Placebo
- First posted
- 2015-03-30
- Last updated
- 2026-09-21
Source ClinicalTrials.gov
Registered outcomes3
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | 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 | From baseline to 24 months | |
| Secondary | Effects of ALK-001 on the progression of Stargardt disease | From baseline to 24 months | Combination of changes in atrophic lesion size, best corrected visual acuity (BCVA), and ocular assessments. |
| Secondary | Pharmacokinetic profile of ALK-001 derived from the concentrations of ALK-001 and metabolites in plasma | Up to 24 months |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers8
The papers the trial lists on ClinicalTrials.gov.
Grants2
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years | Source |
|---|---|---|---|---|---|---|
| R01FD006316 | ALK-001 Phase 2 Treatment of Stargardt Disease IND 108,353 (09/08/2015) | SAAD, LEONIDE; WASHINGTON, ILYAS | ALKEUS PHARMACEUTICALS, INC. | FOOD AND DRUG ADMINISTRATION | 2018 to 2023 | NIH RePORTER |
| R01FD004098 | ALK-001 Phase 2 Treatment of Stargardt Disease IND 108,353 (09/08/2015) | SAAD, LEONIDE; WASHINGTON, ILYAS | ALKEUS PHARMACEUTICALS, INC. | FOOD AND DRUG ADMINISTRATION | 2013 to 2017 | NIH RePORTER |
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT02402660
GET https://conductscience.org/api/trials/v1/NCT02402660/registered