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NCT02774005 · ClinicalTrials.gov registry record · Phase 4
Study to Assess the Efficacy and Safety of Raxone in LHON Patients
A Phase 4 study, sponsored by Santhera Pharmaceuticals.
- Completed
- Registry status
- Phase 4
- Development phase
- 199
- Enrollment target
NCT02774005: Completed Phase 4 study, sponsored by Santhera Pharmaceuticals.
NCT02774005 is a Phase 4 study that has completed, run by Santhera Pharmaceuticals. The registered enrollment target is 199 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (62% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02774005, a Phase 4 study, has completed, sponsored by Santhera Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 199 participants
- Enrollment target
Study Summary
LEROS is an open-label interventional Phase IV study, designed to further assess the efficacy and safety of Raxone® in the long-term treatment of LHON patients.
Primary Outcome
Proportion (number) of eyes with clinically relevant recovery of visual acuity (VA) from Baseline or in which Baseline VA better than 1.0 logMAR was maintained at Month 12 in patients treated with Raxone® ≤1 year after the onset of symptoms, compared to matching external natural history control group
Interventions
- DRUG Idebenone
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 199 participants |
| Start Date | 2016-05 |
| Est. Completion | 2021-03-29 |
| Phase | Phase 4 |
What the finished NCT02774005 record still lists
NCT02774005 is an interventional study that assigns participants to a tested intervention. The registered 199 participants enrollment target is mid-sized for trials with a published cap, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (62% lower).
The record links to 0 conditions, and to 1 intervention - of which Idebenone is the first listed.
NCT02774005 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02774005 about?
NCT02774005 is a clinical study titled "Study to Assess the Efficacy and Safety of Raxone in LHON Patients". LEROS is an open-label interventional Phase IV study, designed to further assess the efficacy and safety of Raxone® in the long-term treatment of LHON patients.
What is the current status of trial NCT02774005?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 199 participants. The study started on 2016-05. Estimated completion is 2021-03-29.
What interventions are being tested in trial NCT02774005?
The interventions under investigation include: Idebenone (DRUG).
Who is sponsoring clinical trial NCT02774005?
This trial is sponsored by Santhera Pharmaceuticals, which has 7 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02774005's enrollment target sits among peer trials
199 445th of 2000 higher than 1,555 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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