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NCT02693119 · ClinicalTrials.gov registry record · Phase 2
A Study Investigating the Safety, Tolerability, and Efficacy of Elamipretide Topical Ophthalmic Solution for Treatment of Leber's Hereditary Optic Neuropathy
A Phase 2 study of Leber's Hereditary Optic Neuropathy, sponsored by Stealth BioTherapeutics.
- Completed
- Registry status
- Phase 2
- Development phase
- 12
- Enrollment target
- 1
- Study location
NCT02693119: Completed Phase 2 study of Leber's Hereditary Optic Neuropathy, sponsored by Stealth BioTherapeutics.
NCT02693119 is a Phase 2 study of Leber's Hereditary Optic Neuropathy that has completed, run by Stealth BioTherapeutics. The registered enrollment target is 12 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (91% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02693119, a Phase 2 study of Leber's Hereditary Optic Neuropathy, has completed, sponsored by Stealth BioTherapeutics.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 12 participants
- Enrollment target
- 1
- Study location
Study Summary
This is a Phase 2, prospective, randomized, double-masked, vehicle controlled, single-center study in approximately 12 subjects with LHON to evaluate safety, tolerability and efficacy of elamipretide (MTP-131) topical ophthalmic solution in this patient population. At the conclusion of 52 weeks of treatment, subjects will be offered the opportunity to enter an Open Label Extension for up to 48 additional weeks of treatment.
Primary Outcome
The incidence of ocular treatment emergent adverse events (TEAEs).
Conditions Studied
Interventions
- DRUG elamipretide (MTP-131) 1% topical ophthalmic solution
- DRUG Vehicle topical ophthalmic solution
Study Locations (1)
California
- Doheny Eye Center - Pasadena
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 12 participants |
| Start Date | 2016-03 |
| Est. Completion | 2019-12 |
| Phase | Phase 2 |
What the finished NCT02693119 record still lists
NCT02693119 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 12 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (91% lower).
The record links to 1 condition, with Leber's Hereditary Optic Neuropathy appearing as the primary indexed condition, and to 2 interventions - of which elamipretide (MTP-131) 1% topical ophthalmic solution is the first listed.
NCT02693119 reports a single indexed study location in California.
Frequently Asked Questions
What is clinical trial NCT02693119 about?
NCT02693119 is a clinical study titled "A Study Investigating the Safety, Tolerability, and Efficacy of Elamipretide Topical Ophthalmic Solution for Treatment of Leber's Hereditary Optic Neuropathy". This is a Phase 2, prospective, randomized, double-masked, vehicle controlled, single-center study in approximately 12 subjects with LHON to evaluate safety, tolerability and efficacy of elamipretide (MTP-131) topical ophthalmic solution in this patient population. At the conclusion of 52 weeks of t...
What is the current status of trial NCT02693119?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 12 participants. The study started on 2016-03. Estimated completion is 2019-12.
What conditions does trial NCT02693119 study?
This clinical trial studies the following conditions: Leber's Hereditary Optic Neuropathy.
What interventions are being tested in trial NCT02693119?
The interventions under investigation include: elamipretide (MTP-131) 1% topical ophthalmic solution (DRUG), Vehicle topical ophthalmic solution (DRUG).
Who is sponsoring clinical trial NCT02693119?
This trial is sponsored by Stealth BioTherapeutics, which has 23 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02693119 being conducted?
This trial has 1 study location across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02693119's enrollment target sits among peer trials
12 1948th of 2000 higher than 34 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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