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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 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. The trial reports 1 study location across 1 state.
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.
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02693119
The ClinicalTrials.gov registry entry for NCT02693119 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 12 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Stealth BioTherapeutics, which has 23 total studies on file at ClinicalTrials.gov.
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 1 study location spanning 1 distinct geographic area - top geographies include 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.
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