At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 12 enrolled
Drug / intervention
elamipretide (MTP-131) 1% topical ophthalmic solution +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Prospective, Randomized, Double-Masked, Vehicle Controlled, Phase 2 Clinical Study to Evaluate the Safety, Tolerability and Efficacy of Elamipretide Topical Ophthalmic Solution in Subjects With Leber's Hereditary Optic Neuropathy (LHON)
In Brief
A Phase 2 clinical trial evaluating elamipretide (MTP-131) 1% topical ophthalmic solution and Vehicle topical ophthalmic solution for Leber's Hereditary Optic Neuropathy. Completed, enrolled 12 participants across 1 site.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsLeber's Hereditary Optic Neuropathy
CountriesUnited States
Collaborators--
Timeline
Phase 2CompletedFinished
20162017201820192020202120222023202420252026
First PostedFeb 2016
Enrollment StartMar 2016
Primary CompletionSep 2019
Study CompletionDec 2019
TodayJul 2026
First PostedFeb 26, 2016
Enrollment StartMar 1, 2016
Primary CompletionSep 1, 2019
Study CompletionDec 1, 2019
TodayJul 2, 2026
Enrollment to primary: 3.5 yearsPosted 10.3 years ago
Interventions
elamipretide (MTP-131) 1% topical ophthalmic solutiondrug
Vehicle topical ophthalmic solutiondrug