ReNEW:Phase 3 Study of Efficacy, Safety & Pharmacokinetics of Subcutaneous Injections of Elamipretide in Subjects With Dry Age-Related Macular Degeneration (Dry AMD)
- Conditions
- Age Related Macular Degeneration (ARMD)
- Interventions
- Drug: Placebo
- First Posted Date
- 2024-04-18
- Last Posted Date
- 2025-04-17
- Lead Sponsor
- Stealth BioTherapeutics Inc.
- Target Recruit Count
- 360
- Registration Number
- NCT06373731
- Locations
- 🇨🇿
Oftex Eye Clinic, Pardubice, Czechia
🇺🇸Associated Retina Consultants, Phoenix, Arizona, United States
🇺🇸Barnet Dulaney Perkins Eye Center, Sun City, Arizona, United States
Study to Evaluate Efficacy and Safety of Elamipretide in Subjects With Primary Mitochondrial Disease From Nuclear DNA Mutations (nPMD)
- Conditions
- Mitochondrial MyopathiesMitochondrial DNA DepletionMitochondrial DNA MutationMitochondrial DiseasesMitochondrial DNA DeletionMitochondrial Complex I DeficiencyMitochondrial PathologyMitochondrial Metabolism Defect
- Interventions
- Drug: Placebo
- First Posted Date
- 2021-12-17
- Last Posted Date
- 2023-12-12
- Lead Sponsor
- Stealth BioTherapeutics Inc.
- Target Recruit Count
- 102
- Registration Number
- NCT05162768
- Locations
- 🇺🇸
Rare Disease Research, LLC, Atlanta, Georgia, United States
🇺🇸University of Pittsburgh School of Medicine Children's Hospital of Pittsburgh of UPMC Department of Genetics, Pittsburgh, Pennsylvania, United States
🇺🇸Massachusetts General Hospital, Boston, Massachusetts, United States
An Intermediate Size Expanded Access Protocol of Elamipretide
- Conditions
- Mitochondrial DiseasesBarth Syndrome
- First Posted Date
- 2020-12-30
- Last Posted Date
- 2025-02-14
- Lead Sponsor
- Stealth BioTherapeutics Inc.
- Registration Number
- NCT04689360
ReCLAIM-2 Study to Evaluate Safety,Efficacy & Pharmacokinetics of Elamipretide in Subjects With AMD With Non-central GA
- Conditions
- Age-related Macular Degeneration
- Interventions
- Combination Product: Subcutaneous elamipretide through the elamipretide delivery systemCombination Product: Subcutaneos placebo through the elamipretide delivery system
- First Posted Date
- 2019-03-27
- Last Posted Date
- 2024-07-12
- Lead Sponsor
- Stealth BioTherapeutics Inc.
- Target Recruit Count
- 176
- Registration Number
- NCT03891875
- Locations
- 🇺🇸
The Retina Care Center, Baltimore, Maryland, United States
🇺🇸Southeast Retina Center, PC, Augusta, Georgia, United States
🇺🇸Cumberland valley retina consultants, Hagerstown, Maryland, United States
A Trial to Evaluate Safety and Efficacy of Elamipretide Primary Mitochondrial Myopathy Followed by Open-Label Extension
- Conditions
- Primary Mitochondrial Myopathy
- Interventions
- Combination Product: elamipretide open label treatmentCombination Product: placebo comparatorCombination Product: elamipretide
- First Posted Date
- 2017-10-27
- Last Posted Date
- 2022-01-24
- Lead Sponsor
- Stealth BioTherapeutics Inc.
- Target Recruit Count
- 218
- Registration Number
- NCT03323749
- Locations
- 🇺🇸
Massachusetts General Hospital, Boston, Massachusetts, United States
🇺🇸Children's Hospital of Pittsburgh of UPMC, Pittsburgh, Pennsylvania, United States
🇺🇸University of Texas Health Science Center, Houston, Texas, United States
A Trial to Evaluate Safety, Tolerability and Efficacy of Elamipretide in Subjects With Barth Syndrome
- First Posted Date
- 2017-04-04
- Last Posted Date
- 2024-04-16
- Lead Sponsor
- Stealth BioTherapeutics Inc.
- Target Recruit Count
- 12
- Registration Number
- NCT03098797
- Locations
- 🇺🇸
McKusick-Nathans Institute of Genetic Medicine, Johns Hopkins University School of Medicine, Baltimore, Maryland, United States
An Observational Study of Patients With Primary Mitochondrial Disease (SPIMM-300)
- Conditions
- Primary Mitochondrial Disease
- First Posted Date
- 2017-02-09
- Last Posted Date
- 2019-04-11
- Lead Sponsor
- Stealth BioTherapeutics Inc.
- Target Recruit Count
- 215
- Registration Number
- NCT03048617
- Locations
- 🇺🇸
University of California San Diego, La Jolla, California, United States
🇩🇪Klinikim der Universitat Muchen, Friedrich-Baur Institute, Munich, Bavaria, Germany
🇺🇸Massachusetts General Hospital, Boston, Massachusetts, United States
Open-Label Extension Trial to Characterize the Long-term Safety and Tolerability of Elamipretide in Subjects With Genetically Confirmed Primary Mitochondrial Myopathy (PMM)
- First Posted Date
- 2016-11-29
- Last Posted Date
- 2021-12-17
- Lead Sponsor
- Stealth BioTherapeutics Inc.
- Target Recruit Count
- 28
- Registration Number
- NCT02976038
- Locations
- 🇺🇸
University of California, San Diego, California, United States
🇺🇸Children's Hospital of Pittsburgh of UPMC, Pittsburgh, Pennsylvania, United States
🇺🇸Massachusetts General Hospital, Boston, Massachusetts, United States
A Phase 2 Study to Evaluate the Cardiac and Renal Effects of Short Term Treatment With Elamipretide in Patients Hospitalized With Congestion Due to Heart Failure
- First Posted Date
- 2016-09-26
- Last Posted Date
- 2020-07-28
- Lead Sponsor
- Stealth BioTherapeutics Inc.
- Target Recruit Count
- 308
- Registration Number
- NCT02914665
- Locations
- 🇬🇧
Torbay Hospital, Torquay, United Kingdom
🇪🇸Hospital ClÃnico San Carlos, Madrid, Spain
🇪🇸Hospital Universitario de Bellvitge, Barcelona, Spain
An Open-Label, Phase 1 Clinical Study to Evaluate the Safety and Tolerability of Subcutaneous Elamipretide in Subjects With Intermediate Age-Related Macular Degeneration
- First Posted Date
- 2016-07-28
- Last Posted Date
- 2020-10-20
- Lead Sponsor
- Stealth BioTherapeutics Inc.
- Target Recruit Count
- 40
- Registration Number
- NCT02848313
- Locations
- 🇺🇸
Duke University School of Medicine / Dept. of Ophthalmology (Duke Eye Center), Durham, North Carolina, United States