An Observational Study of Patients With Primary Mitochondrial Disease (SPIMM-300)

Completed

Conditions studied: Primary Mitochondrial Disease

In brief

This is an observational study of patients with Primary Mitochondrial Disease with either signs or symptoms suggestive of myopathy. The Investigator will identify potential patients through existing medical records and one on-site visit.

Key facts

Study ID

NCT03048617

Run by

Stealth BioTherapeutics Inc.

People needed

215

Starts

2017-02-13

Expected to finish

2019-03-07

Last updated by the study team

2019-04-11

Who can join

Age: 16 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Willing and able to provide a signed informed consent form (ICF) prior to participation in any-trial related procedures
• Patient has clinical presentation of PMD with either signs or symptoms suggestive of myopathy
• Patient is ambulatory and able to attempt 6MWT

You may not qualify if…

• Patient has symptoms of PMD due to secondary mitochondrial dysfunction
• Patient has had prior exposure to elamipretide
• Patient does not have the cognitive capacity to understand and complete all study assessments
• Patient has a medical history of severe renal impairment
• History of active alcoholism or drug addiction during the year before enrollment

Where it is running

• University of California San Diego — La Jolla, California, United States
• Stanford Universtity — Palo Alto, California, United States
• Children's Hospital Colorado — Aurora, Colorado, United States
• Massachusetts General Hospital — Boston, Massachusetts, United States
• Columbia University Medical Center — New York, New York, United States
• Akron Children's Hospital — Akron, Ohio, United States
• Cleveland Clinic — Cleveland, Ohio, United States
• The Children's Hospital of Philadelphia — Philadelphia, Pennsylvania, United States
• Children's Hospital of Pittsburgh of UPMC — Pittsburgh, Pennsylvania, United States
• Baylor College of Medicine — Houston, Texas, United States
• The University of Texas Health Science Center — Houston, Texas, United States
• University of Utah Hospital — Salt Lake City, Utah, United States
• Seattle Children's Hospital — Seattle, Washington, United States
• Calvary Health Care Bethlehem — Caulfield South, Victoria, Australia
• Royal North Shore Hospital — St Leonards, Australia
• University of Calgary Metabolic Disease Clinica — Calgary, Alberta, Canada
• McMaster University Medical Center — Hamilton, Ontario, Canada
• Adult Metabolic Diseases Clinic — Vancouver, Canada
• University of Copenhagen — Copenhagen, Denmark
• Klinikim der Universitat Muchen, Friedrich-Baur Institute — Munich, Bavaria, Germany
• University Hospital of Bonn — Bonn, Germany
• Institute of Genomic Medicine and Rare Disorders — Budapest, Hungary
• IRCCS Institute of Neurological Sciences of Bolgna, Bellaria Hospital — Bologna, Italy
• ASST Spedali Civili di Brescia — Brescia, Italy
• Azienda Ospedaliero Universitaria Policlinico G. Martino — Messina, Italy

Full record on ClinicalTrials.gov

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