An Observational Study of Patients With Primary Mitochondrial Disease (SPIMM-300)
NCT ID: NCT03048617
Last Updated: 2019-04-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
215 participants
OBSERVATIONAL
2017-02-13
2019-03-07
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Natural History Study of Mitochondrial Myopathy
NCT05250375
Safety, Tolerability, Efficacy of MTP-131 for Treatment of Mitochondrial Disease in Subjects From the MMPOWER Study
NCT02805790
Safety, Tolerability, and Efficacy of MTP-131 for the Treatment of Mitochondrial Myopathy
NCT02367014
A Trial to Evaluate Safety and Efficacy of Elamipretide Primary Mitochondrial Myopathy Followed by Open-Label Extension
NCT03323749
Magnetic Resonance Imaging (MRI) Muscle Phenotyping in Mitochondrial Disease
NCT02154711
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
CASE_ONLY
PROSPECTIVE
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Patient has clinical presentation of PMD with either signs or symptoms suggestive of myopathy
* Patient is ambulatory and able to attempt 6MWT
Exclusion Criteria
* 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
16 Years
80 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Stealth BioTherapeutics Inc.
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
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
Istituto Nazionale Neurologico Carlo Besta
Milan, , Italy
Istituto di Neurologia, Fondazione Policlinico Universitario A. Gemelli
Roma, , Italy
Dipartimento Ambientale di Neuroscienze
Roma, , Italy
Ospedale Pediatrico Bambin Gesu
Roma, , Italy
Hospital Universitario 12 de Octubre
Madrid, , Spain
Neurology Department Hospital Universitari i Politecnic La Fe
Valencia, , Spain
MRC Centre for Neuromuscular Diseases
London, , United Kingdom
Royal Victoria Infirmary
Newcastle upon Tyne, , United Kingdom
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
SPIMM-300
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.