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

This study is currently recruiting participants.
Verified October 2017 by Stealth BioTherapeutics Inc.
Sponsor:
ClinicalTrials.gov Identifier:
NCT03048617
First Posted: February 9, 2017
Last Update Posted: October 25, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Stealth BioTherapeutics Inc.
February 3, 2017
February 9, 2017
October 25, 2017
February 13, 2017
January 2018   (Final data collection date for primary outcome measure)
  • Assess the relationship of genotype to phenotype in patients with Primary Mitochondrial Disease [ Time Frame: 1 year ]
  • Compare local and regional differences in standard of care and management of patients with Primary Mitochondrial Disease [ Time Frame: 1 year ]
Same as current
Complete list of historical versions of study NCT03048617 on ClinicalTrials.gov Archive Site
Compare local and regional differences in genetic testing methodologies for Primary Mitochondrial Disease [ Time Frame: 1 year ]
Same as current
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An Observational Study of Patients With Primary Mitochondrial Disease (SPIMM-300)
A Prospective Observational Study of Patients With Primary Mitochondrial Disease (SPIMM-300)
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.
An observational study of patients with presumed Primary Mitochondrial Disease designed to better characterize and correlate symptoms and signs of myopathy and genetic test results and the use of commonly prescribed treatments. The study will help define and identify a subject population for a future trial of an investigational product to treat primary mitochondrial disease associated with signs and symptoms of myopathy.
Observational
Observational Model: Case-Only
Time Perspective: Prospective
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Not Provided
Probability Sample
Patients with clinical presentation of PMD with either signs or symptoms suggestive of myopathy
Primary Mitochondrial Disease
Not Provided
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
300
January 2018
January 2018   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
Sexes Eligible for Study: All
16 Years to 65 Years   (Child, Adult)
No
Australia,   Canada,   Denmark,   Germany,   Hungary,   Italy,   Spain,   United Kingdom,   United States
 
 
NCT03048617
SPIMM-300
No
Not Provided
Not Provided
Stealth BioTherapeutics Inc.
Stealth BioTherapeutics Inc.
Not Provided
Not Provided
Stealth BioTherapeutics Inc.
October 2017