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

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ClinicalTrials.gov Identifier: NCT03048617
Recruitment Status : Active, not recruiting
First Posted : February 9, 2017
Last Update Posted : September 6, 2018
Sponsor:
Information provided by (Responsible Party):
Stealth BioTherapeutics Inc.

February 3, 2017
February 9, 2017
September 6, 2018
February 13, 2017
August 2, 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
Not Provided
Not Provided
Probability Sample
Patients with clinical presentation of PMD with either signs or symptoms suggestive of myopathy
Primary Mitochondrial Disease
Not Provided
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
300
Same as current
December 2018
August 2, 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 80 Years   (Child, Adult, Older Adult)
No
Contact information is only displayed when the study is recruiting subjects
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.
September 2018