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

Description

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.

Study Start Date

February, 13 2017

Estimated Completion Date

January 2018

Interventions

No interventions cited

Study ID

Stealth BioTherapeutics Inc. -- SPIMM-300

Status

Recruiting

Trial ID

NCT03048617

Study Type

Observational

Trial Phase

N/A

Enrollment Quota

300

Sponsor

Stealth BioTherapeutics Inc.

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

Gender

All

Ages

16 Years to 65 Years

Accepts Healthy Volunteers

No

Study Locations and Contact Information (32)

Study Location Distance Name Phone Email
Massachusetts General Hospital - Boston, Massachusetts 2.8 miles Erica Kelly 617-724-7726 elkelly@mgh.harvard.edu
Columbia University Medical Center - New York, New York 181.2 miles Kristin Engelstad 212-305-6834 ke4@cumc.columbia.edu
Childrens Hospital of Pittsburgh of UPMC - Pittsburgh, Pennsylvania 477.6 miles Sandra Braden 412-692-5969 paronishsl@upmc.edu
Childrens Hospital of Pittsburgh of UPMC - Pittsburgh, Pennsylvania 477.6 miles Sandra Braden 412-692-5969 paronishsl@upmc.edu
Childrens Hospital of Pittsburgh of UPMC - Pittsburgh, Pennsylvania 477.6 miles Sandra Braden 412-692-5969 paronishsl@upmc.edu
Childrens Hospital of Pittsburgh of UPMC - Pittsburgh, Pennsylvania 477.6 miles Sandra Braden 412-692-5969 paronishsl@upmc.edu
Childrens Hospital of Pittsburgh of UPMC - Pittsburgh, Pennsylvania 477.6 miles Sandra Braden 412-692-5969 paronishsl@upmc.edu
Cleveland Clinic - Cleveland, Ohio 544.9 miles Irys B Caristo 216-444-0173 caristi@ccf.org
Akron Childrens Hospital - Akron, Ohio 545.3 miles Hilary Tonni BSN MSE RN CCRC 330-543-4743 htonni@chmca.org
Akron Childrens Hospital - Akron, Ohio 545.3 miles Hilary Tonni BSN MSE RN CCRC 330-543-4743 htonni@chmca.org
Akron Childrens Hospital - Akron, Ohio 545.3 miles Hilary Tonni BSN MSE RN CCRC 330-543-4743 htonni@chmca.org
Akron Childrens Hospital - Akron, Ohio 545.3 miles Hilary Tonni BSN MSE RN CCRC 330-543-4743 htonni@chmca.org
Akron Childrens Hospital - Akron, Ohio 545.3 miles Hilary Tonni BSN MSE RN CCRC 330-543-4743 htonni@chmca.org
Baylor College of Medicine - Houston, Texas 1,609.9 miles Catherine Loffredo None catherine.loffredo@bcm.edu
The University of Texas Health Science Center - Houston, Texas 1,609.9 miles Noemy Contress 713-500-5372 Noemy.Y.Contress@uth.tmc.edu
Baylor College of Medicine - Houston, Texas 1,609.9 miles Catherine Loffredo None catherine.loffredo@bcm.edu
The University of Texas Health Science Center - Houston, Texas 1,609.9 miles Noemy Contress 713-500-5372 Noemy.Y.Contress@uth.tmc.edu
Childrens Hospital Colorado - Aurora, Colorado 1,759.8 miles Michelle Hite 720-777-4690 michelle.hite@childrenscolorado.org
Childrens Hospital Colorado - Aurora, Colorado 1,759.8 miles Michelle Hite 720-777-4690 michelle.hite@childrenscolorado.org
Childrens Hospital Colorado - Aurora, Colorado 1,759.8 miles Michelle Hite 720-777-4690 michelle.hite@childrenscolorado.org
Childrens Hospital Colorado - Aurora, Colorado 1,759.8 miles Michelle Hite 720-777-4690 michelle.hite@childrenscolorado.org
Childrens Hospital Colorado - Aurora, Colorado 1,759.8 miles Michelle Hite 720-777-4690 michelle.hite@childrenscolorado.org
University of Utah Hospital - Salt Lake City, Utah 2,094.1 miles Carrie Bailey None carrie.bailey@hsc.utah.edu
University of Utah Hospital - Salt Lake City, Utah 2,094.1 miles Carrie Bailey None carrie.bailey@hsc.utah.edu
University of Utah Hospital - Salt Lake City, Utah 2,094.1 miles Carrie Bailey None carrie.bailey@hsc.utah.edu
Seattle Childrens Hospital - Seattle, Washington 2,487.2 miles Laurie Guidry None laurie.guidry@seattlechildrens.org
Seattle Childrens Hospital - Seattle, Washington 2,487.2 miles Laurie Guidry None laurie.guidry@seattlechildrens.org
Seattle Childrens Hospital - Seattle, Washington 2,487.2 miles Laurie Guidry None laurie.guidry@seattlechildrens.org
Seattle Childrens Hospital - Seattle, Washington 2,487.2 miles Laurie Guidry None laurie.guidry@seattlechildrens.org
Seattle Childrens Hospital - Seattle, Washington 2,487.2 miles Laurie Guidry None laurie.guidry@seattlechildrens.org
University of California San Diego - La Jolla, California 2,581.5 miles Jessica Reit 619-543-2816 jreit@ucsd.edu
Stanford Universtity - Palo Alto, California 2,694.6 miles Thu Quan 650-736-8166 tquan@stanford.edu

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