NCT01301235

Brief Summary

This is a developmental protocol to determine the MRI based 31P-MRS changes seen in subjects with mitochondrial myopathy using our dynamic exercise protocol and to identify the ideal variable(s) to represent mitochondrial function.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
8

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Feb 2011

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2011

Completed
17 days until next milestone

First Submitted

Initial submission to the registry

February 18, 2011

Completed
5 days until next milestone

First Posted

Study publicly available on registry

February 23, 2011

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2011

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2012

Completed
Last Updated

April 30, 2012

Status Verified

April 1, 2012

Enrollment Period

9 months

First QC Date

February 18, 2011

Last Update Submit

April 27, 2012

Conditions

Mitochondrial Disease

Keywords

Mitochondria

Outcome Measures

Primary Outcomes (1)

  • PCr recovery after submaximal exercise by 31P-MRS

    1 year

Study Arms (1)

Subjects with mitochondrial disease

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Adults with mitochondrial disease

You may qualify if:

  • Men and women ≥ age 18 years old with primary mitochondrial myopathy
  • Known alteration in electron transport chain activity (\<25 % activity of ETC) or known mutations in mitochondrial gene.

You may not qualify if:

  • Failure based on standard clinical MRI Screening form - the form is intended to establish the safety of subjects participating in the MRI scan without divulging any confidentiality information -

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

MeSH Terms

Conditions

Mitochondrial Diseases

Condition Hierarchy (Ancestors)

Metabolic DiseasesNutritional and Metabolic Diseases

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Investigator

Study Record Dates

First Submitted

February 18, 2011

First Posted

February 23, 2011

Study Start

February 1, 2011

Primary Completion

November 1, 2011

Study Completion

April 1, 2012

Last Updated

April 30, 2012

Record last verified: 2012-04

Locations

US(1)