NCT00786539

Brief Summary

The objective of this research protocol is to continue investigation of the nature and prevalence of mitochondria disease and to aid patients and health care providers in the understanding of these complex disorders. This research study brings together many clinical sub-specialists to address the etiology of these disorders and to develop more effective approaches for their diagnoses and more reliable prognoses.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
18

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Oct 2006

Longer than P75 for all trials

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

October 1, 2006

Completed
2.1 years until next milestone

First Submitted

Initial submission to the registry

November 4, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 6, 2008

Completed
6.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2015

Completed
Last Updated

October 20, 2022

Status Verified

October 1, 2022

Enrollment Period

8.6 years

First QC Date

November 4, 2008

Last Update Submit

October 19, 2022

Conditions

Mitochondrial Disease

Keywords

mitochondrial

Outcome Measures

Primary Outcomes (1)

  • Symptoms of Mitochondrial diseases

    Up to 12 weeks

Interventions

Diffuse Optical SpectroscopyDEVICE

mitochondria

Eligibility Criteria

Age1 Day+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Study population with mitochondrial disorder and/or their relatives will be referred to MITOMED by Primary Care Physicians or by Clinical Specialists.

You may qualify if:

  • Male or female all ages group with diagnosis of mitochondrial disorder

You may not qualify if:

  • Subjects with visual, auditory and/or neurological problems known to result from toxic or environmental effects

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Beckman Laser Institute Medical clinic

Irvine, California, 92612, United States

Location

MeSH Terms

Conditions

Mitochondrial Diseases

Condition Hierarchy (Ancestors)

Metabolic DiseasesNutritional and Metabolic Diseases

Study Officials

  • Bruce J Tromberg, PhD

    Beckman Laser Institute University of California Irvine

    PRINCIPAL INVESTIGATOR

  • Virginia Kimonis, MD

    UCIMC Pediatrics

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Virginia Kimonis, MD, MRCP

Study Record Dates

First Submitted

November 4, 2008

First Posted

November 6, 2008

Study Start

October 1, 2006

Primary Completion

May 1, 2015

Study Completion

May 1, 2015

Last Updated

October 20, 2022

Record last verified: 2022-10

Locations

US(1)