Phase III Trial of Coenzyme Q10 in Mitochondrial Disease

PHASE3CompletedINTERVENTIONAL
Enrollment

24

Participants

Timeline

Start Date

January 31, 2007

Primary Completion Date

May 31, 2013

Study Completion Date

May 31, 2013

Conditions
Mitochondrial Diseases
Interventions
DRUG

CoenzymeQ10

CoenzymeQ10 will be given in 10 mg/kg daily up to 400 mg. Then a draw of CoQ10 troughs every three months will be performed.

DRUG

Placebo

Placebo will be given in 10 mg/kg daily up to 400 mg. Then a draw of placebo troughs every three months will be performed. This treatment group will be treated as the active group.

Trial Locations (3)

44106

Case Western Reserve University, Cleveland

45267

Cincinnati Children's Hospital Medical Center, Cincinnati

M5G 1X8

Hospital for Sick Children, Toronto

All Listed Sponsors
collaborator

FDA Office of Orphan Products Development

FED

collaborator

Food and Drug Administration (FDA)

FED

lead

University of Florida

OTHER

NCT00432744 - Phase III Trial of Coenzyme Q10 in Mitochondrial Disease | Biotech Hunter | Biotech Hunter