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CoQ10 and Prednisone in Non-Ambulatory DMD

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ClinicalTrials.gov Identifier: NCT00308113
Recruitment Status : Terminated (New enrollment has been suspended, currently following previously enrolled participants)
First Posted : March 29, 2006
Results First Posted : October 11, 2013
Last Update Posted : November 8, 2013
Sponsor:
Collaborator:
United States Department of Defense
Information provided by (Responsible Party):
Cooperative International Neuromuscular Research Group

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Duchenne Muscular Dystrophy
Interventions Drug: Prednisone
Dietary Supplement: Coenzyme Q10
Enrollment 3
Recruitment Details Recruitment started in April 2007 at two participating centers of the Cooperative International Neuromuscular Research Group (CINRG): University of Pittsburgh and University of Puerto Rico. Enrollment closed in December 2008 by the CINRG Data and Safety Monitoring Board (DSMB) due to changes in standard of care.
Pre-assignment Details  
Arm/Group Title Coenzyme Q10 Alone Prednisone Alone Coenzyme Q10 and Prednisone Enhanced Standard of Care
Hide Arm/Group Description

CoenzymeQ10 taken once a day each morning by mouth.

Coenzyme Q10 : serum levels of greater or equal to 2.5 micrograms/mL.

Prednisone taken once a day each morning by mouth

Prednisone : Prednisone 0/75 mg/kg/day.

CoenzymeQ10 and prednisone each taken once a day in the morning by mouth.

Coenzyme Q10 : serum levels of greater or equal to 2.5 micrograms/mL.

Prednisone : Prednisone 0/75 mg/kg/day.

Enhanced standard of care.
Period Title: Overall Study
Started 0 0 1 2
Completed 0 0 1 1
Not Completed 0 0 0 1
Reason Not Completed
Protocol closure             0             0             0             1
Arm/Group Title Coenzyme Q10 Alone Prednisone Alone Coenzyme Q10 and Prednisone Enhanced Standard of Care Total
Hide Arm/Group Description

CoenzymeQ10 taken once a day each morning by mouth.

Coenzyme Q10 : serum levels of greater or equal to 2.5 micrograms/mL.

Prednisone taken once a day each morning by mouth

Prednisone : Prednisone 0/75 mg/kg/day.

CoenzymeQ10 and prednisone each taken once a day in the morning by mouth.

Coenzyme Q10 : serum levels of greater or equal to 2.5 micrograms/mL.

Prednisone : Prednisone 0/75 mg/kg/day.

Enhanced standard of care. Total of all reporting groups
Overall Number of Baseline Participants 0 0 1 2 3
Hide Baseline Analysis Population Description
[Not Specified]
Age, Customized  
Measure Type: Number
Unit of measure:  Participants
10-18 years Number Analyzed 0 participants 0 participants 1 participants 2 participants 3 participants
1 2 3
Gender  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 0 participants 0 participants 1 participants 2 participants 3 participants
Female 0 0 0
Male 1 2 3
1.Primary Outcome
Title One Year Change of Left Ventricular Mean Systolic Wall Stress/Rate-corrected Velocity of Fiber Shortening Relation.
Hide Description Comparing change from baseline of mean systolic wall stress and rate-corrected mean velocity of circumferential shortening in the three treatment groups relative to the enhanced standard of care group and relative to each other at one year. The values are obtained via an echocardiogram read locally at each site.
Time Frame 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
No analysis was performed as only 1 out of 3 participants completed all echocardiogram measurements before the protocol was closed.
Arm/Group Title Coenzyme Q10 Alone Prednisone Alone Coenzyme Q10 and Prednisone Enhanced Standard of Care
Hide Arm/Group Description:

CoenzymeQ10 taken once a day each morning by mouth.

Coenzyme Q10 : serum levels of greater or equal to 2.5 micrograms/mL.

Prednisone taken once a day each morning by mouth

Prednisone : Prednisone 0/75 mg/kg/day.

CoenzymeQ10 and prednisone each taken once a day in the morning by mouth.

Coenzyme Q10 : serum levels of greater or equal to 2.5 micrograms/mL.

Prednisone : Prednisone 0/75 mg/kg/day.

Enhanced standard of care.
Overall Number of Participants Analyzed 0 0 0 0
No data displayed because Outcome Measure has zero total analyzed.
2.Primary Outcome
Title One Year Change in Pulmonary Function (Forced Expiratory Volume, FEV1 and Forced Vital Capacity, FVC)
Hide Description Comparing change from baseline levels in pulmonary function (FEV1 and FVC) in the three treatment groups relative to the enhanced standard of care group and relative to each other at one year.
Time Frame 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
No analysis was performed as only 1 out of 3 participants completed all the pulmonary function measurements before the protocol was closed.
Arm/Group Title Coenzyme Q10 Alone Prednisone Alone Coenzyme Q10 and Prednisone Enhanced Standard of Care
Hide Arm/Group Description:

CoenzymeQ10 taken once a day each morning by mouth.

Coenzyme Q10 : serum levels of greater or equal to 2.5 micrograms/mL.

Prednisone taken once a day each morning by mouth

Prednisone : Prednisone 0/75 mg/kg/day.

CoenzymeQ10 and prednisone each taken once a day in the morning by mouth.

Coenzyme Q10 : serum levels of greater or equal to 2.5 micrograms/mL.

Prednisone : Prednisone 0/75 mg/kg/day.

Enhanced standard of care.
Overall Number of Participants Analyzed 0 0 0 0
No data displayed because Outcome Measure has zero total analyzed.
3.Secondary Outcome
Title Compare Side Effect Profiles of the Three Study Groups
Hide Description To compare side effect profiles of the three regimens to the enhanced standard of care group, to include height, weight, weight/height ratio, body mass index, cataract formation, blood glucose, blood pressure, and behavioral changes.
Time Frame 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
No analysis was performed as the study was closed with N=3 out of 120 and side effects profile between groups could not be analyzed.
Arm/Group Title Coenzyme Q10 Alone Prednisone Alone Coenzyme Q10 and Prednisone Enhanced Standard of Care
Hide Arm/Group Description:

CoenzymeQ10 taken once a day each morning by mouth.

Coenzyme Q10 : serum levels of greater or equal to 2.5 micrograms/mL.

Prednisone taken once a day each morning by mouth

Prednisone : Prednisone 0/75 mg/kg/day.

CoenzymeQ10 and prednisone each taken once a day in the morning by mouth.

Coenzyme Q10 : serum levels of greater or equal to 2.5 micrograms/mL.

Prednisone : Prednisone 0/75 mg/kg/day.

Enhanced standard of care.
Overall Number of Participants Analyzed 0 0 0 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame 12 months
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Coenzyme Q10 Alone Prednisone Alone Coenzyme Q10 and Prednisone Enhanced Standard of Care
Hide Arm/Group Description

CoenzymeQ10 taken once a day each morning by mouth.

Coenzyme Q10 : serum levels of greater or equal to 2.5 micrograms/mL.

Prednisone taken once a day each morning by mouth

Prednisone : Prednisone 0/75 mg/kg/day.

CoenzymeQ10 and prednisone each taken once a day in the morning by mouth.

Coenzyme Q10 : serum levels of greater or equal to 2.5 micrograms/mL.

Prednisone : Prednisone 0/75 mg/kg/day.

Enhanced standard of care.
All-Cause Mortality
Coenzyme Q10 Alone Prednisone Alone Coenzyme Q10 and Prednisone Enhanced Standard of Care
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/--   --/-- 
Hide Serious Adverse Events
Coenzyme Q10 Alone Prednisone Alone Coenzyme Q10 and Prednisone Enhanced Standard of Care
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/0   0/0   1/1 (100.00%)   0/2 (0.00%) 
Surgical and medical procedures         
Tonsilectomy   0/0  0/0  1/1 (100.00%)  0/2 (0.00%) 
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Coenzyme Q10 Alone Prednisone Alone Coenzyme Q10 and Prednisone Enhanced Standard of Care
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/0   0/0   1/1 (100.00%)   1/2 (50.00%) 
Blood and lymphatic system disorders         
Limb edema   0/0  0/0  1/1 (100.00%)  0/2 (0.00%) 
Cardiac disorders         
Cardiac arrhythmia   0/0  0/0  1/1 (100.00%)  0/2 (0.00%) 
Gastrointestinal disorders         
Gastrointestinal Virus   0/0  0/0  0/1 (0.00%)  1/2 (50.00%) 
General disorders         
Mood alteration and agitation   0/0  0/0  1/1 (100.00%)  0/2 (0.00%) 
Infections and infestations         
Upper airway infection   0/0  0/0  1/1 (100.00%)  0/2 (0.00%) 
Indicates events were collected by systematic assessment
In December 2007 the CINRG Data Safety and Monitoring Board (DSMB) met and recommended to close the study as the AAN had released practice parameters recommending that all patients with DMD should be offered treatment with corticosteroids.
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Paula R. Clemens
Organization: University of Pittsburgh
Phone: 412-648-9762
EMail: pclemens@pitt.edu
Layout table for additonal information
Responsible Party: Cooperative International Neuromuscular Research Group
ClinicalTrials.gov Identifier: NCT00308113    
Other Study ID Numbers: PITT0503
First Submitted: March 27, 2006
First Posted: March 29, 2006
Results First Submitted: August 7, 2013
Results First Posted: October 11, 2013
Last Update Posted: November 8, 2013