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Study in PRE-manifest Huntington's Disease of Coenzyme Q10 (UbiquinonE) Leading to Preventive Trials (PREQUEL) (PREQUEL)

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ClinicalTrials.gov Identifier: NCT00920699
Recruitment Status : Completed
First Posted : June 15, 2009
Results First Posted : September 25, 2017
Last Update Posted : September 25, 2017
Sponsor:
Collaborator:
National Institute of Neurological Disorders and Stroke (NINDS)
Information provided by (Responsible Party):
Johns Hopkins University

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition Huntington's Disease
Intervention Drug: CoQ10
Enrollment 90
Recruitment Details  
Pre-assignment Details  
Arm/Group Title 600 mg Per Day of CoQ10 1200 mg Per Day of CoQ10 2400 mg Per Day of CoQ10
Hide Arm/Group Description

All participants will start on a dosage of 600 mg/day of CoQ10 in divided doses, increasing weekly by 600 mg/day to a maximum dosage of 2400 mg/day at week 4. Dosage should be stable from week 4 until week 20.

CoQ10: Capsules containing 300 mg of CoQ10 or matching placebo taken orally twice a day. All participant will start on a dosage of 600 mg/day in divided doses, increasing weekly by 600 mg/day to a maximum dosage of 2400 mg/day at week 4. Dosage should be stable from week 4 until week 20.

All participants will start on a dosage of 600 mg/day in divided doses, increasing weekly by 600 mg/day to a maximum dosage of 2400 mg/day at week 4. Dosage should be stable from week 4 until week 20.

CoQ10: Capsules containing 300 mg of CoQ10 or matching placebo taken orally twice a day. All participant will start on a dosage of 600 mg/day in divided doses, increasing weekly by 600 mg/day to a maximum dosage of 2400 mg/day at week 4. Dosage should be stable from week 4 until week 20.

All participants will start on a dosage of 600 mg/day in divided doses, increasing weekly by 600 mg/day to a maximum dosage of 2400 mg/day at week 4. Dosage should be stable from week 4 until week 20.

CoQ10: Capsules containing 300 mg of CoQ10 or matching placebo taken orally twice a day. All participant will start on a dosage of 600 mg/day in divided doses, increasing weekly by 600 mg/day to a maximum dosage of 2400 mg/day at week 4. Dosage should be stable from week 4 until week 20.

Period Title: Overall Study
Started 29 30 32
Completed 27 29 28
Not Completed 2 1 4
Reason Not Completed
Withdrawal by Subject             2             0             2
no longer met eligibility             0             1             0
Lost to Follow-up             0             0             2
Arm/Group Title 600 mg Per Day of CoQ10 1200 mg Per Day of CoQ10 2400 mg Per Day of CoQ10 Total
Hide Arm/Group Description

All participants will start on a dosage of 600 mg/day of CoQ10 in divided doses, increasing weekly by 600 mg/day to a maximum dosage of 2400 mg/day at week 4. Dosage should be stable from week 4 until week 20.

CoQ10: Capsules containing 300 mg of CoQ10 or matching placebo taken orally twice a day. All participant will start on a dosage of 600 mg/day in divided doses, increasing weekly by 600 mg/day to a maximum dosage of 2400 mg/day at week 4. Dosage should be stable from week 4 until week 20.

All participants will start on a dosage of 600 mg/day in divided doses, increasing weekly by 600 mg/day to a maximum dosage of 2400 mg/day at week 4. Dosage should be stable from week 4 until week 20.

CoQ10: Capsules containing 300 mg of CoQ10 or matching placebo taken orally twice a day. All participant will start on a dosage of 600 mg/day in divided doses, increasing weekly by 600 mg/day to a maximum dosage of 2400 mg/day at week 4. Dosage should be stable from week 4 until week 20.

All participants will start on a dosage of 600 mg/day in divided doses, increasing weekly by 600 mg/day to a maximum dosage of 2400 mg/day at week 4. Dosage should be stable from week 4 until week 20.

CoQ10: Capsules containing 300 mg of CoQ10 or matching placebo taken orally twice a day. All participant will start on a dosage of 600 mg/day in divided doses, increasing weekly by 600 mg/day to a maximum dosage of 2400 mg/day at week 4. Dosage should be stable from week 4 until week 20.

Total of all reporting groups
Overall Number of Baseline Participants 29 29 32 90
Hide Baseline Analysis Population Description
one subject no longer met eligibility criteria in the 1200 mg arm
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 29 participants 29 participants 32 participants 90 participants
39.2  (9.8) 39.3  (11.5) 39.8  (11.6) 39.5  (10.9)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 29 participants 29 participants 32 participants 90 participants
Female
15
  51.7%
16
  55.2%
16
  50.0%
47
  52.2%
Male
14
  48.3%
13
  44.8%
16
  50.0%
43
  47.8%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
United States Number Analyzed 29 participants 29 participants 32 participants 90 participants
29
 100.0%
29
 100.0%
32
 100.0%
90
 100.0%
1.Primary Outcome
Title Tolerability as Assessed by Ability to Complete the Study on the Originally Randomized Treatment Assignment.
Hide Description No dosage modifications, reported as a %
Time Frame 20 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title 600 mg Per Day of CoQ10 1200 mg Per Day of CoQ10 2400 mg Per Day of CoQ10
Hide Arm/Group Description:

All participants will start on a dosage of 600 mg/day of CoQ10 in divided doses, increasing weekly by 600 mg/day to a maximum dosage of 2400 mg/day at week 4. Dosage should be stable from week 4 until week 20.

CoQ10: Capsules containing 300 mg of CoQ10 or matching placebo taken orally twice a day. All participant will start on a dosage of 600 mg/day in divided doses, increasing weekly by 600 mg/day to a maximum dosage of 2400 mg/day at week 4. Dosage should be stable from week 4 until week 20.

All participants will start on a dosage of 600 mg/day in divided doses, increasing weekly by 600 mg/day to a maximum dosage of 2400 mg/day at week 4. Dosage should be stable from week 4 until week 20.

CoQ10: Capsules containing 300 mg of CoQ10 or matching placebo taken orally twice a day. All participant will start on a dosage of 600 mg/day in divided doses, increasing weekly by 600 mg/day to a maximum dosage of 2400 mg/day at week 4. Dosage should be stable from week 4 until week 20.

All participants will start on a dosage of 600 mg/day in divided doses, increasing weekly by 600 mg/day to a maximum dosage of 2400 mg/day at week 4. Dosage should be stable from week 4 until week 20.

CoQ10: Capsules containing 300 mg of CoQ10 or matching placebo taken orally twice a day. All participant will start on a dosage of 600 mg/day in divided doses, increasing weekly by 600 mg/day to a maximum dosage of 2400 mg/day at week 4. Dosage should be stable from week 4 until week 20.

Overall Number of Participants Analyzed 29 29 32
Measure Type: Number
Unit of Measure: percentage of participants
90.0 93.1 81.3
2.Secondary Outcome
Title 8OHdG Levels
Hide Description ng/ml. Negative value signifies an decrease in 8OHdG levels
Time Frame change from baseline to 20 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Lab data not available for all participants to compare baseline and 20 weeks
Arm/Group Title 600 mg Per Day of CoQ10 1200 mg Per Day of CoQ10 2400 mg Per Day of CoQ10
Hide Arm/Group Description:

All participants will start on a dosage of 600 mg/day of CoQ10 in divided doses, increasing weekly by 600 mg/day to a maximum dosage of 2400 mg/day at week 4. Dosage should be stable from week 4 until week 20.

CoQ10: Capsules containing 300 mg of CoQ10 or matching placebo taken orally twice a day. All participant will start on a dosage of 600 mg/day in divided doses, increasing weekly by 600 mg/day to a maximum dosage of 2400 mg/day at week 4. Dosage should be stable from week 4 until week 20.

All participants will start on a dosage of 600 mg/day in divided doses, increasing weekly by 600 mg/day to a maximum dosage of 2400 mg/day at week 4. Dosage should be stable from week 4 until week 20.

CoQ10: Capsules containing 300 mg of CoQ10 or matching placebo taken orally twice a day. All participant will start on a dosage of 600 mg/day in divided doses, increasing weekly by 600 mg/day to a maximum dosage of 2400 mg/day at week 4. Dosage should be stable from week 4 until week 20.

All participants will start on a dosage of 600 mg/day in divided doses, increasing weekly by 600 mg/day to a maximum dosage of 2400 mg/day at week 4. Dosage should be stable from week 4 until week 20.

CoQ10: Capsules containing 300 mg of CoQ10 or matching placebo taken orally twice a day. All participant will start on a dosage of 600 mg/day in divided doses, increasing weekly by 600 mg/day to a maximum dosage of 2400 mg/day at week 4. Dosage should be stable from week 4 until week 20.

Overall Number of Participants Analyzed 19 21 27
Mean (Standard Deviation)
Unit of Measure: ng/ml
0.15  (3.26) -1.56  (3.23) 0.55  (7.1)
3.Secondary Outcome
Title CoQ10 Levels
Hide Description ng/ml
Time Frame change from baseline to 20 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
data was not available for all participants to compare baseline to 20 weeks
Arm/Group Title 600 mg Per Day of CoQ10 1200 mg Per Day of CoQ10 2400 mg Per Day of CoQ10
Hide Arm/Group Description:

All participants will start on a dosage of 600 mg/day of CoQ10 in divided doses, increasing weekly by 600 mg/day to a maximum dosage of 2400 mg/day at week 4. Dosage should be stable from week 4 until week 20.

CoQ10: Capsules containing 300 mg of CoQ10 or matching placebo taken orally twice a day. All participant will start on a dosage of 600 mg/day in divided doses, increasing weekly by 600 mg/day to a maximum dosage of 2400 mg/day at week 4. Dosage should be stable from week 4 until week 20.

All participants will start on a dosage of 600 mg/day in divided doses, increasing weekly by 600 mg/day to a maximum dosage of 2400 mg/day at week 4. Dosage should be stable from week 4 until week 20.

CoQ10: Capsules containing 300 mg of CoQ10 or matching placebo taken orally twice a day. All participant will start on a dosage of 600 mg/day in divided doses, increasing weekly by 600 mg/day to a maximum dosage of 2400 mg/day at week 4. Dosage should be stable from week 4 until week 20.

All participants will start on a dosage of 600 mg/day in divided doses, increasing weekly by 600 mg/day to a maximum dosage of 2400 mg/day at week 4. Dosage should be stable from week 4 until week 20.

CoQ10: Capsules containing 300 mg of CoQ10 or matching placebo taken orally twice a day. All participant will start on a dosage of 600 mg/day in divided doses, increasing weekly by 600 mg/day to a maximum dosage of 2400 mg/day at week 4. Dosage should be stable from week 4 until week 20.

Overall Number of Participants Analyzed 24 25 28
Mean (Standard Deviation)
Unit of Measure: ng/ml
1.82  (1.78) 1.92  (1.66) 2.33  (1.38)
Time Frame up to 20 weeks
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title 600 mg Per Day of CoQ10 1200 mg Per Day of CoQ10 2400 mg Per Day of CoQ10
Hide Arm/Group Description

All participants will start on a dosage of 600 mg/day of CoQ10 in divided doses, increasing weekly by 600 mg/day to a maximum dosage of 2400 mg/day at week 4. Dosage should be stable from week 4 until week 20.

CoQ10: Capsules containing 300 mg of CoQ10 or matching placebo taken orally twice a day. All participant will start on a dosage of 600 mg/day in divided doses, increasing weekly by 600 mg/day to a maximum dosage of 2400 mg/day at week 4. Dosage should be stable from week 4 until week 20.

All participants will start on a dosage of 600 mg/day in divided doses, increasing weekly by 600 mg/day to a maximum dosage of 2400 mg/day at week 4. Dosage should be stable from week 4 until week 20.

CoQ10: Capsules containing 300 mg of CoQ10 or matching placebo taken orally twice a day. All participant will start on a dosage of 600 mg/day in divided doses, increasing weekly by 600 mg/day to a maximum dosage of 2400 mg/day at week 4. Dosage should be stable from week 4 until week 20.

All participants will start on a dosage of 600 mg/day in divided doses, increasing weekly by 600 mg/day to a maximum dosage of 2400 mg/day at week 4. Dosage should be stable from week 4 until week 20.

CoQ10: Capsules containing 300 mg of CoQ10 or matching placebo taken orally twice a day. All participant will start on a dosage of 600 mg/day in divided doses, increasing weekly by 600 mg/day to a maximum dosage of 2400 mg/day at week 4. Dosage should be stable from week 4 until week 20.

All-Cause Mortality
600 mg Per Day of CoQ10 1200 mg Per Day of CoQ10 2400 mg Per Day of CoQ10
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/29 (0.00%)      0/29 (0.00%)      0/32 (0.00%)    
Show Serious Adverse Events Hide Serious Adverse Events
600 mg Per Day of CoQ10 1200 mg Per Day of CoQ10 2400 mg Per Day of CoQ10
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/29 (0.00%)      0/29 (0.00%)      0/32 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
600 mg Per Day of CoQ10 1200 mg Per Day of CoQ10 2400 mg Per Day of CoQ10
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   9/29 (31.03%)      20/29 (68.97%)      16/32 (50.00%)    
Gastrointestinal disorders       
Diarrhea   2/29 (6.90%)  2 7/29 (24.14%)  7 4/32 (12.50%)  4
Abdominal discomfort/pain; dyspepsia   2/29 (6.90%)  2 4/29 (13.79%)  4 1/32 (3.13%)  1
Abdominal distension   1/29 (3.45%)  1 1/29 (3.45%)  1 1/32 (3.13%)  1
Flatulence   0/29 (0.00%)  0 2/29 (6.90%)  2 1/32 (3.13%)  1
Vomiting   1/29 (3.45%)  1 1/29 (3.45%)  1 1/32 (3.13%)  1
Musculoskeletal and connective tissue disorders       
increase creatinine phosphokinase (blood)   2/29 (6.90%)  2 0/29 (0.00%)  0 1/32 (3.13%)  1
Nervous system disorders       
Dizziness   1/29 (3.45%)  1 2/29 (6.90%)  2 1/32 (3.13%)  1
Headache   0/29 (0.00%)  0 1/29 (3.45%)  1 2/32 (6.25%)  2
Psychiatric disorders       
Depression   0/29 (0.00%)  0 2/29 (6.90%)  2 1/32 (3.13%)  1
Renal and urinary disorders       
Hematuria   0/29 (0.00%)  0 0/29 (0.00%)  0 3/32 (9.38%)  3
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Christopher A. Ross M.D. Ph.D.
Organization: Johns Hopkins University
Phone: 410-614-0011
EMail: caross@jhmi.edu
Layout table for additonal information
Responsible Party: Johns Hopkins University
ClinicalTrials.gov Identifier: NCT00920699     History of Changes
Other Study ID Numbers: PREQUEL-01.00
NIH grant: 1 R01 NS060118-01A1
First Submitted: June 9, 2009
First Posted: June 15, 2009
Results First Submitted: August 25, 2017
Results First Posted: September 25, 2017
Last Update Posted: September 25, 2017