We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00920699
First Posted: June 15, 2009
Last Update Posted: September 25, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Institute of Neurological Disorders and Stroke (NINDS)
Information provided by (Responsible Party):
Johns Hopkins University
Results First Submitted: August 25, 2017  
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

  Participant Flow
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
600 mg Per Day of CoQ10

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.

1200 mg Per Day of CoQ10

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.

2400 mg Per Day of CoQ10

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.


Participant Flow:   Overall Study
    600 mg Per Day of CoQ10   1200 mg Per Day of CoQ10   2400 mg Per Day of CoQ10
STARTED   29   30   32 
COMPLETED   27   29   28 
NOT COMPLETED   2   1   4 
Withdrawal by Subject                2                0                2 
no longer met eligibility                0                1                0 
Lost to Follow-up                0                0                2 



  Baseline Characteristics
  Hide Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
one subject no longer met eligibility criteria in the 1200 mg arm

Reporting Groups
  Description
600 mg Per Day of CoQ10

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.

1200 mg Per Day of CoQ10

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.

2400 mg Per Day of CoQ10

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 Total of all reporting groups

Baseline Measures
   600 mg Per Day of CoQ10   1200 mg Per Day of CoQ10   2400 mg Per Day of CoQ10   Total 
Overall Participants Analyzed 
[Units: Participants]
 29   29   32   90 
Age 
[Units: Years]
Mean (Standard Deviation)
 39.2  (9.8)   39.3  (11.5)   39.8  (11.6)   39.5  (10.9) 
Sex: Female, Male 
[Units: Participants]
Count of 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 
[Units: Participants]
Count of Participants
       
United States   29   29   32   90 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Tolerability as Assessed by Ability to Complete the Study on the Originally Randomized Treatment Assignment.   [ Time Frame: 20 weeks ]

2.  Secondary:   8OHdG Levels   [ Time Frame: change from baseline to 20 weeks ]

3.  Secondary:   CoQ10 Levels   [ Time Frame: change from baseline to 20 weeks ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information
  Hide More Information

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:  
Name/Title: Christopher A. Ross M.D. Ph.D.
Organization: Johns Hopkins University
phone: 410-614-0011
e-mail: caross@jhmi.edu



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