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

Primary Purpose

Huntington's Disease

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
CoQ10
Sponsored by
Johns Hopkins University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Huntington's Disease

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Participants will be positive for the CAGn expansion in the Huntingtin gene (>36 repeats) and be pre-manifest by virtue of scoring 3 or less on diagnostic confidence level (Question 17 of the UHDRS)
  • Participants will have received genetic testing prior to enrollment through a standard pre-manifest testing protocol.
  • 18 years of age or older.
  • Concomitant medications are permitted with the exception of CoQ10, creatine > 5g/day and warfarin.

Exclusion Criteria:

  • History of intolerability to CoQ10.
  • CoQ10 use within 60 days prior to randomization.
  • Unstable medical or psychiatric illness;
  • Substance abuse within one year of the baseline visit.
  • Pregnancy, breastfeeding or lack of reliable contraception in women of childbearing age.
  • Subjects with known allergy to FD&C #6 yellow food coloring.

Sites / Locations

  • University of California Davis
  • Colorado Neurological Institute
  • University of Miami School of Medicine
  • Emory University School of Medicine
  • Indiana University School of Medicine
  • University of Iowa
  • Hereditary Neurological Disease Centre (HNDC)
  • Johns Hopkins University
  • Hennepin County Medical Center
  • Washington University
  • Albany Medical College
  • University of Rochester
  • Baylor College of Medicine

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

600 mg per day of CoQ10

1200 mg per day of CoQ10

2400 mg per day of CoQ10

Arm 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.

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.

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.

Outcomes

Primary Outcome Measures

Tolerability as Assessed by Ability to Complete the Study on the Originally Randomized Treatment Assignment.
No dosage modifications, reported as a %

Secondary Outcome Measures

8OHdG Levels
ng/ml. Negative value signifies an decrease in 8OHdG levels
CoQ10 Levels
ng/ml

Full Information

First Posted
June 9, 2009
Last Updated
August 25, 2017
Sponsor
Johns Hopkins University
Collaborators
National Institute of Neurological Disorders and Stroke (NINDS)
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1. Study Identification

Unique Protocol Identification Number
NCT00920699
Brief Title
Study in PRE-manifest Huntington's Disease of Coenzyme Q10 (UbiquinonE) Leading to Preventive Trials (PREQUEL)
Acronym
PREQUEL
Official Title
A Multi-Center, Double-Blind, Randomized, Parallel Group Tolerability Study of Coenzyme Q10 (UbiquinonE)in PRE-manifest Huntington's Disease
Study Type
Interventional

2. Study Status

Record Verification Date
August 2017
Overall Recruitment Status
Completed
Study Start Date
February 2010 (undefined)
Primary Completion Date
March 2012 (Actual)
Study Completion Date
March 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Johns Hopkins University
Collaborators
National Institute of Neurological Disorders and Stroke (NINDS)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
To establish the tolerability of treatment with 600, 1200 or 2400 mg per day of coenzyme Q10 in pre-manifest participants carrying the CAGn expansion for Huntington's Disease (HD).
Detailed Description
secondary objectives: To assess the change from baseline to 20 weeks on biomarkers of oxidative stress (8OHdG and 8OHrG) and DNA repair mechanisms (OGG1) in pre-manifest participants treated with 600, 1200 or 2400 mg per day of CoQ10. To assess the dose-response relationship between CoQ10 at dosages of 600, 1200 or 2400 mg per day and 8OHdG/8OHrG and OGG1. To assess the serum levels of CoQ10 at 600, 1200 or 2400 mg in pre-manifest participants and their relationship to 8OHdG/8OHrG and OGG1. To assess the feasibility of implementing a preventive therapeutic trial in a pre-manifest population. To assess the utility and stability of clinical measures of HD, social relations, behavior and employment in a pre-manifest sample enrolled in a treatment trial.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Huntington's Disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
90 (Actual)

8. Arms, Groups, and Interventions

Arm Title
600 mg per day of CoQ10
Arm Type
Experimental
Arm 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.
Arm Title
1200 mg per day of CoQ10
Arm Type
Experimental
Arm Description
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.
Arm Title
2400 mg per day of CoQ10
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
CoQ10
Other Intervention Name(s)
-Ubiquinone, -coenzyme Q10
Intervention Description
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.
Primary Outcome Measure Information:
Title
Tolerability as Assessed by Ability to Complete the Study on the Originally Randomized Treatment Assignment.
Description
No dosage modifications, reported as a %
Time Frame
20 weeks
Secondary Outcome Measure Information:
Title
8OHdG Levels
Description
ng/ml. Negative value signifies an decrease in 8OHdG levels
Time Frame
change from baseline to 20 weeks
Title
CoQ10 Levels
Description
ng/ml
Time Frame
change from baseline to 20 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Participants will be positive for the CAGn expansion in the Huntingtin gene (>36 repeats) and be pre-manifest by virtue of scoring 3 or less on diagnostic confidence level (Question 17 of the UHDRS) Participants will have received genetic testing prior to enrollment through a standard pre-manifest testing protocol. 18 years of age or older. Concomitant medications are permitted with the exception of CoQ10, creatine > 5g/day and warfarin. Exclusion Criteria: History of intolerability to CoQ10. CoQ10 use within 60 days prior to randomization. Unstable medical or psychiatric illness; Substance abuse within one year of the baseline visit. Pregnancy, breastfeeding or lack of reliable contraception in women of childbearing age. Subjects with known allergy to FD&C #6 yellow food coloring.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christopher A Ross, MD, PhD
Organizational Affiliation
Johns Hopkins University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Kevin M Biglan, MD, MPH
Organizational Affiliation
University of Rochester
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of California Davis
City
Sacramento
State/Province
California
ZIP/Postal Code
95817
Country
United States
Facility Name
Colorado Neurological Institute
City
Englewood
State/Province
Colorado
ZIP/Postal Code
80120
Country
United States
Facility Name
University of Miami School of Medicine
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Facility Name
Emory University School of Medicine
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30329
Country
United States
Facility Name
Indiana University School of Medicine
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
Facility Name
University of Iowa
City
Iowa City
State/Province
Iowa
ZIP/Postal Code
52242
Country
United States
Facility Name
Hereditary Neurological Disease Centre (HNDC)
City
Wichita
State/Province
Kansas
ZIP/Postal Code
67206
Country
United States
Facility Name
Johns Hopkins University
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21287
Country
United States
Facility Name
Hennepin County Medical Center
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55415
Country
United States
Facility Name
Washington University
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
Albany Medical College
City
Albany
State/Province
New York
ZIP/Postal Code
12208
Country
United States
Facility Name
University of Rochester
City
Rochester
State/Province
New York
ZIP/Postal Code
14618
Country
United States
Facility Name
Baylor College of Medicine
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States

12. IPD Sharing Statement

Links:
URL
http://www.huntington-study-group.org
Description
Huntington Study Group

Learn more about this trial

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

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