Trial Outcomes & Findings for Study in PRE-manifest Huntington's Disease of Coenzyme Q10 (UbiquinonE) Leading to Preventive Trials (PREQUEL) (NCT NCT00920699)
NCT ID: NCT00920699
Last Updated: 2017-09-25
Results Overview
No dosage modifications, reported as a %
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
90 participants
Primary outcome timeframe
20 weeks
Results posted on
2017-09-25
Participant Flow
Participant milestones
| Measure |
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.
|
|---|---|---|---|
|
Overall Study
STARTED
|
29
|
30
|
32
|
|
Overall Study
COMPLETED
|
27
|
29
|
28
|
|
Overall Study
NOT COMPLETED
|
2
|
1
|
4
|
Reasons for withdrawal
| Measure |
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.
|
|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
2
|
0
|
2
|
|
Overall Study
no longer met eligibility
|
0
|
1
|
0
|
|
Overall Study
Lost to Follow-up
|
0
|
0
|
2
|
Baseline Characteristics
Study in PRE-manifest Huntington's Disease of Coenzyme Q10 (UbiquinonE) Leading to Preventive Trials (PREQUEL)
Baseline characteristics by cohort
| Measure |
600 mg Per Day of CoQ10
n=29 Participants
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
n=29 Participants
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
n=32 Participants
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
n=90 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
39.2 years
STANDARD_DEVIATION 9.8 • n=5 Participants
|
39.3 years
STANDARD_DEVIATION 11.5 • n=7 Participants
|
39.8 years
STANDARD_DEVIATION 11.6 • n=5 Participants
|
39.5 years
STANDARD_DEVIATION 10.9 • n=4 Participants
|
|
Sex: Female, Male
Female
|
15 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
47 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
14 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
43 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
29 Participants
n=5 Participants
|
29 Participants
n=7 Participants
|
32 Participants
n=5 Participants
|
90 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: 20 weeksNo dosage modifications, reported as a %
Outcome measures
| Measure |
600 mg Per Day of CoQ10
n=29 Participants
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
n=29 Participants
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
n=32 Participants
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.
|
|---|---|---|---|
|
Tolerability as Assessed by Ability to Complete the Study on the Originally Randomized Treatment Assignment.
|
90.0 percentage of participants
|
93.1 percentage of participants
|
81.3 percentage of participants
|
SECONDARY outcome
Timeframe: change from baseline to 20 weeksPopulation: Lab data not available for all participants to compare baseline and 20 weeks
ng/ml. Negative value signifies an decrease in 8OHdG levels
Outcome measures
| Measure |
600 mg Per Day of CoQ10
n=19 Participants
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
n=21 Participants
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
n=27 Participants
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.
|
|---|---|---|---|
|
8OHdG Levels
|
0.15 ng/ml
Standard Deviation 3.26
|
-1.56 ng/ml
Standard Deviation 3.23
|
0.55 ng/ml
Standard Deviation 7.1
|
SECONDARY outcome
Timeframe: change from baseline to 20 weeksPopulation: data was not available for all participants to compare baseline to 20 weeks
ng/ml
Outcome measures
| Measure |
600 mg Per Day of CoQ10
n=24 Participants
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
n=25 Participants
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
n=28 Participants
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.
|
|---|---|---|---|
|
CoQ10 Levels
|
1.82 ng/ml
Standard Deviation 1.78
|
1.92 ng/ml
Standard Deviation 1.66
|
2.33 ng/ml
Standard Deviation 1.38
|
Adverse Events
600 mg Per Day of CoQ10
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
1200 mg Per Day of CoQ10
Serious events: 0 serious events
Other events: 20 other events
Deaths: 0 deaths
2400 mg Per Day of CoQ10
Serious events: 0 serious events
Other events: 16 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
600 mg Per Day of CoQ10
n=29 participants at risk
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
n=29 participants at risk
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
n=32 participants at risk
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.
|
|---|---|---|---|
|
Gastrointestinal disorders
Diarrhea
|
6.9%
2/29 • Number of events 2 • up to 20 weeks
|
24.1%
7/29 • Number of events 7 • up to 20 weeks
|
12.5%
4/32 • Number of events 4 • up to 20 weeks
|
|
Gastrointestinal disorders
Abdominal discomfort/pain; dyspepsia
|
6.9%
2/29 • Number of events 2 • up to 20 weeks
|
13.8%
4/29 • Number of events 4 • up to 20 weeks
|
3.1%
1/32 • Number of events 1 • up to 20 weeks
|
|
Nervous system disorders
Dizziness
|
3.4%
1/29 • Number of events 1 • up to 20 weeks
|
6.9%
2/29 • Number of events 2 • up to 20 weeks
|
3.1%
1/32 • Number of events 1 • up to 20 weeks
|
|
Gastrointestinal disorders
Abdominal distension
|
3.4%
1/29 • Number of events 1 • up to 20 weeks
|
3.4%
1/29 • Number of events 1 • up to 20 weeks
|
3.1%
1/32 • Number of events 1 • up to 20 weeks
|
|
Musculoskeletal and connective tissue disorders
increase creatinine phosphokinase (blood)
|
6.9%
2/29 • Number of events 2 • up to 20 weeks
|
0.00%
0/29 • up to 20 weeks
|
3.1%
1/32 • Number of events 1 • up to 20 weeks
|
|
Psychiatric disorders
Depression
|
0.00%
0/29 • up to 20 weeks
|
6.9%
2/29 • Number of events 2 • up to 20 weeks
|
3.1%
1/32 • Number of events 1 • up to 20 weeks
|
|
Gastrointestinal disorders
Flatulence
|
0.00%
0/29 • up to 20 weeks
|
6.9%
2/29 • Number of events 2 • up to 20 weeks
|
3.1%
1/32 • Number of events 1 • up to 20 weeks
|
|
Renal and urinary disorders
Hematuria
|
0.00%
0/29 • up to 20 weeks
|
0.00%
0/29 • up to 20 weeks
|
9.4%
3/32 • Number of events 3 • up to 20 weeks
|
|
Nervous system disorders
Headache
|
0.00%
0/29 • up to 20 weeks
|
3.4%
1/29 • Number of events 1 • up to 20 weeks
|
6.2%
2/32 • Number of events 2 • up to 20 weeks
|
|
Gastrointestinal disorders
Vomiting
|
3.4%
1/29 • Number of events 1 • up to 20 weeks
|
3.4%
1/29 • Number of events 1 • up to 20 weeks
|
3.1%
1/32 • Number of events 1 • up to 20 weeks
|
Additional Information
Christopher A. Ross M.D. Ph.D.
Johns Hopkins University
Phone: 410-614-0011
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place