Randomized, Double-blind, Placebo-controlled trial on Reduced Coenzyme Q10 in Parkinson Disease

Randomized, Double-blind, Placebo-controlled trial on Reduced Coenzyme Q10 in Parkinson Disease - Randomized, Double-blind, Placebo-controlled trial on Reduced Coenzyme Q10 in Parkinson Disease

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000007521

Enrollment

Registered

2012-03-17

Start date

2009-03-01

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Parkinson disease

Interventions

Reduced CoQ10 capsule (55mg) 6 tablets 2 times a day (Kaneka) A group for 48 weeks, B group for 96 weeks Placebo capsule (6 tablets 2 times a day) is not included reduced CoQ10 (Kaneka). A group fo

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Subjects had diagnosed PD according to the UK Brain Bank criteria. 2. A group : L-dopa/ DCI (over 300mg/day) and having wearing-off. B group: without levodopa medication. 3. No change on medication for PD for eight weeks. 4. Modified Hohen-Yahr scale of on-phase between 0 to 3. 5. Outpatients are preferable than admitted patients. 6. The subjects are over 20 years-old of male or female. 7. Written informed consent must be obtained.

Exclusion criteria

Exclusion criteria: 1. The patietnt with parkinsonism due to corticobasal syndrome, multiple system atrophy, drug parkinsonism, hydrocephalus, essential tremor. 2. Modified Hohen-Yahr score of greater than 4. 3. The subjects had levodopa without DCI 4. The presence of other serious disease. 5. The presence of allergic response or side effects with drugs. 6. Subjects who are inappropriate for the study according to our judgment. 7. The subjects enrolled in other clinical trial.

Design outcomes

Primary

Measure	Time frame
UPDRS A group : Change from baseline to 8th, 24th, 48th week, and post 8th week. B group : Change from baseline to 8th, 24th, 48th, 72th, 96th week, and post 8th week.	—

Secondary

Measure	Time frame
1. Duration to protocol ended because of addition of levodopa or progression of disease. 2. A group : Change from baseline to 8th, 24th, 48th week, and post 8th week of time of daily on-time or off-time in their diary. 3. Progression of dyskinesia 4. Serum concentration of reduced CoQ10 of baseline, 8th, 24th, 48th week, and post 8th week. Safety analysis 1) Adverse events except dyskinesia. 2) Screening laboratory studies included complete blood count, level of total protein, albumin, alkaline phosphatase, aspartate transaminase, alanine transaminase, serum urea nitrogen, calcium, chloride, creatinine, glucose, lactate dehydrogenase, potassium, sodium, creatinine kinase, uric acid, choline esterase, LDL-cholesterol, HDL-cholesterol and triglyceride.	—

Measure

Time frame

1. Duration to protocol ended because of addition of levodopa or progression of disease. 2. A group : Change from baseline to 8th, 24th, 48th week, and post 8th week of time of daily on-time or off-time in their diary. 3. Progression of dyskinesia 4. Serum concentration of reduced CoQ10 of baseline, 8th, 24th, 48th week, and post 8th week. Safety analysis 1) Adverse events except dyskinesia. 2) Screening laboratory studies included complete blood count, level of total protein, albumin, alkaline phosphatase, aspartate transaminase, alanine transaminase, serum urea nitrogen, calcium, chloride, creatinine, glucose, lactate dehydrogenase, potassium, sodium, creatinine kinase, uric acid, choline esterase, LDL-cholesterol, HDL-cholesterol and triglyceride.

—

Countries

Japan

Contacts

Public ContactAsako Yoritaka

Juntendo Koshigaya Hospital Neurology

048-975-0321

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026