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Effects of Coenzyme Q10 in Progressive Supranuclear Palsy (PSP)

Effects of Coenzyme Q10 in Progressive Supranuclear Palsy (PSP): A Multicenter, Randomized, Placebo-controlled, Double Blind Study

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00382824
Enrollment
61
Registered
2006-10-02
Start date
2006-09-30
Completion date
2015-01-31
Last updated
2019-08-01

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

Conditions

Progressive Supranuclear Palsy

Keywords

Progressive Supranuclear Palsy, CoQ10, Coenzyme Q10

Brief summary

The clinical syndrome of PSP responds poorly to all available forms of therapy used in Parkinson's Disease (PD). Currently, no effective treatment exists. Coenzyme Q10 in high doses has been shown to be a beneficial therapy in PD and might possibly be a beneficial therapy for PSP. This study will compare the efficacy, safety and tolerability of Coenzyme Q10 versus placebo in patients with atypical parkinsonian syndrome, progressive supranuclear palsy (PSP).

Detailed description

The study is designed as a multicenter randomized, placebo-controlled, double blind trial. Up to 60 patients with PSP will be enrolled at several centers in the United States

Interventions

DIETARY_SUPPLEMENTCoenzyme Q10

active drug

OTHERPlacebo

Placebo

Sponsors

Lahey Clinic
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Intervention model description

Multicenter, Double-blind, Randomized, Placebo-Controlled Clinical Trial to examine tolerability, safety, and efficacy of CoenzymeQ10

Eligibility

Sex/Gender
ALL
Age
30 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Patients fulfilling the diagnostic criteria of PSP/diagnosed within the past 5 years * Either vertical supranuclear palsy or both slowing of vertical saccades * Prominent postural instability with falls in the first year of disease onset * No evidence of other diseases that could explain the foregoing features

Exclusion criteria

* Current or previous therapeutic use of CoQ10 * Parkinsonism due to drugs * History of pallidotomy, thalamotomy, active deep brain stimulator or fetal tissue transplant * History of active epilepsy, stroke, structural brain disease * Use of methylphenidate hydrochloride, cinnarizine, reserpine, amphetamines, or monoamine oxidase-A inhibitors within 3 months before the baseline visit. * Active cancer or cancer undergoing treatment * Participation in other drug studies or the use of other investigational drugs within 30 days before screening. * Known hypersensitivity to Coenzyme Q10. * Pregnant, planning a pregnancy or nursing woman

Design outcomes

Primary

MeasureTime frameDescription
Efficacy of Coenzyme Q10 (Unified Parkinson's Disease Rating Scale [UPDRS] AND Progressive Supranuclear Palsy Rating Scale [PSPRS])12 monthsUnified Parkinson's Disease Rating Scale \[UPDRS\]: Higher scores indicate a higher degree of impairment The total score is calculated by summing the subscores. Total scores range from 0 (normal) to 166 (severely impaired) Part I \[Mentation, Behavior, & Mood\] Scale: 0-16 Part II \[Activities of Daily Living, Both ON & OFF\] Scale:0-52 Part III \[Motor Examination\] Scale: 0-56 Part IV \[Complications of Therapy\] Scale: 0-34 Part V \[Modified Hoehn & Yahr Staging\] Scale: 0-8 Part VI \[Schwab & England Activities of Daily Living Scale\] Scale: 0 - 100% Progressive Supranuclear Palsy Rating Scale \[PSPRS\] - Total Scale ranges from 0 (normal) to 128 (severely impaired) Section 1 \[History\] Scale: 0-31 Section 2 \[Mentation\] Scale: 0-20 Section 3 \[Bulbar\] Scale: 0-10 Section 4 \[Ocular Motor\] Scale: 0-20 Section 5 \[Limb Motor\] Scale: 0-22 Section 6 \[Gait and midline\] Scale: 0-25

Secondary

MeasureTime frameDescription
Efficacy of Coenzyme Q10 (Mini-Mental State Examination [MMSE] and Activities of Daily Living [ADL] Scales)12 monthsEfficacy of Coenzyme Q10 measured by change in intellectual function (the Mini-Mental State Examination \[MMSE\]) and Activities of Daily Living (ADL) scores. MMSE: 30 point scale with 5 subsections (Total Score Range: minimum score = 0, maximum = 30): Orientation (max=10 pts, min=0 pts), Registration (max=3 pts, min=0 pts), Attention & Calculation (max=5pts, min=0 pts), Recall (max=3 pts, min= 0 pts), Language & Praxis (max=9 pts, min=0 pts). Lower scores indicate greater impairment. Scores \<24 are considered abnormal. Activities of Daily Living scores: The UPDRS part II is used to assess subject's degree in which they can perform their Activities of Daily Living. Part II of the UPDRS rates subjects on a 0-4 scale, with 0 being Normal and 4 being Severe Impairment, for each respective item. For each item, the reported score is divided by the maximum total score for that item and multiplied by 100 to give a 0-100 scale range. Higher scores indicate greater impairment.
Quality of Life Questionnaires: Parkinson's Disease Questionnaire - 39 [PDQ-39], Short Form-36 [SF-36]12 monthsParkinson's Disease Questionnaire - 39 (PDQ-39): 39 Items. 8 subscales: mobility, activities of daily living, emotional well-being, stigma, social support , cognitions, communication, bodily discomfort. Subjects indicate never (0 pts), occasionally (1 pts), sometimes (2pts), often (3pts), or always/cannot do at all (4pts) for each item in each section. The sum of scores of each item in the dimension divided by the maximum possible score of all the items in the dimension, multiplied by 100. Range of scores for each dimension: 0-100. The sum of dimension total scores are divided by 8 to calculate the Parkinson's Disease Severity Index. Range of total score for the Parkinsons' Disease Severity Index: 0-100. Lower scores indicate better quality of life. Short Form-36 (SF-36): 36 items 8 subscales: (2) General Health Sections, Limitations of Activities, Physical Health Problems, Emotional Health Problems, Pain, (2) Social Activities sections, and Energy and Emotions. Each qu
Safety Profile of Coenzyme Q1012 monthsThe safety Profile of Coenzyme Q10 as determined by the analysis of the frequency and severity of the adverse event data, changes in the vital signs, electrocardiograms and clinical laboratory values, recorded over the course of the trial.
Tolerability of Coenzyme Q1012 months1. The tolerability of Coenzyme Q10 as determined by the number of subjects who complete the study on their original treatment assignment, and 2. The tolerability of Coenzyme Q10 as determined by the number of subjects completing the study.

Countries

United States

Participant flow

Participants by arm

ArmCount
Coenzyme Q10 (2400mg/Day)
Patients randomized into this arm received 2400mg of coenzyme Q10 per day (300mg wafers eight times per day). Each wafer also contained 300IU of vitamin E. Patients in this group were to take this dose for 12 months.
32
Placebo
Patients randomized into this arm received placebo wafers. These wafers looked identical to the Coenzyme Q10 wafers. Patients took 8 placebo wafers per day.
29
Total61

Baseline characteristics

CharacteristicCoenzyme Q10 (2400mg/Day)PlaceboTotal
Age, Customized
Age
66.3 years66.9 years66.6 years
Sex: Female, Male
Female
8 Participants16 Participants24 Participants
Sex: Female, Male
Male
24 Participants13 Participants37 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
— / —— / —
other
Total, other adverse events
11 / 328 / 29
serious
Total, serious adverse events
5 / 328 / 29

Outcome results

Primary

Efficacy of Coenzyme Q10 (Unified Parkinson's Disease Rating Scale [UPDRS] AND Progressive Supranuclear Palsy Rating Scale [PSPRS])

Unified Parkinson's Disease Rating Scale \[UPDRS\]: Higher scores indicate a higher degree of impairment The total score is calculated by summing the subscores. Total scores range from 0 (normal) to 166 (severely impaired) Part I \[Mentation, Behavior, & Mood\] Scale: 0-16 Part II \[Activities of Daily Living, Both ON & OFF\] Scale:0-52 Part III \[Motor Examination\] Scale: 0-56 Part IV \[Complications of Therapy\] Scale: 0-34 Part V \[Modified Hoehn & Yahr Staging\] Scale: 0-8 Part VI \[Schwab & England Activities of Daily Living Scale\] Scale: 0 - 100% Progressive Supranuclear Palsy Rating Scale \[PSPRS\] - Total Scale ranges from 0 (normal) to 128 (severely impaired) Section 1 \[History\] Scale: 0-31 Section 2 \[Mentation\] Scale: 0-20 Section 3 \[Bulbar\] Scale: 0-10 Section 4 \[Ocular Motor\] Scale: 0-20 Section 5 \[Limb Motor\] Scale: 0-22 Section 6 \[Gait and midline\] Scale: 0-25

Time frame: 12 months

ArmMeasureGroupValue (MEAN)Dispersion
Coenzyme Q10 (2400mg/Day)Efficacy of Coenzyme Q10 (Unified Parkinson's Disease Rating Scale [UPDRS] AND Progressive Supranuclear Palsy Rating Scale [PSPRS])Change in UPDRS scores5.9 units on a scaleStandard Deviation 10
Coenzyme Q10 (2400mg/Day)Efficacy of Coenzyme Q10 (Unified Parkinson's Disease Rating Scale [UPDRS] AND Progressive Supranuclear Palsy Rating Scale [PSPRS])Change in PSPRS scores11.5 units on a scaleStandard Deviation 11.1
PlaceboEfficacy of Coenzyme Q10 (Unified Parkinson's Disease Rating Scale [UPDRS] AND Progressive Supranuclear Palsy Rating Scale [PSPRS])Change in UPDRS scores11.8 units on a scaleStandard Deviation 8.6
PlaceboEfficacy of Coenzyme Q10 (Unified Parkinson's Disease Rating Scale [UPDRS] AND Progressive Supranuclear Palsy Rating Scale [PSPRS])Change in PSPRS scores12.8 units on a scaleStandard Deviation 9.1
Secondary

Efficacy of Coenzyme Q10 (Mini-Mental State Examination [MMSE] and Activities of Daily Living [ADL] Scales)

Efficacy of Coenzyme Q10 measured by change in intellectual function (the Mini-Mental State Examination \[MMSE\]) and Activities of Daily Living (ADL) scores. MMSE: 30 point scale with 5 subsections (Total Score Range: minimum score = 0, maximum = 30): Orientation (max=10 pts, min=0 pts), Registration (max=3 pts, min=0 pts), Attention & Calculation (max=5pts, min=0 pts), Recall (max=3 pts, min= 0 pts), Language & Praxis (max=9 pts, min=0 pts). Lower scores indicate greater impairment. Scores \<24 are considered abnormal. Activities of Daily Living scores: The UPDRS part II is used to assess subject's degree in which they can perform their Activities of Daily Living. Part II of the UPDRS rates subjects on a 0-4 scale, with 0 being Normal and 4 being Severe Impairment, for each respective item. For each item, the reported score is divided by the maximum total score for that item and multiplied by 100 to give a 0-100 scale range. Higher scores indicate greater impairment.

Time frame: 12 months

ArmMeasureGroupValue (MEAN)Dispersion
Coenzyme Q10 (2400mg/Day)Efficacy of Coenzyme Q10 (Mini-Mental State Examination [MMSE] and Activities of Daily Living [ADL] Scales)Change in ADL scores-13.5 units on a scaleStandard Deviation 20.6
Coenzyme Q10 (2400mg/Day)Efficacy of Coenzyme Q10 (Mini-Mental State Examination [MMSE] and Activities of Daily Living [ADL] Scales)Change in MMSE scores-1.3 units on a scaleStandard Deviation 3.4
PlaceboEfficacy of Coenzyme Q10 (Mini-Mental State Examination [MMSE] and Activities of Daily Living [ADL] Scales)Change in ADL scores-18.4 units on a scaleStandard Deviation 15.9
PlaceboEfficacy of Coenzyme Q10 (Mini-Mental State Examination [MMSE] and Activities of Daily Living [ADL] Scales)Change in MMSE scores-1.3 units on a scaleStandard Deviation 1.8
Secondary

Quality of Life Questionnaires: Parkinson's Disease Questionnaire - 39 [PDQ-39], Short Form-36 [SF-36]

Parkinson's Disease Questionnaire - 39 (PDQ-39): 39 Items. 8 subscales: mobility, activities of daily living, emotional well-being, stigma, social support , cognitions, communication, bodily discomfort. Subjects indicate never (0 pts), occasionally (1 pts), sometimes (2pts), often (3pts), or always/cannot do at all (4pts) for each item in each section. The sum of scores of each item in the dimension divided by the maximum possible score of all the items in the dimension, multiplied by 100. Range of scores for each dimension: 0-100. The sum of dimension total scores are divided by 8 to calculate the Parkinson's Disease Severity Index. Range of total score for the Parkinsons' Disease Severity Index: 0-100. Lower scores indicate better quality of life. Short Form-36 (SF-36): 36 items 8 subscales: (2) General Health Sections, Limitations of Activities, Physical Health Problems, Emotional Health Problems, Pain, (2) Social Activities sections, and Energy and Emotions. Each qu

Time frame: 12 months

ArmMeasureGroupValue (MEAN)Dispersion
Coenzyme Q10 (2400mg/Day)Quality of Life Questionnaires: Parkinson's Disease Questionnaire - 39 [PDQ-39], Short Form-36 [SF-36]Change in Parkinson's Disease Questionnaire scores3.4 units on a scaleStandard Deviation 13.9
Coenzyme Q10 (2400mg/Day)Quality of Life Questionnaires: Parkinson's Disease Questionnaire - 39 [PDQ-39], Short Form-36 [SF-36]Change in Short Form-36 Scores-2.1 units on a scaleStandard Deviation 19.1
PlaceboQuality of Life Questionnaires: Parkinson's Disease Questionnaire - 39 [PDQ-39], Short Form-36 [SF-36]Change in Parkinson's Disease Questionnaire scores7.5 units on a scaleStandard Deviation 12.6
PlaceboQuality of Life Questionnaires: Parkinson's Disease Questionnaire - 39 [PDQ-39], Short Form-36 [SF-36]Change in Short Form-36 Scores-7.2 units on a scaleStandard Deviation 15.4
Secondary

Safety Profile of Coenzyme Q10

The safety Profile of Coenzyme Q10 as determined by the analysis of the frequency and severity of the adverse event data, changes in the vital signs, electrocardiograms and clinical laboratory values, recorded over the course of the trial.

Time frame: 12 months

ArmMeasureGroupValue (NUMBER)
Coenzyme Q10 (2400mg/Day)Safety Profile of Coenzyme Q10Adverse Events27 Adverse Events
Coenzyme Q10 (2400mg/Day)Safety Profile of Coenzyme Q10Serious Adverse Events5 Adverse Events
PlaceboSafety Profile of Coenzyme Q10Adverse Events38 Adverse Events
PlaceboSafety Profile of Coenzyme Q10Serious Adverse Events8 Adverse Events
Secondary

Tolerability of Coenzyme Q10

1. The tolerability of Coenzyme Q10 as determined by the number of subjects who complete the study on their original treatment assignment, and 2. The tolerability of Coenzyme Q10 as determined by the number of subjects completing the study.

Time frame: 12 months

ArmMeasureValue (NUMBER)
Coenzyme Q10 (2400mg/Day)Tolerability of Coenzyme Q1020 Participants
PlaceboTolerability of Coenzyme Q1016 Participants

Source: ClinicalTrials.gov · Data processed: Mar 12, 2026