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).
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
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
61
active drug
Placebo
University of Alabama
Birmingham, Alabama, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States
Lahey Clinic
Burlington, Massachusetts, United States
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
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
Quality of Life Questionnaires: Parkinson's Disease Questionnaire - 39 [PDQ-39], Short Form-36 [SF-36]
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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
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
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