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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CoQ10 | Active Comparator | Half of the enrolled patients will be randomized into the the CoQ10 arm and will receive a dosage of 2400mg/day of Coenzyme Q10 |
|
| Placebo | Placebo Comparator | Half of the enrolled patients will be randomized into the the Placebo arm and will receive a matching dose of placebo that resembles the 2400mg/day dose of the CoQ10 arm. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Coenzyme Q10 | Dietary Supplement | active drug |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Diana Apetauerova, MD | Lahey Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alabama | Birmingham | Alabama | 35294 | United States | ||
| Beth Israel Deaconess Medical Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27583276 | Derived | Apetauerova D, Scala SA, Hamill RW, Simon DK, Pathak S, Ruthazer R, Standaert DG, Yacoubian TA. CoQ10 in progressive supranuclear palsy: A randomized, placebo-controlled, double-blind trial. Neurol Neuroimmunol Neuroinflamm. 2016 Aug 2;3(5):e266. doi: 10.1212/NXI.0000000000000266. eCollection 2016 Oct. |
| Label | URL |
|---|---|
| CurePSP homepage | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 200IU of vitamin E for a total of 1200IU of vitamin E/day. Patients in this group were to take this dose for 12 months. |
| FG001 | 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. Each wafer also contained 200IU of vitamin E. Patients received 1200IU of viatmin E/day |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 | Placebo |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | cannot edit Baseline Measure Title |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 | Posted | Mean | Standard Deviation | units on a scale | 12 months |
|
12 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 200IU of vitamin E for a total of 1200IU of vitamin E/day. Patients in this group were to take this dose for 12 months. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Bone fracture | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Urinary tract infection | Renal and urinary disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jordan Jara | Lahey Hospital & Medical Center | 7817442958 | 2958 | jordan.jara@lahey.org |
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| ID | Term |
|---|---|
| D013494 | Supranuclear Palsy, Progressive |
| ID | Term |
|---|---|
| D001480 | Basal Ganglia Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| C024989 | coenzyme Q10 |
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Multicenter, Double-blind, Randomized, Placebo-Controlled Clinical Trial to examine tolerability, safety, and efficacy of CoenzymeQ10
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| Placebo | Other | Placebo |
|
| 12 months |
| 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 | 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. | 12 months |
| Tolerability of Coenzyme Q10 |
| 12 months |
| Boston |
| Massachusetts |
| 02215 |
| United States |
| Lahey Clinic | Burlington | Massachusetts | 01805 | United States |
| Lahey Clinic homepage | View source |
Patients randomized into this arm received placebo wafers. These wafers looked identical to the Coenzyme Q10 wafers. Patients took 8 placebo wafers per day. |
| BG002 | Total | Total of all reporting groups |
| Mean |
| Full Range |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| OG000 |
| 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 200IU of vitamin E for a total of 1200IU of vitamin E/day. Patients in this group were to take this dose for 12 months. |
| OG001 | 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. Each wafer also contained 200IU of vitamin E. Patients received 1200IU of viatmin E/day |
|
|
| 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. | Posted | Mean | Standard Deviation | units on a scale | 12 months |
|
|
|
| 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 | Posted | Mean | Standard Deviation | units on a scale | 12 months |
|
|
|
| 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. | Posted | Number | Adverse Events | 12 months |
|
|
|
| Secondary | Tolerability of Coenzyme Q10 |
| Posted | Number | Participants | 12 months |
|
|
|
| 5 |
| 32 |
| 11 |
| 32 |
| EG001 | 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. Each wafer also contained 200IU of vitamin E. Patients received 1200IU of viatmin E/day | 8 | 29 | 8 | 29 |
| Aspiration pneumonia | Infections and infestations | Non-systematic Assessment |
|
| Benign postatic hyperplasia with obstruction | Renal and urinary disorders | Non-systematic Assessment |
|
| Stent placement | Surgical and medical procedures | Non-systematic Assessment |
|
| Diverticulitis | Gastrointestinal disorders | Non-systematic Assessment |
|
| C. difficile infection | Infections and infestations | Non-systematic Assessment |
|
| Bleeding ulcer | Gastrointestinal disorders | Non-systematic Assessment |
|
| Ureteral calculus | Renal and urinary disorders | Non-systematic Assessment |
|
| Laceration to head | General disorders | Non-systematic Assessment |
|
| Constipation | Gastrointestinal disorders | Non-systematic Assessment |
|
| Cataract | Eye disorders | Non-systematic Assessment |
|
| Nausea | General disorders | Non-systematic Assessment |
|
| Diarrhea | General disorders | Non-systematic Assessment |
|
| Dizziness | Ear and labyrinth disorders | Non-systematic Assessment |
|
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| D009069 | Movement Disorders |
| D009886 | Ophthalmoplegia |
| D015835 | Ocular Motility Disorders |
| D003389 | Cranial Nerve Diseases |
| D024801 | Tauopathies |
| D019636 | Neurodegenerative Diseases |
| D010243 | Paralysis |
| D009461 | Neurologic Manifestations |
| D005128 | Eye Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |