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Effects of Coenzyme Q10 in Progressive Supranuclear Palsy (PSP)

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ClinicalTrials.gov Identifier: NCT00382824
Recruitment Status : Completed
First Posted : October 2, 2006
Results First Posted : August 1, 2019
Last Update Posted : August 1, 2019
Sponsor:
Information provided by (Responsible Party):
Lahey Clinic

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).

Condition or disease Intervention/treatment Phase
Progressive Supranuclear Palsy Dietary Supplement: Coenzyme Q10 Other: Placebo Not Applicable

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 61 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Multicenter, Double-blind, Randomized, Placebo-Controlled Clinical Trial to examine tolerability, safety, and efficacy of CoenzymeQ10
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effects of Coenzyme Q10 in Progressive Supranuclear Palsy (PSP): A Multicenter, Randomized, Placebo-controlled, Double Blind Study
Study Start Date : September 2006
Actual Primary Completion Date : September 2013
Actual Study Completion Date : January 2015


Arm Intervention/treatment
Active Comparator: CoQ10
Half of the enrolled patients will be randomized into the the CoQ10 arm and will receive a dosage of 2400mg/day of Coenzyme Q10
Dietary Supplement: Coenzyme Q10
active drug
Other Name: CoQ10

Placebo Comparator: Placebo
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.
Other: Placebo
Placebo




Primary Outcome Measures :
  1. Efficacy of Coenzyme Q10 (Unified Parkinson's Disease Rating Scale [UPDRS] AND Progressive Supranuclear Palsy Rating Scale [PSPRS]) [ Time Frame: 12 months ]

    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



Secondary Outcome Measures :
  1. Efficacy of Coenzyme Q10 (Mini-Mental State Examination [MMSE] and Activities of Daily Living [ADL] Scales) [ Time Frame: 12 months ]

    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.


  2. Quality of Life Questionnaires: Parkinson's Disease Questionnaire - 39 [PDQ-39], Short Form-36 [SF-36] [ Time Frame: 12 months ]

    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


  3. Safety Profile of Coenzyme Q10 [ Time Frame: 12 months ]
    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.

  4. Tolerability of Coenzyme Q10 [ Time Frame: 12 months ]
    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.



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Ages Eligible for Study:   30 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00382824


Locations
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United States, Alabama
University of Alabama
Birmingham, Alabama, United States, 35294
United States, Massachusetts
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215
Lahey Clinic
Burlington, Massachusetts, United States, 01805
Sponsors and Collaborators
Lahey Clinic
Investigators
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Principal Investigator: Diana Apetauerova, MD Lahey Clinic

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Lahey Clinic
ClinicalTrials.gov Identifier: NCT00382824     History of Changes
Other Study ID Numbers: LaheyC
First Posted: October 2, 2006    Key Record Dates
Results First Posted: August 1, 2019
Last Update Posted: August 1, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Lahey Clinic:
Progressive Supranuclear Palsy
CoQ10
Coenzyme Q10
Additional relevant MeSH terms:
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Paralysis
Supranuclear Palsy, Progressive
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Movement Disorders
Ophthalmoplegia
Ocular Motility Disorders
Cranial Nerve Diseases
Tauopathies
Neurodegenerative Diseases
Eye Diseases
Coenzyme Q10
Ubiquinone
Vitamins
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs