Effects of Coenzyme Q10 in Progressive Supranuclear Palsy (PSP)

Progressive Supranuclear Palsy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00382824
• Other study ID #: LaheyC
• Status: Completed
• Phase: N/A
• Start date: September 2006
• Est. completion date: January 2015

Study information

• Verified date: June 2019
• Source: Lahey Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 61
• Est. completion date: January 2015
• Est. primary completion date: September 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Paralysis
• Progressive Supranuclear Palsy
• Supranuclear Palsy, Progressive

Intervention

Dietary Supplement:
• Coenzyme Q10
active drug

Other:
• Placebo
Placebo

Locations

Country	Name	City	State
United States	University of Alabama	Birmingham	Alabama
United States	Beth Israel Deaconess Medical Center	Boston	Massachusetts
United States	Lahey Clinic	Burlington	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Lahey Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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	12 months
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.	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	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.	12 months
Secondary	Tolerability of Coenzyme Q10	The tolerability of Coenzyme Q10 as determined by the number of subjects who complete the study on their original treatment assignment, and; The tolerability of Coenzyme Q10 as determined by the number of subjects completing the study.	12 months

External Links

•   CurePSP homepage
•   Lahey Clinic homepage