Effects of Coenzyme Q10 in Progressive Supranuclear Palsy (PSP)

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

61 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-09-30

Study Completion Date

2015-01-31

Brief Summary

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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).

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Detailed Description

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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

Conditions

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Progressive Supranuclear Palsy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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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

Group Type ACTIVE_COMPARATOR

Coenzyme Q10

Intervention Type DIETARY_SUPPLEMENT

active drug

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.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

Placebo

Interventions

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Coenzyme Q10

active drug

Intervention Type DIETARY_SUPPLEMENT

Placebo

Intervention Type OTHER

Other Intervention Names

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CoQ10

Eligibility Criteria

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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

Minimum Eligible Age

30 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No