Effects of Coenzyme Q10 in Progressive Supranuclear Palsy (PSP)

Lahey Health

Status: Completed

Conditions: Progressive Supranuclear Palsy

Treatments: Dietary Supplement: Coenzyme Q10; Other: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT00382824

LaheyC

Details and patient eligibility

About

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).

Full 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

Enrollment: 61 patients

Sex: All

Ages: 30+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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61 participants in 2 patient groups, including a placebo group

CoQ10

Active Comparator group

Description:

Half of the enrolled patients will be randomized into the the CoQ10 arm and will receive a dosage of 2400mg/day of Coenzyme Q10

Treatment:

Dietary Supplement: Coenzyme Q10

Placebo

Placebo Comparator group

Description:

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.

Treatment:

Other: Placebo