Brief Title
Effects of Coenzyme Q10 in Progressive Supranuclear Palsy (PSP)
Official Title
Effects of Coenzyme Q10 in Progressive Supranuclear Palsy (PSP): A Multicenter, Randomized, Placebo-controlled, Double Blind Study
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).
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
Study Type
Interventional
Primary Outcome
Efficacy of Coenzyme Q10 (Unified Parkinson's Disease Rating Scale [UPDRS] AND Progressive Supranuclear Palsy Rating Scale [PSPRS])
Secondary Outcome
Efficacy of Coenzyme Q10 (Mini-Mental State Examination [MMSE] and Activities of Daily Living [ADL] Scales)
Condition
Progressive Supranuclear Palsy
Intervention
Coenzyme Q10
Study Arms / Comparison Groups
CoQ10
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
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Dietary Supplement
Estimated Enrollment
61
Start Date
September 2006
Completion Date
January 2015
Primary Completion Date
September 2013
Eligibility 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
Gender
All
Ages
30 Years - N/A
Accepts Healthy Volunteers
No
Contacts
Diana Apetauerova, MD, ,
Location Countries
United States
Location Countries
United States
Administrative Informations
NCT ID
NCT00382824
Organization ID
LaheyC
Responsible Party
Sponsor
Study Sponsor
Lahey Clinic
Study Sponsor
Diana Apetauerova, MD, Principal Investigator, Lahey Clinic
Verification Date
June 2019