Clinical trial NCT00382824: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Progressive Supranuclear Palsy
Keywords: Progressive Supranuclear Palsy
CoQ10
Coenzyme Q10
Lead sponsor: Lahey Clinic
Sponsor class: OTHER
First posted: 2006-10-02
Enrollment: 61
Sex: ALL
Minimum age (years): 30
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Multicenter, Double-blind, Randomized, Placebo-Controlled Clinical Trial to examine tolerability, safety, and efficacy of CoenzymeQ10
Primary purpose: TREATMENT

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

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

Primary outcomes:
measure: Efficacy of Coenzyme Q10 (Unified Parkinson's Disease Rating Scale [UPDRS] AND Progressive Supranuclear Palsy Rating Scale [PSPRS])
timeFrame: 12 months
Secondary outcomes:
measure: Efficacy of Coenzyme Q10 (Mini-Mental State Examination [MMSE] and Activities of Daily Living [ADL] Scales)
timeFrame: 12 months
measure: Quality of Life Questionnaires: Parkinson's Disease Questionnaire - 39 [PDQ-39], Short Form-36 [SF-36]
timeFrame: 12 months
measure: Safety Profile of Coenzyme Q10
timeFrame: 12 months
measure: Tolerability of Coenzyme Q10
timeFrame: 12 months
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama
state: Alabama
city: Boston
country: United States
facility: Beth Israel Deaconess Medical Center
state: Massachusetts
city: Burlington
country: United States
facility: Lahey Clinic
state: Massachusetts
Study officials:
affiliation: Lahey Clinic
name: Diana Apetauerova, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Apetauerova D, Scala SA, Hamill RW, Simon DK, Pathak S, Ruthazer R, Standaert DG, Yacoubian TA. CoQ10 in progressive supranuclear palsy: A randomized, placebo-controlled, double-blind trial. Neurol Neuroimmunol Neuroinflamm. 2016 Aug 2;3(5):e266. doi: 10.1212/NXI.0000000000000266. eCollection 2016 Oct.