Effects of Coenzyme Q10 in Progressive Supranuclear Palsy (PSP) - Full Text View

Sponsored by:	Lahey Clinic
Information provided by:	Lahey Clinic
ClinicalTrials.gov Identifier:	NCT00382824

Purpose

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).

Condition	Intervention	Phase
Progressive Supranuclear Palsy Atypical Parkinsonism	Drug: Coenzyme Q10	Phase II Phase III

Genetics Home Reference related topics: familial paroxysmal nonkinesigenic dyskinesia

MedlinePlus related topics: Paralysis Progressive Supranuclear Palsy

Drug Information available for: Coenzyme Q10

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Single Group Assignment, Safety/Efficacy Study
Official Title:	Effects of Coenzyme Q10 in Progressive Supranuclear Palsy (PSP): A Multicenter, Randomized, Placebo-Controlled, Double Blind Study

Further study details as provided by Lahey Clinic:

Primary Outcome Measures:

Rate of Functional decline [ Time Frame: 12 months ]
Functional ability [ Time Frame: 12 months ]

Secondary Outcome Measures:

Safety [ Time Frame: 12 months ]
Quality of Life [ Time Frame: 12 months ]

Estimated Enrollment:	60
Study Start Date:	September 2006
Estimated Study Completion Date:	September 2010

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

Ages Eligible for Study:	40 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00382824

Contacts

Contact: Stephanie A Scala, MA

781-744-2950

Stephanie.A.Scala@lahey.org

Locations

United States, Alabama
Universite of Alabama	Recruiting
Birmingham, Alabama, United States, 35294
Contact: Jennifer Newsome, RN 205-996-7499 jnewsome@uab.edu
Principal Investigator: David Standaert, MD, PhD
United States, Massachusetts
Lahey Clinic	Recruiting
Burlington, Massachusetts, United States, 01805
Contact: Stephanie Scala, MA 781-744-2950 Stephanie.A.Scala@lahey.org
Principal Investigator: Diana Apetauerova, MD
Beth Israel Deaconess Medical Center	Recruiting
Boston, Massachusetts, United States, 02215
Contact: Peggy Rose, RN 617-667-9885 PDResearch@bidmc.harvard.edu
Contact: Chen Lim 617-667-9890 celim@bidmc.harvard.edu
Principal Investigator: David Simon, MD
United States, Vermont
University of Vermont	Recruiting
Burlington, Vermont, United States, 05405
Contact: Marilee Jones 802-656-4420 Marilee.Jones@med.uvm.edu
Principal Investigator: Robert W Hamill, MD

Sponsors and Collaborators

Lahey Clinic

Investigators

Principal Investigator:

Diana Apetauerova, MD

Lahey Clinic

More Information

Related Info This link exits the ClinicalTrials.gov site

Responsible Party:	Lahey Clinic ( Diana Apetauerova )
Study ID Numbers:	LaheyC
Study First Received:	September 28, 2006
Last Updated:	March 31, 2008
ClinicalTrials.gov Identifier:	NCT00382824
Health Authority:	United States: Institutional Review Board

Keywords provided by Lahey Clinic:

Progressive Supranuclear Palsy
Atypical Parkinsonism
CoQ10

Study placed in the following topic categories:

Motor neuro-ophthalmic disorders
Ganglion Cysts
Eye Diseases
Basal Ganglia Diseases
Central Nervous System Diseases
Brain Diseases
Neurodegenerative Diseases
Ocular motility disorders
Coenzyme Q10

Paralysis
Ocular Motility Disorders
Signs and Symptoms
Movement Disorders
Ubiquinone
Progressive supranuclear palsy
Supranuclear Palsy, Progressive
Neurologic Manifestations
Parkinsonian Disorders

Additional relevant MeSH terms:

Vitamins
Growth Substances
Physiological Effects of Drugs
Nervous System Diseases
Micronutrients

Cranial Nerve Diseases
Tauopathies
Ophthalmoplegia
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 14, 2009