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Effects of Coenzyme Q10 in Progressive Supranuclear Palsy (PSP)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Lahey Clinic
ClinicalTrials.gov Identifier:
NCT00382824
First received: September 28, 2006
Last updated: May 22, 2013
Last verified: May 2013
History of Changes
  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
Drug: CoenzymeQ10
 Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effects of Coenzyme Q10 in Progressive Supranuclear Palsy (PSP): A Multicenter, Randomized, Placebo-controlled, Double Blind Study

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Lahey Clinic:

Primary Outcome Measures:
  • Rate of Functional decline [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Functional ability [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Safety [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
  • Quality of Life [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 60
Study Start Date: September 2006
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Coenzyme Q10
    1 year
    Other Name: CoQ10; Ubiquinone
    Drug: CoenzymeQ10
    active drug
    Other Name: CoQ10
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:   30 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

Locations
United States, Alabama
University of Alabama
Birmingham, Alabama, United States, 35294
United States, Massachusetts
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215
Lahey Clinic
Burlington, Massachusetts, United States, 01805
Sponsors and Collaborators
Lahey Clinic
Investigators
Principal Investigator: Diana Apetauerova, MD Lahey Clinic
  More Information

Additional Information:
Related Info  This link exits the ClinicalTrials.gov site
Related Info  This link exits the ClinicalTrials.gov site
Related Info  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Lahey Clinic
ClinicalTrials.gov Identifier: NCT00382824     History of Changes
Other Study ID Numbers: LaheyC
Study First Received: September 28, 2006
Last Updated: May 22, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Lahey Clinic:
Progressive Supranuclear Palsy
Atypical Parkinsonism
CoQ10

Additional relevant MeSH terms:
Supranuclear Palsy, Progressive
Parkinsonian Disorders
Paralysis
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Ophthalmoplegia
Ocular Motility Disorders
Cranial Nerve Diseases
Tauopathies
 Neurodegenerative Diseases
Neurologic Manifestations
Eye Diseases
Signs and Symptoms
Coenzyme Q10
Ubiquinone
Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Vitamins

ClinicalTrials.gov processed this record on June 17, 2013