Effects of Coenzyme Q10 in Progressive Supranuclear Palsy (PSP)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00382824
Recruitment Status : Completed
First Posted : October 2, 2006
Last Update Posted : August 6, 2015
Information provided by (Responsible Party):
Lahey Clinic

September 28, 2006
October 2, 2006
August 6, 2015
September 2006
September 2013   (Final data collection date for primary outcome measure)
  • Rate of Functional decline [ Time Frame: 12 months ]
  • Functional ability [ Time Frame: 12 months ]
  • Rate of Functional decline
  • Functional ability
Complete list of historical versions of study NCT00382824 on Archive Site
  • Safety [ Time Frame: 12 months ]
  • Quality of Life [ Time Frame: 12 months ]
  • Safety
  • Quality of Life
Not Provided
Not Provided
Effects of Coenzyme Q10 in Progressive Supranuclear Palsy (PSP)
Effects of Coenzyme Q10 in Progressive Supranuclear Palsy (PSP): A Multicenter, Randomized, Placebo-controlled, Double Blind Study
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).
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
Phase 2
Phase 3
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • Progressive Supranuclear Palsy
  • Atypical Parkinsonism
Drug: CoenzymeQ10
active drug
Other Name: CoQ10
Not Provided
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.

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
January 2015
September 2013   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
30 Years and older   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
United States
Not Provided
Not Provided
Lahey Clinic
Lahey Clinic
Not Provided
Principal Investigator: Diana Apetauerova, MD Lahey Clinic
Lahey Clinic
August 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP