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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: October 7, 2013
Last verified: October 2013

September 28, 2006
October 7, 2013
September 2006
September 2013   (final data collection date for primary outcome measure)
  • Rate of Functional decline [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Functional ability [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Rate of Functional decline
  • Functional ability
Complete list of historical versions of study NCT00382824 on ClinicalTrials.gov Archive Site
  • Safety [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
  • Quality of Life [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • 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

Interventional
Phase 2
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • Progressive Supranuclear Palsy
  • Atypical Parkinsonism
  • Drug: Coenzyme Q10
    1 year
    Other Name: CoQ10; Ubiquinone
  • Drug: CoenzymeQ10
    active drug
    Other Name: CoQ10
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
60
December 2013
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
Both
30 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00382824
LaheyC
No
Lahey Clinic
Lahey Clinic
Not Provided
Principal Investigator: Diana Apetauerova, MD Lahey Clinic
Lahey Clinic
October 2013

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