NCT00532571

Brief Summary

To compare the efficacy, safety and tolerability of Coenzyme Q 10 versus placebo in patients with atypical parkinsonian syndromes corticobasal degeneration (CBD) and progressive supranuclear palsy (PSP) ).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Timeline
Completed

Started Jan 2004

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2004

Completed
1.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2005

Completed
2 years until next milestone

First Submitted

Initial submission to the registry

September 18, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 20, 2007

Completed
Last Updated

June 15, 2018

Status Verified

June 1, 2018

First QC Date

September 18, 2007

Last Update Submit

June 14, 2018

Conditions

Progressive Supranuclear PalsyNeurological Disorders

Keywords

CoQ10PSPCBD

Interventions

CoQ10DRUG

Eligibility Criteria

Age40 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients fulfilling the diagnostic criteria of PSP and CBD (above) and who were diagnosed within the past 5 years
  • Age \> 40
  • Subjects receiving anticholinergics, amantadine, dopamine agonists, carbidopa/levodopa, eldepryl, or comtan must be on a stable dose for at least 30 days prior to baseline visit.
  • Patients agreeable to participate in the study.

You may not qualify if:

  • Prior or concurrent therapy with anticholinergics, amantadine,a dopamine agonist,carbidopa/levodopa or comtan within 30 days of the baseline visit.
  • Parkinsons disease or any other atypical parkinsonism; Parkinsonism due to drugs.
  • History of pallidotomy, thalamotomy, deep brain stimulation or fetal tissue transplant.
  • Previous use of coenzyme Q10 within 60 days of the baseline visit.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Lahey Clinic

Burlington, Massachusetts, 01805, United States

Location

MeSH Terms

Conditions

Supranuclear Palsy, ProgressiveNervous System Diseases

Interventions

coenzyme Q10

Condition Hierarchy (Ancestors)

Basal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesMovement DisordersOphthalmoplegiaOcular Motility DisordersCranial Nerve DiseasesTauopathiesNeurodegenerative DiseasesParalysisNeurologic ManifestationsEye DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Diana Apetauerova, MD

    Lahey Clinic

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 18, 2007

First Posted

September 20, 2007

Study Start

January 1, 2004

Study Completion

September 1, 2005

Last Updated

June 15, 2018

Record last verified: 2018-06

Locations

US(1)