Back to resultsEffects of Coenzyme Q10 in PSP and CBD
Primary Purpose
Progressive Supranuclear Palsy, Neurological Disorders
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
CoQ10
Sponsored by
About this trial
This is an interventional treatment trial for Progressive Supranuclear Palsy focused on measuring CoQ10, PSP, CBD
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Sites / Locations
- Lahey Clinic
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00532571
Brief Title
Effects of Coenzyme Q10 in PSP and CBD
Official Title
Effects of Coenzyme Q10 in PSP and CBD, A Randomized, Placebo-Controlled, Double Blind Cross Over Pilot Study
Study Type
Interventional
2. Study Status
Record Verification Date
June 2018
Overall Recruitment Status
Completed
Study Start Date
January 2004 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
September 2005 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Lahey Clinic
4. Oversight
Data Monitoring Committee
No
5. Study Description
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) ).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Progressive Supranuclear Palsy, Neurological Disorders
Keywords
CoQ10, PSP, CBD
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Crossover Assignment
Masking
Double
Allocation
Randomized
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
CoQ10
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Diana Apetauerova, MD
Organizational Affiliation
Lahey Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Lahey Clinic
City
Burlington
State/Province
Massachusetts
ZIP/Postal Code
01805
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Effects of Coenzyme Q10 in PSP and CBD
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