Effects of Coenzyme Q10 in Progressive Supranuclear Palsy (PSP)
1 other identifier
interventional
61
1 country
3
Brief Summary
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Sep 2006
Longer than P75 for not_applicable
3 active sites
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
September 1, 2006
CompletedFirst Submitted
Initial submission to the registry
September 28, 2006
CompletedFirst Posted
Study publicly available on registry
October 2, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2015
CompletedResults Posted
Study results publicly available
August 1, 2019
CompletedAugust 1, 2019
June 1, 2019
7 years
September 28, 2006
October 6, 2016
June 5, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Efficacy of Coenzyme Q10 (Unified Parkinson's Disease Rating Scale [UPDRS] AND Progressive Supranuclear Palsy Rating Scale [PSPRS])
Unified Parkinson's Disease Rating Scale \[UPDRS\]: Higher scores indicate a higher degree of impairment The total score is calculated by summing the subscores. Total scores range from 0 (normal) to 166 (severely impaired) Part I \[Mentation, Behavior, \& Mood\] Scale: 0-16 Part II \[Activities of Daily Living, Both "ON" \& "OFF"\] Scale:0-52 Part III \[Motor Examination\] Scale: 0-56 Part IV \[Complications of Therapy\] Scale: 0-34 Part V \[Modified Hoehn \& Yahr Staging\] Scale: 0-8 Part VI \[Schwab \& England Activities of Daily Living Scale\] Scale: 0 - 100% Progressive Supranuclear Palsy Rating Scale \[PSPRS\] - Total Scale ranges from 0 (normal) to 128 (severely impaired) Section 1 \[History\] Scale: 0-31 Section 2 \[Mentation\] Scale: 0-20 Section 3 \[Bulbar\] Scale: 0-10 Section 4 \[Ocular Motor\] Scale: 0-20 Section 5 \[Limb Motor\] Scale: 0-22 Section 6 \[Gait and midline\] Scale: 0-25
12 months
Secondary Outcomes (4)
Efficacy of Coenzyme Q10 (Mini-Mental State Examination [MMSE] and Activities of Daily Living [ADL] Scales)
12 months
Quality of Life Questionnaires: Parkinson's Disease Questionnaire - 39 [PDQ-39], Short Form-36 [SF-36]
12 months
Safety Profile of Coenzyme Q10
12 months
Tolerability of Coenzyme Q10
12 months
Study Arms (2)
CoQ10
ACTIVE COMPARATORHalf of the enrolled patients will be randomized into the the CoQ10 arm and will receive a dosage of 2400mg/day of Coenzyme Q10
Placebo
PLACEBO COMPARATORHalf of the enrolled patients will be randomized into the the Placebo arm and will receive a matching dose of placebo that resembles the 2400mg/day dose of the CoQ10 arm.
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Lahey Cliniclead
Study Sites (3)
University of Alabama
Birmingham, Alabama, 35294, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215, United States
Lahey Clinic
Burlington, Massachusetts, 01805, United States
Related Publications (1)
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.
PMID: 27583276DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Jordan Jara
- Organization
- Lahey Hospital & Medical Center
Study Officials
- PRINCIPAL INVESTIGATOR
Diana Apetauerova, MD
Lahey Clinic
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 28, 2006
First Posted
October 2, 2006
Study Start
September 1, 2006
Primary Completion
September 1, 2013
Study Completion
January 1, 2015
Last Updated
August 1, 2019
Results First Posted
August 1, 2019
Record last verified: 2019-06
Data Sharing
- IPD Sharing
- Will not share