N/A
N=61
Effects of Coenzyme Q10 in Progressive Supranuclear Palsy (PSP)
Progressive Supranuclear Palsy
Bottom Line
View on ClinicalTrials.gov: NCT00382824 ↗Enrolled (actual)
61
Serious AEs
21.3%
Results posted
Aug 2019
Primary outcome: Primary: Efficacy of Coenzyme Q10 (Unified Parkinson's Disease Rating Scale [UPDRS] AND Progressive Supranuclear Palsy Rating Scale [PSPRS]) — 5.9; 11.8; 11.5; 12.8 units on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Coenzyme Q10 (Dietary_supplement); Placebo (Other)
- Age
- Adult, Older Adult · 30+ yrs
- Sex
- All
- Sponsor
- Lahey Clinic
- Primary completion
- Sep 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Efficacy of Coenzyme Q10 (Unified Parkinson's Disease Rating Scale [UPDRS] AND Progressive Supranuclear Palsy Rating Scale [PSPRS]) |
5.9; 11.8; 11.5; 12.8 | — |
| SECONDARY Efficacy of Coenzyme Q10 (Mini-Mental State Examination [MMSE] and Activities of Daily Living [ADL] Scales) |
-13.5; -18.4; -1.3; -1.3 | — |
| SECONDARY Quality of Life Questionnaires: Parkinson's Disease Questionnaire - 39 [PDQ-39], Short Form-36 [SF-36] |
3.4; 7.5; -2.1; -7.2 | — |
| SECONDARY Safety Profile of Coenzyme Q10 |
27; 38; 5; 8 | — |
| SECONDARY Tolerability of Coenzyme Q10 |
20; 16 | — |
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).
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT00382824). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.