PSP is a sporadic neurodegenerative disorder resulting in a Parkinson syndrome with postural instability, oculomotor deficits, and cognitive decline. With an average annual incidence of 5.3 / 100000 and an age-adjusted prevalence of 6.4 / 100000, PSP is as common as motor-neuron disease. The progression of PSP is rapid and the median survival after onset of symptoms is 5-10 years. Presently, there is no known effective symptomatic or neuroprotective therapy for PSP.
Conditions
Interventions
Product Name: Coenzym Q10 Nanodispersion
Product Code: ASK Nr. 21972
Pharmaceutical Form: Oral drops*
INN or Proposed INN: Ubidecarenon
CAS Number: 303-98-0
Current Sponsor code: Sanomit
Other descrip
Sponsors
Kompetenznetz Parkinson e.V.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: · Subjects have a diagnosis of clinically probable PSP · Subjects have early stage PSP: PSP staging system = III · Subjects are capable and willing to give written informed consent. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: · Age > 85 years. · Parkinson syndromes other than PSP (e.g. idiopathic Parkinson‘s disease, multiple system atrophy, diffuse Lewy body disease, FTDP17, symptomatic parkinsonism) · Dementia [Mini Mental State Examination (MMSE) = 24] · History of epilepsy, stroke, structural brain disease, brain surgery, or electroconvulsive therapy · Arterial hypertension (systolic >180 or diastolic >110mm Hg) · Diagnosis of systemic disorders affecting the metabolism or function of the brain (e.g. diabetes mellitus) unless sufficiently treated. · Presence of other serious illnesses · Insufficient contraception in male and pre-menopausal female participants. · Participation in other drug studies within 30 days before baseline visit. · Use of coenzyme Q10 within 60 days before baseline visit · Use of any antioxidants (e.g. vitamin E, C) within 60 days before baseline visit · Use of any drugs interfering with mitochondrial activity within 60 days before baseline visit · Use of statins within 60 days before baseline visit (inhibit endogenous coenzyme Q10 production) · Use of drugs interfering with catecholamine metabolism (e.g. reserpine, amphetamines, or monaomine oxidase-A inhibitors, methylphenidate, cinnarizine) within 30 days before baseline visit. · Use of Levodopa within 30 days before baseline visit (coenzyme Q10 may change its metabolism). · An unstable dosage of CNS-active drugs (e.g. anxiolytics, hypnotics, tranquillizer, antidepressants) within 30 days before baseline visit. · An unstable dosage of other antiparkinsonian drugs within 30 days before baseline visit.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The level of ADP measured by Magnetic Resonance (MR-) Spectroscopy will be compared in the frontal cortex and putamen in - healthy control persons vs. PSP patients and - PSP patients prior to and after 6 weeks of treatment with CoQ10.;Secondary Objective: 1. Further parameters of brain energy metabolism [ATP, phosphorylated creatinine (pCre), the total amount of creatinine (tCre), inorganic Phosphate (Pi), lactate (Lac)] as assessed by Magnetic Resonance (MR-) Spectroscopy (Comparison of controls to PSP patients and comparison of PSP patients prior to and after 6 weeks of treatment with CoQ10 or Placebo). 2. Disease severity: Comparison of PSP patients prior to and after 6 weeks of treatment with CoQ10 or placebo. -Movement disorder: UPDRS III PSP rating scale, PSP staging system, H&Y. -Cognition: Frontal Assessment Battery , Mini Mental State Examination, Montgomery-Åsberg scale. -Activities of daily living: Schwab and England score, UPDRS II. 3. Safety and tolerability: -Vital signs and physical examination, Blood tests , urine status, Adverse events and serious adverse events. 4. Levels of reduced / oxidized coenzyme Q 10 in serum: Comparison in PSP patients prior to and after 6 weeks of treatment with CoQ10;Primary end point(s): The primary goal of this study is to investigate whether the amount of adenosine-diphosphate in cells of the frontal cortex and putamen differ between PSP patients and healthy controls. The problem will be formulated statistically as a two-sided test of the hypothesis (H0: “Equal distribution of the the amount of adenosine-diphosphate in cells of the frontal cortex and putamen in the two groups”). Due to the small sample size the Wilcoxon-Mann-Whitney-test will be used. The significance level is set to a = 0.05. Intent-to-treat (ITT) population All PSP patients randomized. Per-protocol (PP) population All PSP patients of the ITT population with completed treatment according to the study plan and no major protocol v | — |
Countries
Germany
Outcome results
None listed