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    Summary
    EudraCT Number:2005-000574-40
    Sponsor's Protocol Code Number:PSP-CoQ10
    National Competent Authority:Germany - BfArM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2006-01-24
    Trial results View results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedGermany - BfArM
    A.2EudraCT number2005-000574-40
    A.3Full title of the trial
    Brain Energy Metabolism in Progressive Supranuclear Palsy: Comparison of PSP Patients and Healthy Controls and Effect of Coenzyme Q10 – nanoQuinon®
    A.3.2Name or abbreviated title of the trial where available
    N/A
    A.4.1Sponsor's protocol code numberPSP-CoQ10
    A.7Trial is part of a Paediatric Investigation Plan Information not present in EudraCT
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorKompetenznetz Parkinson e.V.
    B.1.3.4CountryGermany
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing support
    B.4.2Country
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisation
    B.5.2Functional name of contact point
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Information not present in EudraCT
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameCoenzym Q10 Nanodispersion
    D.3.2Product code ASK Nr. 21972
    D.3.4Pharmaceutical form Oral drops*
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNUbidecarenon
    D.3.9.1CAS number 303-98-0
    D.3.9.2Current sponsor codeSanomit
    D.3.9.3Other descriptive nameCoenzym Q10, Ubiquinon, Ubichinon
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number47.5 to 52.5
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) Information not present in EudraCT
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product Information not present in EudraCT
    D.3.11.8Extractive medicinal product Information not present in EudraCT
    D.3.11.9Recombinant medicinal product Information not present in EudraCT
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboOral drops*
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    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.
    MedDRA Classification
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    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.
    E.2.2Secondary objectives of the trial
    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
    E.2.3Trial contains a sub-study Information not present in EudraCT
    E.3Principal 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.
    E.4Principal 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.
    E.5 End points
    E.5.1Primary 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 α = 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 violations.
    Safety (S) population All PSP patients randomized who received at least one administration of study medication.
    MRS population All PSP patients and healthy control subjects having undergone baseline MRS assessment.
    The test of the primary endpoint (i.e test of H0) will be applied to the MRS population. To examine the robustness of its result, a further test in the FS population with appropriate imputation of missing values will be done.

    In order to obtain evidence for the assumed pathophysiological mechanisms (cf. 2.2), descriptive statistics (mean, median, standard deviation, range, quantiles and 95% confidence intervals) for the parameters measured by MR spectroscopy (total amounts of ATP, ADP, pCre, tCre, Lac, ratio of ADP to ATP, ratio of pCre to tCre; cf 3.2) will be given for the baseline values in the subgroup of non-PSP subjects and the subgroup of PSP patients. These analyses will be done for the MRS population.

    To obtain evidence for the effect of CoQ10 on these mechanisms descriptive statistics for differences from baseline to the 6 weeks visit in the aforementioned parameters will be given for the subgroup of PSP patients for each treatment group (CoQ10 and placebo). These analyses will be done for the ITT population and for the PP population in order to examine the robustness of results.

    Analysis of all secondary endpoints takes place exploratively and descriptively. For categorical variables, the number and proportion of patients in each category will be given. For continuous variables, the number of patients, mean, standard deviation, quartiles, range and 95% confidence intervals will be provided. The data will be summarized for all patients as well as for each of the randomized treatment groups

    Analysis of safety takes place for the S population.
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy Yes
    E.6.4Safety Yes
    E.6.5Efficacy No
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic Information not present in EudraCT
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    investigation into pathomechanisms of the disease
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group Yes
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    E.8.3 The trial involves single site in the Member State concerned Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    E.8.5The trial involves multiple Member States No
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA Information not present in EudraCT
    E.8.7Trial has a data monitoring committee Information not present in EudraCT
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    Healthy controls will only have a baseline visit to obtain normal values for the outcome variables. They will not undergo any treatment.

    PSP patients will be assessed 6 weeks (± 4 days) after the baseline visit. This follow-up visit is the final visit. Drug treatment will be terminated at the 6-week follow-up visit.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months
    E.8.9.1In the Member State concerned days
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.3Elderly (>=65 years) Yes
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers Yes
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Information not present in EudraCT
    F.3.3.1Women of childbearing potential not using contraception For clinical trials recorded in the database before the 10th March 2011 this question read: "Women of childbearing potential" and did not include the words "not using contraception". An answer of yes could have included women of child bearing potential whether or not they would be using contraception. The answer should therefore be understood in that context. This trial was recorded in the database on 2006-01-24. Yes
    F.3.3.2Women of child-bearing potential using contraception Information not present in EudraCT
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state30
    F.4.2 For a multinational trial
    F.4.2.2In the whole clinical trial 30
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    No further procedures are planned after the termination of the study drug treatment.
    The General Practitioners will be informed about the end of the study and asked to follow the patients. Should any indication for an AE arise within the 3 months following the termination of the study, the General Practitioner will immediately inform the Principal Investigator. It is the responsibility of the Principal Investigator to initiate immediately the necessary medical measures.
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2006-04-24
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2005-08-11
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2007-02-01
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