Trial document




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  DRKS00015880

Trial Description

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Title

An omics-based strategy using coenzyme Q10 in patients with Parkinson’s disease: Concept evaluation in a double-blind randomized placebo-controlled parallel group trial

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Trial Acronym

MitoPD

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URL of the Trial

[---]*

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Brief Summary in Lay Language

Clinical intervention with Conenzyme Q10 (period of 6 months) following an omics-based selection process

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Brief Summary in Scientific Language

In this study, we will investigate the role of a six month lasting coenzyme Q10 treatment in Parkinson's disease patients. For this study, we will use a genetic stratification approach investigating homozygous PINK1/Parkin mutation carriers, heterozygous PINK1/Parkin mutation carriers, and two groups with a polygenic mitochondrial (omics+) and without a polygenic mitochondrial (omics-) profile (based on eight predefined SNPs). Besides common clinical endpoints (such as the improvement of motor symptoms as measured by the MDS-UPDRS-III) we will use phosphorus magnetic resonance spectroscopy to directly measure ATP and phosphocreatine (as surrogate markers for mitochondrial impairment in Parkinson's disease patients) levels to objectively measure bioenergetic improvements in vivo.

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Organizational Data

  •   DRKS00015880
  •   2018/11/15
  •   [---]*
  •   yes
  •   Approved
  •   18-294, Ethik-Kommission Universität zu Lübeck Medizinische Fakultät des Universitätsklinikums Schleswig-Holstein
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Secondary IDs

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Health Condition or Problem studied

  •   G20 -  Parkinson disease
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Interventions/Observational Groups

  •   156 mg QuinoMit Q10 fluid (equivalent dosage of 1200 mg Coenzym Q10) ubiquinon emulsion, 8 strokes tid (five hour gap between each intake, e.g. at 8 am 1pm, and 6pm) for an intervention period of 6 months
  •   placebo
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Characteristics

  •   Interventional
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  •   Randomized controlled trial
  •   Blinded
  •   patient/subject, investigator/therapist, assessor
  •   Placebo
  •   Treatment
  •   Parallel
  •   II
  •   N/A
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Primary Outcome

Change of motor symptoms of Parkinson's disease patients following a 6 months intervention period. The primary endpoint will be the difference between the motor subscale of the revised "Unified Parkinson's Disease Rating Scale" (MDS-UPDRS) between baseline visit and after 6 months post-intervention.

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Secondary Outcome

changes from the baseline visit in the following scales
1.) MDS-UPDRS-III motor subscale (after 3 and 9) months
2.) MDS-UPDRS-I (after 3, 6, and 9
months)
3.) Activities of daily living
MDS-UPDRS-II (after 3, 6, and 9 months)
4.) combined sum score based on the
"Timed up and Go-Test", "10-meter walk test", and "finger tapping task" (taken from the MDS-UPDRS-III) (after 3, 6, and 9 months)
5.) Quality of life bassed on the PDQ39 (after 3, 6, and 9 months)
6.) Depression as measured by the BDI II (after 3, 6, and 9 months)
7.) MDS-UPDRS-IV (after 3, 6, and 9 months)
8.) cognitive impairment as measured by Montreal Cognitive Assessment (after 3, 6, and 9 months)
9.)Fatigue Severity Scale (FSS) (after 3, 6, and 9 months)
10.) changes in brain metabolism (as measured via magnetic resonance spectroscopy) of PCr/inorganic phosphate (Pi) in Q10 treated patients (after 6 months)
11.) changes in brain metabolism (as measured via magnetic resonance spectroscopy) of ATP/Pi in Q10 treated patients (after 6 months)
12.) changes of structural MRI measures (based on DWI/DTI) (after 6 months)
13.) changes of structural MRI measures (based on measures of iron depositon/SWI) (after 6 months)
14.) changes of functional (resting state) MRI measures (of motor networks) (after 6 months)

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Planned
  •   2018/12/15
  •   84
  •   Multicenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   no maximum age
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Additional Inclusion Criteria

PD diagnosis based on UK Brain Bank criteria

genotyping and assignment to regarding study group

stable PD mediaction (for at least 4 weeks)

age above or equal to 18 years

written informed consent

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Exclusion Criteria

comorbidities that impair giving informed consent (severe dementia [MMSE<24], psychosis, severe depression)

atypical or secondary parkinsonism

pregnancy, breastfeeding or current wish for pregnancy

no contraception, unless the patient is in her menopause

(self-)treatment with coenzyme Q10 up to 3 months before trial enrollment

known intolerance or allergy to conenzyme Q10

concomitant medication with thyroid drugs

concomitant medication with vitamine K anatgonists

concomitant medication with betablockers

epilepsy

structural brain damage (e. g. following stroke)

allergy to soy

concomitant participation in another clinical trial (besides pure questionnaire-based trials or vitamine K2 interventional trials) within the last 30 days prior to study enrollment

known severe liver or kidney disease

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Addresses

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    • Universitätsklinikum Schleswig-Holstein Campus Lübeck
    • Ratzeburger Allee 160
    • 23538  Lübeck
    • Germany
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    • Klinik für Neurologie, Universitätsklinikum Schleswig-Holstein, Campus LübeckInstitut für Neurogenetik,Universität zu Lübeck
    • Mr.  Prof. Dr.  Norbert  Brüggemann 
    • Ratzeburger Allee 160
    • 23562  Lübeck
    • Germany
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    • Institut für NeurogenetikUniversität zu Lübeck
    • Ms.  Elena  Löwin 
    • Ratzeburger Allee 160
    • 23562  Lübeck
    • Germany
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Sources of Monetary or Material Support

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    • Bundesministerium für Bildung und Forschung Dienstsitz Berlin
    • Friedrichstraße 130 B
    • 10117  Berlin
    • Germany
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Status

  •   Recruiting planned
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Trial Publications, Results and other Documents

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* This entry means the parameter is not applicable or has not been set.