to study search History No further version available for comparison

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

Organizational Data

DRKS-ID:
DRKS00015880
Recruitment Status:
Recruiting planned
Date of registration in DRKS:
2018-11-15
Last update in DRKS:
2018-11-15
Registration type:
Prospective

Acronym/abbreviation of the study

MitoPD

URL of the study

No Entry

Brief summary in lay language

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

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.

Health condition or problem studied

ICD10:
G20 - Parkinson disease
Healthy volunteers:
No Entry

Interventions, Observational Groups

Arm 1:
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
Arm 2:
placebo

Endpoints

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.
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)

Study Design

Purpose:
Treatment
Allocation:
Randomized controlled study
Control:
  • Placebo
Phase:
II
Study type:
Interventional
Mechanism of allocation concealment:
No Entry
Blinding:
Yes
Assignment:
Parallel
Sequence generation:
No Entry
Who is blinded:
  • Assessor
  • Investigator/therapist
  • Patient/subject

Recruitment

Recruitment Status:
Recruiting planned
Reason if recruiting stopped or withdrawn:
No Entry

Recruitment Locations

Recruitment countries:
  • Germany
Number of study centers:
Multicenter study
Recruitment location(s):
  • University medical center Klinik für Neurologie/Institut für Neurogenetik Lübeck

Recruitment period and number of participants

Planned study start date:
2018-12-15
Actual study start date:
No Entry
Planned study completion date:
No Entry
Actual Study Completion Date:
No Entry
Target Sample Size:
84
Final Sample Size:
No Entry

Inclusion Criteria

Sex:
All
Minimum Age:
18 Years
Maximum Age:
no maximum age
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

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

Addresses

Primary Sponsor

Universitätsklinikum Schleswig-Holstein Campus Lübeck
Ratzeburger Allee 160
23538 Lübeck
Germany
Telephone:
No Entry
Fax:
No Entry
Contact per E-Mail
URL:
http://www.uk-sh.de
Investigator Sponsored/Initiated Trial (IST/IIT):
Yes

Contact for Scientific Queries

Klinik für Neurologie, Universitätsklinikum Schleswig-Holstein, Campus LübeckInstitut für Neurogenetik,Universität zu Lübeck
Prof. Dr. Norbert Brüggemann
Ratzeburger Allee 160
23562 Lübeck
Germany
Telephone:
0451-5000
Fax:
No Entry
Contact per E-Mail
URL:
http://www.uksh.de

Contact for Public Queries

Institut für NeurogenetikUniversität zu Lübeck
Elena Löwin
Ratzeburger Allee 160
23562 Lübeck
Germany
Telephone:
0451 3101 7521
Fax:
No Entry
Contact per E-Mail
URL:
http://www.uksh.de

Principal Investigator

Klinik für Neurologie, Universitätsklinikum Schleswig-Holstein, Campus LübeckInstitut für Neurogenetik,Universität zu Lübeck
Prof. Dr. Norbert Brüggemann
Ratzeburger Allee 160
23562 Lübeck
Germany
Telephone:
0451-5000
Fax:
No Entry
Contact per E-Mail
URL:
http://www.uksh.de

Sources of Monetary or Material Support

Public funding institutions financed by tax money/Government funding body (German Research Foundation (DFG), Federal Ministry of Education and Research (BMBF), etc.)

Bundesministerium für Bildung und Forschung Dienstsitz Berlin
Friedrichstraße 130 B
10117 Berlin
Germany
Telephone:
No Entry
Fax:
No Entry
Contact per E-Mail
URL:
http://www.bmbf.de

Ethics Committee

Address Ethics Committee

Ethik-Kommission der Med. Fakultät der Universität zu Lübeck
Ratzeburger Allee 160
23538 Lübeck
Germany
Telephone:
+49-451-5004639
Fax:
+49-451-5003026
Contact per E-Mail
URL:
No Entry

Vote of leading Ethics Committee

Date of ethics committee application:
2018-10-15
Ethics committee number:
18-294
Vote of the Ethics Committee:
Approved
Date of the vote:
2018-11-01

Further identification numbers

Other primary registry ID:
No Entry
EudraCT Number:
No Entry
UTN (Universal Trial Number):
No Entry
EUDAMED Number:
No Entry

IPD - Individual Participant Data

Do you plan to make participant-related data (IPD) available to other researchers in an anonymized form?:
No Entry
IPD Sharing Plan:
No Entry

Study protocol and other study documents

Study protocols:
No Entry
Study abstract:
No Entry
Other study documents:
No Entry
Background literature:
No Entry
Related DRKS studies:
No Entry

Publication of study results

Planned publication:
No Entry
Publikationen/Studienergebnisse:
No Entry
Date of first publication of study results:
No Entry
DRKS entry published for the first time with results:
No Entry

Basic reporting

Basic Reporting / Results tables:
No Entry
Brief summary of results:
No Entry