NCT00180037

Brief Summary

This study was designed to evaluate the symptomatic effects of Coenzyme Q10 nanodispersed solution in middle-stage Parkinson's disease (PD) patients (Hoehn\&Yahr II to III). The treatment phase includes three months period of 300 mg Coenzyme Q10 per day or placebo. The primary outcome measure was the combined Unified Parkinson's Disease Rating Scale (UPDRS) Part II and III. The hypothesis of this study was that Coenzyme Q10 improves the energy status of the diseased dopaminergic neuronal cell type and thus producing more dopamine leading to an improvement of parkinsonian symptoms in PD patients.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
132

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Sep 2003

Geographic Reach
1 country

13 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2003

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2005

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2005

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

September 9, 2005

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 16, 2005

Completed
Last Updated

January 19, 2009

Status Verified

January 1, 2009

Enrollment Period

1.8 years

First QC Date

September 9, 2005

Last Update Submit

January 16, 2009

Conditions

Parkinson's Disease

Keywords

Parkinson's diseaseCoenzyme Q10TreatmentNeuroprotection

Outcome Measures

Primary Outcomes (1)

  • Unified Parkinson's Disease Rating Scale (UPDRS) Part II and III

Secondary Outcomes (10)

  • Total UPDRS

  • Safety

  • PDQ-39

  • SF36

  • CGI

  • +5 more secondary outcomes

Interventions

Coenzyme Q10 Nanodispersion (Nanoquinone)DRUG
PlaceboDRUG

Eligibility Criteria

Age40 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Parkinson's disease according to the UK Brain Bank criteria
  • Hoehn \& Yahr stadium II until III
  • Male or female
  • Age 40 to 75 years
  • UPDRS Part III \> 15 points
  • No motor fluctuations or dyskinesias
  • Outpatients
  • Written informed consent

You may not qualify if:

  • Atypical or drug-induced parkinsonian syndromes
  • Dyskinesias or motor fluctuations
  • Coenzyme Q10 treatment in the past
  • Pregnancy
  • Epileptic seizures in the history
  • Hypothyroidism
  • Severe medical conditions with interference with study drug
  • Treatment with CSE inhibitors, thyroidal hormones, antiarrhythmic drugs, warfarin, metformin
  • Treatment or intake of vitamins, magnesium, vitamin E, calcium

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (13)

Department of Neurology, University of Ulm

Ulm, Baden-Wurttemberg, 89081, Germany

Location

Department of Neurology, Fachklinik Ichenhausen

Ichenhausen, Bavaria, 89335, Germany

Location

Department of Neurology, Leopoldina Krankenhaus

Schweinfurt, Bavaria, 97422, Germany

Location

Department of Neurology, University of Marburg

Marburg, Hesse, 35039, Germany

Location

Department of Neurology, Deutsche Klinik fuer Diagnostik

Wiesbaden, Hesse, 65191, Germany

Location

Department of Nuerology, Klinikum Lippe

Lemgo, Lower Saxony, 32657, Germany

Location

Department of Neurology, Klinikum Lueneburg

Lüneburg, Lower Saxony, 21339, Germany

Location

Department of Neurology, Ruhr-University of Bochum

Bochum, North Rhine-Westphalia, 44791, Germany

Location

Department of Neurology, Klinikum Essen-Borbeck

Essen, North Rhine-Westphalia, 45359, Germany

Location

Department of Neurology, Klinik Ambrock

Hagen, North Rhine-Westphalia, 58091, Germany

Location

Department of Neurology, University of Homburg

Homburg, Saarland, 66421, Germany

Location

Department of Neurology, Technical University of Dresden

Dresden, Saxony, 01307, Germany

Location

Department of Neurology, Charite Berlin

Berlin, State of Berlin, 13353, Germany

Location

Related Publications (1)

  • Storch A, Jost WH, Vieregge P, Spiegel J, Greulich W, Durner J, Muller T, Kupsch A, Henningsen H, Oertel WH, Fuchs G, Kuhn W, Niklowitz P, Koch R, Herting B, Reichmann H; German Coenzyme Q(10) Study Group. Randomized, double-blind, placebo-controlled trial on symptomatic effects of coenzyme Q(10) in Parkinson disease. Arch Neurol. 2007 Jul;64(7):938-44. doi: 10.1001/archneur.64.7.nct60005. Epub 2007 May 14.

    PMID: 17502459RESULT

Related Links

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian DisordersBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMovement DisordersSynucleinopathiesNeurodegenerative Diseases

Study Officials

  • Heinz Reichmann, MD

    Technical University of Dresden

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 9, 2005

First Posted

September 16, 2005

Study Start

September 1, 2003

Primary Completion

June 1, 2005

Study Completion

June 1, 2005

Last Updated

January 19, 2009

Record last verified: 2009-01

Locations

DE(13)