Coenzyme Q10 as a Symptomatic Treatment in Parkinson's Di... | NCT00180037

Studies
Coenzyme Q10 as a Symptomatic Treatment in Parkinson's Disease

NCT00180037

Sponsor

Technische Universität Dresden

Status

Completed

Last Update Posted

Jan 19, 2009Estimated

Enrollment

132

Phase

Phase 3

Conditions

Parkinson's Disease

Interventions

Coenzyme Q10 Nanodispersion (Nanoquinone)
Placebo

Countries

Germany

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2009

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 2003

Primary Completion Date

Jun 2005Actual

Completion Date

Jun 2005Actual

First Submitted Date

Sep 9, 2005

First Submission Date that Met QC Criteria

Sep 9, 2005

First Posted Date

Sep 16, 2005Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 16, 2009

Last Update Posted Date

Jan 19, 2009Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Not provided

Lead Sponsor

Technische Universität DresdenOTHER

Collaborators

Name	Class
Deutsche Parkinson-Vereinigung e.V.	UNKNOWN
MSE Pharmazeutika GmbH, Bad Homburg	UNKNOWN

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

This study was designed to evaluate the symptomatic effects of Coenzyme Q10 nanodispersed solution in middle-stage non-fluctuating 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 design of the study was a prospective, randomized, multicenter, double-blind placebo-controlled protocol. The intervention includes 100 mg Coenzyme Q10 nanodispersion (Nanoquinon solution) tid or matched placebo for three months.

Participating study centers include Neurological University Outpatient Clinics and Neurological Departments of Community-based Hospitals experienced with PD patients.

The primary outcome measure was the combined Unified Parkinson's Disease Rating Scale (UPDRS) Part II and III.

Main inclusion criteria:

Parkinson's disease according to the UK Brain Bank criteria
Hoehn & Yahr stadium II until III
Age 40 to 75 years
UPDRS Part III > 15 points
No motor fluctuations or dyskinesias
Stable medication for 4 weeks prior to inclusion

Main exclusion criteria:

Atypical parkinsonian syndromes
Dyskinesias or motor fluctuations
Coenzyme Q10 treatment in the past
Pregnancy

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

132

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Unified Parkinson's Disease Rating Scale (UPDRS) Part II and III

Secondary Outcomes

Measure	Description	Time Frame
Total UPDRS
Safety
PDQ-39

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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
Stable parkinsonian condition for 4 weeks prior to inclusion
Outpatients
Patients without or with stable levodopa treatment for 4 weeks prior inclusion
Written informed consent

Exclusion Criteria:

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

40 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Heinz Reichmann, MD	Technical University of Dresden	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Department of Neurology, University of Ulm		Ulm	Baden-Wurttemberg	89081	Germany
Department of Neurology, Fachklinik Ichenhausen

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
17502459	Result	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.

ID	Term
D020734	Parkinsonian Disorders
D001480	Basal Ganglia Diseases
D001927	Brain Diseases
D002493	Central Nervous System Diseases