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Completed

NCT Number: NCT00180037

Coenzyme Q10 as a Symptomatic Treatment in Parkinson's Disease

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.

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Key information

Age range

40 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Department of Neurology, University of Ulm, Ulm, Baden-Wurttemberg, Germany

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About this study

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.

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.

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Coenzyme Q10 Nanodispersion (Nanoquinone)

Drug

Placebo

Drug

Primary outcomes

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

Secondary outcomes

  1. Total UPDRS

  2. Safety

  3. PDQ-39

  4. SF36

  5. CGI

  6. Schwab&England

  7. Montgomery-Asperg

  8. Pain

  9. Incontinence

  10. Sexual behavior

Sponsors and collaborators

Lead sponsor

Technische Universität Dresden

Other

Collaborators

  • Deutsche Parkinson-Vereinigung e.V.
  • MSE Pharmazeutika GmbH, Bad Homburg

Registry information

Official study title

Multicenter, Placebo Controlled, Randomized, Double-Blinded Study: Coenzyme Q10 Nanodispersion Versus Placebo as Symptomatic Treatment in Parkinson's Disease

Important dates

Study start
2003
Primary completion
2005
Study completion
2005
First posted
Sep 16, 2005
Registry last updated
Jan 19, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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