This Article  • Full text  • PDF  • Reply to article  • Send to a friend  • Save in My Folder  • Save to citation manager  • Permissions  Citing Articles  • Citation map  • Citing articles on HighWire  • Citing articles on ISI (1)  • Contact me when this article is cited  Related Content  • Similar articles in this journal  Topic Collections  • Drug Therapy, Other  • Alzheimer Disease  • Randomized Controlled Trial  • Prognosis/ Outcomes  • Movement Disorders  • Parkinson Disease/ Parkinsonian Disorders  • Neurology, Other  • Drug Therapy  • Alert me on articles by topic

Alexander Storch, MD; Wolfgang H. Jost, MD; Peter Vieregge, MD; Jörg Spiegel, MD; Wolfgang Greulich, MD; Joachim Durner, MD; Thomas Müller, MD; Andreas Kupsch, MD; Henning Henningsen, MD; Wolfgang H. Oertel, MD; Gerd Fuchs, MD; Wilfried Kuhn, MD; Petra Niklowitz, MD; Rainer Koch, PhD; Birgit Herting, MD; Heinz Reichmann, MD; for the German Coenzyme Q₁₀ Study Group

Arch Neurol. 2007;64(7):938-944. Published online May 14, 2007 (doi:10.1001/archneur.64.7.nct60005).

Background  Major hallmarks in the pathophysiology of Parkinson disease are cellular energy depletion and oxidative stress leading to cellular dysfunction and death. Coenzyme Q₁₀ (CoQ₁₀) is an electron acceptor bridging mitochondrial complexes I and II/III and a potent antioxidant that consistently partially recovers the function of dopaminergic neurons.

Objective  To determine whether nanoparticular CoQ₁₀ is safe and displays symptomatic effects in patients with midstage Parkinson disease without motor fluctuations.

Design  Multicenter, randomized, double-blind, placebo-controlled, stratified, parallel-group, single-dose trial.

Setting  Academic and nonacademic movement disorder clinics.

Patients  One hundred thirty-one patients with Parkinson disease without motor fluctuations and a stable antiparkinsonian treatment.

Intervention  Random assignment to placebo or nanoparticular CoQ₁₀ (100 mg 3 times a day) for a treatment period of 3 months. Stratification criterion was levodopa treatment.

Main Outcome Measure  The subjects underwent evaluation with the Unified Parkinson’s Disease Rating Scale (UPDRS) at each visit on a monthly basis. The primary outcome variable was the change of the sum score of the UPDRS parts II and III between the baseline and 3-month visits.

Results  One hundred thirty-one subjects were randomized according to the protocol. The mean changes of the sum UPDRS parts II/III score were –3.69 for the placebo group and –3.33 for the CoQ₁₀ group (P = .82). Statistical analysis according to the stratification did not result in significant changes of the primary outcome variable. No secondary outcome measure showed a significant change between the placebo group and the CoQ₁₀ group. The frequency and quality of adverse events were similar in both treatment groups.

Conclusions  Nanoparticular CoQ₁₀ at a dosage of 300 mg/d is safe and well tolerated and leads to plasma levels similar to 1200 mg/d of standard formulations. Add-on CoQ₁₀ does not display symptomatic effects in midstage Parkinson disease.

Trial Registration  clinicaltrials.gov Identifier: NCT00180037

Author Affiliations: Department of Neurology, University of Ulm, Ulm, Germany (Dr Storch); Departments of Neurology (Drs Storch, Herting, and Reichmann) and Biometrics and Medical Informatics (Dr Koch), Technical University of Dresden, Dresden, Germany; Department of Neurology, Deutsche Klinik fuer Diagnostik, Wiesbaden, Germany (Dr Jost); Department of Neurology, Klinikum Lemgo, Lemgo, Germany (Dr Vieregge); Department of Neurology, University of Homburg, Homburg/Saar, German (Dr Spiegel); Department of Neurology, Klinikum Ambrock, Hagen, Germany (Dr Greulich); Department of Neurology, Fachklinik Ichenhausen, Ichenhausen, Germany (Dr Durner); Department of Neurology, Ruhr-University of Bochum, Bochum, Germany (Dr Müller); Department of Neurology, Charite Berlin, Berlin, Germany (Dr Kupsch); Department of Neurology, Klinikum Lüneburg, Lüneburg, Germany (Dr Henningsen); Department of Neurology, University of Marburg, Marburg, Germany (Dr Oertel); Fachklinik Wolfach, Wolfach, Germany (Dr Fuchs); Department of Neurology, Leopoldina Krankenhaus, Schweinfurt, Germany (Dr Kuhn); Department of Pediatrics, Vestische Kinderklinik Datteln, University of Witten-Herdecke, Witten, Germany (Dr Niklowitz); and MSE Pharmazeutika GmbH, Bad Homburg, Germany (Dr Koch).

THIS ARTICLE HAS BEEN CITED BY OTHER ARTICLES

Pharmacologic Management of Parkinson Disease: Choice of Initial Therapy in Early Disease
Chen and Pahwa
Journal of Pharmacy Practice 2008;21:244-253.
ABSTRACT  

Current Management of the Cognitive Dysfunction in Parkinson's Disease: How Far Have We Come?
Vale
Exp. Biol. Med. 2008;233:941-951.
ABSTRACT | FULL TEXT