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Sponsors and Collaborators: |
German Parkinson Study Group (GPS) MSE Pharmazeutika GmbH, Louisenstr.114D-61348 Bad Homburg, Germany Pitzer Stiftung Philipps University Marburg Medical Center |
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Information provided by: | German Parkinson Study Group (GPS) |
ClinicalTrials.gov Identifier: | NCT00328874 |
Study hypothesis:
A 6-week p.o treatment with 5 mg/Kg Coenzyme Q10 is safe and tolerable,increases the brain's metabolism and ameliorates clinical symptoms in patients with PSP.
Condition | Intervention | Phase |
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Progressive Supranuclear Palsy |
Drug: Coenzyme Q10 |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Mono-Center, Prospective, Double-Blind, Placebo-Controlled, Randomized Clinical Phase IIa Trial to Assess the Safety, Tolerability, and Immediate Biological Effects of Coenzyme Q10 - nanoQuinon® in Progressive Supranuclear Palsy |
Enrollment: | 20 |
Study Start Date: | May 2006 |
Study Completion Date: | February 2007 |
Background and Rationale:
(1.) Reduced cerebral glucose and ATP metabolism have been shown in functional imaging studies in PSP patients (Forster et al., 1988; Martinelli et al., 2000). (2.) Cybrid cells harboring mitochondrial genes from PSP patients have decreased ATP-levels and complex I activity (Swerdlow et al., 2000; Albers et al., 2001; Chirichigno et al., 2002).
(3.) A tropical PSP-like tauopathy has been linked clinically and experimentally to the consumption of the fruit and teas of leaves of the tropical plant annona muricata rich in lipophilic complex I inhibitors (Caparros-Lefebvre et al., 1999; 2001). These clinical observations suggest a role for mitochondrial dysfunction in the etiology of PSP.
3.Coenzyme Q10 (CoQ10) is the physiological electron recipient of complex I. Exogenous CoQ10 (1.) enhances the electron transport by complex I and (2.) powerfully scavenges free radicals. Thus, CoQ10 has been shown to reduce the toxicity of complex I inhibitors in vitro (Menke et al., 2003) and in vivo (Beal et al., 1998
Ages Eligible for Study: | 40 Years to 85 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Germany, Hessen | |
Neurologische Klinik der Philipps-Universität Marburg | |
Marburg, Hessen, Germany, 35033 |
Principal Investigator: | Wolfgang Oertel, Professor | Neurologische Klinik der Philipps Universität Marburg |
Study ID Numbers: | EudraCT: 2005-000574-40 |
Study First Received: | May 21, 2006 |
Last Updated: | March 25, 2008 |
ClinicalTrials.gov Identifier: | NCT00328874 History of Changes |
Health Authority: | Germany: Federal Institute for Drugs and Medical Devices |
Progressive Supranuclear Palsy Coenzyme Q10 |
Ganglion Cysts Eye Diseases Basal Ganglia Diseases Central Nervous System Diseases Trace Elements Brain Diseases Neurodegenerative Diseases Coenzyme Q10 Paralysis Ocular Motility Disorders |
Signs and Symptoms Movement Disorders Vitamins Ubiquinone Supranuclear Palsy, Progressive Neurologic Manifestations Progressive Supranuclear Palsy Micronutrients Motor Neuro-ophthalmic Disorders |
Growth Substances Eye Diseases Physiological Effects of Drugs Basal Ganglia Diseases Nervous System Diseases Central Nervous System Diseases Brain Diseases Ophthalmoplegia Neurodegenerative Diseases Pharmacologic Actions Coenzyme Q10 |
Paralysis Signs and Symptoms Ocular Motility Disorders Movement Disorders Vitamins Ubiquinone Supranuclear Palsy, Progressive Neurologic Manifestations Micronutrients Cranial Nerve Diseases Tauopathies |