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Study About Safety and Efficacy of Coenzyme Q10 in Progressive Supranuclear Palsy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00328874
Recruitment Status : Completed
First Posted : May 24, 2006
Last Update Posted : January 10, 2020
Sponsor:
Collaborators:
MSE Pharmazeutika GmbH, Louisenstr.114D-61348 Bad Homburg, Germany
Pitzer Stiftung
Philipps University Marburg Medical Center
Information provided by:
German Parkinson Study Group (GPS)

Tracking Information
First Submitted Date  ICMJE May 21, 2006
First Posted Date  ICMJE May 24, 2006
Last Update Posted Date January 10, 2020
Study Start Date  ICMJE May 2006
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE
 (submitted: May 22, 2006)
Brain Energy Metabolites measured by Magnetic Resonance Spectroscopy
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 22, 2006)
  • Slowdown of clinical progression after 6 weeks, rated with UPDRS III, PSP rating scale, PSP staging system, modified Hoehn and Yahr, FAB, MMSE, Montgomery- Asberg Depression scale, Schwab and England Score and UPDRS II
  • Safety and tolerability:Vital signs physical examination and safety laboratory with Blood tests and urine status.
  • Evaluation of occuring adverse events(AE), severe adverse events(SAE) up to 6 Weeks after the beginning of the treatment.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study About Safety and Efficacy of Coenzyme Q10 in Progressive Supranuclear Palsy
Official Title  ICMJE 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
Brief Summary

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.

Detailed Description

Background and Rationale:

1. Progressive Supranuclear Palsy (PSP, Steele-Richardson-Olszewski Syndrome) is a sporadic neurodegenerative disorder resulting clinically in a Parkinson syndrome (i.e. akinetic-rigid movement disorder) with prominent postural instability, oculomotor deficits, and cognitive decline (for review: Albers and Augood, 2001; Burn and Lees, 2002). With an average annual incidence of 5.3 per 100000 and an age-adjusted prevalence of 6.4 per 100000, PSP is as common as motor-neuron disease (Burn and Lees, 2002). There is no symptomatic treatment, because PSP patients do not respond to any known therapy (Albers and Augood, 2001; Burn and Lees, 2002). The progression of PSP is rapid and the median survival after onset of symptoms is 5-10 years (Albers and Augood, 2001). Presently, there is no known effective symptomatic or neuroprotective therapy for PSP.

2. Evidence suggests an impairment of mitochondrial energy metabolism in PSP (Albers and Beal, 2002):

  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

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Progressive Supranuclear Palsy
Intervention  ICMJE Drug: Coenzyme Q10
Study Arms  ICMJE
  • Placebo Comparator: Placebo
    Intervention: Drug: Coenzyme Q10
  • Active Comparator: Coenzyme Q10
    Intervention: Drug: Coenzyme Q10
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 25, 2008)
20
Original Enrollment  ICMJE
 (submitted: May 22, 2006)
30
Actual Study Completion Date  ICMJE February 2007
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Diagnosis of clinically probable PSP (Litvan et al., 1996).
  • Early stage PSP [PSP staging system ≤ III (Golbe, 1997)].
  • Capability and willingness to give written informed consent to participate in the study.

Exclusion Criteria:

  • Age > 85 years.
  • Parkinson syndromes other than PSP (e.g. idiopathic Parkinson's disease, multiple system atrophy, diffuse Lewy body disease, FTDP17, symptomatic parkinsonism)
  • Dementia [Mini Mental State Examination (MMSE) ≤ 24]
  • History of epilepsy, structural brain disease, brain surgery, or electroconvulsive therapy
  • History of stroke related to the onset or progression of PSP symptoms
  • Arterial hypertension (systolic >180 or diastolic >110mm Hg)
  • Thyroid dysfunction requiring thyroxin supplementation (CoQ10 may change its metabolism)
  • Presence of other serious illnesses
  • Insufficient contraception in male and pre-menopausal female participants. Accepted means of contraception are hormonal contraception, intrauterine devices, vaginal rings, preservatives, and abstinence.
  • Pregnancy or lactation period
  • Participation in other drug studies within 60 days before baseline visit.
  • Use of CoQ10 within 60 days before baseline visit
  • Use of any antioxidants (e.g. vitamin E, C) within 60 days before baseline visit
  • Use of any drugs modifying mitochondrial activity within 60 days before baseline visit
  • Use of statins within 60 days before baseline visit (inhibit endogenous CoQ10 production)
  • Use of drugs interfering with catecholamine metabolism (e.g. reserpine, amphetamines, or monaomine oxidase-A inhibitors, methylphenidate, cinnarizine) within 30 days before baseline visit.
  • Use of Levodopa within 30 days before baseline visit (CoQ10 may change its metabolism).
  • An unstable dosage of CNS-active drugs (e.g. anxiolytics, hypnotics, tranquillizer, and antidepressants) within 30 days before baseline visit or throughout the study.
  • An unstable dosage of other antiparkinsonian drugs within 30 days before baseline visit or throughout the study.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 40 Years to 85 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Germany
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00328874
Other Study ID Numbers  ICMJE EudraCT: 2005-000574-40
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE German Parkinson Study Group (GPS)
Collaborators  ICMJE
  • MSE Pharmazeutika GmbH, Louisenstr.114D-61348 Bad Homburg, Germany
  • Pitzer Stiftung
  • Philipps University Marburg Medical Center
Investigators  ICMJE
Principal Investigator: Wolfgang Oertel, Professor Neurologische Klinik der Philipps Universität Marburg
PRS Account German Parkinson Study Group (GPS)
Verification Date March 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP