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Official Study Title: Effects of Coenzyme Q10  Coenzyme Q10An enzyme that improves the function of the "powerhouses" (mitochondria) that produce energy in cells and "mops up" potentially harmful chemicals generated during normal metabolism. People with Parkinson’s have low levels of this potent antioxidant in mitochondria and exhibit impaired mitochondrial function. Levels can be increased by taking CoQ10 supplements, although clinical trial results are not clear that this is beneficial. (CoQ) in Parkinson Disease – Phase III [QE3]
Sponsor: National Institute of Neurological Disorders and Stroke  National Institute of Neurological Disorders and Stroke (NINDS)A branch of the National Institutes of Health whose research concentrates on the brain and conditions that result in brain function irregularities. The NINDS funds much of the research on Parkinson's disease.  Parkinson's DiseaseA chronic, slowly progressive disease of the nervous system characterized by the combination of tremor, rigidity, bradykinesia and stooped posture, among other symptoms. Internet address: http://www.ninds.nih.gov (NINDS)
Clinicaltrials.gov ID:
Study ID: U01 NS050324

Summary

The objective of this study, called ‘QE3’, is to evaluate the safety and effectiveness  EffectivenessAbility of a drug or treatment to produce a result. of high dosages of CoQ in slowing clinical  ClinicalDealing with or based on observation and treatment of people, as opposed to basic science carried out in the laboratory or in animals. decline in people who have early Parkinson's disease. CoQ is a naturally occurring substance in the body and is also a nutritional supplement. In previous studies CoQ has been well tolerated.

Study Phase

Phase 3
What is a study phase?

Symptoms Addressed: Movement and Non-movement

General PD symptoms

Time Commitment

• More than six months
• Visits at screening,  ScreeningPeriod of selection of clinical trial participants based on ELIGIBILITY CRITERIA. baseline,  BaselinBeginning measurements against which a participant’s progress can be quantified at the end of a study. 1, 4, 8, 12 and 16 months.

Eligibility

• Minimum Age: 30
• Gender(s) Accepted: Either
• Maximum Years Since Diagnosis: 5

Inclusion Criteria

• Presence of all 3 of the cardinal features of PD (resting tremor,  Resting TremorA tremor of a limb that increases when the limb is at rest. bradykinesia  BradykinesiaSlowness of movement. and rigidity)  RigidityA symptom in which muscles feel stiff and display resistance to movement even when another person tries to move the affected part of the body. .
• Diagnosis of PD within 5 years prior to the Screening Visit.
• Women of child bearing potential must agree to use approved form of contraception or be either surgically sterile (hysterectomy or tubal ligation) or postmenopausal (last menstruation was 2 years or more prior to Screening Visit).
  
• If the participant was taking CoQ, the participant discontinued use from 2 – 4 months depending on dose prior to Baseline Visit.

Exclusion Criteria

• Use of any PD medication within 60 days prior to the Baseline Visit.
• Prior use of symptomatic medication for PD, such as levodopa,  LevodopaA compound that is converted into dopamine (the brain chemical which is deficient in people with Parkinson's) in the brain. dopaminergic agonists (including ropinirole, pramipexole, pergolide, cabergoline, and the rotigotine transdermal system), selegiline,  SelegilineInhibitor that increases the amount of dopamine in the brain to help control the symptoms of Parkinson's in people who are taking levodopa and carbidopa in combination (Sinemet). Selegiline may help people with Parkinson's to decrease the dose of levodopa/carbidopa needed to control symptoms, stopping the effects of levodopa/carbidopa from wearing off between doses, and increasing the length of time that levodopa/carbidopa will continue to control symptoms. rasagiline, amantadine, and anticholinergic agents cannot exceed 90 days.
• Parkinsonism due to drugs including neuroleptics, alphamethyldopa, reserpine, metoclopramide, valproic acid.
• Use of antioxidants (such as selegiline, rasagiline, vitamins E and C), additional supplemental vitamins or minerals, regular use of neuroleptics, chloramphenicol, valproic acid, warfarin.
• Other diseases with features of PD.
• PD evaluations showing later stage disease.
• Clinically significant cognitive  CognitiveRelated to mental activities having to do with perception, memory, judgment, and reasoning. impairment.
  
• History of stroke.
• Disability sufficient to require treatment with dopaminergic medication or anticipated need for dopaminergic medication within next 3 months.
• Other serious illness, including psychiatric illness.
• People with active cardiovascular, peripheral vascular or cerebrovascular disease within the past year.
• Clinically serious abnormalities in the Screening Visit laboratory studies or electrocardiogram.
• Use of methylphenidate, cinnarizine, reserpine, amphetamine or a MAO-A inhibitor within 6 months prior to the Baseline Visit.
• Unstable dose of CNS active therapies.
• Use of appetite suppressants within 60 days prior to the Baseline Visit.
• History of active epilepsy within the last 5 years.
• Diagnosis of clinically significant depression.
• Participation in other drug studies or use of other investigational drugs within 30 days prior to Screening Visit.
• History of electroconvulsive therapy.  TherapyAnother word for “treatment”.
• History of any brain surgery for PD.
• History of structural brain disease such as prior trauma causing damage detected on a CT scan or MRI, hydrocephalus, or prior brain neoplasms (abnormal growth of tissue).
• Known allergy to specified color additives or any of the ingredients in the study drug (active or placebo)  PlaceboAn inactive substance or procedure (often a pill, liquid, or powder) that has no biological effect. In clinical trials, experimental treatments are often compared with placebos to assess the treatment's effectiveness. In some studies, the participants will be assigned to a control group and will receive a placebo instead of an active drug or treatment. .

Enrollment

Expected Enrollment: 600 (US)
Date Enrollment Began: Oct 2008
Date Enrollment Ends: Sep 2011
Last Updated Date: Jan 07 2009
Trial Post Date: Sep 30 2008
Website: http://www.Parkinson-Study-Group.org

Primary Contacts and Locations

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