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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. in PSP: A Multicenter, Randomized, Placebo-Controlled, Double-Blind  Double-blindClinical study design in which neither investigators nor participants know who is receiving the investigational drug and who is receiving a placebo. Study
Sponsor: Lahey Clinic
Clinicaltrials.gov ID: NCT00382824
Study ID:

Summary

The clinical  ClinicalDealing with or based on observation and treatment of people, as opposed to basic science carried out in the laboratory or in animals. syndrome of PSP responds poorly to all available forms of therapy  TherapyAnother word for “treatment”. used in 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. (PD). Currently, no effective treatment exists. Coenzyme Q10 in high doses has been shown to be a beneficial therapy in PD and might possibly be a beneficial therapy for PSP. This study will compare the efficacy,  EfficacyThe extent to which a specific intervention, procedure, or regimen produces a beneficial result under ideal conditions. safety and tolerability of Coenzyme Q10 versus 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. in participants with atypical parkinsonian syndrome, progressive supranuclear palsy  Progressive Supranuclear Palsy, PSPA rare brain disorder diagnosed by the identification of early gait instability and difficulty moving the eyes. PSP is often misdiagnosed because some of its symptoms are very much like those of PD. Although PSP gets progressively worse and there is no effective treatment for it, the disease itself is not directly life-threatening. (PSP). As part of this study, you will review your current medications and recent health with a member of the Research team. Your physician will assess the severity of your disease and intellectual functioning by using several assessments and scales. You will be asked to complete several questionnaires about your daily activities and quality of life. You may have blood drawn for standard safety tests.

Study Phase

Phase 2
What is a study phase?

Symptoms Addressed: Study does not address symptoms

Study does not address symptoms

Time Commitment

• More than six months
• Every 3 months

Eligibility

• Minimum Age: 40
• Gender(s) Accepted: Either
• Maximum Years Since Diagnosis: 5

Inclusion Criteria

• Participants fulfilling the diagnostic criteria of PSP/diagnosed within the past 5 years
• Either vertical supranuclear palsy or both slowing of vertical saccades
• Prominent postural instability  Postural InstabilityImpaired balance and coordination often causing patients to lean forward or backward and to fall easily. with falls in the first year of disease onset
• No evidence of other diseases that could explain the foregoing features
• No current use of CoQ10

Exclusion Criteria

• Parkinsonism due to drugs
• History of pallidotomy, thalamotomy, active deep brain stimulator or fetal tissue transplant
• History of active epilepsy, stroke, structural brain disease
• Use of methylphenidate hydrochloride, cinnarizine, reserpine, amphetamines, or monoamine oxidase-A inhibitors within 3 months before the baseline  BaselinBeginning measurements against which a participant’s progress can be quantified at the end of a study. visit.
• Active cancer or cancer undergoing treatment
• Participation in other drug studies or the use of other investigational drugs within 30 days before screening
• Known hypersensitivity to Coenzyme Q10
• Pregnant, planning a pregnancy or nursing woman

Enrollment

Expected Enrollment: 60 (US)
Date Enrollment Began: Oct 01 2006
Last Updated Date: Aug 31 2007
Trial Post Date: Aug 31 2007
Website: http://www.clinicaltrials.gov/ct/action/GetStudy

Primary Contacts and Locations

Massachusetts

• Stephanie Scala, MA — Trial Coordinator
  Lahey Clinic
  Stephanie.A.Scala@Lahey.org
  Phone: (781) 744-2950
  31 Mall Rd.
  Burlington, MA 01805
  USA
  

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