Completed

Coenzyme Q10 Impact on Early Parkinson's Disease

0 criteria met from your profileSee at a glance how your profile meets each eligibility criteria.
What is being tested

Coenzyme Q10

Drug
Who is being recruted

Synucleinopathies+6

+ Basal Ganglia Diseases

+ Brain Diseases

Over 30 Years
+3 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 2
Interventional
Study Start: September 1998
See protocol details

Summary

Principal SponsorNational Institute of Neurological Disorders and Stroke (NINDS)
Last updated: June 24, 2005
Sourced from a government-validated database.Claim as a partner

Study start date: September 1, 1998

Actual date on which the first participant was enrolled.

Four groups of 20 subjects/group of subjects will be randomly assigned to receive CoQ10 (at doses of 300, 600 or 1200 mg/day) or matching placebo. A subject must have early PD that does not require treatment. A subject will be evaluated at a Screening Visit, a Baseline Visit (after which the subject begins to take the study drug) and visits at 1, 4, 8, 12, and 16 months after the baseline visit. The subject will be followed until she/he needs treatment with levodopa or for a maximum of 16 months. Because CoQ10 is a component of the mitochondria (the part of a cell that makes energy), blood samples will be taken at the baseline visit and the last visit to study mitochondrial function.

Principal SponsorNational Institute of Neurological Disorders and Stroke (NINDS)
Last updated: June 24, 2005
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.


Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 30 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

SynucleinopathiesBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesMovement DisordersNervous System DiseasesNeurodegenerative DiseasesParkinsonian DisordersParkinson Disease

Criteria

1 inclusion criteria required to participate
The subjects must have the three cardinal features of PD: slowness of movement, resting tremor and rigidity. The signs of PD must be greater on one side

2 exclusion criteria prevent from participating
Disorders that mimic PD

Other serious medical problems

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

University of Rochester

Rochester, United StatesOpen University of Rochester in Google Maps
CompletedOne Study Center