A Trial of MitoQ for the Treatment of People With Parkinson's Disease
A Trial of MitoQ for the Treatment of People With Parkinson's Disease
In Parkinson's Disease, the mitochondrial membranes in cells that produce dopamine become
 damaged by oxidants, leading to the death of these cells and progressive tremor, slowness of
 movement and the loss of neurons in the substantia nigra (a part of the brain that is
 involved in movement). Mitoquinone is targeted to reach the membrane of mitochondria and
 provide protection from damaging oxidants. There are no treatments currently available to
 slow the progression of PD and this trial will help advance the development of this unique
 disease modifying drug.

 This trial will enroll 120 participants with untreated early onset of PD. Participants will
 be randomized to receive 1 of 3 treatments: 40 mg of MitoQ tablets, 80 mg of MitoQ tablets or
 placebo. The researchers, participants and sponsor will all be blinded to the treatment
 allocation. Participants will be assessed after 1, 2, 3, 6, 9, 12 months of treatment and
 again 28 days after their last dose. The effectiveness of the trial drug will be measured via
 the Unified Parkinson's Disease Rating Scale (UPDRS). The safety of the trial drug will be
 monitored via regular participant examinations, blood tests, ECG and collecting information
 on adverse events.
Inclusion Criteria:

 1. Informed consent

 2. 30 yrs or older

 3. Diagnosis of PD (2 or more of bradykinesia; rest tremor, rigidity)

 4. Adequate contraceptive measures (females)

 Exclusion Criteria:

 1. Malignancy within last 2 years

 2. Pregnancy & breast-feeding

 3. Treatment with any anti-PD drugs within 30 days of enrolment

 4. Prior treatment with anti-PD medication exceeding 42 days in total

 5. Medication-induced PD/PD not of idiopathic origin

 6. CoQ10/idebenone doses of 300mg/day or higher within 120 days, >25mg/day within 7 days
 of enrolment

 7. Methylphenidate HCl, neuroleptics, reserpine, amphetamines, selegeline or MAOIs within
 6 months of enrolment

 8. CNS medications at unstable doses within 60 days of enrolment

 9. Dietary supplements > 5 x RDI

 10. Hypersensitivity to CoQ10, idebenone or any components of the study drug

 11. Unable to swallow

 12. Diseases with features of PD

 13. Seizure(s) within 12 months prior to enrolment

 14. UPDRS tremor score of 4

 15. Hamilton Depression Rating Scale score > 10

 16. History of stroke

 17. Requirement for dopaminergic drugs

 18. Modified Hoehn & Yahr score > 2.5

 19. History of brain surgery for Parkinson's disease

 20. History of structural brain disease / congenital brain abnormality

 21. History of ECT

 22. Any other clinically significant medical or psychiatric condition or lab abnormality

 23. Enrolment in any other pharmacological study within 30 days of enrolment