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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
128
Two doses will be compared to placebo: 40 or 80 mg of MitoQ once daily for a period of 12 months.
Westmead Hospital
Sydney, New South Wales, Australia
The Royal Brisbane and Women's Hospital
Brisbane, Queensland, Australia
Austin Hospital
Melbourne, Victoria, Australia
Dunedin Hospital
Dunedin, Otago, New Zealand
Auckland City Hospital
Auckland, New Zealand
Van der Veer Institute for Parkinson's and Brain Research
Christchurch, New Zealand
Waikato Hospital
Hamilton, New Zealand
Hawke's Bay Hospital
Hastings, New Zealand
Nelson Hospital
Nelson, New Zealand
Palmerston North Hospital
Palmerston North, New Zealand
...and 3 more locations
Unified Parkinson's Disease Rating Scale (UPDRS) score at the final study visit compared to baseline
Time frame: 12 months
The following assessments performed at the final study visit compared to baseline
Time frame: 12 months
UPDRS sub scores
Time frame: 12 months
Mini Mental State Examination
Time frame: 12 months
Schwab and England Scale
Time frame: 12 months
Modified Hoehn and Yahr Scale
Time frame: 12 months
Timed tapping score
Time frame: 12 months
The following safety outcomes will be measured over the course of the trial
Time frame: 12 months
Adverse events
Time frame: 12 months
ECG changes
Time frame: 12 months
Laboratory sample results
Time frame: 12 months
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