Parkinson's Disease
Conditions
Keywords
Parkinson's disease, MitoQ, UPDRS
Brief summary
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.
Interventions
DRUGMitoQ
Two doses will be compared to placebo: 40 or 80 mg of MitoQ once daily for a period of 12 months.
Sponsors
Antipodean Pharmaceuticals, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
30 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Unified Parkinson's Disease Rating Scale (UPDRS) score at the final study visit compared to baseline | 12 months |
Secondary
| Measure | Time frame |
|---|---|
| UPDRS sub scores | 12 months |
| Mini Mental State Examination | 12 months |
| Schwab and England Scale | 12 months |
| Modified Hoehn and Yahr Scale | 12 months |
| The following assessments performed at the final study visit compared to baseline | 12 months |
| The following safety outcomes will be measured over the course of the trial | 12 months |
| Adverse events | 12 months |
| ECG changes | 12 months |
| Laboratory sample results | 12 months |
| Timed tapping score | 12 months |
Countries
Australia, New Zealand
Outcome results
None listed