A Trial of MitoQ for the Treatment of People with Parkinson's Disease

A Double-Blind, Prospective, Randomized Comparison of 2 Doses of MitoQ and Placebo for the Treatment of Patients with Parkinson’s Disease

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12606000218594

Acronym

Protect

Enrollment

120

Registered

2006-05-31

Start date

2006-05-19

Completion date

Unknown

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

Eligible participants will be randomised to study medication and treated for 12 months. The researcher will randomise the patient using a centralised phone system. The researcher, participant and sponsor will be blinded to the study treatment. Safety & efficacy reviews occur at the 1, 2, 3, 6, 9 & 12 month timepoints with a 28 day post-study follow-up visit for safety. Withdrawal criteria include unacceptable AEs, participant choice, investigator decision, non-compliance with study drug & requirement for anti-PD medication including dopaminergic drugs.

Interventions

40 mg mitoquinone, 80 mg mitoquinone administered orally one daily for 12 months

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Treatment

Masking

Blinded (masking used)

Eligibility

Sex/Gender

All

Age

30 Years to No maximum

Healthy volunteers

Inclusion criteria

1. Informed consent. 2. Diagnosis of PD (2 or more of bradykinesia; rest tremor, rigidity). 3. Adequate contraceptive measures (females).

Exclusion criteria

1. Malignancy within last 2 years2. Pregnancy & breast-feeding3. Treatment with any anti-PD drugs within 30 days of enrolment4. Prior treatment with anti-PD medication exceeding 42 days in total5. Medication-induced PD/PD not of idiopathic origin6. CoQ10/idebenone doses of 300mg/day or higher within 120 days, >25mg/day within 7 days of enrolment7. Methylphenidate HCl, neuroleptics, reserpine, amphetamines, selegeline or MAOIs within 6 months of enrolment8. CNS medications at unstable doses within 60 days of enrolment9. Dietary supplements > 5 x RDI10. Hypersensitivity to CoQ10, idebenone or any components of the study drug 11. Unable to swallow12. Diseases with features of PD 13. Seizure(s) within 12 months prior to enrolment14. UPDRS tremor score of 415. Hamilton Depression Rating Scale score > 1016. History of stroke17. Requirement for dopaminergic drugs18. Modified Hoehn & Yahr score > 2.519. History of brain surgery for Parkinson’s disease20. History of structural brain disease / congenital brain abnormality21. History of ECT22. Any other clinically significant medical or psychiatric condition or lab abnormality23. Enrolment in any other pharmacological study within 30 days of enrolment.

Outcome results