MedPath

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

Phase 2
Active, not recruiting
Conditions
Parkinson's disease
Neurological - Dementias
Registration Number
ACTRN12606000218594
Lead Sponsor
Antipodean Pharmaceuticals, Inc
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Active, not recruiting
Sex
Female
Target Recruitment
120
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.

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Secondary Outcome Measures
NameTimeMethod
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