Status:
COMPLETED
A Trial of MitoQ for the Treatment of People With Parkinson's Disease
Lead Sponsor:
Antipodean Pharmaceuticals, Inc.
Conditions:
Parkinson's Disease
Eligibility:
All Genders
30+ years
Phase:
PHASE2
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 ...
Eligibility Criteria
Inclusion
- Informed consent
- 30 yrs or older
- Diagnosis of PD (2 or more of bradykinesia; rest tremor, rigidity)
- Adequate contraceptive measures (females)
Exclusion
- Malignancy within last 2 years
- Pregnancy \& breast-feeding
- Treatment with any anti-PD drugs within 30 days of enrolment
- Prior treatment with anti-PD medication exceeding 42 days in total
- Medication-induced PD/PD not of idiopathic origin
- CoQ10/idebenone doses of 300mg/day or higher within 120 days, \>25mg/day within 7 days of enrolment
- Methylphenidate HCl, neuroleptics, reserpine, amphetamines, selegeline or MAOIs within 6 months of enrolment
- CNS medications at unstable doses within 60 days of enrolment
- Dietary supplements \> 5 x RDI
- Hypersensitivity to CoQ10, idebenone or any components of the study drug
- Unable to swallow
- Diseases with features of PD
- Seizure(s) within 12 months prior to enrolment
- UPDRS tremor score of 4
- Hamilton Depression Rating Scale score \> 10
- History of stroke
- Requirement for dopaminergic drugs
- Modified Hoehn \& Yahr score \> 2.5
- History of brain surgery for Parkinson's disease
- History of structural brain disease / congenital brain abnormality
- History of ECT
- Any other clinically significant medical or psychiatric condition or lab abnormality
- Enrolment in any other pharmacological study within 30 days of enrolment
Key Trial Info
Start Date :
May 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2007
Estimated Enrollment :
128 Patients enrolled
Trial Details
Trial ID
NCT00329056
Start Date
May 1 2006
End Date
November 1 2007
Last Update
July 21 2010
Active Locations (13)
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1
Westmead Hospital
Sydney, New South Wales, Australia
2
The Royal Brisbane and Women's Hospital
Brisbane, Queensland, Australia
3
Austin Hospital
Melbourne, Victoria, Australia
4
Dunedin Hospital
Dunedin, Otago, New Zealand