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Trial registered on ANZCTR


Registration number
ACTRN12606000218594
Ethics application status
Approved
Date submitted
19/05/2006
Date registered
31/05/2006
Date last updated
20/08/2007
Type of registration
Retrospectively registered

Titles & IDs
Public title
A Trial of MitoQ for the Treatment of People with Parkinson's Disease
Scientific title
A Double-Blind, Prospective, Randomized Comparison of 2 Doses of MitoQ and Placebo for the Treatment of Patients with Parkinson’s Disease
Universal Trial Number (UTN)
Trial acronym
Protect
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Parkinson's disease 1196 0
Condition category
Condition code
Neurological 1281 1281 0 0
Dementias

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
40 mg mitoquinone, 80 mg mitoquinone administered orally one daily for 12 months
Intervention code [1] 1052 0
Treatment: Drugs
Comparator / control treatment
Placebo administered orally one daily for 12 months
Control group
Placebo

Outcomes
Primary outcome [1] 1731 0
Change in total UPDRS (Unified Parkinson's Disease Rating Scale) score at end of treatment period compared with baseline
Timepoint [1] 1731 0
12 months
Secondary outcome [1] 3087 0
UPDRS sub-scores (mental, motor and Activities of Daily Living)
Timepoint [1] 3087 0
Comparison of baseline and final visit assessments
Secondary outcome [2] 3088 0
Modified Hoehn and Yahr Scale score
Timepoint [2] 3088 0
Comparison of baseline and final visit assessments
Secondary outcome [3] 3089 0
Schwab and England Scale score (observer and subject)
Timepoint [3] 3089 0
Comparison of baseline and final visit assessments
Secondary outcome [4] 3090 0
Mini-Mental State Examination score
Timepoint [4] 3090 0
Comparison of baseline and final visit assessments
Secondary outcome [5] 3091 0
Timed tapping score
Timepoint [5] 3091 0
Comparison of baseline and final visit assessments
Secondary outcome [6] 3092 0
Time to disability sufficient to require treatment with antiparkinsonion medication
Timepoint [6] 3092 0
Comparison of baseline and final visit assessments
Secondary outcome [7] 3093 0
Plasma concentrations of mitoquinone
Timepoint [7] 3093 0
Comparison of baseline and final visit assessments

Eligibility
Key inclusion criteria
1. Informed consent. 2. Diagnosis of PD (2 or more of bradykinesia; rest tremor, rigidity). 3. Adequate contraceptive measures (females).
Minimum age
30 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
No
Key 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
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
central randomisation by phone/fax
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Permuted block randomisation
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
19/05/2006
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
120
Accrual to date
Final
Recruitment outside Australia
Country [1] 319 0
New Zealand
State/province [1] 319 0

Funding & Sponsors
Funding source category [1] 1403 0
Commercial sector/Industry
Name [1] 1403 0
Antipodean Pharmaceuticals, Inc.
Country [1] 1403 0
United States of America
Primary sponsor type
Commercial sector/Industry
Name
Antipodean Pharmaceuticals, Inc
Address
1700 Montgomery Street, Suite 209
San Francisco CA 94111, USA
Country
United States of America
Secondary sponsor category [1] 1233 0
None
Name [1] 1233 0
None
Address [1] 1233 0
Country [1] 1233 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 2755 0
Multiregion Ethics Committee
Ethics committee address [1] 2755 0
Ministry of Health
1 - 3 The Terrace
PO Box 5013
Wellington
Ethics committee country [1] 2755 0
New Zealand
Date submitted for ethics approval [1] 2755 0
Approval date [1] 2755 0
10/05/2006
Ethics approval number [1] 2755 0
MEC/06/03/033
Ethics committee name [2] 2756 0
Sydney West Area Health Service (Westmead Campus) Human Research Ethics Committee
Ethics committee address [2] 2756 0
Research Office, Clinical Sciences
Westmead Hospital Campus
Westmead NSW 2145
Ethics committee country [2] 2756 0
Australia
Date submitted for ethics approval [2] 2756 0
Approval date [2] 2756 0
28/06/2006
Ethics approval number [2] 2756 0
HS/pmeHREC2006/5/4 20(2325)
Ethics committee name [3] 2757 0
Royal Brisbane & Women?s Hospital & Health Service Human Research Ethics Committee
Ethics committee address [3] 2757 0
Royal Brisbane and Women's Hospital Butterfield Street
Herston QLD 4029
Ethics committee country [3] 2757 0
Date submitted for ethics approval [3] 2757 0
Approval date [3] 2757 0
19/06/2006
Ethics approval number [3] 2757 0
2006/068
Ethics committee name [4] 2758 0
Austin Health Human Research Ethics Committee
Ethics committee address [4] 2758 0
Harold Stokes Building,
Austin Health
145 Studely Road
HEIDELBERG VIC 3084
Ethics committee country [4] 2758 0
Australia
Date submitted for ethics approval [4] 2758 0
Approval date [4] 2758 0
Ethics approval number [4] 2758 0
14/07/2006
Ethics committee name [5] 2763 0
Ethics committee address [5] 2763 0
Ethics committee country [5] 2763 0
Date submitted for ethics approval [5] 2763 0
Approval date [5] 2763 0
Ethics approval number [5] 2763 0
MTQ-PD-001,

Summary
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.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 36027 0
Address 36027 0
Country 36027 0
Phone 36027 0
Fax 36027 0
Email 36027 0
Contact person for public queries
Name 10241 0
Fiona Rolfe
Address 10241 0
Antipodean Pharmaceuticals (NZ) Ltd, PO Box 106734, Auckland 1143, New Zealand
Country 10241 0
New Zealand
Phone 10241 0
+64 9 379 8245
Fax 10241 0
+64 9 379 8244
Email 10241 0
[email protected]
Contact person for scientific queries
Name 1169 0
Dr Barry Snow
Address 1169 0
Department of Neurology
Auckland City Hospital
Private Bag 92 189
Park Road
Grafton Auckland
Country 1169 0
New Zealand
Phone 1169 0
+64 9 3074949
Fax 1169 0
+64 9 3074924
Email 1169 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.