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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00329056




Registration number
NCT00329056
Ethics application status
Date submitted
22/05/2006
Date registered
24/05/2006
Date last updated
21/07/2010

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
Secondary ID [1] 0 0
MTQ-PD-001
Universal Trial Number (UTN)
Trial acronym
Linked study record

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

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - MitoQ

Experimental: 1 - 40 mg MitoQ OD

Experimental: 2 - 80 mg MitoQ OD

Placebo comparator: 3 - Placebo


Treatment: Drugs: MitoQ
Two doses will be compared to placebo: 40 or 80 mg of MitoQ once daily for a period of 12 months.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Unified Parkinson's Disease Rating Scale (UPDRS) score at the final study visit compared to baseline
Timepoint [1] 0 0
12 months
Secondary outcome [1] 0 0
The following assessments performed at the final study visit compared to baseline
Timepoint [1] 0 0
12 months
Secondary outcome [2] 0 0
UPDRS sub scores
Timepoint [2] 0 0
12 months
Secondary outcome [3] 0 0
Mini Mental State Examination
Timepoint [3] 0 0
12 months
Secondary outcome [4] 0 0
Schwab and England Scale
Timepoint [4] 0 0
12 months
Secondary outcome [5] 0 0
Modified Hoehn and Yahr Scale
Timepoint [5] 0 0
12 months
Secondary outcome [6] 0 0
Timed tapping score
Timepoint [6] 0 0
12 months
Secondary outcome [7] 0 0
The following safety outcomes will be measured over the course of the trial
Timepoint [7] 0 0
12 months
Secondary outcome [8] 0 0
Adverse events
Timepoint [8] 0 0
12 months
Secondary outcome [9] 0 0
ECG changes
Timepoint [9] 0 0
12 months
Secondary outcome [10] 0 0
Laboratory sample results
Timepoint [10] 0 0
12 months

Eligibility
Key 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)
Minimum age
30 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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

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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Single group
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/05/2006
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/11/2007
Sample size
Target
Accrual to date
Final
128
Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC
Recruitment hospital [1] 0 0
Westmead Hospital - Sydney
Recruitment hospital [2] 0 0
The Royal Brisbane and Women's Hospital - Brisbane
Recruitment hospital [3] 0 0
Austin Hospital - Melbourne
Recruitment postcode(s) [1] 0 0
- Sydney
Recruitment postcode(s) [2] 0 0
- Brisbane
Recruitment postcode(s) [3] 0 0
- Melbourne
Recruitment outside Australia
Country [1] 0 0
New Zealand
State/province [1] 0 0
Otago
Country [2] 0 0
New Zealand
State/province [2] 0 0
Auckland
Country [3] 0 0
New Zealand
State/province [3] 0 0
Christchurch
Country [4] 0 0
New Zealand
State/province [4] 0 0
Hamilton
Country [5] 0 0
New Zealand
State/province [5] 0 0
Hastings
Country [6] 0 0
New Zealand
State/province [6] 0 0
Nelson
Country [7] 0 0
New Zealand
State/province [7] 0 0
Palmerston North
Country [8] 0 0
New Zealand
State/province [8] 0 0
Tauranga
Country [9] 0 0
New Zealand
State/province [9] 0 0
Wellington
Country [10] 0 0
New Zealand
State/province [10] 0 0
Whangarei

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Antipodean Pharmaceuticals, Inc.
Address
Country

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/study/NCT00329056
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Barry J Snow, MD
Address 0 0
Auckland District Health Board, New Zealand
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT00329056