A Trial of MitoQ for the Treatment of People With Parkinson's Disease
NCT ID: NCT00329056
Last Updated: 2010-07-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE2
128 participants
INTERVENTIONAL
2006-05-31
2007-11-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Study to Assess PDM608 in Healthy Adult Subjects
NCT05950906
A Safety and Tolerability Study of Intracerebroventricular Administration of sNN0031 to Patients With Parkinson's Disease
NCT00866502
PF-06669571 In Subjects With Idiopathic Parkinson's Disease
NCT02565628
Rotigotine Patch in Subjects With Advanced Stage, Idiopathic Parkinson's Disease Who Are Not Well Controlled on Levodopa
NCT00244387
A Study to Evaluate Safety and Efficacy of KM-819 in Healthy Adults and Participants with Parkinson's Disease
NCT05670782
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
SINGLE_GROUP
TREATMENT
DOUBLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
1
40 mg MitoQ OD
MitoQ
Two doses will be compared to placebo: 40 or 80 mg of MitoQ once daily for a period of 12 months.
2
80 mg MitoQ OD
MitoQ
Two doses will be compared to placebo: 40 or 80 mg of MitoQ once daily for a period of 12 months.
3
Placebo
MitoQ
Two doses will be compared to placebo: 40 or 80 mg of MitoQ once daily for a period of 12 months.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
MitoQ
Two doses will be compared to placebo: 40 or 80 mg of MitoQ once daily for a period of 12 months.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
2. 30 yrs or older
3. Diagnosis of PD (2 or more of bradykinesia; rest tremor, rigidity)
4. Adequate contraceptive measures (females)
Exclusion Criteria
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
30 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Antipodean Pharmaceuticals, Inc.
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Antipodean Pharmaceuticals
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Barry J Snow, MD
Role: PRINCIPAL_INVESTIGATOR
Auckland District Health Board, New Zealand
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Westmead Hospital
Sydney, New South Wales, Australia
The Royal Brisbane and Women's Hospital
Brisbane, Queensland, Australia
Austin Hospital
Melbourne, Victoria, Australia
Dunedin Hospital
Dunedin, Otago, New Zealand
Auckland City Hospital
Auckland, , New Zealand
Van der Veer Institute for Parkinson's and Brain Research
Christchurch, , New Zealand
Waikato Hospital
Hamilton, , New Zealand
Hawke's Bay Hospital
Hastings, , New Zealand
Nelson Hospital
Nelson, , New Zealand
Palmerston North Hospital
Palmerston North, , New Zealand
Tauranga Hospital
Tauranga, , New Zealand
Wellington Hospital
Wellington, , New Zealand
Whangarei Hospital
Whangarei, , New Zealand
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
MTQ-PD-001
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.