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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00329056
Recruitment Status : Completed
First Posted : May 24, 2006
Last Update Posted : July 21, 2010
Information provided by:
Antipodean Pharmaceuticals, Inc.

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.

Condition or disease Intervention/treatment Phase
Parkinson's Disease Drug: MitoQ Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 128 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Double-Blind, Prospective, Randomized Comparison of 2 Doses of MitoQ and Placebo for the Treatment of Patients With Parkinson's Disease
Study Start Date : May 2006
Actual Study Completion Date : November 2007

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: 1
40 mg MitoQ OD
Drug: MitoQ
Two doses will be compared to placebo: 40 or 80 mg of MitoQ once daily for a period of 12 months.

Experimental: 2
80 mg MitoQ OD
Drug: MitoQ
Two doses will be compared to placebo: 40 or 80 mg of MitoQ once daily for a period of 12 months.

Placebo Comparator: 3
Drug: MitoQ
Two doses will be compared to placebo: 40 or 80 mg of MitoQ once daily for a period of 12 months.

Primary Outcome Measures :
  1. Unified Parkinson's Disease Rating Scale (UPDRS) score at the final study visit compared to baseline [ Time Frame: 12 months ]

Secondary Outcome Measures :
  1. The following assessments performed at the final study visit compared to baseline [ Time Frame: 12 months ]
  2. UPDRS sub scores [ Time Frame: 12 months ]
  3. Mini Mental State Examination [ Time Frame: 12 months ]
  4. Schwab and England Scale [ Time Frame: 12 months ]
  5. Modified Hoehn and Yahr Scale [ Time Frame: 12 months ]
  6. Timed tapping score [ Time Frame: 12 months ]
  7. The following safety outcomes will be measured over the course of the trial [ Time Frame: 12 months ]
  8. Adverse events [ Time Frame: 12 months ]
  9. ECG changes [ Time Frame: 12 months ]
  10. Laboratory sample results [ Time Frame: 12 months ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   30 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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)

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00329056

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Australia, New South Wales
Westmead Hospital
Sydney, New South Wales, Australia
Australia, Queensland
The Royal Brisbane and Women's Hospital
Brisbane, Queensland, Australia
Australia, Victoria
Austin Hospital
Melbourne, Victoria, Australia
New Zealand
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
Sponsors and Collaborators
Antipodean Pharmaceuticals, Inc.
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Principal Investigator: Barry J Snow, MD Auckland District Health Board, New Zealand
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Responsible Party: Dr Ken Taylor, CEO, Antipodean Pharmaceuticals Identifier: NCT00329056    
Other Study ID Numbers: MTQ-PD-001
First Posted: May 24, 2006    Key Record Dates
Last Update Posted: July 21, 2010
Last Verified: July 2010
Keywords provided by Antipodean Pharmaceuticals, Inc.:
Parkinson's disease
Additional relevant MeSH terms:
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Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases