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

This study has been completed.
Sponsor:
Information provided by:
Antipodean Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier:
NCT00329056
First received: May 22, 2006
Last updated: July 19, 2010
Last verified: July 2010
  Purpose

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 Intervention Phase
Parkinson's Disease
Drug: MitoQ
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, 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

Resource links provided by NLM:


Further study details as provided by Antipodean Pharmaceuticals, Inc.:

Primary Outcome Measures:
  • Unified Parkinson's Disease Rating Scale (UPDRS) score at the final study visit compared to baseline [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • The following assessments performed at the final study visit compared to baseline [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • UPDRS sub scores [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Mini Mental State Examination [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Schwab and England Scale [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Modified Hoehn and Yahr Scale [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Timed tapping score [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • The following safety outcomes will be measured over the course of the trial [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
  • Adverse events [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
  • ECG changes [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
  • Laboratory sample results [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]

Enrollment: 128
Study Start Date: May 2006
Study Completion Date: November 2007
Arms Assigned Interventions
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
Placebo
Drug: MitoQ
Two doses will be compared to placebo: 40 or 80 mg of MitoQ once daily for a period of 12 months.

  Eligibility

Ages Eligible for Study:   30 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00329056

Locations
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.
Investigators
Principal Investigator: Barry J Snow, MD Auckland District Health Board, New Zealand
  More Information

No publications provided

Responsible Party: Dr Ken Taylor, CEO, Antipodean Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00329056     History of Changes
Other Study ID Numbers: MTQ-PD-001
Study First Received: May 22, 2006
Last Updated: July 19, 2010
Health Authority: New Zealand: Medsafe

Keywords provided by Antipodean Pharmaceuticals, Inc.:
Parkinson's disease
MitoQ
UPDRS

Additional relevant MeSH terms:
Parkinson Disease
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Movement Disorders
Nervous System Diseases
Neurodegenerative Diseases
Parkinsonian Disorders

ClinicalTrials.gov processed this record on October 23, 2014