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NCT Number: NCT00329056

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

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.

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Key information

Conditions

Parkinson's Disease Basal Ganglia Diseases Brain Diseases Central Nervous System Diseases Movement Disorders Nervous System Diseases Neurodegenerative Diseases Parkinson Disease Parkinsonian Disorders Synucleinopathies

Age range

30 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Westmead Hospital, Sydney, New South Wales, Australia

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Informed consent
  • 30 yrs or older
  • Diagnosis of PD (2 or more of bradykinesia; rest tremor, rigidity)
  • Adequate contraceptive measures (females)

Exclusion criteria

  • Malignancy within last 2 years
  • Pregnancy & breast-feeding
  • Treatment with any anti-PD drugs within 30 days of enrolment
  • Prior treatment with anti-PD medication exceeding 42 days in total
  • Medication-induced PD/PD not of idiopathic origin
  • CoQ10/idebenone doses of 300mg/day or higher within 120 days, >25mg/day within 7 days of enrolment
  • Methylphenidate HCl, neuroleptics, reserpine, amphetamines, selegeline or MAOIs within 6 months of enrolment
  • CNS medications at unstable doses within 60 days of enrolment
  • Dietary supplements > 5 x RDI
  • Hypersensitivity to CoQ10, idebenone or any components of the study drug
  • Unable to swallow
  • Diseases with features of PD
  • Seizure(s) within 12 months prior to enrolment
  • UPDRS tremor score of 4
  • Hamilton Depression Rating Scale score > 10
  • History of stroke
  • Requirement for dopaminergic drugs
  • Modified Hoehn & Yahr score > 2.5
  • History of brain surgery for Parkinson's disease
  • History of structural brain disease / congenital brain abnormality
  • History of ECT
  • Any other clinically significant medical or psychiatric condition or lab abnormality
  • Enrolment in any other pharmacological study within 30 days of enrolment

Treatment and study plan

MitoQ

Drug

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

Primary outcomes

  1. Unified Parkinson's Disease Rating Scale (UPDRS) score at the final study visit compared to baseline

    Time frame: 12 months

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Antipodean Pharmaceuticals, Inc.

Industry

Registry information

Official study title

A Double-Blind, Prospective, Randomized Comparison of 2 Doses of MitoQ and Placebo for the Treatment of Patients With Parkinson's Disease

Important dates

Study start
2006
Study completion
2007
First posted
May 24, 2006
Registry last updated
Jul 21, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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