NCT00329056

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 Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
128

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started May 2006

Shorter than P25 for phase_2

Geographic Reach
2 countries

13 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2006

Completed
21 days until next milestone

First Submitted

Initial submission to the registry

May 22, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 24, 2006

Completed
1.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2007

Completed
Last Updated

July 21, 2010

Status Verified

July 1, 2010

First QC Date

May 22, 2006

Last Update Submit

July 19, 2010

Conditions

Parkinson's Disease

Keywords

Parkinson's diseaseMitoQUPDRS

Outcome Measures

Primary Outcomes (1)

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

    12 months

Secondary Outcomes (10)

  • The following assessments performed at the final study visit compared to baseline

    12 months

  • UPDRS sub scores

    12 months

  • Mini Mental State Examination

    12 months

  • Schwab and England Scale

    12 months

  • Modified Hoehn and Yahr Scale

    12 months

  • +5 more secondary outcomes

Study Arms (3)

1

EXPERIMENTAL

40 mg MitoQ OD

Drug: MitoQ

2

EXPERIMENTAL

80 mg MitoQ OD

Drug: MitoQ

3

PLACEBO COMPARATOR

Placebo

Drug: MitoQ

Interventions

MitoQDRUG

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

123

Eligibility Criteria

Age30 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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
  • +8 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (13)

Westmead Hospital

Sydney, New South Wales, Australia

Location

The Royal Brisbane and Women's Hospital

Brisbane, Queensland, Australia

Location

Austin Hospital

Melbourne, Victoria, Australia

Location

Dunedin Hospital

Dunedin, Otago, New Zealand

Location

Auckland City Hospital

Auckland, New Zealand

Location

Van der Veer Institute for Parkinson's and Brain Research

Christchurch, New Zealand

Location

Waikato Hospital

Hamilton, New Zealand

Location

Hawke's Bay Hospital

Hastings, New Zealand

Location

Nelson Hospital

Nelson, New Zealand

Location

Palmerston North Hospital

Palmerston North, New Zealand

Location

Tauranga Hospital

Tauranga, New Zealand

Location

Wellington Hospital

Wellington, New Zealand

Location

Whangarei Hospital

Whangarei, New Zealand

Location

MeSH Terms

Conditions

Parkinson Disease

Interventions

mitoquinone

Condition Hierarchy (Ancestors)

Parkinsonian DisordersBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMovement DisordersSynucleinopathiesNeurodegenerative Diseases

Study Officials

  • Barry J Snow, MD

    Auckland District Health Board, New Zealand

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

May 22, 2006

First Posted

May 24, 2006

Study Start

May 1, 2006

Study Completion

November 1, 2007

Last Updated

July 21, 2010

Record last verified: 2010-07

Locations

AU(3)NZ(10)