A Trial of MitoQ for the Treatment of People With Parkinson's Disease - Full Text View

Sponsored by:	Antipodean Pharmaceuticals, Inc.
Information provided by:	Antipodean Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier:	NCT00329056

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 II

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Single Group Assignment, Safety/Efficacy Study
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:

Genetics Home Reference related topics: familial paroxysmal nonkinesigenic dyskinesia Parkinson disease

MedlinePlus related topics: Parkinson's Disease

U.S. FDA Resources

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 ]

Secondary Outcome Measures:

The following assessments performed at the final study visit compared to baseline [ Time Frame: 12 months ]
UPDRS sub scores [ Time Frame: 12 months ]
Mini Mental State Examination [ Time Frame: 12 months ]
Schwab and England Scale [ Time Frame: 12 months ]
Modified Hoehn and Yahr Scale [ Time Frame: 12 months ]
Timed tapping score [ Time Frame: 12 months ]
The following safety outcomes will be measured over the course of the trial
Adverse events
ECG changes
Laboratory sample results

Enrollment:	128
Study Start Date:	May 2006
Study Completion Date:	November 2007

Arms	Assigned Interventions
1: Experimental 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.
2: Experimental 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.
3: Placebo Comparator 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:

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

Contacts and Locations

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
Whangarei Hospital
Whangarei, New Zealand
Tauranga Hospital
Tauranga, New Zealand
Auckland City Hospital
Auckland, New Zealand
Waikato Hospital
Hamilton, New Zealand
Hawke's Bay Hospital
Hastings, New Zealand
Palmerston North Hospital
Palmerston North, New Zealand
Wellington Hospital
Wellington, New Zealand
Nelson Hospital
Nelson, New Zealand
Van der Veer Institute for Parkinson's and Brain Research
Christchurch, New Zealand
New Zealand, Otago
Dunedin Hospital
Dunedin, Otago, 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

Study ID Numbers:	MTQ-PD-001
Study First Received:	May 22, 2006
Last Updated:	November 19, 2007
ClinicalTrials.gov Identifier:	NCT00329056 History of Changes
Health Authority:	New Zealand: Medsafe

Keywords provided by Antipodean Pharmaceuticals, Inc.:

Parkinson's disease
MitoQ
UPDRS

Study placed in the following topic categories:

Ganglion Cysts
Movement Disorders
Parkinson Disease
Basal Ganglia Diseases

Central Nervous System Diseases
Parkinsonian Disorders
Neurodegenerative Diseases
Brain Diseases

Additional relevant MeSH terms:

Movement Disorders
Parkinson Disease
Nervous System Diseases
Basal Ganglia Diseases

Central Nervous System Diseases
Parkinsonian Disorders
Neurodegenerative Diseases
Brain Diseases

ClinicalTrials.gov processed this record on September 11, 2009