Parkinson's DiseasePhase 2NCT00329056
A Trial of MitoQ for the Treatment of People With Parkinson's Disease
A Phase 2 study testing MitoQ in people with Parkinson's Disease, run by Antipodean Pharmaceuticals, Inc. at 13 sites in 2 countries.
Trial 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). Read more about this study
- Who is it for?
- Ages 30 years and older
- Conditions the study is for
- Parkinson's Disease
- What is being tested?
- MitoQ
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 128 participants
- Where
- 13 sitesin 2 countries
- Study dates
- May 2006to Nov 2007
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Informed consent
- 30 yrs or older
- Diagnosis of PD (2 or more of bradykinesia; rest tremor, rigidity)
- Adequate contraceptive measures (females)
Who cannot join
- 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
Show all 23Show fewer
- 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
Trial locations and contacts
13 sites in 2 countries.
13 sites in 2 countries
New Zealand10 sites
Auckland City Hospital
Auckland
Van der Veer Institute for Parkinson's and Brain Research
Christchurch
Dunedin Hospital
Dunedin, Otago
Waikato Hospital
Hamilton
Hawke's Bay Hospital
Hastings
Nelson Hospital
Nelson
Palmerston North Hospital
Palmerston North
Tauranga Hospital
Tauranga
Wellington Hospital
Wellington
Whangarei Hospital
Whangarei
Australia3 sites
The Royal Brisbane and Women's Hospital
Brisbane, Queensland
Austin Hospital
Melbourne, Victoria
Westmead Hospital
Sydney, New South Wales
About this 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
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.
- Conditions
- Parkinson's Disease
- Being tested
- MitoQ
- Keywords
- Parkinson's disease, MitoQ, UPDRS
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MitoQDrug
Two doses will be compared to placebo: 40 or 80 mg of MitoQ once daily for a period of 12 months.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | 40 mg MitoQ OD Receives: Drug: MitoQ |
| 2 | Experimental | 80 mg MitoQ OD Receives: Drug: MitoQ |
| 3 | Placebo comparator | Placebo Receives: Drug: MitoQ |
What is being measured
The primary outcome is the main question the study is designed to answer.
Unified Parkinson's Disease Rating Scale (UPDRS) score at the final study visit compared to baseline
Measured: 12 months
Secondary outcomes (10)
The following assessments performed at the final study visit compared to baseline
Measured: 12 months
UPDRS sub scores
Measured: 12 months
Mini Mental State Examination
Measured: 12 months
Schwab and England Scale
Measured: 12 months
Modified Hoehn and Yahr Scale
Measured: 12 months
Timed tapping score
Measured: 12 months
The following safety outcomes will be measured over the course of the trial
Measured: 12 months
Adverse events
Measured: 12 months
ECG changes
Measured: 12 months
Laboratory sample results
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2006 (estimated)
- Study startMay 2006
- Study completionNov 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson's DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 128 participants (actual)
Sponsor and investigators
- Lead sponsor
- Antipodean Pharmaceuticals, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Barry J Snow, MD, Principal investigator, Auckland District Health Board, New Zealand
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00329056
- Sponsor's protocol ID
- MTQ-PD-001
- Status last verified
- Jul 2010
- First submitted
- 22 May 2006
- Last updated
- 21 Jul 2010
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-Blind, Prospective, Randomized Comparison of 2 Doses of MitoQ and Placebo for the Treatment of Patients With Parkinson's Disease
- ClinicalTrials.gov ID
- NCT00329056
- Acronym / sponsor ID
- MTQ-PD-001
- Conditions
- Parkinson's Disease
- Keywords
- Parkinson's disease, MitoQ, UPDRS
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 128 participants (actual)
- Lead sponsor
- Antipodean Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
- Study start
- May 2006
- Study completion
- Nov 2007 (actual)
- First posted
- 24 May 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: MitoQ40 mg MitoQ OD |
| 2 | Experimental | Drug: MitoQ80 mg MitoQ OD |
| 3 | Placebo comparator | Drug: MitoQPlacebo |
Who may qualify
- Ages
- 30 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Informed consent
- 30 yrs or older
- Diagnosis of PD (2 or more of bradykinesia; rest tremor, rigidity)
- Adequate contraceptive measures (females)
Key exclusion criteria (23 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MitoQTwo doses will be compared to placebo: 40 or 80 mg of MitoQ once daily for a period of 12 months. | Drug | 1, 2, 3 |
Primary outcome
Unified Parkinson's Disease Rating Scale (UPDRS) score at the final study visit compared to baseline
Time frame: 12 months
10 secondary outcomes
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
Time frame: 12 months
Adverse events
Time frame: 12 months
ECG changes
Time frame: 12 months
Laboratory sample results
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jul 2010.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Barry J Snow, MD principal investigator
Auckland District Health Board, New Zealand
13 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing MitoQ in people with Parkinson's Disease, run by Antipodean Pharmaceuticals, Inc. at 13 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Jul 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites in New Zealand, Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Unified Parkinson's Disease Rating Scale (UPDRS) score at the final study visit compared to baseline (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jul 2010.