Clinical trial NCT00329056: A Trial of MitoQ for the Treatment of People With Parkinson's Disease
Official title: A Double-Blind, Prospective, Randomized Comparison of 2 Doses of MitoQ and Placebo for the Treatment of Patients With Parkinson's Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Parkinson's Disease
Keywords: Parkinson's disease
MitoQ
UPDRS
Lead sponsor: Antipodean Pharmaceuticals, Inc.
Sponsor class: INDUSTRY
First posted: 2006-05-24
Enrollment: 128
Sex: ALL
Minimum age (years): 30
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: Unified Parkinson's Disease Rating Scale (UPDRS) score at the final study visit compared to baseline
timeFrame: 12 months
Secondary outcomes:
measure: The following assessments performed at the final study visit compared to baseline
timeFrame: 12 months
measure: UPDRS sub scores
timeFrame: 12 months
measure: Mini Mental State Examination
timeFrame: 12 months
measure: Schwab and England Scale
timeFrame: 12 months
measure: Modified Hoehn and Yahr Scale
timeFrame: 12 months
measure: Timed tapping score
timeFrame: 12 months
measure: The following safety outcomes will be measured over the course of the trial
timeFrame: 12 months
measure: Adverse events
timeFrame: 12 months
measure: ECG changes
timeFrame: 12 months
measure: Laboratory sample results
timeFrame: 12 months
Other outcomes:
Locations:
city: Sydney
country: Australia
facility: Westmead Hospital
state: New South Wales
city: Brisbane
country: Australia
facility: The Royal Brisbane and Women's Hospital
state: Queensland
city: Melbourne
country: Australia
facility: Austin Hospital
state: Victoria
city: Dunedin
country: New Zealand
facility: Dunedin Hospital
state: Otago
city: Auckland
country: New Zealand
facility: Auckland City Hospital
city: Christchurch
country: New Zealand
facility: Van der Veer Institute for Parkinson's and Brain Research
city: Hamilton
country: New Zealand
facility: Waikato Hospital
city: Hastings
country: New Zealand
facility: Hawke's Bay Hospital
city: Nelson
country: New Zealand
facility: Nelson Hospital
city: Palmerston North
country: New Zealand
facility: Palmerston North Hospital
city: Tauranga
country: New Zealand
facility: Tauranga Hospital
city: Wellington
country: New Zealand
facility: Wellington Hospital
city: Whangarei
country: New Zealand
facility: Whangarei Hospital
Study officials:
affiliation: Auckland District Health Board, New Zealand
name: Barry J Snow, MD
role: PRINCIPAL_INVESTIGATOR
References: