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

Phase 2

Completed

• Conditions: Parkinson's Disease
• Interventions: Drug: MitoQ

• Registration Number: NCT00329056
• Lead Sponsor: Antipodean Pharmaceuticals, Inc.

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2006-05
• Study First Submitted: 2006-05-22
• Study First Submitted QC: 2006-05-22
• Study First Posted: 2006-05-24
• Study Completion: 2007-11
• Status Verified: 2010-07
• Last Update Submitted: 2010-07-19
• Last Update Posted: 2010-07-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 128

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
1	MitoQ	40 mg MitoQ OD
2	MitoQ	80 mg MitoQ OD
3	MitoQ	Placebo

Primary Outcome Measures

Name	Time	Method
Unified Parkinson's Disease Rating Scale (UPDRS) score at the final study visit compared to baseline	12 months

Secondary Outcome Measures

Name	Time	Method
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
Timed tapping score	12 months
The following safety outcomes will be measured over the course of the trial	12 months
Adverse events	12 months
ECG changes	12 months
Laboratory sample results	12 months

Trial Locations

Locations (13)

Austin Hospital; 🇦🇺 Melbourne, Victoria, Australia

Westmead Hospital; 🇦🇺 Sydney, New South Wales, Australia

The Royal Brisbane and Women's Hospital; 🇦🇺 Brisbane, Queensland, Australia

Auckland City Hospital; 🇳🇿 Auckland, New Zealand

Waikato Hospital; 🇳🇿 Hamilton, New Zealand

Van der Veer Institute for Parkinson's and Brain Research; 🇳🇿 Christchurch, New Zealand

Tauranga Hospital; 🇳🇿 Tauranga, New Zealand

Dunedin Hospital; 🇳🇿 Dunedin, Otago, 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

Whangarei Hospital; 🇳🇿 Whangarei, New Zealand