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

Parkinson's Disease Clinical Trial

Official title:

A Double-Blind, Prospective, Randomized Comparison of 2 Doses of MitoQ and Placebo for the Treatment of Patients With Parkinson's Disease

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00329056
• Other study ID #: MTQ-PD-001
• Status: Completed
• Phase: Phase 2
• First received: May 22, 2006
• Last updated: July 19, 2010
• Start date: May 2006
• Est. completion date: November 2007

Study information

• Verified date: July 2010
• Source: Antipodean Pharmaceuticals, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: New Zealand: Medsafe
• Study type: Interventional

Clinical 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). 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 128
• Est. completion date: November 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 30 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Parkinson Disease
• Parkinson's Disease

Intervention

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

Locations

Country	Name	City	State
Australia	The Royal Brisbane and Women's Hospital	Brisbane	Queensland
Australia	Austin Hospital	Melbourne	Victoria
Australia	Westmead Hospital	Sydney	New South Wales
New Zealand	Auckland City Hospital	Auckland
New Zealand	Van der Veer Institute for Parkinson's and Brain Research	Christchurch
New Zealand	Dunedin Hospital	Dunedin	Otago
New Zealand	Waikato Hospital	Hamilton
New Zealand	Hawke's Bay Hospital	Hastings
New Zealand	Nelson Hospital	Nelson
New Zealand	Palmerston North Hospital	Palmerston North
New Zealand	Tauranga Hospital	Tauranga
New Zealand	Wellington Hospital	Wellington
New Zealand	Whangarei Hospital	Whangarei

Sponsors (1)

Lead Sponsor	Collaborator
Antipodean Pharmaceuticals, Inc.

Countries where clinical trial is conducted

Australia,  New Zealand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Unified Parkinson's Disease Rating Scale (UPDRS) score at the final study visit compared to baseline		12 months	No
Secondary	The following assessments performed at the final study visit compared to baseline		12 months	No
Secondary	UPDRS sub scores		12 months	No
Secondary	Mini Mental State Examination		12 months	No
Secondary	Schwab and England Scale		12 months	No
Secondary	Modified Hoehn and Yahr Scale		12 months	No
Secondary	Timed tapping score		12 months	No
Secondary	The following safety outcomes will be measured over the course of the trial		12 months	Yes
Secondary	Adverse events		12 months	Yes
Secondary	ECG changes		12 months	Yes
Secondary	Laboratory sample results		12 months	Yes