Trial | NCT00329056  Report issue

Title

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

  • Phase

    Phase 2

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    128
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 Started
May 31
2006
Study Completion
Nov 30
2007
Last Update
Jul 21
2010
Estimate

Drug MitoQ

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

1 Experimental

40 mg MitoQ OD

2 Experimental

80 mg MitoQ OD

3 Placebo Comparator

Placebo

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
No Results Posted