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

Primary Purpose

Parkinson's Disease

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
MitoQ
Sponsored by
Antipodean Pharmaceuticals, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Parkinson's Disease focused on measuring Parkinson's disease, MitoQ, UPDRS

Eligibility Criteria

30 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Westmead Hospital
  • The Royal Brisbane and Women's Hospital
  • Austin Hospital
  • Dunedin Hospital
  • Auckland City Hospital
  • Van der Veer Institute for Parkinson's and Brain Research
  • Waikato Hospital
  • Hawke's Bay Hospital
  • Nelson Hospital
  • Palmerston North Hospital
  • Tauranga Hospital
  • Wellington Hospital
  • Whangarei Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Placebo Comparator

Arm Label

1

2

3

Arm Description

40 mg MitoQ OD

80 mg MitoQ OD

Placebo

Outcomes

Primary Outcome Measures

Unified Parkinson's Disease Rating Scale (UPDRS) score at the final study visit compared to baseline

Secondary Outcome Measures

The following assessments performed at the final study visit compared to baseline
UPDRS sub scores
Mini Mental State Examination
Schwab and England Scale
Modified Hoehn and Yahr Scale
Timed tapping score
The following safety outcomes will be measured over the course of the trial
Adverse events
ECG changes
Laboratory sample results

Full Information

First Posted
May 22, 2006
Last Updated
July 19, 2010
Sponsor
Antipodean Pharmaceuticals, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT00329056
Brief Title
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

2. Study Status

Record Verification Date
July 2010
Overall Recruitment Status
Completed
Study Start Date
May 2006 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
November 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Antipodean Pharmaceuticals, Inc.

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson's Disease
Keywords
Parkinson's disease, MitoQ, UPDRS

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
128 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
40 mg MitoQ OD
Arm Title
2
Arm Type
Experimental
Arm Description
80 mg MitoQ OD
Arm Title
3
Arm Type
Placebo Comparator
Arm Description
Placebo
Intervention Type
Drug
Intervention Name(s)
MitoQ
Intervention Description
Two doses will be compared to placebo: 40 or 80 mg of MitoQ once daily for a period of 12 months.
Primary Outcome Measure Information:
Title
Unified Parkinson's Disease Rating Scale (UPDRS) score at the final study visit compared to baseline
Time Frame
12 months
Secondary Outcome Measure Information:
Title
The following assessments performed at the final study visit compared to baseline
Time Frame
12 months
Title
UPDRS sub scores
Time Frame
12 months
Title
Mini Mental State Examination
Time Frame
12 months
Title
Schwab and England Scale
Time Frame
12 months
Title
Modified Hoehn and Yahr Scale
Time Frame
12 months
Title
Timed tapping score
Time Frame
12 months
Title
The following safety outcomes will be measured over the course of the trial
Time Frame
12 months
Title
Adverse events
Time Frame
12 months
Title
ECG changes
Time Frame
12 months
Title
Laboratory sample results
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Barry J Snow, MD
Organizational Affiliation
Auckland District Health Board, New Zealand
Official's Role
Principal Investigator
Facility Information:
Facility Name
Westmead Hospital
City
Sydney
State/Province
New South Wales
Country
Australia
Facility Name
The Royal Brisbane and Women's Hospital
City
Brisbane
State/Province
Queensland
Country
Australia
Facility Name
Austin Hospital
City
Melbourne
State/Province
Victoria
Country
Australia
Facility Name
Dunedin Hospital
City
Dunedin
State/Province
Otago
Country
New Zealand
Facility Name
Auckland City Hospital
City
Auckland
Country
New Zealand
Facility Name
Van der Veer Institute for Parkinson's and Brain Research
City
Christchurch
Country
New Zealand
Facility Name
Waikato Hospital
City
Hamilton
Country
New Zealand
Facility Name
Hawke's Bay Hospital
City
Hastings
Country
New Zealand
Facility Name
Nelson Hospital
City
Nelson
Country
New Zealand
Facility Name
Palmerston North Hospital
City
Palmerston North
Country
New Zealand
Facility Name
Tauranga Hospital
City
Tauranga
Country
New Zealand
Facility Name
Wellington Hospital
City
Wellington
Country
New Zealand
Facility Name
Whangarei Hospital
City
Whangarei
Country
New Zealand

12. IPD Sharing Statement

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

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