MitoQ Drug Trial Closer to Completion

The Phase 2 clinical trial of MitoQ, which is a drug that has been developed in New Zealand, is well underway. It is hoped that this drug may help to slow the progression of Parkinson’s disease

A total of 128 people with early Parkinson’s have been involved in the study.   10 hospitals in New Zealand and 3 on the east coast of Australia started recruiting patients in May last year and the required number of people were reached in October.  Some of the patients that were recruited early on in the study have now completed 9 months of treatment and will finish in another 3 months’ time.

In clinical trials, it is important to study people whose health and symptoms are similar to one another so that any change can be detected.  A total of 230 people with early Parkinson’s were invited to the participating hospitals to learn more about the trial and to have some preliminary tests.  Of these, 102 were not able to take part or chose not to take part in the study.  Common reasons for people not able to take part included:

Diagnosis of Parkinson’s not confirmed or Parkinson’s symptoms not prominent. Required other medications such as levodopa to treat their Parkinson’s.Had another medical condition that might have adversely affected the patient’s heath whilst in the study or had social circumstances that could have made participation difficult.

 The last patient is due to finish the study in November this year.  All the data that has been collected during the trial will then be studied and the results will be available in about one year’s time.  If the results of this trial are promising then further clinical trials will be conducted (Phase 3 trials) and typically involved thousands of people.   

By performing larger trials, we get a more detailed understanding of how the drug works and gain more information of the side effects that can be experienced.  If the results of these Phase 3 studies are positive then the data that has been gathered is submitted to government bodies around the world to obtain permission to market the drug. 

It’s important to remember that not all drugs that are tested make it to the market.  Although MitoQ has come a long way since it was first discovered at The University of Otago, it has to pass many more tests before it can become available for doctors to prescribe.  Nethertheless, this New Zealand-led project will contribute valuable knowledge to our understanding of this particular type of treatment,  

Whether or not the drug proves successful, it has already produced many benefits. These include supporting research at Otago University and 10 hospitals around New Zealand, In addition, the training in Parkinson’s research at each of these hospitals has raised awareness about Parkinson’s disease. It is hoped that at least some of these hospitals will be encouraged to appoint Parkinson’s specialty nurses as a result of their experience with the study. 

Background

What is the Protect study aiming to do?
The Protect study is testing a new drug called MitoQ which may help to prevent the nerve cell damage that leads to Parkinson's disease. This study is a Phase 2 trial, which will test how well MitoQ works and how safe it is. The drug has completed initial safety studies (Phase 1 trials) in people without Parkinson's disease.

If it works, what will MitoQ do?
It is anticipated that MitoQ will slow or arrest the progression of Parkinson's disease symptoms.

Who is running the trial?
Antipodean Pharmaceuticals is developing MitoQ. Founded and based in New Zealand, Antipodean has offices in Auckland and San Francisco.

The principal investigator for this study is Dr Barry Snow, Clinical Director of Auckland Hospital's Neurology Department. Consultant neurologists in nine other hospitals in New Zealand's main centres are also involved in the trial and will be available to assess and advise potential participants.

The trial is supported by Parkinson's New Zealand, with our field officers also being available to advise potential participants.

Further information on Antipodean and MitoQ is available at www.antipodeanpharma.com

What's special about MitoQ?
Where existing treatments only offer relief of symptoms, MitoQ aims to slow or halt Parkinson's disease at its cause by tackling cell damage caused when tiny organs within a cell called mitochondria cease to function normally.

Parkinson's is triggered when the nerve cells in the brain that produce dopamine begin to die. Recently, research has linked the death of these nerve cells to malfunction of their mitochondria, which act like batteries within the cell by converting oxygen and food into energy.

As a by-product of this process, mitochondria also produce harmful free-radicals that cause damage. Normally, these are mopped up by a naturally occurring chemical, called Coenzyme Q10. But if there is insufficient Coenzyme Q10 to mop up these harmful free radicals the result is that the mitochondria get damaged and the nerve cells die. As more nerve cells die, Parkinson's symptoms increase.

MitoQ directly affects the mitochondria in two steps: a targeting component directs the drug to the mitochondria; and an antioxidant component helps to prevent cell damage.

Who developed MitoQ?
MitoQ was discovered by University of Otago scientists, Dr Michael Murphy, who is now Head of the Mitochondrial Dysfunction Laboratory at the Dunn Institute of Human Nutrition, at Cambridge University, and Professor Robin Smith, Department of Chemistry, at the University of Otago.

If the trial is a success when should we expect to see a new drug?
Bringing a new drug to the market is a long and complex process. From this point it will take several more years if all the studies are successful.

Who is eligible for the trial?
The trial will involve participants who have early-onset symptoms of Parkinson's and have not received any treatment for symptom relief.

What are the risks?
Participants in this trial may experience side effects from taking MitoQ. Some people who have taken MitoQ before have experienced mild headaches. Full information on the risks involved in being a participant in the trial will be explained to potential participants by the specialists involved in the trial.

What are the benefits?
The drug may help to slow the progress of the disease which means that if you are allocated to receive MitoQ your symptoms at the end of the trial may not be as bad as they would have been if you had not taken MitoQ. You will not receive any of the potential benefits of MitoQ if you are allocated to the placebo group.
Regardless of which treatment you receive, you may benefit from the supervision you will receive during the trial as your health will be closely monitored.

If I participate what will it involve?
In this study, MitoQ is being compared with placebo. Two thirds of Protect trial participants will receive MitoQ and one third will receive placebo.

During the trial the participant's progression of Parkinson's disease will be evaluated with regular clinical examinations.

Participants should expect to attend a first full consultation with a specialist and study nurse, and thereafter to visit the specialist and study nurse for regular check-ups at monthly intervals for the first 3 months, then at three-monthly intervals.

The study is seeking to involve 120 people. Trial participants will be recruited over six months and each participant is in the trial for up to 12 months.

Where do I get more information?
Call or email Parkinson's New Zealand:
0800 4PD INFO (0800 473 4636)