Parkinson's Disease Clinical Trial Finder Customized for You

You can now register for the Fox Trial Finder for PD Clinical Trials
Follow the link at the bottom of this post

As you have probably surmised, we are believers in clinical trials. For some they are a way to contribute to the body of knowledge, for others they are a way to gain early access to potential treatments which might work for them. Early access generally means that the treatment will be available at no cost until it is marketed.

The Michael J Fox Foundation has created a new way to find a Parkinson's disease clinical trial suited for your personal needs in a location close to your residence. You have the option to select the distance from your home and to change it later if you cannot find trials within the initial range.

Although the Fox Trial Finder won't be up and running for a couple of weeks, it is not too soon to register to receive notification. We've already registered; you can too.

Entering your information into the Trial Finder itself can take a few minutes. You complete by checking the boxes on the form, save the info and move on to the questions on the next page. By doing this you can make sure that you are not wasting your time later or getting your hopes up for a trial which is too far away or for which you cannot participate. You can always reset the distance from your home or make other adjustments in the search parameters as there are changes in your life or lifestyle.

For those of us who have used Clinical Trials.gov, the initial input - the search parameters - are brief but you still have to do considerable reading to find a trial that is specific to your needs. Although you will still have to review the exclusionary info, you will have a personally directed search.

We've been fortunate enough to be able to preview the Fox Trial Finder and think it will benefit those in search of trials because of their specific PD issues. We'll post a direct link in July when it is up and running.
July 14, 2011
Check out the new Fox Trial Finder: Click here for a direct link to the Fox Trial Finder
According to MJFF: With Fox Trial Finder, you can create a profile including basic information about yourself (such as location and experience with PD) to identify your potential clinical trial matches. Registered users have the ability to review trial matches, bookmark interest in trials, and send messages directly – and anonymously – to trial coordinators registered on Fox Trial Finder.

Don't forget to adjust the mileage bar in the left column to the farthest distance you are willing to travel for a trial - if you don't, you'll receive results from the next state or more.
You can also see the subjects of the trials in the left margin and can simply select a topic.

Parkinson's Disease News Updates: August 2010

For PD not all of the news is good but there is plenty of reason to hope

Beginning with the fun stuff. How good is it to hear that Michael J Fox will be appearing again on the small screen, accessible to us all. Sometime in or after September 2010 an episode of The Good Wife will air on CBS with Mr Fox as a guest star in the role of an attorney. You may not like the character he plays but we're looking forward to a performance to rival his outstanding work in Dennis Leary’s Rescue Me on FX.

About Cogane - not yet. The paper work for the Phase II Clinical Trials are being by prepared for submission to the FDA by Phytopharm. Phytopharm is a company which develops products from medicinal plants.  Clinical Trial NCT01060878 is not yet recruiting in New York.

How is the pipeline doing?

There is no point in speculating on timeline to market because we’ve seen such nasty dates as 2013. Phytopharm is looking at two medications for Amyotrophic lateral sclerosis (ALS). One is Cogane and the other is a similar drug, Myogane, which already was awarded Orphan Medicinal Product designation by the European Agency for the Evaluation of Medicinal Products (EMEA) in 2008 following its orphan drug status by the FDA.

The financials for UCB look good this year with 63,500 patients in Europe alone using the Neupro Rotigotine transdermal patch.  In the North America, Canadians and Mexicans can fill their Neupro prescriptions. This is not the case for those in the USA.

Mongo hates shortages

The Federal Food and Drug Administration (FDA) has an interesting web site where you can check current drug shortages. The site lists the drug name and the manufacturer as well as the reason provided for the shortage. The last UCB Neupro update was on 5/05/2010. The information provided: FDA has requested that UCB reformulate Neupro (rotigotine transdermal system) patches. UCB is committed to bringing Neupro to U.S. patients and has already made significant progress in the development of the new formulation.

Unfortunately there has been no actual update for PD patients since we last reported about the Neupro patch status. At the end of July, UCB announced the study results which demonstrated that Neupro had proved effective for people with moderate to severe Restless Leg Syndrome (RLS), 80% of whom often suffer from Periodic Limb Movement Disorder. The question remains, how will people with RLS and PLMD obtain the patch if they live in the US?  See: our January 31, 2011 article for helpful links to the Neupro study for which you might just be eligible.

There does appear to be a Neupro Rotigotine Transdermal Patch clinical trial now recruiting. The NIH number is NCT00522379.

In our search for the latest information about UCB and Neupro, we came across a document which is worth a read in the light of public animosity towards big pharma. It is a UCB corporate 2009 publication: Patients, People, Planet, Ethics.

Addendum April 2012: The FDA finally approved the Neupro patch and UCB anticipates a return to the US market in July, 2012

Road Closed again?

Stem Cell research has been dealt a blow by a splinter group and a Federal judge. The Obama Executive Order funding stem cell research has been hit with an injunction. You can read more of the recent story in this blog article by PZ Myers which references the New Yorker article which many have read. The basis for the injunction is the destruction of the embryo for research and means that the federal guidelines would need to be rewritten for those researchers receiving federal funding. Private research is not affected. Federal monies can be used if another lab supplies the stem cells.  The basis for the injuction is the Dickey-Wicker amendment.

One of the best articles for explaining the injunction which grew from Sherley v. Sebelius can be found in the Jolt Digest of the Harvard Journal of Law and Technology. 

For those following stem cell research news, you can read more at the Coalition for the Advancement of Medical Research (CAMR)

We found this Op Ed piece from the New York Times very interesting.
For more food for discussion and debate, take a look at Don C Reed's article "Overturn Dickey-Wicker Abomination, or Forget Stem Cell Cures" for a Generation at The Huffington Post.

For those PwPs concerned about a shortage of Sinemet (levodopa-carbidopa) we refer you to a public letter written to Amy Comstock Rick CEO of the Parkinson’s Action Network (PAN) by Michael Rosenblatt, M.D. Executive Vice President and Chief Medical Officer of Merck and Co, Inc. In the letter Dr Rosenblatt explains that the shortage arose as a result of changing the supplier of the active ingredient. The shortage was not due to a product defect. Generic substitutes which may not contain the exact proportion of the components but which are also safe and effective are also available.

September 2, 2010 addendum
You can read the 8/31/10 Motion to Stay filed by the Secretary of the Dept of Health and Human Services.
You can add your voice for support through Parkinson's Action Network and letters to your elected officials in Washington, DC.  Just click on Take Action

September 9, 2010 addendum
Per an item from PAN:  "...within the last hour the DC Court of Appeals issued a stay of the preliminary injunction halting federal funding for human embryonic stem cell research. It would appear that the stay is only in place while the full arguments about the request for a stay of the preliminary injunction are heard in the Court of Appeals, but the important aspect is that, for at least the time period that it takes for this next phase of the case, the injunction is no longer in place against National Institutes of Health (NIH) and funding can continue."

You can read a few more details at the NPR website

At the PAN website you will also see a link to VA information: VA Publishes Final Regulation to Aid Vietnam Veterans Exposed to Agent Orange
On August 31, 2010, The Department of Veterans Affairs (VA)  published its final regulation establishing Parkinson’s disease, ischemic heart condition, and B-cell leukemias as service-connected disabilities for Vietnam veterans exposed to Agent Orange. The final regulation grants a 100% disability rating for Parkinson's disease, as well as retroactive veteran and survivor payments for qualifying veterans. There will still be a 60 day review period by Congress before payments go into effect.

The University of Maryland Medical Center recently published an article about the Parkinson’s disease diagnosis procedure. It is brief and worth a read for anyone with questions.

On the fun side, the American Parkinson Disease Association (APDA) recently published the Walk-A-Thon schedule for September and October 2010. Just scroll down the page to see 3 upcoming events.

Although the Parkinson’s Disease Foundation has not announced its next Expert Briefing or on-line educational events schedule, you can still access past seminars. The information remains both timely and helpful covering a broad range of information.

For many people with Parkinson’s, when the “off” times become too symptomatic, there is little choice but to add a COMT inhibitor to the levodopa-carbidopa mix. Stalevo is the medication of many who need to add entacapone to their l-dopa-carbidopa regimen in order to control the dyskinesia - dystonia which occurs. The FDA has now announced a safety review of a possible cardiac risk from use of Stalevo.

A bit off balance?

At Steve’s last neurology appointment he tried to discuss orthostatic hypotension (OH) with the doctor. The doctor was in agreement that the symptom could be PD related, medication related or a symptom exacerbated by medication(s). I think that he is waiting for us to propose something. We’ve mentioned Northera (TM) droxidopa before. I thought it was interesting to learn that Chelsea Therapeutics International, Ltd is now considering droxidopa for Chronic Fatigue Syndrome (CFS) as well as neurogenic orthostatic hypotension (NOH).

Droxidopa is a synthetic precursor to norepinephrine. Dopamine is also a precursor and it is thought that the serious symptoms of PD do not appear until norepinephrine neurons begin to decline in numbers. Currently in two phase III clinical trials for NOH in a number of conditions with primary autonomic failure as well as fibromyalgia and ADD for which it is in phase II trials.

If you are considering a Droxidopa Clinical Trial, there are several locations from which to choose.

Recently there was an announcement that a study by the NeuroGenetics Research Consortium has found a there is a link between immune system gene variants and Parkinson’s disease. This particular study led by Haydeh Payami has been active for at least 20 years. Based upon the study results closer scrutiny will be given to “the possible role of infection, inflammation and autoimmunity in Parkinson's disease.” Other Parkinson’s specialists have long proposed the possibility of PD as a disease on inflammation.

Then there is the news about the search and discovery of LRRK2 blockers for patients with mutations of that overactive protein which appears to cause neuron death and consequently PD. Two medications were found which appear to block LRRK2 and to prevent neurotransmitter death in lab rodents. Hence is a new target for treatment development.

On a personal note: Steve has been trying another herbal supplement. Huperzine A is a low level acetylcholinesterase inhibitor for improved cognitive function. It has been a few weeks and we have not seen any negative side effects although we have seen some positive effects, so we plan to order another bottle from Swanson.

We do realize that this is really an Alzheimer's disease (AD) supplement rather than a PD supplement so we are watching carefully and will probably stop for a few weeks to observe changes.

If you are interested in Clinical Trials with open recruiting for Parkinson's Disease, check the NIH listings.  You can select MAP in order to find trials in your area.

At this Clinical Trials.gov page you will see a wide variety of PD specific trials now recruiting in such area as Transdermal nicotine patches, Transcranial Magnetic Stimulation (TMS), Overactive bladder, Urate elevation, antidepressants, Rivastigamine Patch, Rasagiline (Azolect) as an add-on to dopamine agonists, effect of exercise, Safinamide, Non9nvasive Brain stimulation, Memantine for gait and attention deficits, Ropinerole (open label), facial expression, efficacy of voice treatment, CoQ10 (there is also one for Huntington'sdisease), SAM-e, biomarkers, Naltrexone for impulse control disorders, Isradipine (Dynacirc), green tea (polyphenols), Vitamin B12, Apathy, Swallowing Training. In all there are 274 open trials although not all are recruiting yet.

One last note: the PD-chocolate trial is only being conducted in Germany at Dresden University of Technology.  On a personal note, some of us are waiting for the caregiver trials involving fine chocolates.

Neupro Rotigotine Patch for Parkinson's Disease and TMS Clinical Trials for PD - Updates

Updates: Neupro Rotigotine Transdermal Patch
Clinical trials for Transcranial Magnetic Stimulation

We spoke to UCB yesterday about the FDA status of the Neupro(R) Rotigotine (reh tig' ih teen) Transdermal System in the US. UCB is firmly committed to seeing the patch returned to the US market and is actively negotiating with the FDA to determine the next steps.

For those who don't know, Neupro is a patch of the small molecule type (NCE) which delivers rotigotine, a non-ergoline dopamine agonist, on a once daily application. It was approved for treatment of early stage idiopathic Parkinson's disease. The unique aspect of Neupro is that it offers continuous delivery for 24 hours day and night.

Neupro developed a problem of crystallization on the patch which did not interfere with delivery but did require a change in the storage of the product and it was withdrawn from markets worldwide. Patients who had success with the product were distressed. Although Neupro was restored in several European countries, it remains off the US market until the FDA is satisfied.

According to my conversation with Medical Information at UCB, they are very interested in hearing the stories of patients who have used the Neupro Patch. Joanne C in Med Info has indicated that you can share your stories with the company by using the following:
email address at UCB
Please put "Share Neupro - Parkinson's disease stories/experiences with UCB" in the subject line.
The email body should begin: Attn: Joanne C, Medical Information.
Take advantage of this opportunity - they're listening.

If you prefer drop one in the mail box:
UCB, Inc
Medical Information
Attention: Joanne C
1950 Lake Park Drive
Smyrna, Georgia 30080

Here is a link to the original article: http://parkinsonsfocustoday.blogspot.com/2009/04/rotigotine-transdermal-patch-for.html

For those folks looking for information about clinical trials for Transcranial Magnetic Stimulation, here are some additional links to accompany the article posted on 4/07/09

http://clinicaltrials.gov/ct2/results?term=transcranial+magnetic+stimulation+Parkinson%27s+disease&recr=Open&show_flds=Y
http://clinicaltrials.gov/ct2/results?term=transcranial+magnetic+stimulation+Parkinson%27s+disease&show_flds=Y

Transcranial Magnetic Stimulation - a future treatment for Parkinson's Disease

Exciting the Neurons - a potential noninvasive treatment for PD

Will Transcranial Magnetic Stimulation (TMS) using pulsating low electrical currents be a future treatment of PD motor impairment symptoms? Will it hold the line or slightly reduce symptoms?

Essentially TMS causes a group of neurons in the brain to depolarize and discharge an action potential. We're already familiar with that from what we know about Spinal Cord Stimulation. "rTMS can increase or decrease the excitability of corticalspinal or corticocortical pathways depending on the intensity of stimulation, coil orientation and frequency of stimulation." There are two types of TMS: rTMS, repetitive transcranial stimulation and tDCS which is transcranial direct current stimulation.

TMS hardware varies but the basics are coils of varying shapes of plastic encasing wires with either a magnetically inert inner layer or a ferromagneticlly active solid core. The shape varience my result in changes in the focus, shape and depth of the magnetic field cortical penetration. There are several designs to move the electrical current across the scalp and skull. The most discomfort has been some pain from the scalp and related muscles or a loud audio click caused by the TMS pulse.

The patient sits in a chair similar to a dental chair but without anethesia while the coils are placed. In the case of the TMS device which received FDA approval for use in treating non-medication responsive depression, the coils are located to stimulate the area of the brain responsible for mood regulation. In treating depression the short MRI strength magnetic pulses continue for about 40 minutes. The patient returns over the next month and a half for at least 20 to 30 sessions. At the end of each session, the patient can return to routine activity.

It is felt that for Parkinson's disease motor function 15-20 sessions will have a positive effect for six to eight months. Aften that time fewer sessions will be needed to sustain the effects. The sessions are always carried out by a team which includes a Biological Psychologist and an rTMS Specialist.

The whys of how it can work for PD are still unclear but it does seem to have an effect on the presynaptic inhibition of the motor cortex. TMS appears to help balance neural network activity and to stimulate dopamine release.

There aren't many diseases where the patient would simply want to stop the progression or simply eliminate just a few symptoms but Parkinson's disease happens to be one of these diseases because until a cure is found, that is the option.

Transcranial Magnetic Stimulation is a noninvasive brain stimulation to treat Parkinson's disease symptoms and dystonia. There are several studies in underway.
What have the researchers been studying for the last few years?
Sleep disorders: which may be may be partially reversed without affecting mood or motor symptoms.
Dyskinesia: slight reduction of symptoms with no negative effects upon motor function using low frequency rTMS.
Motor function: significant improvement in UPDRS with stimulation of the motor cortex resulting in increased dopamine in the striatum which was maintained for three days following the rTMS.
Depression: improved scores were observed at three days and three weeks after treatment. An improvement was also seen in anxiety scores and movement.

Some stimulating reading:Beneficial effect of transcranial magnetic stimulation on sleep in Parkinson's disease 2/17/09
http://www.ncbi.nlm.nih.gov/pubmed/19224604
KD van Dijk, EI Most, EJ Van Someren, HW Berendse, YD van der Werk, Dept of Neurology Medical Center, Amsterdam, The Netherlands

Repetitive transcranial magnetic stimulation for levadopa induced dyskinesias in Parkinson's disease 1/30/09
http://www.ncbi.nlm.nih.gov/pubmed/18951540
SR Filipovic, JC Rothwell, BP van de Warenburg, K Bhatia

Dopamine levels after repetitive transcranial magnetic stimulation Dept of Neurology: Assiut University Hospital, Assuit, Egypt
Sobell Research Dept of Motor Neuroscience and Movement disorders, National Hospital for Neurology and Neurosurgery, Queen Square, London - 2007
http://cat.inist.fr/?aModele=afficheN&cpsidt=18817071

More Abstracts on topic:
http://www.ncbi.nlm.nih.gov/pubmed/19255412?dopt=Abstract
http://www.ncbi.nlm.nih.gov/pubmed/19255412?dopt=Abstract
http://74.125.93.104/search?q=cache:51PhTWpmWsUJ:www.bioportfolio.com/indepth/Transcranial_Magnetic_Stimulation.pdf+magnetic+stimulation+parkinson%27s+disease&cd=16&hl=en&ct=clnk&gl=us Link to trancranial magnetic stimulation info
http://www.ncbi.nlm.nih.gov/pubmed/15464863?ordinalpos=2&itool=EntrezSystem2.PEntrez.Pubmed.Pubmed_ResultsPanel.Pubmed_RVDocSum

Patent Applications:
http://patft.uspto.gov/netacgi/nph-Parser?Sect2=PTO1&Sect2=HITOFF&p=1&u=%2Fnetahtml%2FPTO%2Fsearch-bool.html&r=1&f=G&l=50&d=PALL&RefSrch=yes&Query=PN%2F7236830 2002 Patent info on systems and methods for enhancing or optimizing neural stimulation therapy for treating symptoms of Parkinson's disease and/or other movement disorders
http://patft.uspto.gov/netacgi/nph-Parser?Sect2=PTO1&Sect2=HITOFF&p=1&u=%2Fnetahtml%2FPTO%2Fsearch-bool.html&r=1&f=G&l=50&d=PALL&RefSrch=yes&Query=PN%2F7277758 2004 Patent info
http://patft.uspto.gov/netacgi/nph-Parser?Sect2=PTO1&Sect2=HITOFF&p=1&u=%2Fnetahtml%2FPTO%2Fsearch-bool.html&r=1&f=G&l=50&d=PALL&RefSrch=yes&Query=PN%2F7437196 2006 Systems and methods for selecting stimulation sites and applying treatment, including treatment of symptoms of Parkinson's disease, other movement disorders, and/or drug side effects
Patent info: North Neuroscience, Inc

Clinical Trials of Transcranial Magnetic Stimulation:

TMS intermittent theta-burst (ITBS) Transcranial Magnetic Stimulation to treat Parkinson's Disease.Accepted age range: 40-80 years
Accepted gender: male and female with Dopa responsive PD
Trial location: appears to be Rockville, MD only
http://clinicaltrials.gov/ct2/show/NCT00753519?term=NCT00753519&rank=1
Contact: Patient Recruitment and Public Liason Office (800)411-1122 National Institute of Health in Rockville, MD identifier #NCT00753519 email contact

Study on the Effect of External Magnetic Stimulation on Patients with Parkinson's Disease
Accepted age range: 40-80 years
Accepted gender: male and female
Therapeutic restrictions: none seen
For more information about study #1EA-0000071
Government identifier: NCT00841464
http://clinicaltrials.gov/ct2/show/NCT00841464
Contact: Eileen Hummel or Cassandra Brasile

Transcranial Magnetic Stimulation to Treat Parkinson's Disease
http://clinicaltrials.gov/ct2/show/NCT00753519

http://clinicaltrials.gov/ct2/results?term=transcranial+magnetic+stimulation+Parkinson%27s+disease&recr=Open

FYI: Other PD Clinical Trials
To view all Parkinson's Clinical Trials:
http://www.pdtrials.org/en/browse/all
To view Parkinson's Clinical Trials by location:
http://www.pdtrials.org/en/browse/location
To view Parkinson's clinical trials by symptomCan be movement or non-movement or both:
http://www.pdtrials.org/en/browse/location

You Have to Kiss A Lot of Lab Rats

Not all Parkinson's research will be the big one.

Every so often we come across the blogger who criticizes, for example, the funding by the Michael J Fox Foundation because no results have been seen: no cure for Parkinson's disease. And that attitude miffs us. It doesn't get us angry because to do that would be to acknowledge that this was someone who knew what the heck was going on. But it is dangerous because the monies which must go into research are enormous and the backlash effect of these attitudes can jeopardize donations and research funding if believed.

Research often leads down a dead end road...for a particular condition.
These paths aren't marked that way from the outset...it just happens that this direction or that one didn't turn out to be viable. Sometimes they are a bridge and sometimes they are a dead end.  But you've got to take the road to discover and that's not always a bad thing because you know how to improve, where not to look, whatever...

Some of these clinical trials can take a long time to open for participation. After that a trial can last for a significantly long time - years sometimes.

One of the recent directions of research found from an earlier study that in people who had naturally high levels of urate, an antioxidant, had a slower Parkinson's disease progression rate. This is especially important for the understudied young onset Parkinson's patients (YOPD).  See: our 1/20/10 post

For those who were following the April 2008 announcement that the MJFF was one of the sponsors of the Phase II trial of Drs. Michael Schwarzschild and Alberto Ascherio studying patients with early onset Parkinson's to determine the safety and efficacy of Inosine which raises urate levels - a potentially risky business and contraindicated under certain conditions but by no means all - there is no news except to say that the study, Safety of Urate Elevation (SURE-PD) has not begun to enroll yet.   (9-2009 update: study now recruiting.  See: below)

You can find the contact information and the nine states where the trials will be conducted here:
Safety of Urate Elevation in Parkinson's Disease (SURE-PD)

NCT00833690

Another grant from MJFF went to Drs. Rowen Chang and Chuantao Jiang at the Brown Foundation Institute of Molecular Medicine for the Prevention of Human Diseases, part of the University of Texas Health Science Center in Houston, TX. They are developing a vaccine targeting the protein alpha-synuclein relavent to the regulation and transportation of dopamine.

Every year there are tens of thousands more PD patients. The cost of the disease is enormous on so many levels. We just wanted to express our gratitude to not only the funders and the researchers but also the trial subjects for their courage and dedication. To the patients, families and caregivers we want to demonstrate that there are many people out there working to find solutions.

2015 Addenda
In 2013 the Michael J fox Foundation published this information about the SURE-PD (Safety of Urate Elevation in Parkinson's disease.

Phase 3 of the SURE-PD study will begin enrolling in 2016.  Here's a link to one news report from Science Daily, the summary of which is below:
A study from members of the research team investigating whether increasing blood levels of the antioxidant urate can slow the progression of Parkinson's disease has found that the neuroprotective effects of urate extend beyond its own antioxidant properties. An NIH-funded phase 3 trial of a urate-elevating drug, led by the senior author of the current study, will begin enrolling patients next year.
As of September 2015, I'm sure you've already see reports from many PD organizations about the urate/inosine Phase 2 study results.