First Drug Approved for Dyskinesia in Parkinson’s Disease

By Kristen Teesdale

Adamas Pharmaceuticals yesterday announced U.S. Food and Drug Administration (FDA) approval of an extended-release formulation of amantadine (GOCOVRI) to treat dyskinesia in Parkinson’s disease (PD). This is the first drug indicated specifically for dyskinesia — uncontrolled, involuntary movements that can develop with long-term levodopa use.

Extended-release amantadine is intended to be taken once daily at bedtime. In this way it can control dyskinesia during the day, when it typically is most prevalent. The new therapy’s approval is based on data from three placebo-controlled trials that demonstrated safety and efficacy. In addition to easing dyskinesia, the drug also may lessen total daily “off” time, when Parkinson’s symptoms return because medication is not working optimally.

The Michael J. Fox Foundation (MJFF) helped move this drug to market by supporting the creation and authentication of the Unified Dyskinesia Rating Scale, a tool that was used to measure the drug’s impact in trials.

“Dyskinesia can significantly compromise quality of life for people with Parkinson’s,” says Todd Sherer, MJFF CEO. “We are pleased that patients have another option to manage this aspect of the disease and glad the Unified Dyskinesia Rating Scale — a tool our support helped develop and validate — could show clinical efficacy of GOCOVRI for the treatment of dyskinesia.”

Extended-release amantadine is a reformulation of a currently available generic immediate-release version, which is approved to treat Parkinson’s symptoms. (Read more about this and other medications for Parkinson’s disease.)

Read more about extended-release amantadine.

Register for Fox Trial Finder to participate in dyskinesia and other studies to advance PD understandings and therapies.

Source: Fox Feed Blog

Visual system changes that may signal parkinson’s disease

Changes in the visual systems of newly diagnosed Parkinson’s disease patients may provide important biomarkers for the early detection and monitoring of the disease, according to a new study published online in the journal Radiology.

“Just as the eye is a window into the body, the visual system is a window into brain disorders,” said lead researcher Alessandro Arrigo, M.D., a resident in ophthalmology at the University Vita-Salute San Raffaele of Milan, Italy.

Parkinson’s disease is a neurodegenerative condition caused by neuronal loss in several brain structures. Parkinson’s disease is characterized by tremors, rigidity or stiffness throughout the body, and impaired balance and coordination.

“Although Parkinson’s disease is primarily considered a motor disorder, several studies have shown non-motor symptoms are common across all stages of the disease,” Dr. Arrigo said. “However, these symptoms are often undiagnosed because patients are unaware of the link to the disease and, as a result, they may be under-treated.”

Non-motor symptoms experienced by patients with Parkinson’s disease include visual alterations such as an inability to perceive colors, a change in visual acuity, and a decrease in blinking which can lead to dry eye. Read more…

Source: Science Daily

Online Survey Participants Needed: Alabama PD Patients and Caregivers

Find a Cure Panel (FACP) specializes in patient research for rare and serious diseases and they have some confidential and anonymous online research for people and caregivers with PD. If you complete the survey, FACP will donate $50 to the Parkinson’s Association of Alabama.

The completed survey is tracked anonymously off the customized link below.

To qualify for this online survey,

1)      You or your loved must have had PD for 5+ years;

2)      a) Your or your loved one must have or had experience with DBS OR b) be currently on Sinemet or Rytary or their generics.

3)      PD must have some impact on your life. If you have NO off time then you will not qualify for this research.

4)      It’s best to take the survey on a computer/ipad/tablet and NOT a smart phone.

If you are interested in participating, please click on the survey link below.

Survey link

https://www.sampleczar.com/survey/SC_RD.aspx?supplier_id=5096

If you have any questions about participating, please email FACP at info@findacurepanel.com

Discovery may lead to a treatment to slow Parkinson’s disease

Scientists have shown that the most common genetic cause of Parkinson’s disease — a mutant LRRK2 kinase enzyme — contributes to the formation of inclusions in neurons, resembling one of the hallmark pathologies seen in Parkinson’s disease. These inclusions are made up of aggregated alpha synuclein protein, which — the research also shows — can be prevented from forming by using two LRRK2 kinase inhibitor drugs now being developed for clinical use. Click the link below to read the full article…

Source: Science Daily

Record Pace of Recruitment Speeds Isradipine Trial

Great Clinical Trial Insight from the Michael J Fox Foundation By Allyse Falce.

Clinical trial news update: A recent MedPage Today article, “Quick Enrollment for STEADY-PD III Trial,” highlighted the accelerated enrollment of participants in the Safety, Tolerability and Efficacy Assessment of Dynacirc for PD (STEADY-PD) III trial, thanks in part to MJFF’s online trial matching tool, Fox Trial Finder.

A few months ago, we interviewed Kevin Biglan, MD, MPH, associate chair of clinical research for the Department of Neurology at the University of Rochester and co-principal investigator of STEADY-PD. Read more below about the trial and the remarkable efforts that led to the study’s successful recruitment:


Phase III testing for the compound isradipine is progressing after a remarkably short recruitment period; 336 participants enrolled in less than one year. Slow recruitment is a significant roadblock to testing of potential treatments and slows the pace of bringing new drugs to market. This success advances the pace of this study and may serve as a model for other programs.

Isradipine is a calcium channel blocker currently prescribed to treat high blood pressure. It came to the attention of Parkinson’s researchers when data from large studies showed lower risk of Parkinson’s disease (PD) among people who took the drug for hypertension. Scientists believe isradipine works to prevent the death of dopamine-producing cells and therefore may slow the progression of PD. The Michael J. Fox Foundation (MJFF) funded pre-clinical work to make that connection, as well as the Phase II trial. In 2014, isradipine researchers received a $23 million grant from the National Institutes of Health to move the Safety, Tolerability and Efficacy Assessment of Dynacirc® for PD (STEADY-PD) study into Phase III efficacy testing. Dynacirc® is the commercial name of the isradipine hypertension drug.

Kevin Biglan, MD, MPH, associate chair of clinical research for the Department of Neurology at the University of Rochester, is co-principal investigator of STEADY-PD. Dr. Biglan spoke to MJFF about the study’s successful recruitment period, and answered some commonly asked questions about Parkinson’s disease and calcium.

MJFF: Congratulations on completing study recruitment. What kind of participants were you looking for and how did you find them?

KB: We were looking for newly diagnosed individuals who had not yet started treatment for PD. Traditionally, this is a very difficult population to recruit. These individuals are just getting the news that they have Parkinson’s disease, and they’re not necessarily thinking about participating in research. And a lot of newly diagnosed people need treatment right away, so that eliminates many potential volunteers.

About 60 percent of people enrolled directly through the 55 study sites. The second largest group came through the MJFF online trial matching tool Fox Trial Finder. One hundred people were prescreened through the site, and about half of them ended up enrolling. And another subset of participants were referred by neurologists outside of the study sites.

Our timeline was 18 months; we were six months ahead of schedule. We worked with MJFF on a recruitment plan, and we think our methods of communication with the study sites and with volunteers who came through other sources may be of use to the Parkinson’s research community. We’re planning to write an article and share those tactics soon.

MJFF: How does accelerated trial recruitment speed drug development?

KB: The biggest barrier to drug development is enrolling an adequate number of individuals into a study. A lot of the time and costs of trials are associated with this delay in recruitment. The longer it takes to get people into a study, the longer it takes for us to find the results.

MJFF: When might isradipine be approved to treat PD?

KB: The last person will be out of the study in November 2018. After that, it’ll probably be about three to six months before we have final results. That would put us into the beginning of 2019. If the results look promising, because it’s a readily available drug, it may be prescribed for Parkinson’s soon after.

MJFF: Many Parkinson’s patients who don’t have hypertension have asked if they should begin taking isradipine. Is this a good idea?

KB: At this point, we still don’t know that isradipine has beneficial effects on Parkinson’s disease, so we recommend that people don’t start taking this medication until we have more information. Also, low blood pressure is a symptom of PD, and if you don’t have hypertension, this medication may exacerbate that condition. There are other side effects, mainly dizziness and swelling, associated with isradipine, too. Certainly, before you start any medication you should talk to your physician about it. There could be something specific to you that might put you at higher risk of developing problems, so it’s not something people should start without some discussion.

MJFF: If a patient is currently taking another calcium channel blocker, should they switch to isradipine?

KB: If a person with PD needs to be on a calcium channel blocker, for whatever reason, high blood pressure or otherwise, and their cardiologist or primary care doctor thinks isradipine is a reasonable alternative choice, then there’s likely no harm in switching between calcium channel blockers. But again, that’s a discussion that needs to occur between the patient and physician.

MJFF: Since this is a calcium blocker, should people stop taking calcium supplements? Or cut out calcium-rich foods?

KB: There’s no reason to worry about calcium supplements or calcium-rich foods. With isradipine, it’s targeting a specific calcium channel in the brain that we think may play a role in the cause of Parkinson’s disease. Calcium itself is highly regulated in the bloodstream. You don’t need to stop taking calcium supplements or avoid calcium-rich foods; there’s no evidence that those things have any negative effect on Parkinson’s disease.

MJFF: Thanks for speaking with us, Dr. Biglan. Anything else you’d like to add?

KB: We’re incredibly grateful to the Parkinson’s community for their partnership in this study. It’s going to allow us to answer a very important question about whether this treatment can slow progression of Parkinson’s disease sooner than we would have been able to without the assistance of patients, their families, and advocacy and research organizations.

Source:: Fox Feed Blog

Eat Your Pie Pizza and Support Parkinson’s research

Whats better than pizza?!? Your Pie Pizza that supports Parkinson’s disease research! PAA is thrilled to partner with Your Pie Birmingham this Monday, April 25 to accelerate a cure for Parkinson’s through their delicious pizza. Your Pie will generously donate 10% of it’s Monday proceeds to PAA programs that help accelerate a cure for PD and we can think of no better way to close out a Monday. Be sure mention the Parkinson’s Association of Alabama when ordering and we look forward to seeing you there.

 

UAB Neurology – 2015 Parkinson’s Research Progress Report

The Parkinson Association of Alabama is thankful for it’s partnership with UAB and proud of their ongoing research contributions to accelerate a cure for Parkinson’s Disease. We are excited to share the 2015 Parkinson’s Research Progress Report from the UAB Department of Neurology and hope you’ll take a moment to review.

Experimental Parkinson’s Treatment uses MRI Guided Ultrasound

Interesting news out of the University of Maryland Medical Center  and the University of Maryland Medical School on an experimental treatment for Parkinson’s disease that utilizes MRI Guided Ultrasound and shows promising early results. Click this link to read more about this experimental treatment.

Click this link to read more about this experimental treatment.