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Update on Tozadenant Trial for Parkinson’s

On 11/20/17, Acorda Therapeutics, Inc. announced that it is discontinuing the tozadenant clinical trial A research study in humans that aims to test a new intervention – this could be a drug, surgery or therapy like exercise or diet guidelines – to make sure it is effective and safe..  They concluded that they could not be confident that weekly white blood cell count screening would sufficiently ensure patient safety.


On 11/15/17, Acorda Therapeutics, Inc. announced that several people living with Parkinson's who participated in the Phase III trial for tozadenant experienced agranulocytosis — a severe drop in the number of white blood cells which fight infection — leading to cases of sepsis and five fatalities. Participants in the trial will now have blood cell count monitoring increased from monthly to weekly.  The study has paused new enrollment in the long-term safety studies, pending further discussion with the independent Data Safety Monitoring Board (DSMB) and the United States Food and Drug Administration (FDA).

Tozadenant is an oral adenosine A2a receptor antagonist currently in Phase III development as an adjunctive Supplemental or secondary. In the context of Parkinson's, adjunctive medications are used to enhance the effects of levodopa. treatment to levodopaThe medication most commonly given to control the movement symptoms of Parkinson’s, usually with carbidopa. It is converted in the brain into dopamine. in Parkinson’s disease patients to reduce OFF time When medication is not working well. Symptoms become more noticeable and movement becomes more difficult..

Statement from the Parkinson’s Foundation

Our thoughts are with the family members who lost a loved one enrolled in this trial. Their participation in clinical research will ultimately help make life better for the people diagnosed with Parkinson's in the future. 

The Parkinson’s Foundation remains confident that Acorda and the FDA will investigate this rare event. Clinical trials in Parkinson’s disease — from oral therapies to surgical treatments — have had a strong safety record and they are critical in testing the safety and efficacy of investigational therapies.

In order to discover new PD therapies, we rely on brave and altruistic people, like the ones in this trial, to participate in clinical research. The Parkinson’s Foundation remains committed to supporting clinical research through our global network of Centers of Excellence and Parkinson’s Advocates in Research.

If you would like more information about the benefits and risks of clinical trial participation, learn more here.  If you have questions or concerns, please call our toll-free Helpline at 1-800-4PD-INFO (473-4636).

Thursday, November 16, 2017
Advocates Guide $16 Million in US Department of Defense Parkinson’s Research Funding for Second Straight Year
Tuesday, March 7, 2017

Recently, four Parkinson’s Foundation Research Advocates helped guide $16 million in government funding for Parkinson’s disease (PD) research. This is the second straight year in which our Research Advocates have served as consumer reviewers for research funded by the US Department of Defense (DoD). The group included:

Parkinson’s Foundation Receives Award to Develop National Recommendations to Improve Care for Women with Parkinson’s
Tuesday, February 28, 2017

NEW YORK CITY & MIAMI — The Parkinson's Foundationhas received a $250,000 award to develop new patient-centered recommendations to improve the health of women living with Parkinson’s disease.

Parkinson’s Foundation Invests $500,000 in Community-Driven Clinical Research To Ease Cognition, Sleep and Fatigue in Parkinson’s
Monday, February 27, 2017

Five New Awards Address Unmet Needs

New York, NY and Miami, FL — The Parkinson’s Foundation has awarded $500,000 for translational research grants to address critical unmet needs in Parkinson’s disease.  The investments jumpstart practical solutions to ease difficulties related to cognition, fatigue and sleep, all of which are debilitating yet under-recognized symptoms in Parkinson’s.

The Parkinson's Foundation’s Moving Day® Walks Fund Local Parkinson’s Programs in 2017
Monday, February 13, 2017

$13.7 million dollars raised over five years
 

Young New Yorkers for the Fight Against Parkinson’s Committee and the Parkinson’s Foundation Celebrate the 10th Anniversary of Celebrate Spring New York Wednesday, April 5, 2017
Friday, February 10, 2017

The 10th Anniversary of Celebrate Spring New York will take place on Wednesday, April 5, 2017 at Lavo located at 39 East 58th Street between Madison and Park Avenues.  The event is hosted by the Young New Yorkers for the Fight Against Parkinson’s and the Parkinson’s Disease Foundation (PDF), a division of the Parkinson’s Foundation.

Parkinson’s Foundation Designates NewYork-Presbyterian/Columbia, Rush University Medical Centers as Parkinson’s Care ‘Centers of Excellence’
Monday, February 6, 2017

As foundation continues to invest in programs to improve the lives of Parkinson’s patients, designation of new Centers of Excellence further expand expert care network
 

Local Residents to Host Scotch & Sangria for Parkinson’s Research at Sear House in Closter, NJ, on Thursday, March 2
Monday, January 30, 2017

Proceeds From Fourth Annual Helping Hours Event Benefit Parkinson’s Foundation

Parkinson's Foundation Appoints John L. Lehr as Chief Executive Officer
Tuesday, January 10, 2017

 Lehr Charged with Advancing Foundation’s Mission to Accelerate the Science and Care for Parkinson’s Disease
 

The National Parkinson Foundation Announces Initiative to Further Define Stages of Parkinson’s Disease
Monday, January 9, 2017

Currently, there is no one definition of what it means to have advanced Parkinson’s disease
 

Initiative will support the creation of a tool to help physicians assess changes in the disease
 

Apply to the Parkinson’s Foundation People with Parkinson's Advisory Council by Monday, December 19
Monday, November 21, 2016

Are you interested in helping the Parkinson’s Foundation (PF) work toward a world without Parkinson’s? Apply to the People with Parkinson's Advisory Council by Monday, December 19.

In August, the Parkinson’s Disease Foundation and the National Parkinson Foundation merged to form the Parkinson’s Foundation. We are seeking advisors from the community to help us kick off a new and exciting era in the Parkinson’s community.

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