Tag Archives: clinical trials

Dr. Bill Weiner: Eminent Scientist, Independent Voice and True Friend

Last month, the Parkinson’s community lost a dear member, one who dedicated his career to the treatment of the disease. William J. “Bill” Weiner, M.D.,  known to many at the University of Maryland where he served as Chairman of Neurology and the Director of the Maryland Parkinson’s Disease and Movement Disorders Center, passed away on December 29, 2012. Involved in treatment trials for Parkinson’s disease since levodopa in the 1960s, Bill was truly one of a kind in his profession – a fine scientist and a dedicated clinician who was committed to thinking for himself and to expressing his views… read more Read More

PAIRing up for Research: The Importance of Saying Thank You

Last week, we were excited to see a great example of pairing up (the slogan for our Parkinson’s Advocates in Research, or “PAIR” program) at Vanderbilt University Medical Center (VUMC). In an article entitled, “Events honor early patients of novel Parkinson’s study,” VUMC reports on their study of deep brain stimulation surgery as a treatment for early stage Parkinson’s. DBS is approved by the FDA as a treatment for mid stage Parkinson’s, but not for those with earlier stage PD. We were impressed to see how VUMC thanked their volunteers, all people with Parkinson’s, who made the study possible. As… read more Read More

Protecting the People Who Test New Parkinson’s Treatments

We all want better treatments for Parkinson’s.  Tuesday’s announcement that one of PDF’s Research Centers – Rush University Medical Center, in Chicago, IL – received full accreditation from The Association for the Accreditation of Human Research Protection Programs, Inc. (AAHRPP) is another step in the right direction. Fewer than 200 institutions around the country are fully or partially accredited by AAHRPP. Before any new treatment, for PD or another condition, is approved it must first be tested in people – in clinical research studies – to ensure it is safe and effective.  The AAHRPP accreditation means that Rush is following… read more Read More

Easing Dyskinesia: PDF-funded Research from 2007 Leads to Testing of Experimental Drug

Earlier this week, PsychoGenics Inc., announced that an experimental drug for Parkinson’s, eltoprazine, seemed to reduce dyskinesia in people with Parkinson’s in early studies.  Dyskinesias are the twisting and writhing movements that occur as PD progresses – a common side effect of the medication levodopa (Sinemet®).    Back in 2007, it was PDF-funded researcher Manolo Carta Ph.D., along with Anders Björklund, M.D., who performed the pre-clinical research that led to the identification of this drug.  At the time, while many researchers were looking at dopamine neurons as the culprit behind dyskinesias (through their interaction with levodopa), Dr. Carta’s proposal suggested something… read more Read More

Understanding the FDA Committee’s Decision to Recommend Approval for Neurogenic Orthostatic Hypotension Drug

From James Beck, Ph.D., Director of Research Programs You may have read the recent news about the small pharmaceutical company,Chelsea Therapeutics, and their drug Northera™ (droxidopa). Chelsea recently received the recommendation of a FDA advisory committee to approve droxidopa as a treatment for neurogenic orthostatic hypotension or NOH for short. This recommendation was a big surprise since FDA documents released ahead of the committee meeting showed that agency staff members were clearly against approval; nevertheless, this approval recommendation will strongly influence the final decision expected to be made later this month. What is NOH? Normally, blood pressure increases as you… read more Read More

Sham Surgery

In clinical trials that test new drugs for Parkinson’s disease, the process is fairly straightforward: some people get the real stuff and others get a sugar or placebo pill. It looks identical to the pill containing the new drug, but doesn’t offer the new compound. Here everyone (the person with Parkinson’s and physician) enters the trial knowing that a certain amount of deception is necessary from the outset….no one knows which pill is which. That is a good thing scientifically. There is an overwhelming consensus that double-blinded experiments, in which participants are randomly assigned to receive a placebo, result in… read more Read More