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PD Clinical Trials
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The Therapeutic Opportunities for Parkinson's Disease Working Group Meeting was held October 10, 2000. The aims of this meeting were to take inventory of the state of clinical trials for Parkinson's Disease and to identify the highest priority areas in which to focus new NINDS efforts. This discussion assisted in shaping approaches to encourage clinical trials involving Deep Brain Stimulation (DBS) and pharmacological interventions. The major conclusions of the meeting are outlined below:
Deep Brain Stimulation (DBS)
DBS is an immediately promising treatment for Parkinson's Disease in terms of extent of improvement of symptoms and potential
for altering the course of disease. This meeting considered the most important new directions for clinical trials, with the
aim of advancing the effectiveness of DBS as a treatment for PD. In this meeting, two areas were evaluated: the possible benefit
& risk of extending the use of DBS to patients early in the disease and the importance of encouraging new trials in late stage
patients. NINDS is working closely with applicants to improve the design of proposed DBS clinical trials for Parkinson's Disease
based on these discussions.
Pharmacological Approaches
The goal was to identify therapies that would go beyond treating symptoms to slowing disease progression. A number of compounds
were identified as being potentially effective, and with little likelihood of being pursued in industry. Such interventions
are candidates for NINDS sponsored clinical trials. To evaluate these efficiently, the need for a large simple clinical trial
design was identified. Initiatives to establish such a structure are now in development.
Non-motor symptoms (e.g. depression, sleep, autonomic disturbances)
Finally, members of the working group discussed treatments for non-motor symptoms of PD, which have an often underestimated
effect on quality of life. It was pointed out that mood and sleep disorders may themselves worsen the disease. Currently,
many treatments for non-motor symptoms are chosen or avoided based on anecdotal claims, and systematic studies are needed.
An RFA is being developed to encourage clinical trials for treatments of non-motor symptoms of PD.
Last updated February 09, 2005