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NINDS Launches Two Large Clinical Trials for Parkinsonís Disease
The National Institutes of Neurological Disorders and Stroke (NINDS) has launched two clinical trials for Parkinsonís disease (PD); one for deep brain stimulation (DBS) and another to study two potentially neuroprotective agents.
The DBS clinical trial is proceeding under a new collaborative agreement between the National Institute of Neurological Disorders and Stroke (NINDS) and the Department of Veterans Affairs (VA). A total of 316 patients will be chosen to participate in the treatment study, which is taking place at six locations around the country.
DBS is a surgical procedure that uses electrical stimulation to stop uncontrollable movements. The Food and Drug Administration has already approved DBS for the treatment of PD. In this trial, participants will have access to a stimulator more advanced than the one that is in general use.
Doctors hope that the trial will provide them with information about the best site for stimulation in the brain and also about the potential benefit of DBS for other PD symptoms.
Individuals who want to be considered for the trial should ask their physicians to contact one of the participating centers directly to inquire about eligibility criteria for participation. The trials are being conducted at the following locations:
- Baylor College of Medicine, Houston, Texas
Contact: Farah Atassi, M.D., M.P.H. Ph: (713) 798-4773
- University of Pennsylvania, Philadelphia
Contact: Heather A. Maccarone, R.N., B.S.N. Ph: (215) 829-7181
- Medical College of Virginia, Richmond
Contact: Mariann A. Haselman, R.N. Ph: (804) 828-5235
- University of Oregon Health Sciences Center, Portland
Contact: Susan Loehner, R.N., B.S.N., M.B.A. Ph: (503) 494-7950
- University of California, San Francisco
Contact: Elaine M. Lanier, R.N., M.S. Ph: (415) 221-4810 Ext. 2488
- University of California at Los Angeles.
Contact: Wes Morrow, M.S., M.M.Sc., PA-C Ph: (310) 794-7239
The second trial is a multi-center, pilot study in 195 patients with previously untreated PD. Over an 18-month period, the impact of minocycline and creatine on disease features will be examined at more than 40 centers across the U.S. Minocycline is an FDA-approved antibiotic that has been shown to have anti-inflammatory and anti-apoptotic properties. Creatine is a dietary supplement that increases muscle and brain phosphocreatine concentrations, and has been shown to protect against neuronal injury in mice. This is the first study of a long term NINDS effort to examine neuroprotective agents that prior research indicates may be useful in the treatment of PD. Agents that continue to show promise in these pilot studies will then be tested in larger studies of efficacy.