Parkinson's Drug for Fibromyalgia?
In 2007, the United States Food and Drug Administration (FDA) gave its approval to a drug called Neupro, a transdermal patch for the delivery of rotigotine for the treatment of the symptoms associated with the onset of Parkinson's disease. Now phase II trials are being held to test whether Neupro might also alleviate fibromyalgia symptoms. Another goal of this trial is to find the smallest and safest dose of this medication for the relief of fibromyalgia. The smaller the dose, the better chance there is that a patient won't suffer too many side effects. The sponsor for this trial is Schwarz Biosciences, Inc.
Rotigotine is a medication in the dopamine agonists family. The drugs in this class act like dopamine. The main distinction between rotigotine and the other dopamine agonists is in its delivery system. Until now, dopamine agonists were oral drugs. Rotigotine is different by virtue of the fact that it delivers its active ingredient through the means of a transdermal patch that is affixed to the patient's skin, much like an adhesive bandage.
The trial hopes to find that rotigotine serves to lessen the symptoms of fibromyalgia symptoms, for instance: chronic pain, sleep disturbances, physical immobility, moodiness, reduced quality of life, and the need for the occasional dose of stronger medication to control a severe attack of pain (rescue medication).
Thirty US medical centers will be participating in this phase II trial and the researchers hope to recruit some 240 subjects with fibromyalgia for the randomized, double-blind, placebo control study. The scientists believe the trial will last a maximum of 19 weeks and will necessitate a total of 10 patient visits to the clinic. The participants will be given a random assignment to one of three groups.
The first group will take 4 mg. rotigotine every 24 hours, the second group will be administered double this amount, and the third group will receive a placebo that is made to look like the real thing. The odds work out that participants have a 67% chance of receiving rotigotine, and a 33% chance of getting the placebo. Doctors and patients will not know which patients are receiving the drug or the placebo, though there are emergency controls in place should a reaction be observed so that doctors can identify whether or not the drug is implicated.
In exchange for their participation, subjects will be given exams, evaluations, and study medications free of charge. Participants are expected to keep a daily journal. Some of the clinics offer reimbursement for a participant's time and for expenses incurred due to participation in the study.
There are study criteria that participants will have to fulfill in order to be considered as candidates for the study. If you're interested in participating in this trial and you want to know if you qualify, ask your doctor about the closest medical center acting as a participant in the rotigotine trial.