Research in fibromyalgia is taking place all over the world. Studies are becoming more and more productive as the scientific understanding of FM is yielding to increasingly sophisticated research methodology. In addition, many small and large pharmaceutical firms have realized that FM is an unmet need and are developing innovative therapies for FM patients.

Fibromyalgia patients have enthusiastically participated in research studies over the last 25 years. This research is now paying off in terms of newer medications and the increasing recognition of FM in medical professionals and the general public.

To find research studies taking place near you, we recommend checking the national database of registered studies sponsored by the US National Institutes of Health, Registered U.S. Research Studies.
As we learn about specific studies seeking participants, we will add them here.

A Research Study Opportunity from Schwarz-Pharma:

SP888:

A Parallel, Randomized, Double-blind, Placebo-Controlled, Multicenter Proof of Concept Trial to assess the Efficacy and Safety of Two Different Transdermal Doses of Rotigotine in Subjects with Signs and Symptoms Associated with Fibromyalgia Syndrome



About this trial:
Rotigotine is an experimental drug being studied for the effectiveness and safety in reducing signs and symptoms of fibromyalgia syndrome. This trial will investigate the best dose of rotigotine in controlling signs and symptoms (such as pain, sleep, general activity, mood, quality of life, and use of rescue medication) and causing the smallest number of side effects. Rotigotine belongs to a class of drugs called dopamine agonists. The major difference between rotigotine and other dopamine agonists is that rotigotine is administered in the form of a patch worn on the skin whereas other drugs are taken by mouth.

To find out whether rotigotine works in people with fibromyalgia syndrome, and if so, how well it works, eligible participants will be randomly assigned to one of three groups. One group will receive rotigotine at 4mg/24hrs, one group will receive rotigotine at 8mg/24hrs and the other group will receive a placebo. A placebo is a ‘dummy’ drug, which looks like rotigotine, but has no active ingredient. Whether participants receive rotigotine or placebo will be decided by chance (like flipping a coin). There is a 2:3 or 67% chance of getting Rotigotine and a 33% chance of getting placebo. Neither study participants nor their study doctor will know the assigned study group, although in an emergency the exact study drug you receive can be identified.

Approximately 240 subjects with fibromyalgia syndrome age 18 to 65 will be randomized in approximately 30 centers in the United States. Participation in this study may last up to 19 weeks and will involve 10 visits to the clinic.

Participants will receive at no cost, study-related exams, evaluations, and study medications. Many sites offer reimbursements for time and expenses incurred during participation.

Allowed Medical Conditions:
Some people with certain medical conditions will not be allowed to participate in this trial including those with extreme skin sensitivities, osteoarthritis (OA), rheumatoid arthritis (RA), Lupus, major depression, severe heart conditions, severe high or low blood pressure, sleep disorders, impulse control disorders, and drug addiction(s).

Medical conditions that may be allowed are those with osteoarthritis of just the hands, those who successfully treat sleep apnea with CPAP (>4 months), and other chronic conditions that are successfully treated may be allowed upon discussion with the study physician.

Allowed Medication Use:
There are medications that are not allowed during participation of the trial including but not limited to anti-epileptic drugs (AEDs), tricyclic anti-depressants, SNRIs, MAOIs, opiods/opiod analgesics, tramadol, dextromethorphan, barbiturates, benzodiazepines, dopamine agonists, anti-parkinson’s medications, neuroleptics, methylphenidate, muscle-relaxants, tenderpoint injections, acupuncture, neurostimulating devices, blockade, and surgery.

Some medications are allowed but must have been used at a stable dose for 3 months or more. These medications include SSRIs, NSAIDs (ibuprofen, naproxen) – if used for other than fibromyalgia pain; some sleep medications (Non-benzodiazapine such as zaleplon, zopiclone and eszoplicone), aspirin for prevention of heart-attack/stroke, certain medications for other chronic, stable conditions, and acetamenophin (up to 2g per day) for fibromyalgia pain.

Trial Results
Results of this trial will be based on subject diaries that are kept on a daily basis. Additional questionnaires and medical assessments (including study-related medical exams) will be conducted as secondary and safety measures for the medication.

Trial Centers
If you are interested in participating in this trial, you may contact one of the trial centers below. Please be prepared to discuss your fibromyalgia syndrome, medical history and ability to participate in the trial.

Rapid Medical Research, Inc.
Cleveland, OH
Contact Name: Lynn Tucker
Contact Phone: 216-682-0320 or 1-888-460-2275

AAIR Research Center
Rochester, NY
Contact Name: Joyce Greenwood, CCRC
Contact Phone: 585-442-1980

Future Care Studies
Springfield, MA
Contact Phone: 413-788-1400

International Clinical Research Associates
Richmond, VA
Contact Name: Karen Anderson
Contact Phone: 804-270-6811, ext. 108

Meridien Research
Tampa, FL
Contact Name: Chris Heironimus
Contact Phone: 813-877-8839

University of Medicine and Denstistry of New Jersey
Stratford, NJ
Contact Name: Patty DiVito
Contact Phone: 856-566-6318

Pivotal Clinical Research
Souderton, PA
Contact Name: Diane Barnolt
Contact Phone: 215-723-7121

Pivotal Research Centers
Peoria, AZ
Contact Name: Company’s Website - www.pivotalresearch.com
Contact Phone: 1-866-STUDY21 (1-866-788-3921)

University Clinical Research
Deland, FL
Contact Name: Recruiting Department
Contact Phone: 386-785-2400 or 1-866-4-STUDIES

Neurology Clinical Research
Sunrise, FL
Contact Name: Dalia Ramos
Contact Phone: 954-475-8171

Lynn Health Science Institute
Oklahoma City, OK
Contact Name: Shelly Brunson
Contact Phone: 405-602-3939

Neuropsychiatric Associates
Woodstock, VT
Contact Name: Eryn Bagley
Contact Phone: 802-457-2338

Renstar Medical Research
Ocala, FL
Contact Name: Lynn Craggs
Contact Phone: 352-629-5800 or 1-877-629-5800

Lovelace Scientific Resources
Albuquerque, NM
Contact Name: Jeanie Tovrea, RN, CCRC
Contact Phone: 505-348-9700

Wake Research Associates
Raleigh, NC
Contact Name: Marion Peoples
Contact Phone: 919-781-2514

Future Search Trials
Dallas, TX 75231
Contact Name: Susan Cutler
Contact Phone: 214-369-2600, ext. 105

Midwest Clinical Research Center
Dayton, OH
Contact Name: Stephanie
Contact Phone: 937-424-1050

Compass Research
Orlando, FL
Contact Name: Sandra Chapman
Contact Phone: 407-426-9299

Connecticut Clinical Research
Cromwell, CT
Contact Name: Caola Schonberg
Contact Phone: 860-632-0144

Analgesic Development Ltd.
New York, NY
Contact Name: Nancy Olson or J. Brent Spears
Contact Phone: 212-813-9467

Mercy Health Research
St. Louis, MO
Contact Name: Donna Straatmann
Contact Phone: 314-251-8893

Apex Research Institute
Santa Ana, CA
Contact Name: Lisa Thurman
Contact Phone: 714-542-3008, ext. 306

Columbia Medical Practice
Columbia, MD
Contact Name: Kim Nordstrom, CCRC
Contact Phone: 410-465-2455, ext. 104


FDA APPROVES CYMBALTA (DULOXETINE) FOR THE MANAGEMENT OF FIBROMYALGIA
more details
Home
Optimized by: SearchFit.us.com | Resources | SiteMap
[ Shopping Cart Software SearchFit v7.7.2 ] [ SearchFit Directory ]