Treatment Studies

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Rotigotine for efficacy and safety in reducing signs of fibromyalgia symptoms

Trial will investigate the best dose of rotigotine in controlling signs and symptoms of fibromyalgia and causing the smallest number of side effects.

Study Drug: Rotigotine Transdermal

Sponsor: Schwarz Biosciences, Inc.

FDA Status: The U.S. Food and Drug Administration approved in 2007 Neupro (rotigotine transdermal) to treat symptoms of early Parkinson's disease.

Basic Information: Rotigotine belongs to a class of drugs called dopamine agonists (i.e., they act like dopamine). 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. The study intends to find out whether rotigotine works to reduce fibromyalgia symptoms such as pain, sleep, physical inactivity, mood, poor quality of life, and use of rescue medication.

Recruiting for Phase II Trial: Approximately 240 subjects with fibromyalgia will participate at about 30 centers in the United States in this randomized, double-blind, placebo control, study. The study may last up to 19 weeks and will involve 10 visits to the clinic. Eligible participants will be randomly assigned to one of three groups. One group will receive rotigotine at 4 mg per 24 hours, one group will receive rotigotine at 8 mg per 24 hrs, and the other group will receive a placebo. A placebo, or ‘dummy’ drug, looks like rotigotine, but has no active ingredient. Whether participants receive rotigotine or placebo will be decided by chance. There is a 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 received can be identified.

Participants will receive at no cost, study-related exams, evaluations, and study medications. Subjects must maintain diaries on a daily basis. Many sites offer reimbursements for time and expenses incurred during participation.

Study Criteria (key requirements):

• Male or female 18-65 years
• Subject must have signs and symptoms of primary fibromyalgia lasting more than 3 months (primary means that you cannot have another chronic painful condition)
• Cannot have any of the following conditions
  • extreme skin sensitivities
    
  • osteoarthritis (OA)
    
  • rheumatoid arthritis (RA)
    
  • lupus
    
  • major depression
    
  • severe heart conditions
    
  • severe high or low blood pressure
    
  • sleep disorders such as restless legs syndrome or narcolepsy
    
  • impulse control disorders
    
  • drug addiction(s)
• Allowed to have osteoarthritis, but only in the hands. Those patients diagnosed with obstructive sleep apnea who are successfully treated with CPAP, and other chronic conditions that are successfully treated may be allowed in the study.
• Cannot be on anti-epileptic drugs (such as Neurontin or Lyrica), tricyclic anti-depressants, SNRIs (such as Cymbalta), MAOIs, opioid analgesics, tramadol, dextromethorphan, barbiturates, benzodiazepines, dopamine agonists, anti-Parkinson’s medications, neuroleptics, methylphenidate, or muscle relaxants. Patients are also not allow to receive trigger point injections, acupuncture, neurostimulating devices, anesthetic blockades, or surgery during the study.
• Allowable medications used at a stable doses include SSRIs (Paxil, Zoloft, Lexapro, etc.), NSAIDs (ibuprofen, naproxen) – if used for other than fibromyalgia pain; some sleep medications (non-benzodiazapine such as Sonata or Lunesta), aspirin for prevention of heart-attack/stroke, certain medications for other chronic, stable conditions, and acetamenophin (up to 2g per day) for fibromyalgia pain

Study Locations

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.

Arizona

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

California

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

Connecticut

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

Florida

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

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

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

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

Maryland

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

Massachusetts

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

Missouri

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

New Jersey

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

New Mexico

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

New York

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

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

North Carolina

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

Ohio

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

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

Oklahoma

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

Pennsylvania

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

Texas

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

Vermont

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

Virginia

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

More information on the rotigotine transdermal.

The Fibromyalgia Network is not in any way associated with any clinical trials, pharmaceutical companies, device manufacturers, or government agencies. As a self-help organization, we accept no sponsorship, advertisements, or government funds. The information on these pages is provided as a public service.

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