Treatment Studies

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AGN 203818 to Evaluate Safety & Efficacy for Pain Relief

Study to measure reduction in daily pain scores, safety, and effectiveness of different doses compared to a placebo.

Study Drug: AGN 203818

Sponsor: Allergan

FDA Status: None

Recruiting for Phase II Trial: This placebo-controlled, blinded and randomized study is designed to explore the safety and effectiveness of different doses of AGN 203818 in treating pain associated with fibromyalgia. AGN 203818 is being tested at 47 clinical research sites in the United States and Europe. During Phase II testing, 160 participants will be evaluated. Participants will be asked to make up to eight visits to the research site over a minimum 10-week period.

Patients that qualify for participation in the study will have up to a 4-week medication washout period, followed by a 1-week baseline period. After the baseline period, patients will be on the study medication up to 4 weeks and then will have a 1-week post-treatment follow-up. Patients will make daily entries into an electronic diary that is used to assess fibromyalgia symptoms. All study-related physical exams, medication, laboratory tests, and ECGs will be provided to qualified participants at no cost.

Study Criteria (key requirements):

• females between 18 and 75 years of age
• must meet the diagnostic criteria for fibromyalgia syndrome
• fibromyalgia must be patient’s primary painful condition
• must not have an additional uncontrolled disease other than fibromyalgia
  
• cannot be pregnant, nursing or planning a pregnancy
  
• cannot be currently applying for disability or have ongoing litigation
  
• Cannot have any of the following conditions:
  
  • uncontrolled disease other than fibromyalgia
    
  • Hepatitis B, Hepatitis C, HIV antibodies
    
  • history of rheumatoid arthritis, inflammatory arthritis, autoimmune disease, or other significant painful condition
    
  • major depression, dysthymic disorder, or generalized anxiety
    
  • history of any significant allergic condition including severe drug-related hypersensitivity
    
  • low blood pressure

Study Locations: At least four trial centers are still recruiting patients for this study.

Nutley, NJ - Contact research coordinator Caroline Streicher at
(973) 235-1433, or e-mail her at cstreicher@cnsmail.com.

Los Gatos, CA - Contact research coordinator Jack Taw at
(408) 356-0503, or e-mail him at jtaw@samaritan-research.com.

Phoenix, AZ - Contact recruiter Diane Griffith, CRC, at (602) 636-1880 or e-mail dgriffit@lrri.org.

Austin, TX - Contact recruiter Nicole Cortichiato at (512) 374-0881 or e-mail emilyb@fstrials.com.

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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