Pramipexole ER vs. Placebo in Fibromyalgia

Exclusion Criteria

• •1. Employees of Boehringer Ingelheim (BI) (that is, employees, temporary contract workers, or designees responsible for the conduct of the study)
• •2. Have received treatment within 30 days prior to screening with a drug that has not received regulatory approval for any indication
• •3. Have previously completed or withdrawn from this study or any other study investigating pramipexole.
• •4. Any current or previous diagnosis of psychosis, bipolar disorder, or schizoaffective disorder as assessed by the Mini International Neuropsychiatric Interview (MINI)
• •5. Have any primary anxiety disorder within the past year as assessed by the Mini International Neuropsychiatric Interview (MINI)
• •6. Have any Diagnosis of Statistical Manual of Mental Diseases, 4th Edition (DSM-IV) Axis II disorder that would interfere with protocol compliance
• •7. Medium or high risk of suicidality as assessed by the Mini International Neuropsychiatric Interview (MINI)
• •8. History of substance abuse/dependence within the past year, excluding nicotine and caffeine
• •9. A positive urine drug screen for any substance of abuse or excluded medication
• •10. Women who are pregnant or breast-feeding
• •11. Have pain symptoms related to traumatic injury that will interfere with the interpretation of outcome measures
• •12. Patients with regional pain syndromes, multiple surgeries or failed back surgery syndrome
• •13. A confirmed or previous diagnosis of rheumatoid arthritis, inflammatory arthritis, or infectious arthritis, or an autoimmune disease
• •14. Abnormal C-Reactive Protein, Anti-Nuclear Antibody (ANA), Rheumatoid factor, or Thyroid Stimulating Hormone (TSH)
• •15. Any serious or unstable medical or psychiatric condition or clinically significant abnormalities in labs at screening that would lead to hospitalization during the course of the study or otherwise compromise study participation
• •16. Have uncontrolled seizures
• •17. Taking any prohibited medications that cannot be discontinued at screening
• •18. Patients who are treatment-refractory or whose response may be compromised by disability compensation issues
• •19. Patients with frequent or severe allergic reactions to multiple medications
• •20. Prior or current treatment with pramipexole
• •21. Clinically significant renal disease
• •22. Current or previous diagnosis of malignant melanoma
• •23. Clinically relevant ophthalmopathy
• •24. Documented sleep apnea