Pramipexole ER vs. Placebo in Fibromyalgia

The primary objective of this study is to assess the efficacy and safety of an extended-release (ER) formulation of pramipexole in comparison with placebo for the treatment of fibromyalgia.

The objective of the open-label phase is to assess the safety profile and effect of Pramipexole (PPX) extended-release (ER) in fibromyalgia patients over a 24-week period.


Eligibility Criteria:
Inclusion Criteria:

1. Male and female outpatients greater than or equal to 18 years of age
2. Meet criteria for primary fibromyalgia as defined by the American College of Rheumatology (ACR): widespread aching pain in all four quadrants of the body and axial skeleton for greater than 3 months duration and greater than or equal to 11 of 18 tender points under digital palpitation examination with an approximate force of 4 kilograms per centimeters squared (kg/cm2)
3. Pain score of greater than or equal to 4 (scored once at screening and as a weekly mean at baseline) on the 11-point Likert pain scale with 0 = no pain and 10 = worst possible pain
4. Score of greater than or equal to 4 (= moderately ill) on the Clinical Global Impression of Severity (CGI-S) at screening and at baseline
5. All females of child-bearing potential must test negative for pregnancy at Visit 1. Females of child-bearing potential (not surgically sterilized and between menarche and two years postmenopausal) must agree to utilize medically acceptable and reliable means of birth control as determined by the investigator during the study and for one month following the last dose of study medication. Examples of reliable methods include: use of hormonal contraception (oral, injectable, or subcutaneous), double-barrier method, abstinence, partner with vasectomy, or hormonal intrauterine devices
6. Educational level and degree of understanding such that the patient can communicate intelligibly with the investigator and study coordinator
7. Judged to be reliable and agree to keep all appointments for clinic visits, tests, and procedures required by the protocol

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 Have previously completed or withdrawn from this study or any other study investigating pramipexole.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