Pramipexole ER vs. Placebo in Fibromyalgia
Condition: Fibromyalgia
MeSH terms: Fibromyalgia; Myofascial Pain Syndromes
Intervention: pramipexole ER; placebo
Intervention MeSH terms: Pramipexole
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 61.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      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