Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Forest Laboratories
With
Cypress Bioscience, Inc.
* Two weeks Duloxetine 60 mg Open-Label Period
* Randomization to Double-Blind Treatment Period: 10 weeks Milnacipran (direct switch) or 10 weeks placebo (one week blinded 30 mg duloxetine)
* One week Double-Blind Down-Taper Period
Age
18–70
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Diagnosis of fibromyalgia
Have been treated with a stable dosage of duloxetine (60 mg/day) for ≥ 4 weeks immediately before Screening (Visit 1)
Duloxetine must have been prescribed for the treatment of Fibromyalgia
Have a VAS 1-week pain recall score ≥ 40 mm and ≤ 90 mm
At Visit 2, to be eligible to enter the randomized treatment period, must continue to have a VAS 1-week pain recall score ≥ 40 mm and be dissatisfied with current Duloxetine treatment.
You may not be if
Suicidal risk
History of mania, bipolar disorder, psychotic disorder, schizophrenia, or a current episode of major depressive disorder
Myocardial infarction and/or stroke within the prior 6 months
Systolic blood pressure \> 160 mm Hg or mean diastolic blood pressure \> 100 mm Hg at Screening (Visit 1)
Substance abuse
Pulmonary dysfunction
Severe renal impairment
Active cardiac disease
Liver disease
Uncontrolled narrow-angle glaucoma
Autoimmune disease
Cancer
Inflammatory bowel disease
Unstable endocrine disease
Prostatic enlargement
Female patients who are pregnant or breastfeeding
Clareo Health | Study of Milnacipran in Patients With Inadequate Response to Duloxetine for the Treatment of Fibromyalgia
