Trial Design   Dose(S)   Primary Outcome(S)  Reference  Db-Pc1 Flexible Dose Escalation Up To 200 mg/Day Pain Reduction: 50% Milnacipran; 14% Placebo (P<0.05) Improvement- Fatigue, Sleep, Depression: 75%Milnacipran; 38% Placebo (P<0.01)   60   Db-Pc1  100 mg/200 mg/Day Pain: Global Status, Physical Function And Fatigue All Improved With Milnacipran At 100 mg And 200 mg/Day   61 Db-Pc1  100 mg/200 mg/Day  ↑ In Fms Pain Response Compared To Placebo (P<0.32);Pain (P<0.05); Fatigue(P<0.016); Cognition(P<0.025) And In Multiple Sf-36 Domains2   62 Db-Pc1   100 mg/200 mg/Day ↑Composite Responder Rate And Improved Pain Score Compared To Placebo – Pooled Doses   63 Db3 For 3 Months Followed By 1 Year Extension 100 mg/150 mg/200 mg/Day 1 Yr Result: Improvement From Baseline In Pain, Fatigue, Sleep And Quality Of Life   64 1double Blind-Placebo Controlled 2Sf-36 Is Physical Component Summary-36 3Double Blind

Table 1: Results of Clinical Trials Involving Milnacipran Treatment of Fms.