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Table 3 Mean changes from baseline in the open-label period of the randomized withdrawal study

From: Preliminary experience using milnacipran in patients with juvenile fibromyalgia: lessons from a clinical trial program

 

Nonrandomized

Randomized

n = 96

n = 20

Measures, mean (SD)

Baseline

Changea

Baseline

Changea

Pain, range 0-10

6.5 (1.4)

−1.1 (1.6)

6.1 (1.3)

−3.3 (1.0)

PGIS, range 1-7

4.0 (0.8)

−0.4 (1.0)

4.0 (0.8)

−1.0 (1.0)

PedsQL-Generic Core Scales, range 0-100

55.6 (14.8)

4.5 (13.0)

54.2 (11.4)

10.9 (10.9)

PedsQL-Multidimensional Fatigue Scale, range 0-100

46.1 (17.6)

5.8 (15.3)

41.3 (13.3)

13.3 (12.1)

MASC, range 0-117

45.1 (16.5)

−2.4 (12.2)

46.1 (13.4)

−5.4 (13.2)

CDI, range 0-54b

11.9 (7.1)

−1.2 (5.0)

11.1 (5.5)

−2.4 (4.9)

  1. aChanges are based on end-of-treatment values. Negative changes represent mean improvements in pain, PGIS, MASC, and CDI scores; positive values represent mean improvements in PedsQL scores. For pain, data were based on electronic entries from Week 7 (i.e., the last week prior to randomization). For other measures, data were based on last available open-label assessments, including those from patients who prematurely discontinued the study
  2. bPrimarily used in this study as a safety assessment to monitor changes in depressive symptoms
  3. CDI = Children’s Depression Inventory, MASC = Multidimensional Anxiety Scale, PGIS = Patient Global Impression of Severity, PedsQL = Pediatric Quality of Life Inventory-Teen Report, SD = standard deviation
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Pediatric Rheumatology

ISSN: 1546-0096