Skip to main content

Table 2 Change from baseline in efficacy endpoints (full-analysis set)

From: Adjunct rasagiline to treat Parkinson’s disease with motor fluctuations: a randomized, double-blind study in China

 

Adjusted mean change from baseline (SE)

Difference vs placebo (95% CI)

p-values

Placebo (n = 152)

Rasagiline 1 mg/day (n = 158)

Primary endpoint (mean change over Weeks 4, 8, 12, and 16; ANCOVA, OC)

Total daily OFF time, hoursa

− 0.76 (0.16)

−1.25 (0.16)

−0.50 (− 0.92, − 0.07)

0.023

Secondary endpoints (Week 16; ANCOVA, LOCF)

 CGI-Ib

3.56 (0.07)

3.15 (0.07)

−0.41 (− 0.61, − 0.22)

< 0.001

 UPDRS-ADL OFF

−1.20 (0.28)

− 2.21 (0.28)

− 1.01 (− 1.75, − 0.27)

0.008

 UPDRS-Motor ON

−1.75 (0.55)

− 3.34 (0.55)

− 1.60 (− 3.05, − 0.14)

0.032

Exploratory analyses (mean change from baseline to Week 16 in total daily OFF time)

 ANCOVA, OC

−0.87 (0.21) (n = 147)

− 1.39 (0.21) (n = 151)

− 0.52 (− 1.06, 0.02)

0.0602

 ANCOVA, LOCF

−0.81 (0.20)

− 1.36 (0.20)

−0.55 (− 1.08, − 0.02)

0.0412

 MMRM, OC

−0.81 (0.20)

−1.34 (0.20)

− 0.53 (− 1.07, 0.00)

0.0514

PDQ-39 summary index and dimension scores (mean change, SE at Week 16; ANCOVA, OC)

 Summary index

−0.1 (0.8)

−1.9 (0.8)

−1.8 (−3.96, 0.42)

0.1122

 Activities of daily living

2.0 (1.3)

−4.0 (1.3)

−6.1 (−9.52, − 2.64)

< 0.001

 Bodily discomfort

1.7 (1.4)

− 2.2 (1.4)

−3.9 (− 7.65, − 0.12)

0.043

 Cognition

0.9 (1.2)

0.4 (1.2)

−0.6 (−3.77, 2.67)

0.737

 Communication

−1.0 (1.2)

0.1 (1.2)

1.1 (−2.09, 4.23)

0.506

 Emotional well-being

−0.6 (1.5)

−3.0 (1.5)

−2.4 (−6.35, 1.49)

0.224

 Mobility

−1.6 (1.2)

−4.1 (1.2)

−2.5 (−5.59, 0.53)

0.104

 Social support

−1.2 (1.1)

0.4 (1.1)

1.6 (−1.35, 4.53)

0.288

Stigma

−2.2 (1.4)

−4.7 (1.4)

−2.5 (−6.22, 1.32)

0.202

EQ-5D (mean change, SE at Week 16; ANCOVA, OC)

 Utility index

0.00 (0.02)

0.05 (0.02)

0.05 (0.01, 0.09)

0.024

 Health statec

0.77 (1.18)

5.09 (1.20)

4.31 (1.18, 7.45)

0.007

  1. an = 150 for placebo group
  2. babsolute value at Week 16
  3. cmeasured using visual analogue scale