Results tables

Results tables

Table 5 Ferreira J et al. 2016 (BIPARK I)

Placebo

Opicapone

50 mg

Entacapone

200 mg

Analysis

n (full analysis set) a

120

115

120

Primary outcome

Adjusted least squares mean change from baseline in absolute time (mins) in the off state

−56.0

(from a baseline of 6.2 hours)

−116.8

(from a baseline of 6.2 hours)

−96.3

(from a baseline of 6.5 hours)

Mean difference vs placebo (95% CI)b

Opicapone 50 mg:

−60.8 mins (−97.2 to −24.4), p=0.0015

Entacapone 200 mg:

−40.3 mins (−76.2 to −4.3), p=0.014

Mean difference between entacapone 200 mg vs opicapone 50 mg

(95% CI)c, d

−26.2 mins (−63.8 to 11.4), p=0.0051

Selected secondary outcomes

Number of participants achieving a 1 hour or more reduction in absolute time in the off state

57/120 (48%)

80/115
(70%)

70/120
(58%)

Comparison with placebo OR (95% CI)

Opicapone 50 mg:

2.5 (1.5 to 4.3), p=0.001

Entacapone 200 mg:

1.6 (0.9 to 2.6), p=0.094, NS

Number of participants achieving a 1 hour or more increase in the absolute time in the on state

55/120 (46%)

75/115 (65%)

69/120 (58%)

Comparison with placebo OR (95% CI)

Opicapone 50 mg:

2.2 (1.3 to 3.8), p=0.003

Entacapone 200 mg:

1.6 (1.0 to 2.7), p=0.067, NS

Least squares mean change in total time (mins) in the on state to study end

47.1

(from a baseline of 10 hours)

119.0

(from a baseline of 9.9 hours)

99.7

(from a baseline of 9.6 hours)

Mean difference vs placebo (95% CI)

Opicapone 50 mg:

71.9 (35.0 to 108.8), p=0.0001

Entacapone 200 mg:

52.6 (16.1 to 89.1), p=0.005

Least squares mean change in time (mins) in the on state without troublesome dyskinesia

46.5

109.1

94.1

Mean difference vs placebo (95% CI)

Opicapone 50 mg:

62.6 (23.8 to 101.4), p=0.002

Entacapone 200 mg:

47.6 (9.3 to 6.0), p=0.02

Least squares mean change in the UPDRS total score from baseline to study ende

−5.4

−6.1

−6.1

p value vs placebof

Opicapone 50 mg, p=0.56, NS

Entacapone 200 mg, p=0.56, NS

Least squares mean change in the PDSS score from baseline to study endg

1.0

2.9

2.9

p value vs placebof

Opicapone 50 mg, p=0.45, NS

Entacapone 200 mg, p=0.45, NS

Least squares mean change in the PDQ-39 total score from baseline to study endh

−2.6

−2.8

−4.0

p value vs placebof

Opicapone 50 mg, p=0.90, NS

Entacapone 200 mg, p=0.28, NS

Least squares mean change in the NMSS score from baseline to study endi

−5.7

−2.0

−4.7

p value vs placebof

Opicapone 50 mg, p=0.06, NS

Entacapone 200 mg, p=0.63, NS

CGI-C (% of patients with improvement)j

49.9

73

50.9

p value vs placebof

Opicapone 50 mg, p=0.0005

Entacapone 200 mg, p=0.61, NS

PGI-C (% of patients with improvement)j

50.9

72.1

52.5

p value vs placebof

Opicapone 50 mg, p=0.0008

Entacapone 200 mg, p=0.47, NS

Safety and tolerability outcomes

n (safety set)

121

115

122

Number of participants with at least 1 TEAEs

60/121 (50%)

62/115 (54%)

69/122 (57%)

Not reported

Number of participants with TEAEs leading to study medicine discontinuation

8/121 (7%)

5/115 (4%)

8/122 (7%)

Not reported

Number of participants with TEAEs

6/121 (5%)

4/115 (3%)

8/122 (7%)

Not reported

Number of participants with dyskinesia

5/121 (4%)

18/115 (16%)

10/122 (8%)

Not reported

a Intention-to-treat analysis (full analysis set)

b Superiority test vs placebo

c Non-inferiority test vs entacapone (non-inferiority margin of 30 minutes)

d Per protocol set: entacapone 200 mg, n=104; opicapone 50 mg, n=106, see EPAR for details.

e Analysed in 114 participants in the placebo group, 109 in the opicapone 50 mg group and 111 in the entacapone group

f Effect size not reported in the paper

g Analysed in 117 participants in the placebo group, 112 in the opicapone 50 mg group and 118 in the entacapone group

h Analysed in 120 patients in the placebo group, 113 in the opicapone 50 mg group and 117 in the entacapone group

i Analysed in 118 patients in the placebo group, 112 in the opicapone 50 mg group and 116 in the entacapone group

J Data for 3 participants in the entacapone group and for 2 participants in the opicapone group were missing or they were not assessed

Abbreviations: CGI‑C, clinician global impression of change; CI, confidence interval; NS, not statistically significant; OR, odds ratio; PGI‑C, patient global impression of change; TEAE, treatment-emergent adverse event.