Table 2.

Efficacy endpoints for the 8- and 4-study pools

Efficacy endpoint	LS mean difference from placebo in the change from baseline (95%CI)
	Istradefylline 20 mg/day	Istradefylline 40 mg/day
Total OFF time (hours/day)
8-study pool	–0.38 (–0.61, –0.15)	–0.45 (–0.68, –0.22)
4-study pool	–0.75 (–1.10, –0.40)	–0.82 (–1.17, –0.47)
ON time without troublesome dyskinesia (hours/day)
8-study pool	0.40 (0.15, 0.66)	0.33 (0.08, 0.59)
4-study pool	0.68 (0.31, 1.06)	0.69 (0.32, 1.07)
Total ON time (hours/day)
8-study pool	0.48 (0.24, 0.71)	0.45 (0.22, 0.69)
4-study pool	0.81 (0.46, 1.16)	0.84 (0.49, 1.20)
ON time without dyskinesia (hours/day)
8-study pool	0.15 (–0.13, 0.44)	0.07 (–0.22, 0.35)
4-study pool	0.50 (0.10, 0.90)	0.53 (0.13, 0.94)
ON time with troublesome dyskinesia (hours/day)
8-study pool	0.08 (–0.06, 0.21)	0.13 (0.00, 0.26)
4-study pool	0.13 (–0.07, 0.32)	0.15 (–0.05, 0.34)
UPDRS Part II ON (score)
8-study pool	0.1 (–0.2, 0.4)	–0.2 (–0.5, 0.1)
4-study pool	0.19 (–0.19, 0.56)	–0.24 (–0.61, 0.14)
UPDRS Part III ON (score)
8-study pool	–0.6 (–1.3, 0.1)	–1.3 (–2.0, –0.6)
4-study pool	–1.36 (–2.34, –0.38)	–1.82 (–2.80, –0.84)

CI, confidence interval; LS, least-squares; UPDRS, Unified Parkinson’s Disease Rating Scale.