Table 4.

Summary outcomes for patients receiving modafinil or placebo in the narcolepsy studies

Study/Reference	Measure	Treatment	Mean (SD) at baseline	Mean (SD) at final visit	Mean (SD) change from baseline to final visit	P-valuea
9-week study #1/US Modafinil in Narcolepsy Multicenter Study Group 1998	MSLT sleep latency (min)	Modafinil 200 mg	2.9 (2.5)	4.7 (4.4)		<0.001
		Modafinil 400 mg	3.3 (2.9)	5.2 (4.5)		<0.001
		Placebo	2.8 (2.2)	3.3 (3.2)
	MWT sleep latency (min)	Modafinil 200 mg	5.8 (5.0)	8.1 (6.1)		<0.001
		Modafinil 400 mg	6.6 (5.2)	8.9 (6.2)		<0.001
		Placebo	5.8 (4.7)	5.1 (4.7)
	ESS score	Modafinil 200 mg	17.9 (3.8)	14.4 (5.7)		<0.001
		Modafinil 400 mg	17.1 (4.2)	13.0 (5.7)		<0.001
		Placebo	18.3 (3.3)	17.1 (5.0)
9-week study #2/US Modafinil in Narcolepsy Multicenter Study Group 2000	MSLT sleep latency (min)	Modafinil 200 mg	3.0 (2.2)	4.9 (4.3)		<0.001
		Modafinil 400 mg	2.7 (2.0)	5.1 (4.0)
		Placebo	2.2 (1.8)	3.5 (3.4)
	MWT sleep latency (min)	Modafinil 200 mg	6.1 (4.9)	8.2 (5.9)		0.001
		Modafinil 400 mg	5.9 (4.4)	7.8 (5.3)		<0.001
		Placebo	6.0 (5.0)	5.5 (4.5)
	ESS score	Modafinil 200 mg	17.4 (3.8)	13.0 (5.1)		<0.001
		Modafinil 400 mg	18.0 (3.4)	12.3 (5.1)		<0.001
		Placebo	17.6 (4.0)	15.8 (4.8)
9-week studies combined/Beusterien et al 1999	SF-36 vitality	Modafinil 200 mg			11	<0.05
		Modafinil 400 mg			13	<0.05
		Placebo			3
	SF-36 role limitations-	Modafinil 200 mg			6
	emotional	Modafinil 400 mg			10	<0.05
		Placebo			–1
	SF-36 role limitations-	Modafinil 200 mg			14	<0.05
	physical	Modafinil 400 mg			20	<0.05
		Placebo			6
	SF-36 social function	Modafinil 200 mg			6
		Modafinil 400 mg			11	<0.05
		Placebo			2

^aFor the change from baseline for modafinil versus placebo.

Abbreviations: SD, standard deviation; MSLT, Multiple Sleep Latency Test; MWT, Maintenance of Wakefulness Test; ESS, Epworth Sleepiness Scale.