Table 4 Vigabatrin studies: Short-term results

Ref.	n	Class	Dose, mg/kg	Other Rx	Mean (range) F/U, mo	Cessation of spasms, no. (%)	Cessation at later F/U, no. (%)	SIS vs. CIS, no. (%)
* Following entry to open-label phase.
† At end of double-blind phase.
‡ Fifty-two percent of tuberous sclerosis patients were spasm-free and had no hypsarrhythmia 2 wk after starting treatment. The number of patients seizure-free increased to 87 (65%) at 3 mo.
§ Results describe outcome at end of phase I (prior to crossover).
∥ Four (36%) have completely normal EEG.
¶ At end of phase II (after crossover).
** Cause of death unrelated to treatment.
†† Outcome at 3 mo.
‡‡ Cause of death not stated.
Rx = treatments; F/U = follow-up; SIS = symptomatic infantile spasm; CIS = cryptogenic spasm; D/C = discontinued because of side effects; VGB = vigabatrin; Sed = sedation; Insom = insomnia; Irrit = irritability/agitation; LD = low dose; NS = not stated; HD = high dose; CN = completely normal.
31	40	I	150	Yes	5	15 (42)^*		9 (32) vs 6 (50)
Placebo	20					2 (10)^†
VGB	20					7 (35)^†
32	179	III		Yes	(3–24)	32 (23)^‡	87 (65)^‡	20 (21) vs 45 (27)
LD	90		18–36			8 (11)	NS
HD	89		100–148			24 (36)	NS
19^§	23	III	100–150	No	(9–24)	11 (48)		7 (44) vs 4 (57)
33	116	IV	50–200	No	23	45 (39)		24 (29) vs 21 (62)
34	23	IV	50–150	Yes	65	11 (48)	13 (72)^††	7 (37) vs 4 (100)
35	29	IV	50–125	No	18	17 (59)		13 (59) vs 4 (66)
36	6	IV	50–100	No	13	4 (75)		1 (33) vs 3 (100)
37	28	IV	75–150	No	20	18 (57)		8 (47) vs 6 (55)
38	42	IV	40–150	Yes	10	11 (26)		6 (19) vs 5 (50)
25	21	IV	100–150	NS	21	14 (67)	11 (69)	8 (72) vs 8 (80)
39	18	IV	50–150	No	25	9 (50)		4 (36) vs 5 (71)
40	25	IV	60–80	NS	19	16 (64)		13 (68) vs 3 (50)
41	7	IV	50–100	Yes	NS	4 (57)		3 (75) vs 1 (50)
42	250	IV	25–400	Yes	8	131 (68)		97 (75) vs 43 (69)