Table 4 Continued

Resolution of hypsarrhythmia, no. (%)Relapse, no. (%)Side effects, no. (%)D/C, no. (%)Time to improved, d
* 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.
1 (2) diedNil12
1 (5)2 (10)6 (30)Nil
5 (25)4 (20)12 (60)Nil
32 (23)14 (16)Sed 42 (25), Insom 15 (9), Irrit 15 (9)9 (6)NS
8 (11)NS
24 (36)NS
11 (48)1 (8)2 (13), 1 (5) died**I (4)14
45 (39)20 (17)Sed 19 (16), Irrit 15 (13)Nil30
NS3 (14)2 (10) 2 died‡‡Nil35
NS5 (29)Weight gain, Irrit, Sed 4 (14)NilNS
5 (83)1 (25)Hypotonia, Irrit 2 (33)NilNS
14 (50)0 (0)Sed 4 (14)Nil14
NS3 (27)MildNil17
8 (39)1 (6)3 (14)NilNS
NS5 (56)Irrit, Sed 2 (11)NilNS
19 (76)4 (25)3 (12) Irrit 2, Sed 1Nil12
1 (14) CN0 (0)NSNS21
132 (69)28 (21)33 (13)2 (1)7