Table 4 Vigabatrin studies: Short-term results

Ref.nClassDose, mg/kgOther RxMean (range) F/U, moCessation 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.
3140I150Yes515 (42)*9 (32) vs 6 (50)
    Placebo202 (10)
    VGB207 (35)
32179IIIYes(3–24)32 (23)87 (65)20 (21) vs 45 (27)
    LD9018–368 (11)NS
    HD89100–14824 (36)NS
19§23III100–150No(9–24)11 (48)7 (44) vs 4 (57)
33116IV50–200No2345 (39)24 (29) vs 21 (62)
3423IV50–150Yes6511 (48)13 (72)††7 (37) vs 4 (100)
3529IV50–125No1817 (59)13 (59) vs 4 (66)
366IV50–100No134 (75)1 (33) vs 3 (100)
3728IV75–150No2018 (57)8 (47) vs 6 (55)
3842IV40–150Yes1011 (26)6 (19) vs 5 (50)
2521IV100–150NS2114 (67)11 (69)8 (72) vs 8 (80)
3918IV50–150No259 (50)4 (36) vs 5 (71)
4025IV60–80NS1916 (64)13 (68) vs 3 (50)
417IV50–100YesNS4 (57)3 (75) vs 1 (50)
42250IV25–400Yes8131 (68)97 (75) vs 43 (69)