Introduction: The trial was performed to determine the effectiveness and safety of high-dose oral pyridoxine (300mg/kg/day) as an adjunct to standard high dose ACTH (150 IU/m²) versus standard ACTH alone. The primary objective was to evaluate whether there was any significant group difference in  the proportion of children with complete cessation of epileptic spasms within 2 weeks of initiation of therapy and persistent till 6 weeks.

Methodology: The study design was an open-label, randomized controlled trial. Of 80 eligible participants, 42 were randomized in intervention (ACTH and pyridoxine) and 37 in control arm (ACTH). Group randomization was performed by the simple block randomization with unequal block sizes by a computer-generated sequence. Allocation was concealed.

Results: The study participants had a male preponderance, a high treatment lag and predominant symptomatic etiology. Comparison of efficacies of combined pyridoxine with ACTH versus ACTH alone were as following: cessation of epileptic spasms (51.2% vs. 59.5%, p=0.5), median EEG scores (interquartile range) by Jeavon’s Score at 6 weeks (2.5 (0-9) vs. 3 (0-11), p=0.2), median mental scores (interquartile range) by DASII at 12 weeks (34 (29.3 -37.8) vs. 49 (32.3-60), p=0.04), and median motor scores (interquartile range) by DASII at 12 weeks (39.5 (29 -49) vs. 45 (34.3- 62.8), p=0.7). Overall, high-dose oral pyridoxine was tolerable and safe.

Conclusion: There was no evidence to suggest the superiority of adjunct high-dose pyridoxine to ACTH versus ACTH alone for the treatment of West syndrome.