A randomized controlled trial of flunarizine as add-on therapy and effect on cognitive outcome in children with infantile spasms
Bitton JY et al. – The study failed to demonstrate a protective effect of flunarizine on cognitive outcome in a cohort of children with IS. An analysis of subgroups suggested that flunarizine may further improve cognitive outcome in children with no identified etiology.Methods
- In a randomized controlled trial, patients received a standardized therapy plus flunarizine or placebo.
- The standardized treatment consisted of vigabatrin as first-line therapy.
- Nonresponders were switched to intramuscular synthetic adrenocorticotropic hormone (sACTH depot) after 2 weeks and, if necessary, to topiramate after two additional weeks.
- The Vineland Adaptive Behavior Scale (VABS) and Bayley Scales of Infant Development (BSID) were used as outcome measures 24 months after the intervention.
- Sixty-eight of 101 children diagnosed over 3 years in seven centers in Canada received either adjunctive flunarizine or placebo.
- Sixty-five of the 68 children (96%) became spasm-free within 8 weeks and no late relapse occurred.
- Bayley and Vineland results were available at baseline and at 24 months in 45 children.
- There was no significant difference in the BSID developmental quotient between the flunarizine- and placebo-treated children at baseline (44.3 ± 35.5 vs. 30.9 ± 29.8; p=0.18) or 24 months later (56.9 ± 33.3 vs. 46 ± 34.2; p=0.29).
- However, the 10 flunarizine-treated children with no identified etiology had a better outcome than the eight controls at 24 months on both the Vineland Scale (84.1 ± 11.3 vs. 72.3 ± 9.8; p=0.03) and the Bayley Scale (87.6 ± 14.7 vs. 69.9 ± 25.3; p=0.07).