Gabapentin: Efficacy and tolerability as adjuvant therapy for dystonic cerebral palsy

Objectives: To study the effectiveness, safety and tolerability of Gabapentin as adjuvant therapy in dystonic cerebral palsy

Methods: A prospective, double-blind, randomised placebo-controlled trial was conducted in children with predominantly dystonic cerebral palsy. Only those patients with upto two tone medications were enrolled. They were scaled for motor severity by Gross Motor Functional Classification system (GMFCS), quality of life by PedsQL Cerebral Palsy Module, dystonia by Barry-Albright Dystonia Scale (BADS) and Movement Disorder Childhood Rating Scale (MD-CRS). Patients were randomised for treatment with gabapentin or placebo. The scales were administered on first visit , first follow-up (week-12), second follow-up (week-24), video-recorded, by same neurophysician each visit. Results: 48 children were enrolled, mean age 4.8 years, M:F ratio 2.1:1. Dose of gabapentin ranged 12.6 -64.8 mg/kg/day, reduction needed in 19%, in placebo, dose reduction needed in 5%. The ongoing tone medications- trihexyphenidyl, baclofen, tizanidine, clonazepam. Change of atleast 2 points in dystonia scales noted higher in gabapentin group (BADS 60% vs 50%, MDCRS-1 63.6% vs 55%, MDCRS-2 45.4% vs 35%). Improvement in PedsQL reported in 68.2% versus 50%. However, no significant difference was observed in change in scores in gabapentin versus placebo groups at 12 and 24 weeks: p-value for BADS, MDCRS-1, MDCRS-2, PedsQL not significant. Incidence of side effect comparable in both groups (28.7% vs 26.7%). Most common side effect observed: gabapentin- increased appetite, insomnia; placebo- irritability, increased stiffness. Conclusion: Additional gabapentin as adjuvant therapy to already existing tone medications is well tolerated, however, does not show significant additional therapy.