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 at Jaslok Hospital and Research Centre from May 2019 in children with predominantly dystonic cerebral palsy. Only those patients with upto two-tone medications were enrolled for the trial. 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 the first visit and then on the first follow-up(week-12,V1) and second follow-up(week-24,V2). Through physician interview, side effects were noted and doses adjusted. Results: 48 children were enrolled, mean age 4.92 years, M: F ratio 2:1. Dose of gabapentin ranged 12.6-64.8 mg/kg/day, reduction needed of 19%, in placebo, dose reduction required in 5%. The ongoing tone medications were trihexyphenidyl, baclofen, tizanidine and clonazepam. Mean percentage change in scores from the baseline at V1 and V2 for gabapentin group and placebo group showed no significant difference among the two: p-value at V1 being BADS 0.76, MD-CRS 0.77, PedsQL 0.84 and p-value at V2 being BADS 0.93, MD-CRS 0.78, PedsQL 0.83. Incidence of side effects was comparable in both groups (28.7% vs 26.7%). Most common side effect with gabapentin was increased appetite and insomnia, with placebo, irritability and increased stiffness. Conclusion: Gabapentin as adjuvant therapy is well tolerated; however, it is non-superior to placebo.
Keywords: Gabapentin, adjuvant, dystonic, cerebral palsy