Efficacy and safety of nabiximols cannabinoid medicine for paediatric spasticity in cerebral palsy or traumatic brain injury: A randomized controlled trial
Researchers conducted this multicentre, randomized, placebo‐controlled trial to evaluate the effectiveness, safety, and tolerability of oromucosal nabiximols cannabinoid medicine as adjunct therapy for children with spasticity due to cerebral palsy/traumatic central nervous system injury with inadequate response to existing treatment. In total, 72 individuals (mean [SD] age 12y 4mo [3y 1mo], range 8‒18y) were randomized at a ratio of 2:1 to receive nabiximols (n = 47; 29 males, 18 females) or placebo (n = 25; 15 males, 10 females) for 12 weeks (12 sprays/day max. based on clinical response/tolerability). Paediatric patients usually respond well to oromucosal nabiximols.
Three cases of hallucinations, one of which involved auditory hallucinations and a suicide attempt, were however observed. Oromucosal nabiximols compared with placebo did not minimize cerebral palsy/central nervous system injury‐related spasticity.