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.
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