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Glycopyrronium 320 μg/mL in children and adolescents with severe sialorrhoea and neurodisabilities: A randomized, double-blind, placebo-controlled trial.

Pierre FayouxMickael DinomaisHelen ShawFrédéric VillainDéborah SchwartzStéphane RondeauGuy LetellierStėphane Auvin
Published in: Developmental medicine and child neurology (2024)
The formulation of 320 μg/mL glycopyrronium significantly improved Drooling Impact Scale score versus placebo at day 84. The formulation reduced the impact of drooling on the child's and family's quality of life. There were no safety or tolerability concerns with this specific formulation.
Keyphrases
  • double blind
  • placebo controlled
  • drug delivery
  • clinical trial
  • phase iii
  • study protocol
  • phase ii
  • mental health
  • open label
  • early onset
  • randomized controlled trial