Randomized Phase III evaluation of the efficacy and safety of a novel glycopyrrolate oral solution for the management of chronic severe drooling in children with cerebral palsy or other neurologic conditions

@inproceedings{Zeller2012RandomizedPI,
  title={Randomized Phase III evaluation of the efficacy and safety of a novel glycopyrrolate oral solution for the management of chronic severe drooling in children with cerebral palsy or other neurologic conditions},
  author={Robert S Zeller and Hak-Myung Lee and Paul F. Cavanaugh and Jennifer Davidson},
  booktitle={Therapeutics and clinical risk management},
  year={2012}
}
AIM To evaluate the efficacy of glycopyrrolate oral solution (1 mg/5 mL) in managing problem drooling associated with cerebral palsy and other neurologic conditions. METHOD Thirty-eight patients aged 3-23 years weighing at least 27 lb (12.2 kg) with severe drooling (clothing damp 5-7 days/week) were randomized to glycopyrrolate (n = 20), 0.02-0.1 mg/kg three times a day, or matching placebo (n = 18). Primary efficacy endpoint was responder rate, defined as percentage showing ≥3-point change… CONTINUE READING

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