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
Robert S Zeller1, Hak-Myung Lee2, Paul Cavanaugh2, Jennifer Davidson2
1Blue Bird Circle Clinic for Pediatric Neurology at Texas Children's Hospital and Baylor College of Medicine, Houston, TX, USA; 2Shionogi Inc, Florham Park, NJ, USA
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 on the modified Teacher's Drooling Scale (mTDS).
Results: Responder rate was significantly higher for the glycopyrrolate (14/19; 73.7%) than for the placebo (3/17; 17.6%) group (P = 0.0011), with improvements starting 2 weeks after treatment initiation. Mean improvements in mTDS at week 8 were significantly greater in the glycopyrrolate than in the placebo group (3.94 ± 1.95 vs 0.71 ± 2.14 points; P < 0.0001). In addition, 84% of physicians and 100% of parents/caregivers regarded glycopyrrolate as worthwhile compared with 41% and 56%, respectively, for placebo (P ≤ 0.014). Most frequently reported treatment-emergent adverse events (glycopyrrolate vs placebo) were dry mouth, constipation, and vomiting.
Interpretation: Children aged 3–16 years with problem drooling due to neurologic conditions showed a significantly better response, as assessed by mTDS, to glycopyrrolate than to placebo.
ClinicalTrials.gov identifier: NCT00425087.
Keywords: sialorrhea, randomized controlled trial, cholinergic antagonists
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Other article by this author:
Safety and efficacy of glycopyrrolate oral solution for management of pathologic drooling in pediatric patients with cerebral palsy and other neurologic conditions
Zeller RS, Davidson J, Lee HM, Cavanaugh PF
Published Date: 25 January 2012
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