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      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

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          Abstract

          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.

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          Author and article information

          Journal
          Ther Clin Risk Manag
          Ther Clin Risk Manag
          Therapeutics and Clinical Risk Management
          Therapeutics and Clinical Risk Management
          Dove Medical Press
          1176-6336
          1178-203X
          2012
          2012
          25 January 2012
          : 8
          : 15-23
          Affiliations
          [1 ]Blue Bird Circle Clinic for Pediatric Neurology at Texas Children’s Hospital and Baylor College of Medicine, Houston, TX, USA
          [2 ]Shionogi Inc, Florham Park, NJ, USA
          Author notes
          Correspondence: Robert S Zeller, Texas Children’s Hospital, Clinical Care Center, 6701 Fannin Street, Houston, TX 77030, USA, Tel +1 832 822 0150, Fax +1 832 825 3072, Email rszeller@ 123456texaschildrens.org
          Article
          tcrm-8-015
          10.2147/TCRM.S26893
          3269347
          22298950
          © 2012 Zeller et al, publisher and licensee Dove Medical Press Ltd.

          This is an Open Access article which permits unrestricted noncommercial use, provided the original work is properly cited.

          Categories
          Original Research

          Medicine

          cholinergic antagonists, randomized controlled trial, sialorrhea

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