Table 1.
Summary of clinical trials that investigated efficacy and safety of glycopyrrolate in children with drooling
| Reference | Study design | Subjects | Dose range | Duration | Outcome measure(s) |
|---|---|---|---|---|---|
| Blasco and Stansbury15 | Open-label, dose-ranging | 40 children and young adults (4–27 years, mean 12.5 years) | 0.01–0.082 mg/kg/day, median 0.09 mg/kg/day, split into 1–5 times daily | 8 months–4 years | Change in drooling quantity (“better, worse, same”) and side effects |
| Stern16 | Open-label | 24 children (3–23 years, mean 13.4 years) and young adults with moderate to profuse drooling | 0.04–0.1 mg/kg/day with maximum of 0.175 mg/kg/day, given as once daily dose | Up to 28 months | Questionnaire and drooling scale of Thomas-Stonell and Greenberg21 |
| Bachrach et al13 | Open-label, retrospective | 37 patients with cerebral palsy (9 months–20 years, mean 8.3 ± 4.8) | 0.01–0.04 mg/kg/dose, “most commonly” given tid (ie, 0.03–0.12 mg/kg/day) | 1–34 months | 5-point rating scale of Camp-Bruno22 and side effects (Teacher Drooling Scale) |
| Mier et al19 | Double-blind, dose-ranging | 39 children (4.33–19 years, mean 10.75 years) mixed neurological disorders, mostly cerebral palsy | 0.04 mg/kg/dose to 0.2 mg/kg/dose, mean 0.22 mg/kg/dose in tid dosing Subjects <30 kg: 0.6 mg, increasing each week up to 2.4 mg, split into tid dosing Subjects >30 kg: 1.2 mg, increasing each week up to 3.0 mg, split into tid dosing |
8 weeks placebo or glycopyrrolate, 1 week washout then 8 weeks in reciprocal treatment | Parental/caregiver and investigator evaluation of change in sialorrhea on 9-point drooling scale, modified Teacher Drooling Scale (0 = never drools to 9 = profuse drooling) |
| Package insert study 17 | Double-blind, placebo-controlled | 20 subjects with cerebral palsy, mental retardation, or other neurologic condition associated with problem drooling defined as drooling in the absence of treatment so that clothing became damp on most days (approximately 5–7 days per week) | 0.02 mg/kg/dose to 0.1 mg/kg/dose tid, not exceeding 3 mg tid | Up to 4 week titration plus 4 weeks at maximum tolerated dose | 9-point modified Teacher Drooling Scale6 (0 = dry, never drools to 9 = profuse, clothing, hands, tray, and objects frequently become wet) |
| Study 27 | Open-label | 151 patients (20 patients from study 1 plus additional 131 patients) | Not stated in package insert; per FDA Summary Review,18 max 3 mg tid 0.02 mg/kg, 0.04 mg/kg, 0.06 mg/kg, 0.08 mg/kg, 0.1 mg/kg | Not stated in package insert; per FDA Summary Review, 24 weeks | Not stated in package insert; per FDA Summary Review,18 9-point modified Teacher Drooling Scale |
Abbreviations: FDA, Food and Drug Administration; tid, three times a day.