Safety and Efficacy Study of Oral Glycopyrrolate Liquid for the Treatment of Pathologic (Chronic Moderate to Severe) Drooling in Pediatric Patients 3 to 18 Years of Age With Cerebral Palsy or Other Neurologic Conditions

Inclusion Criteria: To be included in this study, patients must meet the following criteria:

• Male or female, weighing at least 13 kilograms (27 pounds), aged 3 through 18 years

• Diagnosis of cerebral palsy and/or mental retardation or any other neurologicimpairment or condition (cognitively capable and cognitively impaired patients may beenrolled)

• Chronic drooling in the absence of treatment to the extent that the chin or clothingbecomes wet on most days by confirming the Modified Teacher's Drooling Scale score ≥ 5

• Must be living in a situation where reliable parents/caregivers are willing andcapable of administering medications, as determined by the investigator

• Written informed consent signed by the parent or legally acceptable representative

• Written assent signed by the age-appropriate patient if mentally capable, asdetermined by the investigator, and required by the site's Institutional Review Board

• If female of childbearing potential, the patient must have a negative pregnancy testat screening and Visit 2

• If female of childbearing potential and sexually active, she must use a medicallyacceptable form of contraception

Exclusion Criteria: Patients are excluded from this study if they meet any of the following criteria:

• Patients who used glycopyrrolate within approximately 24 hours prior to the start ofthe baseline period, which began on Day -2

• Patients who used prohibited medications within 5 plasma half-lives of the medicationprior to the start of the baseline period

• Patients injected with intrasalivary gland botulinum toxin within 10 months prior tothe start of the baseline period

• Patients using intraoral devices or prosthetics for the treatment of drooling within 1week prior to the start of the baseline period

• Patients receiving acupuncture for the treatment of drooling or who have receivedacupuncture for the treatment of drooling within 3 months prior to the start of thebaseline period

• Patients who have medical conditions contraindicating anticholinergic therapyincluding gastrointestinal reflux, narrow-angle glaucoma, obstructive uropathy,obstructive disease of the gastrointestinal tract (i.e., delayed gastric emptying,pyloroduodenal stenosis, etc.), paralytic ileus, intestinal atony, vesicoureteralreflux, reactive airway disease, myasthenia gravis, hyperthyroidism, cardiacarrhythmias and/or tachycardia, and/or clinically significant electrocardiogramabnormalities, as determined by the investigator

• Patients who have a known contraindication to the study medication, including allergyto the study medication or any of its components

• Patients who have poorly controlled seizures defined as daily seizures

• Patients who have a history of obstructive disease of the gastrointestinal tract (i.e., intestinal obstruction)

• Patients who have clinically significant hepatic or renal impairment, at thediscretion of the investigator

• Patients who are pregnant or breastfeeding

• Patients who have received any investigational drugs within 30 days of study entry

• Patient, families, or parents/caregivers who are expected to be non-compliant with thestudy procedures, as judged by the investigator

• Patients who are unable to meet the requirements of the study for any reason, asdetermined by the investigator

• Patients who have unstable mental disease, as determined by the investigator