• Assessment of the proportion of responders between the placebo and glycopyrrolate-treated patients
• Evaluation of the proportion of patients who drop out of the study due to lack of efficacy between test groups
• Parent/caregiver's global assessment, patient's global assessment (for those patients deemed cognitively capable by the investigator); and physician's global assessment performed at the last visit, Week 8, using a 5-point scale
• Assessment using a modified Behavioral and Medical Rating Scale (mBMRS) and by tabulation and description of all adverse events (AEs).
• Safety also will be evaluated by physical examinations (PEs), 12-lead electrocardiogram (ECGs), clinical laboratory test results, and urinalysis, assessed at baseline and Week 8.

• Assessment of the proportion of responders between the placebo and glycopyrrolate-treated patients
• Evaluation of the proportion of patients who drop out of the study due to lack of efficacy between test groups
• Parent/caregiver’s global assessment, patient’s global assessment (for those patients deemed cognitively capable by the investigator); and physician’s global assessment performed at the last visit, Week 8, using a 5-point scale
• Assessment using a modified Behavioral and Medical Rating Scale (mBMRS) and by tabulation and description of all adverse events (AEs).
• Safety also will be evaluated by physical examinations (PEs), 12-lead electrocardiogram (ECGs), clinical laboratory test results, and urinalysis, assessed at baseline and Week 8.

This multi-center randomized, double blind, eight-week study is designed to assess the safety and efficacy of oral Glycopyrrolate Liquid in the management of problem drooling associated with cerebral palsy or other neurologic conditions in children. In addition, the effectiveness of a training tool to help educate parents and caregivers in dose titration and the identification of adverse events associated with glycopyrrolate will also be assessed.

This is a clinical research study of an experimental oral liquid for the treatment of profuse, severe drooling in patients with cerebral palsy or other neurological conditions.

Patients participating in the study may receive an active drug (Oral Glycopyrrolate Liquid), or an inactive drug (placebo). What treatment a patient will receive is determined by chance (like drawing a number from a hat). Dosing amounts will be based on patient's weight and will be increased for possibly 4 weeks until optimal dose is achieved. All patients, no matter which treatment is assigned will receive very close attention by the study staff, during the time of participation.

Participation in the study can be up to 8 weeks.

• Sialorrhea
• Cerebral Palsy
• Neurological Condition
• Mental Retardation

Inclusion Criteria:

• Weigh at least 27 pounds.
• Be ages 3-16 years
• Have a diagnosis of cerebral palsy, mental retardation or any other neurological impairment or condition.
• Have profuse, severe drooling.
• Have a caregiver to administer medications.
• May have a tracheostomy.
• May have a gastrostomy feeding tube.

Exclusion Criteria:

• Using certain types of drugs, treatments, or therapies.
• Been injected with intra-salivary-gland botulinum toxin within 10 months.
• Received irradiation of salivary glands to reduce drooling.
• Received acupuncture for the treatment of drooling within 3 months.
• Symptomatic gastro-esophageal reflux (i.e., active vomiting).
• Poorly controlled seizures defined as daily seizures.
• Known delayed gastric emptying.
• History of intestinal obstruction.
• Pregnant or breastfeeding.