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

NCT ID: NCT00491894

Last Updated: 2012-07-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 137 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-03-31
• Study Completion Date: 2008-06-30

Brief Summary

This is an open-label clinical research study of an oral glycopyrrolate liquid for the treatment of chronic moderate to severe drooling in patients with cerebral palsy or other neurological conditions. Patients participating in the study will receive oral glycopyrrolate liquid (1 mg/5 ml) three times a day (TID) for study duration of 24 weeks. After a washout, screening, and 2-day baseline period, patients will be enrolled in a 4-week dose titration period. Glycopyrrolate liquid doses will be titrated using dose levels in the Dose Titration Schedule. Titration will begin at 0.02 mg/kg per dose TID and sequentially increased in 0.02 mg/kg per dose increments TID every 5-7 days during the first four weeks until optimal individualized response is obtained for each patient or a maximum dose of 0.1 mg/kg TID is reached, not exceeding 3 mg TID or Dose-level 5 in the Dose Titration Schedule, whichever is lesser. Optimal dose for each patient is the dose at which he/she is receiving the maximum benefit from the study drug (greatest improvement in drooling) while experiencing minimum side effects. All patients will receive close attention by study staff throughout the study.

Conditions

Cerebral Palsy; Neurological Conditions; Mental Retardation; Sialorrhea

Keywords

Mental Retardation; Neurological Impairment; Cerebral Palsy; Drooling; Neurological Conditions

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Patients with Chronic Drooling

Arm receiving study drug

Group Type: OTHER

Oral Glycopyrrolate Liquid

Intervention Type: DRUG

Study medication is administered three times a day at 7-8 AM, 1-2 PM, and 7-8 PM by the parent/caregiver

Interventions

Oral Glycopyrrolate Liquid

Study medication is administered three times a day at 7-8 AM, 1-2 PM, and 7-8 PM by the parent/caregiver

Intervention Type: DRUG

Eligibility Criteria

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 neurologic impairment or condition (cognitively capable and cognitively impaired patients may be enrolled)
• Chronic drooling in the absence of treatment to the extent that the chin or clothing becomes 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 and capable 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, as determined by the investigator, and required by the site's Institutional Review Board
• If female of childbearing potential, the patient must have a negative pregnancy test at screening and Visit 2
• If female of childbearing potential and sexually active, she must use a medically acceptable 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 of the baseline period, which began on Day -2
• Patients who used prohibited medications within 5 plasma half-lives of the medication prior to the start of the baseline period
• Patients injected with intrasalivary gland botulinum toxin within 10 months prior to the start of the baseline period
• Patients using intraoral devices or prosthetics for the treatment of drooling within 1 week prior to the start of the baseline period
• Patients receiving acupuncture for the treatment of drooling or who have received acupuncture for the treatment of drooling within 3 months prior to the start of the baseline period
• Patients who have medical conditions contraindicating anticholinergic therapy including 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, vesicoureteral reflux, reactive airway disease, myasthenia gravis, hyperthyroidism, cardiac arrhythmias and/or tachycardia, and/or clinically significant electrocardiogram abnormalities, as determined by the investigator
• Patients who have a known contraindication to the study medication, including allergy to 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 the discretion 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 the study procedures, as judged by the investigator
• Patients who are unable to meet the requirements of the study for any reason, as determined by the investigator
• Patients who have unstable mental disease, as determined by the investigator

• Minimum Eligible Age: 3 Years
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shionogi

INDUSTRY

Sponsor Role: lead

Responsible Party

Shionogi

Principal Investigators

Shionogi Clinical Trials Administrator Clinical Support Help Line

Role: STUDY_DIRECTOR

Shionogi

Locations

Rocky Mountain Pediatrics

Lakewood, Colorado, United States

Child Neurology Associates, PC

Atlanta, Georgia, United States

St. Mary's for Children

Bayside, New York, United States

Akron's Childrens

Akron, Ohio, United States

Hattie Larltham Center for Children with Disabilities

Mantua, Ohio, United States

The Children's Center

Bethany, Oklahoma, United States

Alamo City Clinical Research

San Antonio, Texas, United States

Countries

United States

References

Zeller RS, Lee HM, Cavanaugh PF, Davidson J. 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. Ther Clin Risk Manag. 2012;8:15-23. doi: 10.2147/TCRM.S26893. Epub 2012 Jan 25.

Reference Type: DERIVED

PMID: 22298950 (View on PubMed)

Other Identifiers

Sc-GLYCO-06-01

Identifier Type: -

Identifier Source: org_study_id

NCT00425087

Identifier Type: -

Identifier Source: nct_alias