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

NCT00491894 | Completed Phase 3 Results

• 1 other identifier: Sc-GLYCO-06-01
• Study Type: interventional
• Target: 137
• Locations: 1 country
• Sites: 7

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

Outcome Measures

Primary Outcomes (1)

• Proportion of Responders According to the Modified Teacher's Drooling Scale (mTDS)

  The primary efficacy variable was patient's response status using the change from baseline to Week 24 evaluations of the mTDS assessment. Each patient was classified as a responder or non-responder according to the change in their mean mTDS rating from baseline to Week 24. Responders were patients who had at least a 3-point decrease in mTDS rating from baseline

  6 months

Secondary Outcomes (4)

• Parent/Caregiver's Assessment of the Extent of Drooling Using Visual Analog Scale (VAS)

  Baseline

• Parent/Caregiver's Assessment of the Extent of Drooling Using VAS

  Week 24

• Parent/Caregiver's Global Assessment of Treatment

  Week 24

• Investigator's Global Assessment of Treatment

  Week 24

Study Arms (1)

Patients with Chronic Drooling

OTHER

Arm receiving study drug

Drug: Oral Glycopyrrolate Liquid

Interventions

Oral Glycopyrrolate Liquid DRUG

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

Patients with Chronic Drooling

Eligibility Criteria

• Age: 3 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Shionogi: lead

Study Sites (7)

Rocky Mountain Pediatrics

Lakewood, Colorado, 80214, United States

Location

Child Neurology Associates, PC

Atlanta, Georgia, 30342, United States

Location

St. Mary's for Children

Bayside, New York, 11360, United States

Location

Akron's Childrens

Akron, Ohio, 44308, United States

Location

Hattie Larltham Center for Children with Disabilities

Mantua, Ohio, 44255, United States

Location

The Children's Center

Bethany, Oklahoma, 73008, United States

Location

Alamo City Clinical Research

San Antonio, Texas, 78258, United States

Location

Related Publications (1)

• 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.

  PMID: 22298950 DERIVED

MeSH Terms

Conditions

Cerebral Palsy; Intellectual Disability; Sialorrhea; Neurologic Manifestations

Condition Hierarchy (Ancestors)

Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurobehavioral Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurodevelopmental Disorders; Mental Disorders; Salivary Gland Diseases; Mouth Diseases; Stomatognathic Diseases

Limitations and Caveats

There were no limitations of the trial

Results Point of Contact

• Title: Shionogi Clinical Trials Administrator
• Organization: Shionogi USA

shionogiclintrialsadmin@shionogi.com

800-849-9707

Study Officials

• Shionogi Clinical Trials Administrator Clinical Support Help Line

  Shionogi

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: June 22, 2007
• First Posted: June 26, 2007
• Study Start: March 1, 2007
• Primary Completion: May 1, 2008
• Study Completion: June 1, 2008
• Last Updated: July 9, 2012
• Results First Posted: July 9, 2012

Record last verified: 2012-04

Locations

US (7)