Efficacy and Safety Study of Oral Glycopyrrolate Liquid to Manage Problem Drooling Associated With Cerebral Palsy or Other Neurologic Conditions in Children
Information source: ResearchPoint
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Sialorrhea; Cerebral Palsy; Neurological Condition; Mental Retardation
Intervention: Oral Glycopyrrolate Liquid (Drug)
Phase: Phase 2/Phase 3
Status: Completed
Sponsored by: ResearchPoint
Summary
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.
Clinical Details
Official title: A Double-Blind, Randomized, Placebo-Controlled Trial to Evaluate the Efficacy and Safety of Oral Glycopyrrolate Liquid (1 mg Per 5 mL) for the Management of Problem Drooling Associated With Cerebral Palsy or Other Neurologic Conditions in Children
Study design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Primary outcome: Primary efficacy measurement will be assessment of the degree (severity and frequency) of drooling as measured by parents/caregivers using the modified 9-point Teacher's Drooling Scale (TDS) at baseline and weeks 2, 4, 6 and 8.
Secondary outcome: Assessment of the proportion of responders between the placebo and glycopyrrolate-treated patientsEvaluation 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.
Eligibility
Minimum age: 3 Years.
Maximum age: 16 Years.
Gender(s): Both.
Criteria:
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.
Locations and Contacts
Alfred I. duPont Hospital for Children, Wilmington, Delaware 49899, United States
Shriners Hospital for Children, Lexington, Kentucky 40502, United States
University of Rochester Medical Center, Rochester, New York 14642, United States
Winthrop University Hospital - Clinical Trials Center, Mineola, New York 11501, United States
Cincinnati Children's Hospital Medical Center, Cincinnati, Ohio 45229-3039, United States
Mid-South Physicians Group, P.L.L.C., Germantown, Tennessee 38138, United States
Alamo City Clinical Research, San Antonio, Texas 78258, United States
Cook Children's Medical Center, Fort Worth, Texas 76104, United States
Texas Children's Hospital, Houston, Texas 77030-2303, United States
Texas Scottich Rite Hospital for Children, Dallas, Texas 75219-3924, United States
University of Virginia - Kluge Children's Rehabilitation Center, Charlottesville, Virginia 22903, United States
Additional Information
Ending date: February 2008
Last updated: February 5, 2008
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