Efficacy and Safety Study of Oral Glycopyrrolate Liquid to Manage Problem Drooling Associated With Cerebral Palsy or Other Neurologic Conditions in Children - Full Text View

Purpose

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.

Condition	Intervention	Phase
Sialorrhea Cerebral Palsy Neurological Condition Mental Retardation	Drug: Oral Glycopyrrolate Liquid	Phase II Phase III

MedlinePlus related topics:

Caregivers Cerebral Palsy Paralysis

ChemIDplus related topics:

Glycopyrrolate

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study

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

Further study details as provided by ResearchPoint:

Primary Outcome Measures:

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 Measures:

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.

Estimated Enrollment:	40
Study Completion Date:	February 2008
Primary Completion Date:	April 2007 (Final data collection date for primary outcome measure)

Eligibility

Ages Eligible for Study:	3 Years to 16 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00425087

Locations


United States, Delaware
	Alfred I. duPont Hospital for Children
	Wilmington, Delaware, United States, 49899

United States, Kentucky
	Shriners Hospital for Children
	Lexington, Kentucky, United States, 40502

United States, New York
	University of Rochester Medical Center
	Rochester, New York, United States, 14642
	Winthrop University Hospital - Clinical Trials Center
	Mineola, New York, United States, 11501

United States, Ohio
	Cincinnati Children's Hospital Medical Center
	Cincinnati, Ohio, United States, 45229-3039

United States, Tennessee
	Mid-South Physicians Group, P.L.L.C.
	Germantown, Tennessee, United States, 38138

United States, Texas
	Alamo City Clinical Research
	San Antonio, Texas, United States, 78258
	Cook Children's Medical Center
	Fort Worth, Texas, United States, 76104
	Texas Children's Hospital
	Houston, Texas, United States, 77030-2303
	Texas Scottich Rite Hospital for Children
	Dallas, Texas, United States, 75219-3924

United States, Virginia
	University of Virginia - Kluge Children's Rehabilitation Center
	Charlottesville, Virginia, United States, 22903

Sponsors and Collaborators

ResearchPoint

Sciele Pharma

More Information

Study ID Numbers:	FH-00-01
First Received:	January 18, 2007
Last Updated:	February 5, 2008
ClinicalTrials.gov Identifier:	NCT00425087
Health Authority:	United States: Food and Drug Administration

Keywords provided by ResearchPoint:

Drooling

Cerebral Palsy

Neurological Condition

Neurological Impairment

Mental Retardation

Study placed in the following topic categories:

Mouth Diseases

Sialorrhea

Brain Damage, Chronic

Central Nervous System Diseases

Brain Diseases

Mental Retardation

Paralysis

Signs and Symptoms

Cerebral Palsy

Mental Disorders

Glycopyrrolate

Mental Disorders Diagnosed in Childhood

Neurologic Manifestations

Stomatognathic Diseases

Brain Injuries

Salivary Gland Diseases

Neurobehavioral Manifestations

Additional relevant MeSH terms:

Muscarinic Antagonists

Adjuvants, Anesthesia

Neurotransmitter Agents

Molecular Mechanisms of Pharmacological Action

Cholinergic Antagonists

Therapeutic Uses

Physiological Effects of Drugs

Nervous System Diseases

Cholinergic Agents

Central Nervous System Agents

Pharmacologic Actions

ClinicalTrials.gov processed this record on September 05, 2008

Sponsors and Collaborators:	ResearchPoint Sciele Pharma
Information provided by:	ResearchPoint
ClinicalTrials.gov Identifier:	NCT00425087