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

Sponsor:	ResearchPoint
Collaborator:	Sciele Pharma
Information provided by:	ResearchPoint
ClinicalTrials.gov Identifier:	NCT00425087

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

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

Resource links provided by NLM:

MedlinePlus related topics: Caregivers Cerebral Palsy Paralysis

Drug Information available for: Glycopyrrolate

U.S. FDA Resources

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

No publications provided

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

Keywords provided by ResearchPoint:

Drooling
Cerebral Palsy
Neurological Condition
Neurological Impairment
Mental Retardation

Additional relevant MeSH terms:

Mouth Diseases
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Cholinergic Antagonists
Physiological Effects of Drugs
Brain Damage, Chronic
Brain Diseases
Cholinergic Agents
Signs and Symptoms
Cerebral Palsy
Mental Disorders
Therapeutic Uses
Mental Disorders Diagnosed in Childhood
Neurobehavioral Manifestations

Salivary Gland Diseases
Sialorrhea
Nervous System Diseases
Central Nervous System Diseases
Pharmacologic Actions
Paralysis
Mental Retardation
Adjuvants, Anesthesia
Muscarinic Antagonists
Glycopyrrolate
Neurologic Manifestations
Stomatognathic Diseases
Central Nervous System Agents

ClinicalTrials.gov processed this record on November 27, 2009