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Safety 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 Condition

This study is ongoing, but not recruiting participants.

Sponsored by: Sciele Pharma
Information provided by: Sciele Pharma
ClinicalTrials.gov Identifier: NCT00491894
  Purpose

This is an open-label clinical research study of an experimental glycopyrrolate oral liquid for the treatment of chronic to severe drooling in patients with cerebral palsy or other neurological conditions.

Patients participating in the study will receive oral glycopyrrolate three times a day for study duration of 24 weeks. Dosing amounts will be based on patient's weight and will be increased for possibly 4 weeks until optimal individual response is achieved or a maximum of 0.1mg/kg or 3 mg TID is attained, whichever is lesser. Optimal dose for each patient is defined as 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, during the time of participation.

Participation in the study can be up to 24 weeks.


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

MedlinePlus related topics:   Cerebral Palsy    Paralysis   

ChemIDplus related topics:   Glycopyrrolate   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title:   A Six-Month, Multi-Center, Open-Label Study to Assess the Safety and Efficacy of Oral Glycopyrrolate 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

Further study details as provided by Sciele Pharma:

Estimated Enrollment:   130
Study Start Date:   March 2007

  Eligibility
Ages Eligible for Study:   3 Years to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Criteria

To be included in this study, patients must meet the following criteria:

  1. Male or female, weighing at least 13 kg (27 lbs), ages 3 through 18 years;
  2. Diagnosis of cerebral palsy and/or mental retardation or any other neurologic impairment or condition (cognitively capable and cognitively impaired patients may be enrolled);
  3. Chronic drooling in the absence of treatment to the extent that the chin or clothing becomes wet most days by confirming mTDS score ≥ 5;
  4. Must be living in a situation where reliable parents/caregivers are willing and capable of administering medications, as determined by the Investigator;
  5. Written informed consent signed by the parent or legally acceptable representative;
  6. Written assent signed by the age-appropriate patient if mentally capable, as determined by the Investigator, and required by the site's IRB;
  7. If female of childbearing potential, the patient must have a negative pregnancy test at Screening and Visit 1.
  8. If female of childbearing potential and sexually active, she must use a medically acceptable form of contraception.

Patients are excluded from this study if they meet any of the following criteria:

  1. Patients who use glycopyrrolate within approximately 24 hours prior to the start of the baseline period which begins Day -2.
  2. Patients who use prohibited medications within five plasma half-lives of the medication (see Appendix H) prior to the start of the baseline period.
  3. Patients injected with intra-salivary-gland botulinum toxin within 10 months prior to the start of the baseline period.
  4. Patients using intra-oral devices or prosthetics for the treatment of drooling within one week prior to the start of the baseline period.
  5. 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.
  6. Patients who have medical conditions contraindicating anticholinergic therapy including: gastro-intestinal reflux, narrow-angle glaucoma, obstructive uropathy, obstructive disease of the gastrointestinal tract (i.e., delayed gastric emptying, pyloroduodenal stenosis, etc.), paralitic ileus, intestinal atony, vesicoureteral reflux, reactive airway disease, myasthenia gravis, hyperthyroidism, cardiac arrhythmias and/or tachycardia, and/or clinically significant ECG abnormalities, as determined by the Investigator.
  7. Patients who have a known contraindication to the study medication, including allergy to the study medication or any of its components.
  8. Patients who have poorly controlled seizures defined as daily seizures.
  9. Patients who have a history of obstructive disease of the gastrointestinal tract (i.e., intestinal obstruction).
  10. Patients who have clinically significant hepatic or renal impairment, at the discretion of the Investigator.
  11. Patients who are pregnant or breastfeeding.
  12. Patients who have received any investigational drugs within thirty days of study entry.
  13. Patient, families or parents/caregivers who are expected to be non-compliant with the study procedures, as judged by the Investigator.
  14. Patients who are unable to meet the requirements of the study for any reason, as determined by the Investigator.
  15. Patients who have unstable mental disease, as determined by the Investigator.
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00491894

Locations
United States, Colorado
Rocky Mountain Pediatrics    
      Lakewood, Colorado, United States, 80214
United States, Georgia
Ialim Clinical Research    
      Decatur, Georgia, United States, 30032
Child Neurology Associates, PC    
      Atlanta, Georgia, United States, 30342
United States, New York
St. Mary's for Children    
      Bayside, New York, United States, 11360
United States, Ohio
Hattie Larltham Center for Children with Disabilities    
      Mantua, Ohio, United States, 44255
Akron's Childrens    
      Akron, Ohio, United States, 44308
United States, Oklahoma
The Children's Center    
      Bethany, Oklahoma, United States, 73008
United States, Texas
Alamo City Clinical Research    
      San Antonio, Texas, United States, 78258

Sponsors and Collaborators
Sciele Pharma
  More Information

Study ID Numbers:   Sc-GLYCO-06-01
First Received:   June 22, 2007
Last Updated:   February 27, 2008
ClinicalTrials.gov Identifier:   NCT00491894
Health Authority:   United States: Food and Drug Administration

Keywords provided by Sciele Pharma:
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




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