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

Condition(s) targeted: Sialorrhea; Cerebral Palsy; Neurological Conditions; Mental Retardation

Intervention: Oral Liquid Glycopyrrolate (Drug)

Phase: Phase 3

Status: Active, not recruiting

Sponsored by: Sciele Pharma

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.

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

Study design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study

Minimum age: 3 Years. Maximum age: 18 Years. Gender(s): Both.

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.

Rocky Mountain Pediatrics, Lakewood, Colorado 80214, United States

Ialim Clinical Research, Decatur, Georgia 30032, United States

Child Neurology Associates, PC, Atlanta, Georgia 30342, United States

St. Mary's for Children, Bayside, New York 11360, United States

Hattie Larltham Center for Children with Disabilities, Mantua, Ohio 44255, United States

Akron's Childrens, Akron, Ohio 44308, United States

The Children's Center, Bethany, Oklahoma 73008, United States

Alamo City Clinical Research, San Antonio, Texas 78258, United States

Starting date: March 2007
Last updated: February 27, 2008