This is an open-label clinical research study of an oral glycopyrrolate liquid for the treatment of chronic moderate to severe drooling in patients with cerebral palsy or other neurological conditions. Patients participating in the study will receive oral glycopyrrolate liquid (1 mg/5 ml) three times a day (TID) for study duration of 24 weeks. After a washout, screening, and 2-day baseline period, patients will be enrolled in a 4-week dose titration period. Glycopyrrolate liquid doses will be titrated using dose levels in the Dose Titration Schedule. Titration will begin at 0.02 mg/kg per dose TID and sequentially increased in 0.02 mg/kg per dose increments TID every 5-7 days during the first four weeks until optimal individualized response is obtained for each patient or a maximum dose of 0.1 mg/kg TID is reached, not exceeding 3 mg TID or Dose-level 5 in the Dose Titration Schedule, whichever is lesser. Optimal dose for each patient is 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 throughout the study.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
137
Study medication is administered three times a day at 7-8 AM, 1-2 PM, and 7-8 PM by the parent/caregiver
Rocky Mountain Pediatrics
Lakewood, Colorado, United States
Child Neurology Associates, PC
Atlanta, Georgia, United States
St. Mary's for Children
Bayside, New York, United States
Akron's Childrens
Akron, Ohio, United States
Hattie Larltham Center for Children with Disabilities
Mantua, Ohio, United States
The Children's Center
Bethany, Oklahoma, United States
Alamo City Clinical Research
San Antonio, Texas, United States
Proportion of Responders According to the Modified Teacher's Drooling Scale (mTDS)
The primary efficacy variable was patient's response status using the change from baseline to Week 24 evaluations of the mTDS assessment. Each patient was classified as a responder or non-responder according to the change in their mean mTDS rating from baseline to Week 24. Responders were patients who had at least a 3-point decrease in mTDS rating from baseline
Time frame: 6 months
Parent/Caregiver's Assessment of the Extent of Drooling Using Visual Analog Scale (VAS)
Parents/caregivers were to complete a 10 cm "Parent/Caregiver's Assessment of Extent of Drooling for the Day" VAS assessment (0 = normal; 10 = extremely wet) to provide an overall assessment of the extent of drooling for that day.
Time frame: Baseline
Parent/Caregiver's Assessment of the Extent of Drooling Using VAS
Parents/caregivers were to complete a 10 cm "Parent/Caregiver's Assessment of Extent of Drooling for the Day" VAS assessment (0 = normal; 10 = extremely wet) to provide an overall assessment of the extent of drooling for that day.
Time frame: Week 24
Parent/Caregiver's Global Assessment of Treatment
The parent/caregiver performed an overall evaluation of glycopyrrolate liquid for the treatment of drooling, benefits, and side effects over the duration of the study. The parent/caregiver selected one of the following choices to assess if 'This is a worthwhile treatment': 1 = strongly agree, 2 = agree, 3 = neutral, 4 = disagree, 5 = strongly disagree. A dichotomous global assessment was also performed and summarized with the categories 'responder' (strongly agree and agree responses aggregated) and 'non-responder'(neutral, disagree, and strongly disagree responses aggregated)
Time frame: Week 24
Investigator's Global Assessment of Treatment
The investigator performed an overall evaluation of glycopyrrolate liquid for the treatment of drooling, benefits, and side effects over the duration of the study. The investigator selected one of the following choices to assess if 'This is a worthwhile treatment': 1 = strongly agree, 2 = agree, 3 = neutral, 4 = disagree, 5 = strongly disagree. A dichotomous global assessment was also performed and summarized with the categories 'responder' (strongly agree and agree responses aggregated) and 'non-responder' (neutral, disagree, and strongly disagree responses aggregated)
Time frame: Week 24
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