Who is sponsoring NCT00491894?

NCT00491894 is sponsored by Shionogi.

What condition does NCT00491894 study?

NCT00491894 studies Cerebral Palsy, Neurological Conditions, Mental Retardation, Sialorrhea.

What drugs are being tested in NCT00491894?

Interventions: Oral Glycopyrrolate Liquid.

What is the status of NCT00491894?

NCT00491894 is currently COMPLETED.

Last reviewed 2012-06-05 · How we verify

A Six-Month, Multi-Center, Open-Label Study to Assess the Safety and Efficacy 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 Conditions

NCT00491894 Phase 3 COMPLETED Results posted

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.

Details

Lead sponsor	Shionogi
Phase	Phase 3
Status	COMPLETED
Enrolment	137
Start date	2007-03
Completion	2008-06

Conditions

Cerebral Palsy
Neurological Conditions
Mental Retardation
Sialorrhea

Interventions

Oral Glycopyrrolate Liquid

Primary outcomes

Proportion of Responders According to the Modified Teacher's Drooling Scale (mTDS) — 6 months
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

Countries

United States