Safety and Efficacy 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 Conditions
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
Sponsor: Shionogi
Listed as NCT00491894, this PHASE3 trial focuses on Cerebral Palsy and Mental Retardation and remains completed. Sponsored by Shionogi, it has been updated 7 times since 2007, reflecting limited change activity. Mental health research at this phase helps define safety and dosing parameters for future study.
Status Flow
Change History
7 versions recorded-
Sep 2024 — Present [monthly]
Completed PHASE3
-
Jul 2024 — Sep 2024 [monthly]
Completed PHASE3
-
Dec 2021 — Jul 2024 [monthly]
Completed PHASE3
-
Jan 2021 — Dec 2021 [monthly]
Completed PHASE3
-
Jun 2018 — Jan 2021 [monthly]
Completed PHASE3
▶ Show 2 earlier versions
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Feb 2017 — Jun 2018 [monthly]
Completed PHASE3
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Jan 2017 — Feb 2017 [monthly]
Completed PHASE3
First recorded
Mar 2007
Trial started
Per CT.gov start date — pre-dates our first snapshot
Eligibility Summary
No eligibility information available.
Contact Information
- Shionogi
For direct contact, visit the study record on ClinicalTrials.gov .