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

This study has been completed.
Sponsor:
Information provided by:
Shionogi Inc.
ClinicalTrials.gov Identifier:
NCT00491894
First received: June 22, 2007
Last updated: June 5, 2012
Last verified: April 2012
Results First Received: August 2, 2010  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Cerebral Palsy
Neurological Conditions
Mental Retardation
Sialorrhea
Intervention: Drug: Oral Glycopyrrolate Liquid

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
First patient was enrolled on April 03, 2007 and last patient completed on May 30, 2008

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
After a washout and screening period, and 2-day baseline period, patients were enrolled in a 4-week dose titration period which commenced with the goal of identifying an optimal 3 times daily maintenance dose for each patient. The resulting individualized optimal maintenance dose was to be administered for the remainder of the 24-week study

Reporting Groups
  Description
Patients With Chronic Drooling A 4-week dose titration period until an optimal individualized response was obtained for each patient or a maximum dose of 0.1 mg/kg/dose was reached. Doses were not to exceed 3.0 mg/kg TID

Participant Flow:   Overall Study
    Patients With Chronic Drooling  
STARTED     137  
COMPLETED     103  
NOT COMPLETED     34  
Adverse Event                 14  
Withdrawal by Subject                 5  
Death                 3  
Lost to Follow-up                 3  
Lack of Efficacy                 2  
Other-Failed to meet any criteria                 2  
Physician Decision                 2  
Protocol Violation                 2  
Other-Intake of prohibited medication                 1  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Patients With Chronic Drooling A 4-week dose titration period until an optimal individualized response was obtained for each patient or a maximum dose of 0.1 mg/kg/dose was reached. Doses were not to exceed 3.0 mg/kg TID

Baseline Measures
    Patients With Chronic Drooling  
Number of Participants  
[units: participants]
  137  
Age  
[units: participants]
 
<=18 years     137  
Between 18 and 65 years     0  
>=65 years     0  
Age  
[units: years]
Mean ± Standard Deviation
  11.0  ± 4.35  
Gender  
[units: participants]
 
Female     60  
Male     77  
Ethnicity (NIH/OMB)  
[units: Participants]
 
Hispanic or Latino     15  
Not Hispanic or Latino     121  
Unknown or Not Reported     1  
Race (NIH/OMB)  
[units: Participants]
 
American Indian or Alaska Native     1  
Asian     4  
Native Hawaiian or Other Pacific Islander     0  
Black or African American     29  
White     98  
More than one race     0  
Unknown or Not Reported     5  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Proportion of Responders According to the Modified Teacher’s Drooling Scale (mTDS)   [ Time Frame: 6 months ]

2.  Secondary:   Parent/Caregiver's Assessment of the Extent of Drooling Using Visual Analog Scale (VAS)   [ Time Frame: Baseline ]

3.  Secondary:   Parent/Caregiver's Assessment of the Extent of Drooling Using VAS   [ Time Frame: Week 24 ]

4.  Secondary:   Parent/Caregiver's Global Assessment of Treatment   [ Time Frame: Week 24 ]

5.  Secondary:   Investigator's Global Assessment of Treatment   [ Time Frame: Week 24 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
There were no limitations of the trial


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Shionogi Clinical Trials Administrator
Organization: Shionogi USA
phone: 800-849-9707 ext 1454
e-mail: shionogiclintrialsadmin@shionogi.com


No publications provided


Responsible Party: Shionogi Clinical Trials Administrator, Shionogi
ClinicalTrials.gov Identifier: NCT00491894     History of Changes
Obsolete Identifiers: NCT00425087
Other Study ID Numbers: Sc-GLYCO-06-01
Study First Received: June 22, 2007
Results First Received: August 2, 2010
Last Updated: June 5, 2012
Health Authority: United States: Food and Drug Administration