Determination of Absorption and Elimination of Lamotrigine-XR

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00789113
Recruitment Status : Completed
First Posted : November 11, 2008
Results First Posted : January 20, 2016
Last Update Posted : January 20, 2016
Information provided by (Responsible Party):
University of Minnesota - Clinical and Translational Science Institute

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Diagnostic
Conditions: Epilepsy
Bipolar Disorder
Bipolar Depression
Intervention: Drug: Extended Release Lamotrigine

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
Extended Release Lamotrigine

Extended Release Lamotrigine

Extended Release Lamotrigine

Participant Flow:   Overall Study
    Extended Release Lamotrigine

  Baseline Characteristics

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.
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Reporting Groups
Extended Release Lamotrigine Once daily dose of extended release lamotrigine given for two weeks following completion of part I of the study (regular lamotrigine)

Baseline Measures
   Extended Release Lamotrigine 
Overall Participants Analyzed 
[Units: Participants]
Age, Customized 
[Units: Participants]
Age 65 and older   12 
[Units: Participants]
Female   7 
Male   5 
Region of Enrollment 
[Units: Participants]
United States   12 

  Outcome Measures

1.  Primary:   Area Under the Curve (AUC) for Oral Bioavailability of Lamotrigine (LTG   [ Time Frame: 1 week ]

  Serious Adverse Events

  Other Adverse Events

  Limitations and Caveats

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
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  More Information

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT 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.

Results Point of Contact:  
Name/Title: Dr. Rory P. Remmel
Organization: University of Minnesota College of Pharmacy
phone: 6126240472

Responsible Party: University of Minnesota - Clinical and Translational Science Institute Identifier: NCT00789113     History of Changes
Other Study ID Numbers: 0308M51662
IND72642 ( Other Identifier: FDA )
First Submitted: November 7, 2008
First Posted: November 11, 2008
Results First Submitted: January 29, 2015
Results First Posted: January 20, 2016
Last Update Posted: January 20, 2016