Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 79 of 215 for:    Lamotrigine

An Open-Label Extension Study Of Lamotrigine In Subjects With Bipolar Disorder

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.
 
ClinicalTrials.gov Identifier: NCT00360126
Recruitment Status : Completed
First Posted : August 3, 2006
Results First Posted : March 30, 2017
Last Update Posted : March 30, 2017
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Bipolar Disorder
Intervention Drug: lamotrigine
Enrollment 11
Recruitment Details A total of 11 participants were enrolled and randomized from 13 October 2005 to 12 February 2007.
Pre-assignment Details Participants who had completed 32 weeks treatment period in study SCA101469 were enrolled in this extension study.
Arm/Group Title Lamotrigine
Hide Arm/Group Description Participants received Lamotrigine tablets orally once daily up to 52 weeks in evenings or mornings (in case of non-tolerance) or the dose was administered twice daily if the morning dose was not tolerated.
Period Title: Overall Study
Started 11
Completed 11
Not Completed 0
Arm/Group Title Lamotrigine
Hide Arm/Group Description Participants received Lamotrigine tablets orally once daily up to 52 weeks in evenings or mornings (in case of non-tolerance) or the dose was administered twice daily if the morning dose was not tolerated.
Overall Number of Baseline Participants 11
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 11 participants
45.64  (3.28)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 11 participants
Female
7
  63.6%
Male
4
  36.4%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Australia Number Analyzed 11 participants
11
1.Primary Outcome
Title Number of Participants With Serious Adverse Events (SAEs)
Hide Description An adverse event (AE) is defined as any untoward medical occurrence that occurred during the course of the trial after study treatment had started. An adverse event is therefore any unfavorable and unintended sign, symptom, or disease temporally associated with the use of study drug, whether or not considered related to the study drug. An SAE is any untoward medical occurrence that at any dose results in death, are life threatening, requires hospitalization or prolongation of hospitalization or results in disability/incapacity, and congenital anomaly/birth defect. Only SAEs were recorded and reported in this extension study.
Time Frame Up to 54 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
All subject population consisted of all participants enrolled into the study and received study drug.
Arm/Group Title Lamotrigine
Hide Arm/Group Description:
Participants received Lamotrigine tablets orally once daily up to 52 weeks in evenings or mornings (in case of non-tolerance) or the dose was administered twice daily if the morning dose was not tolerated.
Overall Number of Participants Analyzed 11
Measure Type: Number
Unit of Measure: Participants
0
Time Frame Up to 54 weeks
Adverse Event Reporting Description SAEs were collected for 'All subject population'. Only SAEs were recorded and reported in this extension study. Other [non-serious] adverse events were not collected or assessed as part of the study
 
Arm/Group Title Lamotrigine
Hide Arm/Group Description Participants received Lamotrigine tablets orally once daily up to 52 weeks in evenings or mornings (in case of non-tolerance) or the dose was administered twice daily if the morning dose was not tolerated.
All-Cause Mortality
Lamotrigine
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Lamotrigine
Affected / at Risk (%)
Total   0/11 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Lamotrigine
Affected / at Risk (%)
Total   0/0 
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.
GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: GSK Response Center
Organization: GlaxoSmithKline
Phone: 866-435-7343
Layout table for additonal information
Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00360126     History of Changes
Other Study ID Numbers: SCA104753
First Submitted: August 2, 2006
First Posted: August 3, 2006
Results First Submitted: February 13, 2017
Results First Posted: March 30, 2017
Last Update Posted: March 30, 2017