Trial Outcomes & Findings for An Open-Label Extension Study Of Lamotrigine In Subjects With Bipolar Disorder (NCT NCT00360126)
NCT ID: NCT00360126
Last Updated: 2017-03-30
Results Overview
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.
COMPLETED
PHASE4
11 participants
Up to 54 weeks
2017-03-30
Participant Flow
A total of 11 participants were enrolled and randomized from 13 October 2005 to 12 February 2007.
Participants who had completed 32 weeks treatment period in study SCA101469 were enrolled in this extension study.
Participant milestones
| Measure |
Lamotrigine
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 Study
STARTED
|
11
|
|
Overall Study
COMPLETED
|
11
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
An Open-Label Extension Study Of Lamotrigine In Subjects With Bipolar Disorder
Baseline characteristics by cohort
| Measure |
Lamotrigine
n=11 Participants
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.
|
|---|---|
|
Age, Continuous
|
45.64 Years
STANDARD_DEVIATION 3.28 • n=5 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=5 Participants
|
|
Region of Enrollment
Australia
|
11 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Up to 54 weeksPopulation: All subject population consisted of all participants enrolled into the study and received study drug.
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.
Outcome measures
| Measure |
Lamotrigine
n=11 Participants
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.
|
|---|---|
|
Number of Participants With Serious Adverse Events (SAEs)
|
0 Participants
|
Adverse Events
Lamotrigine
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
GSK Response Center
GlaxoSmithKline
Results disclosure agreements
- Principal investigator is a sponsor employee 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.
- Publication restrictions are in place
Restriction type: OTHER