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Trial record 56 of 216 for:    Lamotrigine

An Evaluation Of BW430C (Lamotrigine) Versus Placebo In The Prevention Of Mood Episodes In Bipolar I Disorder Patients

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ClinicalTrials.gov Identifier: NCT00550407
Recruitment Status : Completed
First Posted : October 29, 2007
Results First Posted : July 27, 2010
Last Update Posted : November 23, 2016
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition Bipolar Disorder
Interventions Drug: lamotrigine
Drug: Placebo
Enrollment 215
Recruitment Details  
Pre-assignment Details Participants whose symptoms of mood episodes were stabilized with lamotrigine in the Preliminary Phase (Clinical Global Impressions of Severity score of 3 [mild] or less for at least 4 consecutive weeks, and lamotrigine given as monotherapy for at least 1 week before the start of the Randomized Phase) were randomized to placebo or lamotrigine.
Arm/Group Title Lamotrigine 25-200 mg Placebo Lamotrigine 200 mg
Hide Arm/Group Description The dose of lamotrigine was increased gradually in the dose range of 25-200 milligrams (mg)/day, while the doses of other medications for bipolar disorder were decreased gradually Matching placebo Lamotrigine 200 mg once a day. The dose may have been reduced to 100 mg/day for safety reasons at the discretion of the investigator/subinvestigator. The use of other medications for bipolar disorder was prohibited.
Period Title: 8-16 Week Preliminary (Open-Label) Phase
Started 215 0 0
Completed 103 0 0
Not Completed 112 0 0
Reason Not Completed
Adverse Event             55             0             0
Lack of Efficacy             39             0             0
Protocol Violation             1             0             0
Defined Stopping Criteria Reached             1             0             0
Lost to Follow-up             1             0             0
Investigator Discretion             8             0             0
Withdrew Consent             6             0             0
Continuation Criteria Not Met             1             0             0
Period Title: 26-Week Randomized Phase
Started 0 58 45
Completed 0 15 21
Not Completed 0 43 24
Reason Not Completed
Adverse Event             0             5             2
Lack of Efficacy             0             36             19
Investigator Discretion             0             1             0
Withdrawal by Subject             0             1             3
Arm/Group Title Placebo Lamotrigine 200 mg Total
Hide Arm/Group Description Matching placebo Lamotrigine 200 mg once a day. The dose may have been reduced to 100 mg/day for safety reasons at the discretion of the investigator/subinvestigator. The use of other medications for bipolar disorder was prohibited. Total of all reporting groups
Overall Number of Baseline Participants 58 45 103
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 58 participants 45 participants 103 participants
43.1  (12.68) 42.4  (11.79) 42.8  (12.25)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 58 participants 45 participants 103 participants
Female
31
  53.4%
27
  60.0%
58
  56.3%
Male
27
  46.6%
18
  40.0%
45
  43.7%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 58 participants 45 participants 103 participants
Asian-Japanese Heritage 58 44 102
Asian-East Asian Heritage 0 1 1
1.Primary Outcome
Title Time to Withdrawal From Study
Hide Description The time from randomization to the time at which the participant was withdrawn from the Double-Blind Phase of the study for any reason was measured. No data are reported for the Lamotrigine group because of an incalculable confidence interval. See the outcome measure entitled "Number of Participants with a Withdrawal Event" for data regarding the number of participants who withdrew from the study.
Time Frame Randomization to Study Withdrawal (up to Week 26)
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set in Randomized (double-blind) Phase (FAS2): participants who received at least one dose of study medication in the Randomized Phase (RP) and had at least one post-treatment efficacy assessment in the RP. The upper limit of the confidence interval was not calculable for the Lamotrigine group due to an insufficient number of events.
Arm/Group Title Placebo Lamotrigine 200 mg
Hide Arm/Group Description:
Matching placebo
Lamotrigine 200 mg once a day. The dose may have been reduced to 100 mg/day for safety reasons at the discretion of the investigator/subinvestigator. The use of other medications for bipolar disorder was prohibited.
Overall Number of Participants Analyzed 58 0
Median (95% Confidence Interval)
Unit of Measure: days
67.5
(32.0 to 127.0)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Lamotrigine 200 mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.010
Comments [Not Specified]
Method Log Rank
Comments [Not Specified]
2.Secondary Outcome
Title Time to Intervention for Any Mood Episode (TIME)
Hide Description The TIME was defined as the time from entry into the Randomized Phase to the time of the first prescription of any additional pharmacotherapy or electroconvulsive therapy (ECT) determined by the Investigator to be necessary for treatment of a relapse or recurrence of depression or the recurrence of a manic, hypomanic, or mixed episode, whichever occurred first. Categorization as a manic, hypomanic, or mixed episode was left to the Investigator's discretion. See the outcome measure entitled "Number of Participants with Intervention for Any Mood Episode" for data related to TIME.
Time Frame Randomization to Study Withdrawal (up to Week 26)
Hide Outcome Measure Data
Hide Analysis Population Description
FAS2. In the Lamotrigine 200 mg group, the estimated median TIME was not calculable because the probability of not reaching TIME remained greater than 0.50 throughout the study.
Arm/Group Title Placebo Lamotrigine 200 mg
Hide Arm/Group Description:
Matching placebo
Lamotrigine 200 mg once a day. The dose may have been reduced to 100 mg/day for safety reasons at the discretion of the investigator/subinvestigator. The use of other medications for bipolar disorder was prohibited.
Overall Number of Participants Analyzed 58 0
Median (95% Confidence Interval)
Unit of Measure: days
109.0
(43.0 to 141.0)
3.Secondary Outcome
Title Time to Intervention for Depressive Episode (TIDep)
Hide Description The TIDep was defined as the time from entry into the Randomized Phase to the time of the first prescription of any additional pharmacotherapy or ECT determined by the Investigator to be necessary for treatment of a relapse or recurrence of depression episode. No data are being presented for either treatment group. See the outcome measure entitled "Number of Participants with Intervention for Depressive Episode" for data related to TIDep.
Time Frame Randomization to Study Withdrawal (up to Week 26)
Hide Outcome Measure Data
Hide Analysis Population Description
FAS2. In the Lamotrigine 200 mg group, the estimated median TIDep was not calculable because the probability of not reaching TIDep remained greater than 0.50 throughout the study. The upper limit of the confidence interval was not calculable for the Placebo group due to an insufficient number of events.
Arm/Group Title Placebo Lamotrigine 200 mg
Hide Arm/Group Description:
Matching placebo
Lamotrigine 200 mg once a day. The dose may have been reduced to 100 mg/day for safety reasons at the discretion of the investigator/subinvestigator. The use of other medications for bipolar disorder was prohibited.
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
4.Secondary Outcome
Title Time to Intervention for Manic, Hypomanic, or Mixed Episode (TIMan)
Hide Description The TIMan was defined as the time from entry into the Randomized Phase to the time of the first prescription of any additional pharmacotherapy or ECT determined by the Investigator to be necessary for treatment of the relapse or recurrence of a manic, hypomanic, or mixed episode. No data are being presented for either treatment group. See the outcome measure entitled "Number of Participants with Intervention for a Manic, Hypomanic, or Mixed Episode" for data related to TIMan.
Time Frame Randomization to Study Withdrawal (up to Week 26)
Hide Outcome Measure Data
Hide Analysis Population Description
FAS2. In both groups, the estimated median TIMan was not calculable because the probability of not reaching TIMan remained greater than 0.50 throughout the study.
Arm/Group Title Placebo Lamotrigine 200 mg
Hide Arm/Group Description:
Matching placebo
Lamotrigine 200 mg once a day. The dose may have been reduced to 100 mg/day for safety reasons at the discretion of the investigator/subinvestigator. The use of other medications for bipolar disorder was prohibited.
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
5.Secondary Outcome
Title Clinical Global Impressions of Improvement (CGI-I) at Week 26/Withdrawal (Randomized Phase)
Hide Description The CGI-I is a 7-point scale that assessed the participant's global improvement compared to his/her condition at study entry whether or not, in the judgement of the Investigator, it was due entirely to drug treatment; 0=not assessed, 1= very much improved to 7= very much worse.
Time Frame Week 26/Withdrawal
Hide Outcome Measure Data
Hide Analysis Population Description
FAS2
Arm/Group Title Placebo Lamotrigine 200 mg
Hide Arm/Group Description:
Matching placebo
Lamotrigine 200 mg once a day. The dose may have been reduced to 100 mg/day for safety reasons at the discretion of the investigator/subinvestigator. The use of other medications for bipolar disorder was prohibited.
Overall Number of Participants Analyzed 58 45
Mean (Standard Deviation)
Unit of Measure: points on a scale
3.5  (1.50) 2.4  (1.29)
6.Secondary Outcome
Title Clinical Global Impressions of Improvement (CGI-I) at Week 16/Withdrawal (Preliminary Phase)
Hide Description The CGI-I is a 7-point scale that assessed the participant's global improvement compared to his/her condition at study entry whether or not, in the judgement of the Investigator, it was due entirely to drug treatment; 0=not assessed, 1= very much improved to 7= very much worse.
Time Frame Week 16/Withdrawal
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set in the Preliminary Phase (FAS1): all participants who received at least one dose of study medication for the Preliminary Phase and underwent at least one efficacy assessment after receiving the study medication in the Preliminary Phase. Nine participants in the Lamotrigine 25-200 mg group have no data for the CGI-I.
Arm/Group Title Lamotrigine 25-200 mg
Hide Arm/Group Description:
The dose of lamotrigine was increased gradually in the dose range of 25-200 milligrams (mg)/day, while the doses of other medications for bipolar disorder were decreased gradually
Overall Number of Participants Analyzed 206
Mean (Standard Deviation)
Unit of Measure: points on a scale
3.1  (1.56)
7.Secondary Outcome
Title Change From Baseline in Clinical Global Impressions of Severity (CGI-S) Scores at Week 26/Withdrawal (Randomized Phase)
Hide Description The CGI-S is a 7-point scale that assessed the participant's severity of illness based on the total clinical experience of the Investigator with this particular population; 0=not assessed, 1= normal, not at all ill to 7= among the most extremely ill participants. Change from baseline was calculated as the Week 26/Withdrawal value minus the baseline value (at the time of randomization).
Time Frame Baseline and Week 26/Withdrawal
Hide Outcome Measure Data
Hide Analysis Population Description
FAS2
Arm/Group Title Placebo Lamotrigine 200 mg
Hide Arm/Group Description:
Matching placebo
Lamotrigine 200 mg once a day. The dose may have been reduced to 100 mg/day for safety reasons at the discretion of the investigator/subinvestigator. The use of other medications for bipolar disorder was prohibited.
Overall Number of Participants Analyzed 58 45
Mean (Standard Deviation)
Unit of Measure: points on a scale
1.0  (1.19) 0.4  (1.25)
8.Secondary Outcome
Title Change From Baseline in Clinical Global Impressions of Severity (CGI-S) Scores at Week 16/Withdrawal (Preliminary Phase)
Hide Description The CGI-S is a 7-point scale that assessed the participant's severity of illness based on the total clinical experience of the Investigator with this particular population; 0=not assessed, 1= normal, not at all ill to 7= among the most extremely ill participants. Change from baseline was calculated as the Week 16/Withdrawal value minus the baseline value (at Week 0 of the Preliminary Phase).
Time Frame Baseline and Week 16/Withdrawal
Hide Outcome Measure Data
Hide Analysis Population Description
FAS1. Nine participants in the Lamotrigine 25-200 mg group have no data for the CGI-S at Week 16/Withdrawal.
Arm/Group Title Lamotrigine 25-200 mg
Hide Arm/Group Description:
The dose of lamotrigine was increased gradually in the dose range of 25-200 milligrams (mg)/day, while the doses of other medications for bipolar disorder were decreased gradually
Overall Number of Participants Analyzed 206
Mean (Standard Deviation)
Unit of Measure: points on a scale
-0.7  (1.39)
9.Secondary Outcome
Title Change From Baseline in Hamilton Rating Scale for Depression (HAMD-17) Scores at Week 26/Withdrawal (Randomized Phase)
Hide Description The HAMD-17 is a 17-item questionnaire that detects change and measures illness severity. Individual items are rated on a scale of 0-4, 0-3, and 0-2 with the total HAMD-17 score ranging from 0 (not ill) to 52 (severely ill). Change from baseline was calculated as the Week 26/Withdrawal value minus the baseline value (at the time of randomization).
Time Frame Baseline and Week 26/Withdrawal
Hide Outcome Measure Data
Hide Analysis Population Description
FAS2
Arm/Group Title Placebo Lamotrigine 200 mg
Hide Arm/Group Description:
Matching placebo
Lamotrigine 200 mg once a day. The dose may have been reduced to 100 mg/day for safety reasons at the discretion of the investigator/subinvestigator. The use of other medications for bipolar disorder was prohibited.
Overall Number of Participants Analyzed 58 45
Mean (Standard Deviation)
Unit of Measure: points on a scale
5.4  (7.39) 2.7  (7.77)
10.Secondary Outcome
Title Change From Baseline in Hamilton Rating Scale for Depression (HAMD-17) Scores at Week 16/Withdrawal (Preliminary Phase)
Hide Description The HAMD-17 is a 17-item questionnaire that detects change and measures illness severity. Individual items are rated on a scale of 0-4, and 0-2, with the total HAMD-17 score ranging from 0 (not ill) to 52 (severely ill). Change from baseline was calculated as the Week 16/Withdrawal value minus the baseline value (at Week 0 of the Preliminary Phase).
Time Frame Baseline and Week 16/Withdrawal
Hide Outcome Measure Data
Hide Analysis Population Description
FAS1. Nine participants in the Lamotrigine 25-200 mg group have no data for the HAMD-17 at Week 16/Withdrawal.
Arm/Group Title Lamotrigine 25-200 mg
Hide Arm/Group Description:
The dose of lamotrigine was increased gradually in the dose range of 25-200 milligrams (mg)/day, while the doses of other medications for bipolar disorder were decreased gradually
Overall Number of Participants Analyzed 206
Mean (Standard Deviation)
Unit of Measure: points on a scale
-4.1  (9.14)
11.Secondary Outcome
Title Change From Baseline in Young Mania Rating Scale (YMRS) Total Scores at Week 26/Withdrawal (Randomized Phase)
Hide Description The YMRS is an 11-item questionnaire that detects change and measures illness severity. Individual items are rated on a scale of 0-8 and 0-4, with the total YMRS score ranging from 0 (not ill) to 60 (severely ill). Change from baseline was calculated as the Week 26/Withdrawal value minus the baseline value (at the time of randomization).
Time Frame Baseline and Week 26/Withdrawal
Hide Outcome Measure Data
Hide Analysis Population Description
FAS2
Arm/Group Title Placebo Lamotrigine 200 mg
Hide Arm/Group Description:
Matching placebo
Lamotrigine 200 mg once a day. The dose may have been reduced to 100 mg/day for safety reasons at the discretion of the investigator/subinvestigator. The use of other medications for bipolar disorder was prohibited.
Overall Number of Participants Analyzed 58 45
Mean (Standard Deviation)
Unit of Measure: points on a scale
2.2  (6.59) 1.0  (5.67)
12.Secondary Outcome
Title Change From Baseline in Young Mania Rating Scale (YMRS) Total Scores at Week 16/Withdrawal (Preliminary Phase)
Hide Description The YMRS is an 11-item questionnaire that detects change and measures illness severity. Individual items are rated on a scale of 0-8 and 0-4, with the total YMRS score ranging from 0 (not ill) to 60 (severely ill). Change from baseline was calculated as the Week 16/Withdrawal value minus the baseline value (at Week 0 of the Preliminary Phase).
Time Frame Baseline and Week 16/Withdrawal
Hide Outcome Measure Data
Hide Analysis Population Description
FAS1. Nine participants in the Lamotrigine 25-200 mg group have no data for the HAMD-17 at Week 16/Withdrawal.
Arm/Group Title Lamotrigine 25-200 mg
Hide Arm/Group Description:
The dose of lamotrigine was increased gradually in the dose range of 25-200 milligrams (mg)/day, while the doses of other medications for bipolar disorder were decreased gradually
Overall Number of Participants Analyzed 206
Mean (Standard Deviation)
Unit of Measure: points on a scale
0.4  (10.45)
13.Post-Hoc Outcome
Title Number of Participants With a Withdrawal Event
Hide Description The number of participants who withdrew from the study was measured. This outcome measure was added post-hoc because no data are being reported for the Lamotrigine group regarding time to study withdrawal. See the primary outcome measure for time to study withdrawal data for the Placebo group. Data from participants who had not withdrawn were defined as censored.
Time Frame Randomization to Study Withdrawal (up to Week 26)
Hide Outcome Measure Data
Hide Analysis Population Description
FAS2
Arm/Group Title Placebo Lamotrigine 200 mg
Hide Arm/Group Description:
Matching placebo
Lamotrigine 200 mg once a day. The dose may have been reduced to 100 mg/day for safety reasons at the discretion of the investigator/subinvestigator. The use of other medications for bipolar disorder was prohibited.
Overall Number of Participants Analyzed 58 45
Measure Type: Number
Unit of Measure: participants
Withdrawal Event 43 24
Censored 15 21
14.Post-Hoc Outcome
Title Number of Participants With Intervention for Any Mood Episode
Hide Description The number of participants with intervention for any mood episode was measured. The necessity of the intervention was determined by the Investigator’s discretion. This outcome measure was added post-hoc because no data are being reported for the Lamotrigine group regarding time to intervention for any mood episode (TIME). See the outcome measure for TIME for data for the Placebo group. Data from participants who had not met TIME were defined as censored.
Time Frame Randomization to Study Withdrawal (up to Week 26)
Hide Outcome Measure Data
Hide Analysis Population Description
FAS2
Arm/Group Title Placebo Lamotrigine 200 mg
Hide Arm/Group Description:
Matching placebo
Lamotrigine 200 mg once a day. The dose may have been reduced to 100 mg/day for safety reasons at the discretion of the investigator/subinvestigator. The use of other medications for bipolar disorder was prohibited.
Overall Number of Participants Analyzed 58 45
Measure Type: Number
Unit of Measure: participants
Intervention Event 37 20
Censored 21 25
15.Post-Hoc Outcome
Title Number of Participants With Intervention for Depressive Episode
Hide Description The number of participants with intervention for depressive episode was measured. The necessity of the intervention was determined by the Investigator’s discretion. This outcome measure was added post-hoc because no data are being reported for the Placebo or Lamotrigine groups regarding time to intervention for depressive episode (TIDep). Data from participants who had not met TIDep were defined as censored.
Time Frame Randomization to Study Withdrawal (up to Week 26)
Hide Outcome Measure Data
Hide Analysis Population Description
FAS2
Arm/Group Title Placebo Lamotrigine 200 mg
Hide Arm/Group Description:
Matching placebo
Lamotrigine 200 mg once a day. The dose may have been reduced to 100 mg/day for safety reasons at the discretion of the investigator/subinvestigator. The use of other medications for bipolar disorder was prohibited.
Overall Number of Participants Analyzed 58 45
Measure Type: Number
Unit of Measure: participants
Intervention Event 27 15
Censored 31 30
16.Post-Hoc Outcome
Title Number of Participants With Intervention for a Manic, Hypomanic, or Mixed Episode
Hide Description The number of participants with intervention for a manic, hypomanic, or mixed episode was measured. The necessity of the intervention was determined by the Investigator’s discretion. This outcome measure was added post-hoc because no data are being reported for the Placebo or Lamotrigine groups regarding time to intervention for manic, hypomanic, or mixed episode (TIMan). Data from participants who had not met TIMan were defined as censored.
Time Frame Randomization to Study Withdrawal (up to Week 26)
Hide Outcome Measure Data
Hide Analysis Population Description
FAS2
Arm/Group Title Placebo Lamotrigine 200 mg
Hide Arm/Group Description:
Matching placebo
Lamotrigine 200 mg once a day. The dose may have been reduced to 100 mg/day for safety reasons at the discretion of the investigator/subinvestigator. The use of other medications for bipolar disorder was prohibited.
Overall Number of Participants Analyzed 58 45
Measure Type: Number
Unit of Measure: participants
Intervention Event 10 5
Censored 48 40
Time Frame [Not Specified]
Adverse Event Reporting Description Adverse events (AEs) and serious adverse events (SAEs) were collected in the Safety Population (SP). The SP is defined for the Preliminary and Randomized Phases as all participants who received at least one dose of study medication for each phase.
 
Arm/Group Title Lamotrigine 25-200 mg Placebo Lamotrigine 200 mg
Hide Arm/Group Description The dose of lamotrigine was increased gradually in the dose range of 25-200 milligrams (mg)/day, while the doses of other medications for bipolar disorder were decreased gradually Matching placebo Lamotrigine 200 mg once a day. The dose may have been reduced to 100 mg/day for safety reasons at the discretion of the investigator/subinvestigator. The use of other medications for bipolar disorder was prohibited.
All-Cause Mortality
Lamotrigine 25-200 mg Placebo Lamotrigine 200 mg
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Lamotrigine 25-200 mg Placebo Lamotrigine 200 mg
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   14/215 (6.51%)   1/58 (1.72%)   1/45 (2.22%) 
Injury, poisoning and procedural complications       
Upper limb fracture  1  0/215 (0.00%)  0/58 (0.00%)  1/45 (2.22%) 
Nervous system disorders       
Altered state of consciousness  1  1/215 (0.47%)  0/58 (0.00%)  0/45 (0.00%) 
Psychiatric disorders       
Mania  1  8/215 (3.72%)  1/58 (1.72%)  0/45 (0.00%) 
Bipolar I disorder  1  2/215 (0.93%)  0/58 (0.00%)  0/45 (0.00%) 
Affect lability  1  1/215 (0.47%)  0/58 (0.00%)  0/45 (0.00%) 
Suicide ideation  1  1/215 (0.47%)  0/58 (0.00%)  0/45 (0.00%) 
Suicide attempt  1  1/215 (0.47%)  0/58 (0.00%)  0/45 (0.00%) 
Completed suicide  1  1/215 (0.47%)  0/58 (0.00%)  0/45 (0.00%) 
Skin and subcutaneous tissue disorders       
Drug eruption  1  1/215 (0.47%)  0/58 (0.00%)  0/45 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (12.1)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Lamotrigine 25-200 mg Placebo Lamotrigine 200 mg
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   84/215 (39.07%)   17/58 (29.31%)   15/45 (33.33%) 
Gastrointestinal disorders       
Nausea  1  17/215 (7.91%)  2/58 (3.45%)  0/45 (0.00%) 
Constipation  1  11/215 (5.12%)  3/58 (5.17%)  2/45 (4.44%) 
Diarrhoea  1  11/215 (5.12%)  1/58 (1.72%)  0/45 (0.00%) 
Infections and infestations       
Nasopharyngitis  1  49/215 (22.79%)  13/58 (22.41%)  11/45 (24.44%) 
Nervous system disorders       
Headache  1  22/215 (10.23%)  2/58 (3.45%)  2/45 (4.44%) 
Dizziness  1  16/215 (7.44%)  1/58 (1.72%)  1/45 (2.22%) 
Respiratory, thoracic and mediastinal disorders       
Oropharyngeal pain  1  0/215 (0.00%)  0/58 (0.00%)  3/45 (6.67%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (12.1)
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
Publications:
Tsukasa Koyama, Teruhiko Higuchi, Shigeto Yamawaki, Shigenobu Kanba, Takeshi Terao, Atsuko Shinohara. Study SCA104779, an evaluation of BW430C (lamotrigine) versus placebo in the prevention of mood episodes in bipolar I disorder patients. Japanese Journal of Clinical Psychiatry. 2011;40(3):369-383.
Layout table for additonal information
Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00550407     History of Changes
Other Study ID Numbers: SCA104779
First Submitted: October 26, 2007
First Posted: October 29, 2007
Results First Submitted: May 24, 2010
Results First Posted: July 27, 2010
Last Update Posted: November 23, 2016