Trial Outcomes & Findings for Conversion To Monotherapy With Lamictal Extended Release Tablets For Treatment Of Partial Epilepsy (NCT NCT00355082)
NCT ID: NCT00355082
Last Updated: 2017-01-02
Results Overview
The percentage of participants prematurely discontinuing the study was calculated as the number of participants who discontinued the study divided by the number who reached Visit 5 minus major protocol violators. The Control group is composed of data from other similar studies and is not part of this study.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
226 participants
Primary outcome timeframe
From Study Visit 5 through Visit 9 of the Treatment Phase (approximately Week 7 through Week 23)
Results posted on
2017-01-02
Participant Flow
All participants in the Treatment phase and all Baseline Failure participants are eligible to enter the Continuation phase. The Continuation phase is for long-term safety exposure to lamotrigine extended release (LTG XR) at 300 mg/day; it is not a cross-over phase.
The number of participants (par.) starting the Continuation phase (CP) does not equal the number completing the Treatment phase (TP), as 1) the CP was optional, 2) not everyone from the TP was eligible to enter the CP, and 3) par. who failed to qualify for the TP (Baseline Failures) were allowed to enter the CP. All par. start the TP at 300 mg/day.
Participant milestones
| Measure |
Lamotrigine Extended-release (LTG XR), 300 mg
LTG XR, 300 mg/day. In the Continuation phase, Treatment phase participants received LTG XR, 300 mg/day.
|
LTG XR, 250 mg
LTG XR, 250 mg/day
|
Baseline Failures
Baseline failures that entered the Continuation Phase; LTG XR; 300 mg/day
|
|---|---|---|---|
|
Double-Blind (DB) Treatment Phase
STARTED
|
113
|
113
|
0
|
|
Double-Blind (DB) Treatment Phase
COMPLETED
|
94
|
79
|
0
|
|
Double-Blind (DB) Treatment Phase
NOT COMPLETED
|
19
|
34
|
0
|
|
Continuation Phase
STARTED
|
184
|
0
|
11
|
|
Continuation Phase
COMPLETED
|
160
|
0
|
8
|
|
Continuation Phase
NOT COMPLETED
|
24
|
0
|
3
|
Reasons for withdrawal
| Measure |
Lamotrigine Extended-release (LTG XR), 300 mg
LTG XR, 300 mg/day. In the Continuation phase, Treatment phase participants received LTG XR, 300 mg/day.
|
LTG XR, 250 mg
LTG XR, 250 mg/day
|
Baseline Failures
Baseline failures that entered the Continuation Phase; LTG XR; 300 mg/day
|
|---|---|---|---|
|
Double-Blind (DB) Treatment Phase
Adverse Event
|
4
|
10
|
0
|
|
Double-Blind (DB) Treatment Phase
Withdrawal by Subject
|
9
|
8
|
0
|
|
Double-Blind (DB) Treatment Phase
Lack of Efficacy
|
6
|
7
|
0
|
|
Double-Blind (DB) Treatment Phase
Lost to Follow-up
|
0
|
4
|
0
|
|
Double-Blind (DB) Treatment Phase
Protocol Violation
|
0
|
4
|
0
|
|
Double-Blind (DB) Treatment Phase
Pregnancy
|
0
|
1
|
0
|
|
Continuation Phase
Adverse Event
|
2
|
0
|
1
|
|
Continuation Phase
Lost to Follow-up
|
2
|
0
|
1
|
|
Continuation Phase
Protocol Violation
|
1
|
0
|
1
|
|
Continuation Phase
Withdrawal by Subject
|
4
|
0
|
0
|
|
Continuation Phase
Lack of Efficacy
|
5
|
0
|
0
|
|
Continuation Phase
Site Closed by Sponsor
|
8
|
0
|
0
|
|
Continuation Phase
Scheduling Error
|
1
|
0
|
0
|
|
Continuation Phase
Ran Out of Drug Due to Travel
|
1
|
0
|
0
|
Baseline Characteristics
Conversion To Monotherapy With Lamictal Extended Release Tablets For Treatment Of Partial Epilepsy
Baseline characteristics by cohort
| Measure |
Treatment Phase: LTG XR, 300 mg
n=112 Participants
LTG XR, 300 mg/day in the Treatment phase
|
Treatment Phase: LTG XR, 250 mg
n=111 Participants
LTG XR, 250 mg/day in the Treatment phase
|
Total
n=223 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
33.8 years
STANDARD_DEVIATION 14.3 • n=5 Participants
|
32.9 years
STANDARD_DEVIATION 12.6 • n=7 Participants
|
33.4 years
STANDARD_DEVIATION 13.5 • n=5 Participants
|
|
Gender
Female
|
56 Participants
n=5 Participants
|
66 Participants
n=7 Participants
|
122 Participants
n=5 Participants
|
|
Gender
Male
|
56 Participants
n=5 Participants
|
45 Participants
n=7 Participants
|
101 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
African American
|
5 participants
n=5 Participants
|
4 participants
n=7 Participants
|
9 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
11 participants
n=5 Participants
|
11 participants
n=7 Participants
|
22 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Arabic/North African
|
0 participants
n=5 Participants
|
2 participants
n=7 Participants
|
2 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
96 participants
n=5 Participants
|
94 participants
n=7 Participants
|
190 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian - Central/South Asian
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian - East Asian
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
|
Number of participants taking indicated concurrent antiepileptic drug at study entry
Valproate
|
73 participants
n=5 Participants
|
70 participants
n=7 Participants
|
143 participants
n=5 Participants
|
|
Number of participants taking indicated concurrent antiepileptic drug at study entry
Levetiracetam
|
11 participants
n=5 Participants
|
13 participants
n=7 Participants
|
24 participants
n=5 Participants
|
|
Number of participants taking indicated concurrent antiepileptic drug at study entry
Oxcarbazepine
|
12 participants
n=5 Participants
|
12 participants
n=7 Participants
|
24 participants
n=5 Participants
|
|
Number of participants taking indicated concurrent antiepileptic drug at study entry
Topiramate
|
12 participants
n=5 Participants
|
10 participants
n=7 Participants
|
22 participants
n=5 Participants
|
|
Number of participants taking indicated concurrent antiepileptic drug at study entry
Zonisamide
|
3 participants
n=5 Participants
|
5 participants
n=7 Participants
|
8 participants
n=5 Participants
|
|
Number of participants taking indicated concurrent antiepileptic drug at study entry
Pregabalin
|
1 participants
n=5 Participants
|
1 participants
n=7 Participants
|
2 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: From Study Visit 5 through Visit 9 of the Treatment Phase (approximately Week 7 through Week 23)Population: All randomized participants in the 300 mg/day dose group who began withdrawal of background antiepileptic drug (AED) (Visit 5) minus any major protocol violators
The percentage of participants prematurely discontinuing the study was calculated as the number of participants who discontinued the study divided by the number who reached Visit 5 minus major protocol violators. The Control group is composed of data from other similar studies and is not part of this study.
Outcome measures
| Measure |
Lamotrigine Extended-release (LTG XR), 300 mg
n=93 Participants
LTG XR, 300 mg/day
|
LTG XR, 250 mg
LTG XR, 250 mg/day
|
|---|---|---|
|
The Percentage of Participants in the 300 mg/Day Dose Group Who Prematurely Discontinued the Study Between Study Visit 5 (Approximately Week 7) and Visit 9 (End of the Treatment Phase)
|
12 percentage of participants
|
—
|
SECONDARY outcome
Timeframe: From Study Visit 5 through Visit 9 of the Treatment phase (approximately Week 7 through Week 23)Population: All randomized participants in the 250 mg/day dose group who began withdrawal of background AED (Visit 5) minus any major protocol violators
The percentage of participants prematurely discontinuing the study was calculated as the number of participants who discontinued the study divided by the number who had reached Visit 5 minus major protocol violators. The Control group was composed of data from other similar studies and is not part of this study.
Outcome measures
| Measure |
Lamotrigine Extended-release (LTG XR), 300 mg
n=81 Participants
LTG XR, 300 mg/day
|
LTG XR, 250 mg
LTG XR, 250 mg/day
|
|---|---|---|
|
The Percentage of Participants in the 250 mg/Day Dose Group Who Prematurely Discontinued the Study Between Study Visit 5 (Approximately Week 7) and Visit 9 (End of the Treatment Phase)
|
16 percentage of participants
|
—
|
SECONDARY outcome
Timeframe: From Study Visit 5 through Visit 9 of the Treatment phase (approximately Week 7 through Week 23)Population: Intent-to-Treat (ITT) Population: All participants who were randomized and began dosing with study drug
Time (days) until the participant discontinued the study
Outcome measures
| Measure |
Lamotrigine Extended-release (LTG XR), 300 mg
n=112 Participants
LTG XR, 300 mg/day
|
LTG XR, 250 mg
n=111 Participants
LTG XR, 250 mg/day
|
|---|---|---|
|
Time to Discontinuation in the Treatment Phase
|
147.3 Days
Standard Deviation 31.5
|
133.2 Days
Standard Deviation 45.6
|
SECONDARY outcome
Timeframe: Study Visit 5 through Visit 9 of the Treatment phase (approximately Week 7 through Week 23)Population: All randomized participants who began withdrawal of background AED (Visit 5) minus any major protocol violators
The percentage of participants meeting Escape Criteria was calculated as the number of participants who met an Escape Criterion divided by the number who had reached Visit 5 minus major protocol violators. Escape Criteria are: (1) doubling of average monthly seizure frequency; (2) doubling of the highest consecutive 2-day seizure total; (3) occurrence of a new, more severe seizure type; or (4) worsening of generalized tonic-clonic seizures.
Outcome measures
| Measure |
Lamotrigine Extended-release (LTG XR), 300 mg
n=93 Participants
LTG XR, 300 mg/day
|
LTG XR, 250 mg
n=81 Participants
LTG XR, 250 mg/day
|
|---|---|---|
|
Percentage of Participants Meeting Escape Criteria in the Treatment Phase
|
4 percentage of participants
|
6 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline and Study Visit 3 through Visit 9 of the Treatment phase (Treatment Week 0 through Week 23)Population: All randomized participants who began withdrawal of background AED (Visit 5) minus any major protocol violators
Change from Baseline was measured as the number of seizures at Visits 3 through 9 minus the number of seizures at Baseline. The number of partial seizures during treatment divided by the number of weeks of treatment was compared to the weekly seizure frequency during Baseline. A positive number equals a reduction in seizure frequency.
Outcome measures
| Measure |
Lamotrigine Extended-release (LTG XR), 300 mg
n=93 Participants
LTG XR, 300 mg/day
|
LTG XR, 250 mg
n=81 Participants
LTG XR, 250 mg/day
|
|---|---|---|
|
Percent Change From Baseline in Weekly Seizure Frequency Between Study Visits 3 (Start of Dosing) and 9 (End of the Treatment Phase)
|
54.8 percent change in seizures
Interval -124.5 to 100.0
|
52.2 percent change in seizures
Interval -221.3 to 100.0
|
SECONDARY outcome
Timeframe: The last 12 weeks of treatment of the Treatment phase (Monotherapy phase - approximately Week 11 through Week 23)Population: All randomized participants who began withdrawal of background AED (Visit 5) minus any major protocol violators
The number of participants who had no seizures during the treatment period was calculated. The last 12 weeks of treatment were either Weeks 11-22 or 12-23 depending on which background AED was being withdrawn
Outcome measures
| Measure |
Lamotrigine Extended-release (LTG XR), 300 mg
n=89 Participants
LTG XR, 300 mg/day
|
LTG XR, 250 mg
n=76 Participants
LTG XR, 250 mg/day
|
|---|---|---|
|
Number of Seizure-free Participants During the Last 12 Weeks of Treatment of the Treatment Phase
|
22 participants
|
8 participants
|
SECONDARY outcome
Timeframe: Baseline and start of Continuation phase through Week 24 or end of participation in the Continuation phasePopulation: All participants who began the Continuation Phase
Change from baseline was calculated as the average seizure frequency at the end of the Continuation Phase minus the average seizure frequency at Baseline. The number of seizures during the Continuation phase divided by the number of weeks was compared to the number of seizures at Baseline. A positive number indicates a reduction in seizure frequency.
Outcome measures
| Measure |
Lamotrigine Extended-release (LTG XR), 300 mg
n=184 Participants
LTG XR, 300 mg/day
|
LTG XR, 250 mg
n=11 Participants
LTG XR, 250 mg/day
|
|---|---|---|
|
Percent Change From Baseline in the Average Seizure Frequency Measured at the End of Participation in the Continuation Phase
|
72.2 percent change in seizures
Interval -840.7 to 100.0
|
68.8 percent change in seizures
Interval -111.0 to 100.0
|
SECONDARY outcome
Timeframe: Baseline and entire Continuation phase (24 Weeks)Population: All participants who entered the Continuation Phase
Change in seizure frequency was calculated as the average seizure frequency during the Continuation Phase minus the seizure frequency at Baseline.
Outcome measures
| Measure |
Lamotrigine Extended-release (LTG XR), 300 mg
n=184 Participants
LTG XR, 300 mg/day
|
LTG XR, 250 mg
n=11 Participants
LTG XR, 250 mg/day
|
|---|---|---|
|
The Number of Participants With at Least the Specified Change in Seizure Frequency, Compared to Baseline, at the End of Participation in the Continuation Phase (Maximum of 24 Weeks)
At least a 25% reduction in seizures
|
169 participants
|
7 participants
|
|
The Number of Participants With at Least the Specified Change in Seizure Frequency, Compared to Baseline, at the End of Participation in the Continuation Phase (Maximum of 24 Weeks)
At least a 50% reduction in seizures
|
137 participants
|
6 participants
|
|
The Number of Participants With at Least the Specified Change in Seizure Frequency, Compared to Baseline, at the End of Participation in the Continuation Phase (Maximum of 24 Weeks)
At least a 75% reduction in seizures
|
85 participants
|
3 participants
|
|
The Number of Participants With at Least the Specified Change in Seizure Frequency, Compared to Baseline, at the End of Participation in the Continuation Phase (Maximum of 24 Weeks)
100% reduction in seizures
|
38 participants
|
2 participants
|
|
The Number of Participants With at Least the Specified Change in Seizure Frequency, Compared to Baseline, at the End of Participation in the Continuation Phase (Maximum of 24 Weeks)
At least a 50% increase in seizures
|
6 participants
|
3 participants
|
Adverse Events
Treatment Phase: LTG XR, 300 mg
Serious events: 3 serious events
Other events: 44 other events
Deaths: 0 deaths
Treatment Phase: LTG XR, 250 mg
Serious events: 5 serious events
Other events: 52 other events
Deaths: 0 deaths
Continuation Phase: LTG XR, 300 mg
Serious events: 3 serious events
Other events: 47 other events
Deaths: 0 deaths
Continuation Phase: Baseline Failures
Serious events: 1 serious events
Other events: 4 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Treatment Phase: LTG XR, 300 mg
n=112 participants at risk
LTG XR, 300 mg/day in the Treatment phase
|
Treatment Phase: LTG XR, 250 mg
n=111 participants at risk
LTG XR, 250 mg/day in the Treatment phase
|
Continuation Phase: LTG XR, 300 mg
n=184 participants at risk
Treatment phase participants; LTG XR, 300 mg/day
|
Continuation Phase: Baseline Failures
n=11 participants at risk
Baseline failures that entered the Continuation Phase; LTG XR; 300 mg/day
|
|---|---|---|---|---|
|
Injury, poisoning and procedural complications
Back injury
|
0.00%
0/112
For the Treatment phase, a frequency threshold of 5% in either treatment group was used. Because there are only 11 participants in the Baseline Failure group, only adverse events occurring in at least 3 participants in the 300 mg/day group are listed (1.6%).
|
0.00%
0/111
For the Treatment phase, a frequency threshold of 5% in either treatment group was used. Because there are only 11 participants in the Baseline Failure group, only adverse events occurring in at least 3 participants in the 300 mg/day group are listed (1.6%).
|
0.54%
1/184
For the Treatment phase, a frequency threshold of 5% in either treatment group was used. Because there are only 11 participants in the Baseline Failure group, only adverse events occurring in at least 3 participants in the 300 mg/day group are listed (1.6%).
|
0.00%
0/11
For the Treatment phase, a frequency threshold of 5% in either treatment group was used. Because there are only 11 participants in the Baseline Failure group, only adverse events occurring in at least 3 participants in the 300 mg/day group are listed (1.6%).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Brain cancer
|
0.89%
1/112
For the Treatment phase, a frequency threshold of 5% in either treatment group was used. Because there are only 11 participants in the Baseline Failure group, only adverse events occurring in at least 3 participants in the 300 mg/day group are listed (1.6%).
|
0.00%
0/111
For the Treatment phase, a frequency threshold of 5% in either treatment group was used. Because there are only 11 participants in the Baseline Failure group, only adverse events occurring in at least 3 participants in the 300 mg/day group are listed (1.6%).
|
0.00%
0/184
For the Treatment phase, a frequency threshold of 5% in either treatment group was used. Because there are only 11 participants in the Baseline Failure group, only adverse events occurring in at least 3 participants in the 300 mg/day group are listed (1.6%).
|
0.00%
0/11
For the Treatment phase, a frequency threshold of 5% in either treatment group was used. Because there are only 11 participants in the Baseline Failure group, only adverse events occurring in at least 3 participants in the 300 mg/day group are listed (1.6%).
|
|
Injury, poisoning and procedural complications
Concussion
|
0.00%
0/112
For the Treatment phase, a frequency threshold of 5% in either treatment group was used. Because there are only 11 participants in the Baseline Failure group, only adverse events occurring in at least 3 participants in the 300 mg/day group are listed (1.6%).
|
0.90%
1/111
For the Treatment phase, a frequency threshold of 5% in either treatment group was used. Because there are only 11 participants in the Baseline Failure group, only adverse events occurring in at least 3 participants in the 300 mg/day group are listed (1.6%).
|
0.00%
0/184
For the Treatment phase, a frequency threshold of 5% in either treatment group was used. Because there are only 11 participants in the Baseline Failure group, only adverse events occurring in at least 3 participants in the 300 mg/day group are listed (1.6%).
|
0.00%
0/11
For the Treatment phase, a frequency threshold of 5% in either treatment group was used. Because there are only 11 participants in the Baseline Failure group, only adverse events occurring in at least 3 participants in the 300 mg/day group are listed (1.6%).
|
|
General disorders
Fever
|
0.00%
0/112
For the Treatment phase, a frequency threshold of 5% in either treatment group was used. Because there are only 11 participants in the Baseline Failure group, only adverse events occurring in at least 3 participants in the 300 mg/day group are listed (1.6%).
|
0.90%
1/111
For the Treatment phase, a frequency threshold of 5% in either treatment group was used. Because there are only 11 participants in the Baseline Failure group, only adverse events occurring in at least 3 participants in the 300 mg/day group are listed (1.6%).
|
0.00%
0/184
For the Treatment phase, a frequency threshold of 5% in either treatment group was used. Because there are only 11 participants in the Baseline Failure group, only adverse events occurring in at least 3 participants in the 300 mg/day group are listed (1.6%).
|
0.00%
0/11
For the Treatment phase, a frequency threshold of 5% in either treatment group was used. Because there are only 11 participants in the Baseline Failure group, only adverse events occurring in at least 3 participants in the 300 mg/day group are listed (1.6%).
|
|
Nervous system disorders
Generalized seizure
|
0.00%
0/112
For the Treatment phase, a frequency threshold of 5% in either treatment group was used. Because there are only 11 participants in the Baseline Failure group, only adverse events occurring in at least 3 participants in the 300 mg/day group are listed (1.6%).
|
0.90%
1/111
For the Treatment phase, a frequency threshold of 5% in either treatment group was used. Because there are only 11 participants in the Baseline Failure group, only adverse events occurring in at least 3 participants in the 300 mg/day group are listed (1.6%).
|
0.00%
0/184
For the Treatment phase, a frequency threshold of 5% in either treatment group was used. Because there are only 11 participants in the Baseline Failure group, only adverse events occurring in at least 3 participants in the 300 mg/day group are listed (1.6%).
|
0.00%
0/11
For the Treatment phase, a frequency threshold of 5% in either treatment group was used. Because there are only 11 participants in the Baseline Failure group, only adverse events occurring in at least 3 participants in the 300 mg/day group are listed (1.6%).
|
|
Nervous system disorders
Grand mal seizure
|
0.89%
1/112
For the Treatment phase, a frequency threshold of 5% in either treatment group was used. Because there are only 11 participants in the Baseline Failure group, only adverse events occurring in at least 3 participants in the 300 mg/day group are listed (1.6%).
|
0.00%
0/111
For the Treatment phase, a frequency threshold of 5% in either treatment group was used. Because there are only 11 participants in the Baseline Failure group, only adverse events occurring in at least 3 participants in the 300 mg/day group are listed (1.6%).
|
0.00%
0/184
For the Treatment phase, a frequency threshold of 5% in either treatment group was used. Because there are only 11 participants in the Baseline Failure group, only adverse events occurring in at least 3 participants in the 300 mg/day group are listed (1.6%).
|
0.00%
0/11
For the Treatment phase, a frequency threshold of 5% in either treatment group was used. Because there are only 11 participants in the Baseline Failure group, only adverse events occurring in at least 3 participants in the 300 mg/day group are listed (1.6%).
|
|
Injury, poisoning and procedural complications
Head Injury
|
0.89%
1/112
For the Treatment phase, a frequency threshold of 5% in either treatment group was used. Because there are only 11 participants in the Baseline Failure group, only adverse events occurring in at least 3 participants in the 300 mg/day group are listed (1.6%).
|
0.00%
0/111
For the Treatment phase, a frequency threshold of 5% in either treatment group was used. Because there are only 11 participants in the Baseline Failure group, only adverse events occurring in at least 3 participants in the 300 mg/day group are listed (1.6%).
|
0.54%
1/184
For the Treatment phase, a frequency threshold of 5% in either treatment group was used. Because there are only 11 participants in the Baseline Failure group, only adverse events occurring in at least 3 participants in the 300 mg/day group are listed (1.6%).
|
0.00%
0/11
For the Treatment phase, a frequency threshold of 5% in either treatment group was used. Because there are only 11 participants in the Baseline Failure group, only adverse events occurring in at least 3 participants in the 300 mg/day group are listed (1.6%).
|
|
Injury, poisoning and procedural complications
Joint sprain
|
0.00%
0/112
For the Treatment phase, a frequency threshold of 5% in either treatment group was used. Because there are only 11 participants in the Baseline Failure group, only adverse events occurring in at least 3 participants in the 300 mg/day group are listed (1.6%).
|
0.00%
0/111
For the Treatment phase, a frequency threshold of 5% in either treatment group was used. Because there are only 11 participants in the Baseline Failure group, only adverse events occurring in at least 3 participants in the 300 mg/day group are listed (1.6%).
|
0.54%
1/184
For the Treatment phase, a frequency threshold of 5% in either treatment group was used. Because there are only 11 participants in the Baseline Failure group, only adverse events occurring in at least 3 participants in the 300 mg/day group are listed (1.6%).
|
0.00%
0/11
For the Treatment phase, a frequency threshold of 5% in either treatment group was used. Because there are only 11 participants in the Baseline Failure group, only adverse events occurring in at least 3 participants in the 300 mg/day group are listed (1.6%).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Liver Cancer
|
0.00%
0/112
For the Treatment phase, a frequency threshold of 5% in either treatment group was used. Because there are only 11 participants in the Baseline Failure group, only adverse events occurring in at least 3 participants in the 300 mg/day group are listed (1.6%).
|
0.90%
1/111
For the Treatment phase, a frequency threshold of 5% in either treatment group was used. Because there are only 11 participants in the Baseline Failure group, only adverse events occurring in at least 3 participants in the 300 mg/day group are listed (1.6%).
|
0.00%
0/184
For the Treatment phase, a frequency threshold of 5% in either treatment group was used. Because there are only 11 participants in the Baseline Failure group, only adverse events occurring in at least 3 participants in the 300 mg/day group are listed (1.6%).
|
0.00%
0/11
For the Treatment phase, a frequency threshold of 5% in either treatment group was used. Because there are only 11 participants in the Baseline Failure group, only adverse events occurring in at least 3 participants in the 300 mg/day group are listed (1.6%).
|
|
Injury, poisoning and procedural complications
Periorbital hematoma
|
0.00%
0/112
For the Treatment phase, a frequency threshold of 5% in either treatment group was used. Because there are only 11 participants in the Baseline Failure group, only adverse events occurring in at least 3 participants in the 300 mg/day group are listed (1.6%).
|
0.00%
0/111
For the Treatment phase, a frequency threshold of 5% in either treatment group was used. Because there are only 11 participants in the Baseline Failure group, only adverse events occurring in at least 3 participants in the 300 mg/day group are listed (1.6%).
|
0.54%
1/184
For the Treatment phase, a frequency threshold of 5% in either treatment group was used. Because there are only 11 participants in the Baseline Failure group, only adverse events occurring in at least 3 participants in the 300 mg/day group are listed (1.6%).
|
0.00%
0/11
For the Treatment phase, a frequency threshold of 5% in either treatment group was used. Because there are only 11 participants in the Baseline Failure group, only adverse events occurring in at least 3 participants in the 300 mg/day group are listed (1.6%).
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/112
For the Treatment phase, a frequency threshold of 5% in either treatment group was used. Because there are only 11 participants in the Baseline Failure group, only adverse events occurring in at least 3 participants in the 300 mg/day group are listed (1.6%).
|
0.90%
1/111
For the Treatment phase, a frequency threshold of 5% in either treatment group was used. Because there are only 11 participants in the Baseline Failure group, only adverse events occurring in at least 3 participants in the 300 mg/day group are listed (1.6%).
|
0.00%
0/184
For the Treatment phase, a frequency threshold of 5% in either treatment group was used. Because there are only 11 participants in the Baseline Failure group, only adverse events occurring in at least 3 participants in the 300 mg/day group are listed (1.6%).
|
0.00%
0/11
For the Treatment phase, a frequency threshold of 5% in either treatment group was used. Because there are only 11 participants in the Baseline Failure group, only adverse events occurring in at least 3 participants in the 300 mg/day group are listed (1.6%).
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.89%
1/112
For the Treatment phase, a frequency threshold of 5% in either treatment group was used. Because there are only 11 participants in the Baseline Failure group, only adverse events occurring in at least 3 participants in the 300 mg/day group are listed (1.6%).
|
0.00%
0/111
For the Treatment phase, a frequency threshold of 5% in either treatment group was used. Because there are only 11 participants in the Baseline Failure group, only adverse events occurring in at least 3 participants in the 300 mg/day group are listed (1.6%).
|
0.00%
0/184
For the Treatment phase, a frequency threshold of 5% in either treatment group was used. Because there are only 11 participants in the Baseline Failure group, only adverse events occurring in at least 3 participants in the 300 mg/day group are listed (1.6%).
|
0.00%
0/11
For the Treatment phase, a frequency threshold of 5% in either treatment group was used. Because there are only 11 participants in the Baseline Failure group, only adverse events occurring in at least 3 participants in the 300 mg/day group are listed (1.6%).
|
|
Nervous system disorders
Status epilepticus
|
0.00%
0/112
For the Treatment phase, a frequency threshold of 5% in either treatment group was used. Because there are only 11 participants in the Baseline Failure group, only adverse events occurring in at least 3 participants in the 300 mg/day group are listed (1.6%).
|
0.00%
0/111
For the Treatment phase, a frequency threshold of 5% in either treatment group was used. Because there are only 11 participants in the Baseline Failure group, only adverse events occurring in at least 3 participants in the 300 mg/day group are listed (1.6%).
|
0.00%
0/184
For the Treatment phase, a frequency threshold of 5% in either treatment group was used. Because there are only 11 participants in the Baseline Failure group, only adverse events occurring in at least 3 participants in the 300 mg/day group are listed (1.6%).
|
9.1%
1/11
For the Treatment phase, a frequency threshold of 5% in either treatment group was used. Because there are only 11 participants in the Baseline Failure group, only adverse events occurring in at least 3 participants in the 300 mg/day group are listed (1.6%).
|
|
Gastrointestinal disorders
Upper GI bleeding
|
0.00%
0/112
For the Treatment phase, a frequency threshold of 5% in either treatment group was used. Because there are only 11 participants in the Baseline Failure group, only adverse events occurring in at least 3 participants in the 300 mg/day group are listed (1.6%).
|
0.90%
1/111
For the Treatment phase, a frequency threshold of 5% in either treatment group was used. Because there are only 11 participants in the Baseline Failure group, only adverse events occurring in at least 3 participants in the 300 mg/day group are listed (1.6%).
|
0.00%
0/184
For the Treatment phase, a frequency threshold of 5% in either treatment group was used. Because there are only 11 participants in the Baseline Failure group, only adverse events occurring in at least 3 participants in the 300 mg/day group are listed (1.6%).
|
0.00%
0/11
For the Treatment phase, a frequency threshold of 5% in either treatment group was used. Because there are only 11 participants in the Baseline Failure group, only adverse events occurring in at least 3 participants in the 300 mg/day group are listed (1.6%).
|
Other adverse events
| Measure |
Treatment Phase: LTG XR, 300 mg
n=112 participants at risk
LTG XR, 300 mg/day in the Treatment phase
|
Treatment Phase: LTG XR, 250 mg
n=111 participants at risk
LTG XR, 250 mg/day in the Treatment phase
|
Continuation Phase: LTG XR, 300 mg
n=184 participants at risk
Treatment phase participants; LTG XR, 300 mg/day
|
Continuation Phase: Baseline Failures
n=11 participants at risk
Baseline failures that entered the Continuation Phase; LTG XR; 300 mg/day
|
|---|---|---|---|---|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/112
For the Treatment phase, a frequency threshold of 5% in either treatment group was used. Because there are only 11 participants in the Baseline Failure group, only adverse events occurring in at least 3 participants in the 300 mg/day group are listed (1.6%).
|
0.00%
0/111
For the Treatment phase, a frequency threshold of 5% in either treatment group was used. Because there are only 11 participants in the Baseline Failure group, only adverse events occurring in at least 3 participants in the 300 mg/day group are listed (1.6%).
|
2.7%
5/184
For the Treatment phase, a frequency threshold of 5% in either treatment group was used. Because there are only 11 participants in the Baseline Failure group, only adverse events occurring in at least 3 participants in the 300 mg/day group are listed (1.6%).
|
9.1%
1/11
For the Treatment phase, a frequency threshold of 5% in either treatment group was used. Because there are only 11 participants in the Baseline Failure group, only adverse events occurring in at least 3 participants in the 300 mg/day group are listed (1.6%).
|
|
Nervous system disorders
Dizziness
|
10.7%
12/112
For the Treatment phase, a frequency threshold of 5% in either treatment group was used. Because there are only 11 participants in the Baseline Failure group, only adverse events occurring in at least 3 participants in the 300 mg/day group are listed (1.6%).
|
9.0%
10/111
For the Treatment phase, a frequency threshold of 5% in either treatment group was used. Because there are only 11 participants in the Baseline Failure group, only adverse events occurring in at least 3 participants in the 300 mg/day group are listed (1.6%).
|
6.0%
11/184
For the Treatment phase, a frequency threshold of 5% in either treatment group was used. Because there are only 11 participants in the Baseline Failure group, only adverse events occurring in at least 3 participants in the 300 mg/day group are listed (1.6%).
|
18.2%
2/11
For the Treatment phase, a frequency threshold of 5% in either treatment group was used. Because there are only 11 participants in the Baseline Failure group, only adverse events occurring in at least 3 participants in the 300 mg/day group are listed (1.6%).
|
|
Nervous system disorders
Headache
|
25.9%
29/112
For the Treatment phase, a frequency threshold of 5% in either treatment group was used. Because there are only 11 participants in the Baseline Failure group, only adverse events occurring in at least 3 participants in the 300 mg/day group are listed (1.6%).
|
27.9%
31/111
For the Treatment phase, a frequency threshold of 5% in either treatment group was used. Because there are only 11 participants in the Baseline Failure group, only adverse events occurring in at least 3 participants in the 300 mg/day group are listed (1.6%).
|
17.9%
33/184
For the Treatment phase, a frequency threshold of 5% in either treatment group was used. Because there are only 11 participants in the Baseline Failure group, only adverse events occurring in at least 3 participants in the 300 mg/day group are listed (1.6%).
|
9.1%
1/11
For the Treatment phase, a frequency threshold of 5% in either treatment group was used. Because there are only 11 participants in the Baseline Failure group, only adverse events occurring in at least 3 participants in the 300 mg/day group are listed (1.6%).
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/112
For the Treatment phase, a frequency threshold of 5% in either treatment group was used. Because there are only 11 participants in the Baseline Failure group, only adverse events occurring in at least 3 participants in the 300 mg/day group are listed (1.6%).
|
4.5%
5/111
For the Treatment phase, a frequency threshold of 5% in either treatment group was used. Because there are only 11 participants in the Baseline Failure group, only adverse events occurring in at least 3 participants in the 300 mg/day group are listed (1.6%).
|
0.00%
0/184
For the Treatment phase, a frequency threshold of 5% in either treatment group was used. Because there are only 11 participants in the Baseline Failure group, only adverse events occurring in at least 3 participants in the 300 mg/day group are listed (1.6%).
|
0.00%
0/11
For the Treatment phase, a frequency threshold of 5% in either treatment group was used. Because there are only 11 participants in the Baseline Failure group, only adverse events occurring in at least 3 participants in the 300 mg/day group are listed (1.6%).
|
|
Infections and infestations
Nasalpharyngitis
|
6.2%
7/112
For the Treatment phase, a frequency threshold of 5% in either treatment group was used. Because there are only 11 participants in the Baseline Failure group, only adverse events occurring in at least 3 participants in the 300 mg/day group are listed (1.6%).
|
6.3%
7/111
For the Treatment phase, a frequency threshold of 5% in either treatment group was used. Because there are only 11 participants in the Baseline Failure group, only adverse events occurring in at least 3 participants in the 300 mg/day group are listed (1.6%).
|
2.7%
5/184
For the Treatment phase, a frequency threshold of 5% in either treatment group was used. Because there are only 11 participants in the Baseline Failure group, only adverse events occurring in at least 3 participants in the 300 mg/day group are listed (1.6%).
|
0.00%
0/11
For the Treatment phase, a frequency threshold of 5% in either treatment group was used. Because there are only 11 participants in the Baseline Failure group, only adverse events occurring in at least 3 participants in the 300 mg/day group are listed (1.6%).
|
|
Gastrointestinal disorders
Nausea
|
5.4%
6/112
For the Treatment phase, a frequency threshold of 5% in either treatment group was used. Because there are only 11 participants in the Baseline Failure group, only adverse events occurring in at least 3 participants in the 300 mg/day group are listed (1.6%).
|
5.4%
6/111
For the Treatment phase, a frequency threshold of 5% in either treatment group was used. Because there are only 11 participants in the Baseline Failure group, only adverse events occurring in at least 3 participants in the 300 mg/day group are listed (1.6%).
|
3.3%
6/184
For the Treatment phase, a frequency threshold of 5% in either treatment group was used. Because there are only 11 participants in the Baseline Failure group, only adverse events occurring in at least 3 participants in the 300 mg/day group are listed (1.6%).
|
9.1%
1/11
For the Treatment phase, a frequency threshold of 5% in either treatment group was used. Because there are only 11 participants in the Baseline Failure group, only adverse events occurring in at least 3 participants in the 300 mg/day group are listed (1.6%).
|
|
Skin and subcutaneous tissue disorders
Rash
|
3.6%
4/112
For the Treatment phase, a frequency threshold of 5% in either treatment group was used. Because there are only 11 participants in the Baseline Failure group, only adverse events occurring in at least 3 participants in the 300 mg/day group are listed (1.6%).
|
10.8%
12/111
For the Treatment phase, a frequency threshold of 5% in either treatment group was used. Because there are only 11 participants in the Baseline Failure group, only adverse events occurring in at least 3 participants in the 300 mg/day group are listed (1.6%).
|
0.00%
0/184
For the Treatment phase, a frequency threshold of 5% in either treatment group was used. Because there are only 11 participants in the Baseline Failure group, only adverse events occurring in at least 3 participants in the 300 mg/day group are listed (1.6%).
|
0.00%
0/11
For the Treatment phase, a frequency threshold of 5% in either treatment group was used. Because there are only 11 participants in the Baseline Failure group, only adverse events occurring in at least 3 participants in the 300 mg/day group are listed (1.6%).
|
|
Nervous system disorders
Somnolence
|
4.5%
5/112
For the Treatment phase, a frequency threshold of 5% in either treatment group was used. Because there are only 11 participants in the Baseline Failure group, only adverse events occurring in at least 3 participants in the 300 mg/day group are listed (1.6%).
|
5.4%
6/111
For the Treatment phase, a frequency threshold of 5% in either treatment group was used. Because there are only 11 participants in the Baseline Failure group, only adverse events occurring in at least 3 participants in the 300 mg/day group are listed (1.6%).
|
2.7%
5/184
For the Treatment phase, a frequency threshold of 5% in either treatment group was used. Because there are only 11 participants in the Baseline Failure group, only adverse events occurring in at least 3 participants in the 300 mg/day group are listed (1.6%).
|
9.1%
1/11
For the Treatment phase, a frequency threshold of 5% in either treatment group was used. Because there are only 11 participants in the Baseline Failure group, only adverse events occurring in at least 3 participants in the 300 mg/day group are listed (1.6%).
|
Additional Information
GSK Response Center
GlaxoSmithKline
Phone: 866-435-7343
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