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Lamotrigine Extended-Release In Elderly Patients With Epilepsy

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: NCT00516139
Recruitment Status : Completed
First Posted : August 15, 2007
Results First Posted : January 13, 2012
Last Update Posted : January 18, 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 Epilepsy
Intervention Drug: Lamotrigine
Enrollment 122
Recruitment Details  
Pre-assignment Details The study consisted of 4 phases (Ph): 7-week (w) Dose-escalation Ph, 8-w Adjunctive Maintenance (AM) Ph, 13-w Adj. Optimization (AO) Ph or 13-w Conversion/Monotherapy (C/M) Ph, and a 2-5 w Taper/Follow up (T/F) Ph.
Arm/Group Title Lamotrigine (LTG)-Extended Release (XR) Tablets
Hide Arm/Group Description LTG-XR tablets (25, 50, 100, and 200 milligrams [mg]) administered once a day (OD) in the 7-week (w) Dose-Escalation Phase and titrated to target doses of 300, 500, or 200 mg/day for participants (par.) depending on their concomitant antiepileptic drug (AED), followed by an 8-w Adjunctive Maintenance Phase in which LTG-XR tablets were administered OD at the target dose. Par. on a single concomitant AED who converted to LTG-XR monotherapy (based on investigator's judgment) entered the 5-w Conversion Phase, followed by an 8-w Monotherapy Phase, whereas par. who did not transition to monotherapy entered the 13-w Adjunctive Optimization Phase. At the end of the study, par. entered the 2- to 5-w Taper/Follow-Up Phase, in which par. either switched to commercial LTG (received same total daily dose of commercial LTG in 2 divided doses [BID]) or did not switch to commercial LTG (current dose was reduced by approximately one-fourth per week) with a final visit 2 weeks after last LTG-XR dose.
Period Title: Overall Study
Started 122
Completed 84 [1]
Not Completed 38
Reason Not Completed
Adverse Event             27
Lost to Follow-up             1
Protocol Violation             1
Withdrawal by Subject             8
Lack of Efficacy             1
[1]
Study completers completed Escalation, AM, and either AO or both Conversion and Monotherapy Phases.
Arm/Group Title LTG-XR Tablets
Hide Arm/Group Description LTG-XR tablets (25, 50, 100, and 200 milligrams [mg]) administered once a day (OD) in the 7-week (w) Dose-Escalation Phase and titrated to target doses of 300, 500, or 200 mg/day for participants (par.) depending on their concomitant antiepileptic drug (AED), followed by an 8-w Adjunctive Maintenance Phase in which LTG-XR tablets were administered OD at the target dose. Par. on a single concomitant AED who converted to LTG-XR monotherapy (based on investigator's judgment) entered the 5-w Conversion Phase, followed by an 8-w Monotherapy Phase, whereas par. who did not transition to monotherapy entered the 13-w Adjunctive Optimization Phase. At the end of the study, par. entered the 2- to 5-w Taper/Follow-Up Phase, in which par. either switched to commercial LTG (received same total daily dose of commercial LTG in 2 divided doses [BID]) or did not switch to commercial LTG (current dose was reduced by approximately one-fourth per week) with a final visit 2 weeks after last LTG-XR dose.
Overall Number of Baseline Participants 121
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous   [1] 
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 121 participants
72.5  (5.53)
[1]
Measure Description: Baseline characteristics were collected for the Safety Population, which included all participants who were enrolled and took at least one dose of the study drug. One participant enrolled in the study did not take at least one dose of the study drug.
Gender   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 121 participants
Female
59
  48.8%
Male
62
  51.2%
[1]
Measure Description: Baseline characteristics were collected for the Safety Population, which included all participants who were enrolled and took at least one dose of the study drug. One participant enrolled in the study did not take at least one dose of the study drug.
Race/Ethnicity, Customized   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 121 participants
African American/African Heritage 14
Asian - South East Asian Heritage 2
White - Arabic/North African Heritage 1
White - White/Caucasian/European Heritage 105
[1]
Measure Description: Baseline characteristics were collected for the Safety Population, which included all participants who were enrolled and took at least one dose of the study drug. One participant enrolled in the study did not take at least one dose of the study drug. Participants are allowed to select more than one race.
1.Primary Outcome
Title Number of Participants With Any Serious Adverse Event (SAE) and Any Non-serious Adverse Event
Hide Description An adverse event (AE) is any untoward medical occurrence in a participant, temporally associated with the use of medicinal product, whether or not considered related to the medicinal product. An SAE is any untoward medical occurrence that, at any dose, results in death, is life-threatening, requires inpatient hospitalization or causes its prolongation, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, or is an important medical event. A complete list of all SAEs and AEs experienced in the study can be found in the SAE/AE section.
Time Frame From Baseline (Week 0) until 3 weeks after the end of treatment (Week 30 or 33)
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population: all participants who were enrolled and took at least one dose of study drug
Arm/Group Title LTG-XR Tablets
Hide Arm/Group Description:
LTG-XR tablets (25, 50, 100, and 200 milligrams [mg]) administered once a day (OD) in the 7-week (w) Dose-Escalation Phase and titrated to target doses of 300, 500, or 200 mg/day for participants (par.) depending on their concomitant antiepileptic drug (AED), followed by an 8-w Adjunctive Maintenance Phase in which LTG-XR tablets were administered OD at the target dose. Par. on a single concomitant AED who converted to LTG-XR monotherapy (based on investigator's judgment) entered the 5-w Conversion Phase, followed by an 8-w Monotherapy Phase, whereas par. who did not transition to monotherapy entered the 13-w Adjunctive Optimization Phase. At the end of the study, par. entered the 2- to 5-w Taper/Follow-Up Phase, in which par. either switched to commercial LTG (received same total daily dose of commercial LTG in 2 divided doses [BID]) or did not switch to commercial LTG (current dose was reduced by approximately one-fourth per week) with a final visit 2 weeks after last LTG-XR dose.
Overall Number of Participants Analyzed 121
Measure Type: Number
Unit of Measure: participants
Participants with any SAE 22
Participants with any non-serious AE 112
2.Secondary Outcome
Title Percent Change From Baseline (BL) in Weekly Seizure (sz.) Frequency for All Partial Seizures During Each Phase of the Study
Hide Description Partial-onset sz. have a focal site of onset; sz. activity is initially limited to 1 brain hemisphere. Partial sz. can remain simple or complex, or evolve to generalized tonic-clonic sz. Participants (par.) recorded the number of sz., by type as well as the episode duration of innumerable sz. activity), in daily diaries. If par. withdrew from study, data were averaged for the study portion the par. completed up to the time of drug discontinuation. Percent change from BL = (BL value minus study phase value divided by BL value) x 100; positive values indicate reduction from BL in sz. frequency.
Time Frame Baseline (Week 0), Dose-Escalation Phase (Week 7), Maintenance Phase (Week 15), Adjunctive Optimization Phase (Week 28), Conversion Phase (Week 20), Monotherapy Phase (Week 28), and end of treatment (Week 30 or 33)
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population. Only those participants who had seizures at baseline were analyzed.
Arm/Group Title LTG-XR Tablets
Hide Arm/Group Description:
LTG-XR tablets (25, 50, 100, and 200 milligrams [mg]) administered once a day (OD) in the 7-week (w) Dose-Escalation Phase and titrated to target doses of 300, 500, or 200 mg/day for participants (par.) depending on their concomitant antiepileptic drug (AED), followed by an 8-w Adjunctive Maintenance Phase in which LTG-XR tablets were administered OD at the target dose. Par. on a single concomitant AED who converted to LTG-XR monotherapy (based on investigator's judgment) entered the 5-w Conversion Phase, followed by an 8-w Monotherapy Phase, whereas par. who did not transition to monotherapy entered the 13-w Adjunctive Optimization Phase. At the end of the study, par. entered the 2- to 5-w Taper/Follow-Up Phase, in which par. either switched to commercial LTG (received same total daily dose of commercial LTG in 2 divided doses [BID]) or did not switch to commercial LTG (current dose was reduced by approximately one-fourth per week) with a final visit 2 weeks after last LTG-XR dose.
Overall Number of Participants Analyzed 55
Median (Full Range)
Unit of Measure: Percent change in seizure frequency
Dose-Escalation Phase (Week 7), n=55
97.8
(-146.3 to 100.0)
Maintenance Phase (Week 15), n=43
100.0
(-162.5 to 100.0)
Adjunctive Optimization Phase (Week 28), n=15
100.0
(33.3 to 100.0)
Conversion Phase (Week 20), n=24
100.0
(-44.5 to 100.0)
Monotherapy Phase (Week 28), n=24
100.0
(-269.8 to 100.0)
End Of Treatment (Week 30/33), n=55
90.4
(-86.7 to 100.0)
3.Secondary Outcome
Title Number of Participants With the Indicated Change From Baseline in Weekly Seizure Frequency During Each Phase of the Study
Hide Description Participants recorded the number of seizures, by seizure type, as well as the duration of episodes of innumerable seizure activity in their daily diaries during all phases of the study. For participants who withdrew from the study, seizure data were averaged for the portion of the study the participant completed up to the time of study drug discontinuation. Participants who experienced a change from Baseline in the weekly seizure frequency were categorized as having a >=25%, >=50%, >=75%, or 100% reduction or a >=50% increase in percent change from Baseline in weekly seizure frequency.
Time Frame Baseline (Week 0), Dose-Escalation Phase (Week 7), Maintenance Phase (Week 15), Adjunctive Optimization (Adj O) Phase (Week 28), Conversion Phase (Week 20), Monotherapy Phase (Week 28), and end of treatment (ET, Week 30 or 33)
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population. Only those participants who had seizures at baseline were analyzed.
Arm/Group Title LTG-XR Tablets
Hide Arm/Group Description:
LTG-XR tablets (25, 50, 100, and 200 milligrams [mg]) administered once a day (OD) in the 7-week (w) Dose-Escalation Phase and titrated to target doses of 300, 500, or 200 mg/day for participants (par.) depending on their concomitant antiepileptic drug (AED), followed by an 8-w Adjunctive Maintenance Phase in which LTG-XR tablets were administered OD at the target dose. Par. on a single concomitant AED who converted to LTG-XR monotherapy (based on investigator's judgment) entered the 5-w Conversion Phase, followed by an 8-w Monotherapy Phase, whereas par. who did not transition to monotherapy entered the 13-w Adjunctive Optimization Phase. At the end of the study, par. entered the 2- to 5-w Taper/Follow-Up Phase, in which par. either switched to commercial LTG (received same total daily dose of commercial LTG in 2 divided doses [BID]) or did not switch to commercial LTG (current dose was reduced by approximately one-fourth per week) with a final visit 2 weeks after last LTG-XR dose.
Overall Number of Participants Analyzed 55
Measure Type: Number
Unit of Measure: participants
Dose-Escalation (Week 7), >=25% reduction, n=55 49
Dose-Escalation (Week 7), >=50% reduction, n=55 41
Dose-Escalation (Week 7), >=75% reduction, n=55 30
Dose-Escalation (Week 7), 100% reduction, n=55 27
Dose-Escalation (Week 7), >=50% increase, n=55 2
Maintenance (Week 15), >=25% reduction, n=43 39
Maintenance (Week 15), >=50% reduction, n=43 37
Maintenance (Week 15), >=75% reduction, n=43 33
Maintenance (Week 15), 100% reduction, n=43 30
Maintenance (Week 15), >=50% increase, n=43 2
Adj O (Week 28), >=25% reduction, n=15 15
Adj O (Week 28), >=50% reduction, n=15 14
Adj O (Week 28), >=75% reduction, n=15 12
Adj O (Week 28), 100% reduction, n=15 11
Adj O (Week 28), >=50% increase, n=15 0
Conversion (Week 20), >=25% reduction, n=24 23
Conversion (Week 20), >=50% reduction, n=24 23
Conversion (Week 20), >=75% reduction, n=24 19
Conversion (Week 20), 100% reduction, n=24 17
Conversion (Week 20), >=50% increase, n=24 0
Monotherapy (Week 28), >=25% reduction, n=24 23
Monotherapy (Week 28), >=50% reduction, n=24 20
Monotherapy (Week 28), >=75% reduction, n=24 17
Monotherapy (Week 28), 100% reduction, n=24 13
Monotherapy (Week 28), >=50% increase, n=24 1
ET (Week 30/33), >=25% reduction, n=55 47
ET (Week 30/33), >=50% reduction, n=55 44
ET (Week 30/33), >=75% reduction, n=55 36
ET (Week 30/33), 100% reduction, n=55 24
ET (Week 30/33), >=50% increase, n=55 1
4.Secondary Outcome
Title Number of Seizure-free Participants at Baseline Who Remained Seizure-free Throughout the Entire Treatment Period
Hide Description Participants were considered to be seizure-free if they did not report any seizures at Baseline.
Time Frame Week 30 or 33
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population. Participants who were seizure-free at Baseline were analyzed.
Arm/Group Title LTG-XR Tablets
Hide Arm/Group Description:
LTG-XR tablets (25, 50, 100, and 200 milligrams [mg]) administered once a day (OD) in the 7-week (w) Dose-Escalation Phase and titrated to target doses of 300, 500, or 200 mg/day for participants (par.) depending on their concomitant antiepileptic drug (AED), followed by an 8-w Adjunctive Maintenance Phase in which LTG-XR tablets were administered OD at the target dose. Par. on a single concomitant AED who converted to LTG-XR monotherapy (based on investigator's judgment) entered the 5-w Conversion Phase, followed by an 8-w Monotherapy Phase, whereas par. who did not transition to monotherapy entered the 13-w Adjunctive Optimization Phase. At the end of the study, par. entered the 2- to 5-w Taper/Follow-Up Phase, in which par. either switched to commercial LTG (received same total daily dose of commercial LTG in 2 divided doses [BID]) or did not switch to commercial LTG (current dose was reduced by approximately one-fourth per week) with a final visit 2 weeks after last LTG-XR dose.
Overall Number of Participants Analyzed 66
Measure Type: Number
Unit of Measure: participants
Remained Seizure-Free 53
Did Not Remain Seizure-Free 13
5.Secondary Outcome
Title Number of Participants With Changes From Baseline in Seizure Severity in the Indicated Categories, as Measured by the Investigator's Global Evaluation (IGE) Scale
Hide Description Investigators rated the participants' seizure severity at Weeks 15 and 28 of the study treatment by using the IGE scale, comprised of 7 categories: 3 for improvement (mild improvement, moderate improvement, and marked improvement), 3 for deterioration (marked deterioration, moderate deterioration, mild deterioration), and 1 for no change. Investigators assessed the degree of the participants' improvement or deterioration or determined whether the participants’ condition had not changed compared to their Baseline condition.
Time Frame Week 15 (Adjunctive Maintenance [Adj M] Phase), Week 28 (Adjunctive Optimization [Adj O] Phase), Week 28 (Monotherapy [Mono] Phase), and Week 28 (Early Withdrawal [WD])
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population. Only those participants who had seizures at baseline were analyzed.
Arm/Group Title LTG-XR Tablets
Hide Arm/Group Description:
LTG-XR tablets (25, 50, 100, and 200 milligrams [mg]) administered once a day (OD) in the 7-week (w) Dose-Escalation Phase and titrated to target doses of 300, 500, or 200 mg/day for participants (par.) depending on their concomitant antiepileptic drug (AED), followed by an 8-w Adjunctive Maintenance Phase in which LTG-XR tablets were administered OD at the target dose. Par. on a single concomitant AED who converted to LTG-XR monotherapy (based on investigator's judgment) entered the 5-w Conversion Phase, followed by an 8-w Monotherapy Phase, whereas par. who did not transition to monotherapy entered the 13-w Adjunctive Optimization Phase. At the end of the study, par. entered the 2- to 5-w Taper/Follow-Up Phase, in which par. either switched to commercial LTG (received same total daily dose of commercial LTG in 2 divided doses [BID]) or did not switch to commercial LTG (current dose was reduced by approximately one-fourth per week) with a final visit 2 weeks after last LTG-XR dose.
Overall Number of Participants Analyzed 91
Measure Type: Number
Unit of Measure: participants
Week 15, Adj M Phase, Improvement, n=91 36
Week 15, Adj M Phase, No change, n=91 54
Week 15, Adj M Phase, Deterioration, n=91 1
Week 28, Adj O Phase, Improvement, n=21 13
Week 28, Adj O Phase, No change, n=21 7
Week 28, Adj O Phase, Deterioration, n=21 1
Week 28, Mono Phase, Improvement, n=63 29
Week 28, Mono Phase, No change, n=63 33
Week 28, Mono Phase, Deterioration, n=63 1
Week 28, WD, Improvement, n=35 7
Week 28, WD, No change, n=35 25
Week 28, WD, Deterioration, n=35 3
6.Secondary Outcome
Title Number of Participants With Changes From Baseline in Overall Clinical Status in the Indicated Categories, as Measured by the IGE Scale
Hide Description Investigators rated the participants' overall clinical status at Weeks 15 and 28 of the study treatment by using the IGE scale, comprised of 7 categories: 3 for improvement (mild improvement, moderate improvement, and marked improvement), 3 for deterioration (marked deterioration, moderate deterioration, mild deterioration), and 1 for no change. Investigators assessed the degree of the participants' improvement or deterioration or determined whether the participants’ condition had not changed compared to their Baseline condition.
Time Frame Week 15 (Adjunctive Maintenance [Adj M] Phase), Week 28 (Adjunctive Optimization [Adj O] Phase), Week 28 (Monotherapy [Mono] Phase), and Week 28 (Early Withdrawal [WD])
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population. Participants with missing data were not analyzed.
Arm/Group Title LTG-XR Tablets
Hide Arm/Group Description:
LTG-XR tablets (25, 50, 100, and 200 milligrams [mg]) administered once a day (OD) in the 7-week (w) Dose-Escalation Phase and titrated to target doses of 300, 500, or 200 mg/day for participants (par.) depending on their concomitant antiepileptic drug (AED), followed by an 8-w Adjunctive Maintenance Phase in which LTG-XR tablets were administered OD at the target dose. Par. on a single concomitant AED who converted to LTG-XR monotherapy (based on investigator's judgment) entered the 5-w Conversion Phase, followed by an 8-w Monotherapy Phase, whereas par. who did not transition to monotherapy entered the 13-w Adjunctive Optimization Phase. At the end of the study, par. entered the 2- to 5-w Taper/Follow-Up Phase, in which par. either switched to commercial LTG (received same total daily dose of commercial LTG in 2 divided doses [BID]) or did not switch to commercial LTG (current dose was reduced by approximately one-fourth per week) with a final visit 2 weeks after last LTG-XR dose.
Overall Number of Participants Analyzed 91
Measure Type: Number
Unit of Measure: participants
Week 15, Adj M Phase, Improvement, n=91 51
Week 15, Adj M Phase, No change, n=91 29
Week 15, Adj M Phase, Deterioration, n=91 11
Week 28, Adj O Phase, Improvement, n=21 17
Week 28, Adj O Phase, No change, n=21 2
Week 28, Adj O Phase, Deterioration, n=21 2
Week 28, Mono Phase, Improvement, n=63 43
Week 28, Mono Phase, No change, n=63 14
Week 28, Mono Phase, Deterioration, n=63 6
Week 28, WD, Improvement, n=35 7
Week 28, WD, No change, n=35 12
Week 28, WD, Deterioration, n=35 16
7.Secondary Outcome
Title Change From Baseline in Systolic and Diastolic Blood Pressure (BP) at the Indicated Time Points in the Study
Hide Description Change from Baseline was calculated by subtracting the values of systolic and diastolic blood pressures recorded by the investigator at the indicated time points in the study from the respective Baseline values.
Time Frame Baseline (Week 0) and Week 15 (Adj M Phase), Week 28 (Adj O Phase), Week 28 (Mono Phase), Week 28 (WD), and Week 30/33 (End of study [EOS])
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population. Only those participants with both a baseline and post-baseline value were analyzed.
Arm/Group Title LTG-XR Tablets
Hide Arm/Group Description:
LTG-XR tablets (25, 50, 100, and 200 milligrams [mg]) administered once a day (OD) in the 7-week (w) Dose-Escalation Phase and titrated to target doses of 300, 500, or 200 mg/day for participants (par.) depending on their concomitant antiepileptic drug (AED), followed by an 8-w Adjunctive Maintenance Phase in which LTG-XR tablets were administered OD at the target dose. Par. on a single concomitant AED who converted to LTG-XR monotherapy (based on investigator's judgment) entered the 5-w Conversion Phase, followed by an 8-w Monotherapy Phase, whereas par. who did not transition to monotherapy entered the 13-w Adjunctive Optimization Phase. At the end of the study, par. entered the 2- to 5-w Taper/Follow-Up Phase, in which par. either switched to commercial LTG (received same total daily dose of commercial LTG in 2 divided doses [BID]) or did not switch to commercial LTG (current dose was reduced by approximately one-fourth per week) with a final visit 2 weeks after last LTG-XR dose.
Overall Number of Participants Analyzed 119
Mean (Standard Deviation)
Unit of Measure: Millimeters of mercury
Systolic BP, Week 15, Adj M Phase, n=88 1.51  (19.038)
Systolic BP, Week 28, Adj O Phase, n=21 -0.62  (15.377)
Systolic BP, Week 28, Mono Phase, n=63 0.68  (20.509)
Systolic BP, Week 28, WD, n=35 -4.00  (15.566)
Systolic BP, Week 30/33, EOS, n=119 -2.19  (15.928)
Diastolic BP, Week 15, Adj M Phase, n=88 -1.22  (10.547)
Diastolic BP, Week 28, Adj O Phase, n=21 -1.05  (7.214)
Diastolic BP, Week 28, Mono Phase, n=63 -0.08  (10.754)
Diastolic BP, Week 28, WD, n=35 -2.09  (8.763)
Diastolic BP, Week 30/33, EOS, n=119 -2.07  (9.102)
8.Secondary Outcome
Title Change From Baseline in the Height at the Indicated Time Points in the Study
Hide Description Change from Baseline was calculated by subtracting the value of height measured by the investigator at the indicated time points in the study from the Baseline value.
Time Frame Baseline (Week 0) and Week 15 (Adj M Phase), Week 28 (Adj O Phase), Week 28 (Mono Phase), Week 28 (WD), and Week 30/33 (End of study [EOS])
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population. Only those participants with both a baseline and post-baseline value were analyzed.
Arm/Group Title LTG-XR Tablets
Hide Arm/Group Description:
LTG-XR tablets (25, 50, 100, and 200 milligrams [mg]) administered once a day (OD) in the 7-week (w) Dose-Escalation Phase and titrated to target doses of 300, 500, or 200 mg/day for participants (par.) depending on their concomitant antiepileptic drug (AED), followed by an 8-w Adjunctive Maintenance Phase in which LTG-XR tablets were administered OD at the target dose. Par. on a single concomitant AED who converted to LTG-XR monotherapy (based on investigator's judgment) entered the 5-w Conversion Phase, followed by an 8-w Monotherapy Phase, whereas par. who did not transition to monotherapy entered the 13-w Adjunctive Optimization Phase. At the end of the study, par. entered the 2- to 5-w Taper/Follow-Up Phase, in which par. either switched to commercial LTG (received same total daily dose of commercial LTG in 2 divided doses [BID]) or did not switch to commercial LTG (current dose was reduced by approximately one-fourth per week) with a final visit 2 weeks after last LTG-XR dose.
Overall Number of Participants Analyzed 120
Mean (Standard Deviation)
Unit of Measure: centimeters
Week 15, Adj M Phase, n=90 0.03  (1.302)
Week 28, Adj O Phase, n=21 0.29  (2.217)
Week 28, Mono Phase, n=62 -0.03  (1.293)
Week 28, WD, n=36 -0.03  (1.028)
Week 30/33, EOS, n=120 0.03  (1.417)
9.Secondary Outcome
Title Change From Baseline in the Weight at the Indicated Time Points in the Study
Hide Description Change from Baseline was calculated by subtracting the value of weight measured by the investigator at the indicated time points in the study from the Baseline value.
Time Frame Baseline (Week 0) and Week 15 (Adj M Phase), Week 28 (Adj O Phase), Week 28 (Mono Phase), Week 28 (WD), and Week 30/33 (End of study [EOS])
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population. Only those participants with both a baseline and post-baseline value were analyzed.
Arm/Group Title LTG-XR Tablets
Hide Arm/Group Description:
LTG-XR tablets (25, 50, 100, and 200 milligrams [mg]) administered once a day (OD) in the 7-week (w) Dose-Escalation Phase and titrated to target doses of 300, 500, or 200 mg/day for participants (par.) depending on their concomitant antiepileptic drug (AED), followed by an 8-w Adjunctive Maintenance Phase in which LTG-XR tablets were administered OD at the target dose. Par. on a single concomitant AED who converted to LTG-XR monotherapy (based on investigator's judgment) entered the 5-w Conversion Phase, followed by an 8-w Monotherapy Phase, whereas par. who did not transition to monotherapy entered the 13-w Adjunctive Optimization Phase. At the end of the study, par. entered the 2- to 5-w Taper/Follow-Up Phase, in which par. either switched to commercial LTG (received same total daily dose of commercial LTG in 2 divided doses [BID]) or did not switch to commercial LTG (current dose was reduced by approximately one-fourth per week) with a final visit 2 weeks after last LTG-XR dose.
Overall Number of Participants Analyzed 119
Mean (Standard Deviation)
Unit of Measure: kilograms
Week 15, Adj M Phase, n=88 -0.22  (3.204)
Week 28, Adj O Phase, n=21 -0.41  (2.968)
Week 28, Mono Phase, n=62 -0.48  (3.520)
Week 28, WD, n=36 -0.27  (3.735)
Week 30/33, EOS, n=119 -0.41  (3.470)
10.Secondary Outcome
Title Change From Baseline in the Basophil, Eosinophil, Hemoglobin, Lymphocyte, Monocyte, Absolute Neutrophil Count (ANC), Platelet Count, and White Blood Cell (WBC) Count at the Indicated Time Points in the Study
Hide Description The blood samples collected at the study visits were analyzed and assessed at the central laboratory, and the investigator reviewed and assessed the clinical significance. Change from Baseline was calculated by subtracting the value of basophil, eosinophil, hemoglobin, lymphocyte, monocyte, ANC, platelet count, and WBC count at the indicated time points in the study from the Baseline value.
Time Frame Baseline (Week 0) and Week 15 (Adj M Phase), Week 28 (Adj O Phase), Week 28 (Mono Phase), and Week 28 (WD)
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population. Only those participants with both a baseline and post-baseline value were analyzed.
Arm/Group Title LTG-XR Tablets
Hide Arm/Group Description:
LTG-XR tablets (25, 50, 100, and 200 milligrams [mg]) administered once a day (OD) in the 7-week (w) Dose-Escalation Phase and titrated to target doses of 300, 500, or 200 mg/day for participants (par.) depending on their concomitant antiepileptic drug (AED), followed by an 8-w Adjunctive Maintenance Phase in which LTG-XR tablets were administered OD at the target dose. Par. on a single concomitant AED who converted to LTG-XR monotherapy (based on investigator's judgment) entered the 5-w Conversion Phase, followed by an 8-w Monotherapy Phase, whereas par. who did not transition to monotherapy entered the 13-w Adjunctive Optimization Phase. At the end of the study, par. entered the 2- to 5-w Taper/Follow-Up Phase, in which par. either switched to commercial LTG (received same total daily dose of commercial LTG in 2 divided doses [BID]) or did not switch to commercial LTG (current dose was reduced by approximately one-fourth per week) with a final visit 2 weeks after last LTG-XR dose.
Overall Number of Participants Analyzed 89
Median (Full Range)
Unit of Measure: Giga (10^9) cells per liter
Basophil, Week 15, Adj M, n=85
0.00
(-0.03 to 0.06)
Basophil, Week 28, Adj O, n=19
0.00
(-0.02 to 0.02)
Basophil, Week 28, Mono, n=55
0.00
(-0.05 to 0.05)
Basophil, Week 28, WD, n=33
0.00
(-0.04 to 0.04)
Eosinophil, Week 15, Adj M, n=89
0.00
(-0.38 to 0.55)
Eosinophil, Week 28, Adj O, n=21
0.01
(-0.06 to 0.26)
Eosinophil, Week 28, Mono, n=61
0.01
(-0.23 to 0.54)
Eosinophil, Week 28, WD, n=33
-0.01
(-0.17 to 0.84)
Hemoglobin, Week 15, Adj M, n=85
-4.00
(-38.00 to 19.00)
Hemoglobin, Week 28, Adj O, n=19
-6.00
(-22.00 to 4.00)
Hemoglobin, Week 28, Mono, n=55
-4.00
(-25.00 to 10.00)
Hemoglobin, Week 28, WD, n=33
-2.00
(-21.00 to 31.00)
Lymphocytes, Week 15, Adj M, n=85
-0.12
(-1.55 to 1.52)
Lymphocytes, Week 28, Adj O, n=19
-0.05
(-0.61 to 0.40)
Lymphocytes, Week 28, Mono, n=55
-0.20
(-1.75 to 0.62)
Lymphocytes, Week 28, WD, n=33
-0.09
(-0.94 to 0.66)
Monocytes, Week 15, Adj M, n=85
-0.03
(-0.41 to 0.47)
Monocytes, Week 28, Adj O, n=19
0.00
(-0.55 to 0.26)
Monocytes, Week 28, Mono, n=55
-0.04
(-0.37 to 0.40)
Monocytes, Week 28, WD, n=33
-0.01
(-0.48 to 0.64)
Absolute Neutrophil Count, Week 15, Adj M, n=85
-0.23
(-3.00 to 5.04)
Absolute Neutrophil Count, Week 28, Adj O, n=19
0.09
(-2.17 to 3.31)
Absolute Neutrophil Count, Week 28, Mono, n=55
-0.17
(-3.18 to 2.71)
Absolute Neutrophil Count, Week 28, WD, n=33
0.17
(-1.99 to 6.47)
Platelet Count, Week 15, Adj M, n=84
1.50
(-91.00 to 226.00)
Platelet Count, Week 28, Adj O, n=19
3.00
(-55.00 to 216.00)
Platelet Count, Week 28, Mono, n=54
0.00
(-75.00 to 104.00)
Platelet Count, Week 28, WD, n=32
6.50
(-80.00 to 172.00)
White Blood Cell Count, Week 15, Adj M, n=85
-0.30
(-2.80 to 5.70)
White Blood Cell Count, Week 28, Adj O, n=19
-0.20
(-2.40 to 3.20)
White Blood Cell Count, Week 28, Mono, n=55
-0.60
(-3.50 to 2.00)
White Blood Cell Count, Week 28, WD, n=33
0.30
(-2.20 to 6.00)
11.Secondary Outcome
Title Percent Change From Baseline in the Basophil, Eosinophil, Hemoglobin, Lymphocyte, Monocyte, Absolute Neutrophil Count, Platelet Count, and White Blood Cell Count at the Indicated Time Points in the Study
Hide Description The blood samples collected at the study visits were analyzed and assessed at the central laboratory, and the investigator reviewed and assessed the clinical significance. Percent change from Baseline = (value at each indicated time point in the study minus respective Baseline value divided by Baseline value) x 100.
Time Frame Baseline (Week 0) and Week 15 (Adj M Phase), Week 28 (Adj O Phase), Week 28 (Mono Phase), and Week 28 (WD)
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population. Only those participants with both a baseline and post-baseline value were analyzed.
Arm/Group Title LTG-XR Tablets
Hide Arm/Group Description:
LTG-XR tablets (25, 50, 100, and 200 milligrams [mg]) administered once a day (OD) in the 7-week (w) Dose-Escalation Phase and titrated to target doses of 300, 500, or 200 mg/day for participants (par.) depending on their concomitant antiepileptic drug (AED), followed by an 8-w Adjunctive Maintenance Phase in which LTG-XR tablets were administered OD at the target dose. Par. on a single concomitant AED who converted to LTG-XR monotherapy (based on investigator's judgment) entered the 5-w Conversion Phase, followed by an 8-w Monotherapy Phase, whereas par. who did not transition to monotherapy entered the 13-w Adjunctive Optimization Phase. At the end of the study, par. entered the 2- to 5-w Taper/Follow-Up Phase, in which par. either switched to commercial LTG (received same total daily dose of commercial LTG in 2 divided doses [BID]) or did not switch to commercial LTG (current dose was reduced by approximately one-fourth per week) with a final visit 2 weeks after last LTG-XR dose.
Overall Number of Participants Analyzed 89
Median (Full Range)
Unit of Measure: Percent change in counts
Basophil, Week 15, Adj M, n=89
0.00
(-0.80 to 1.00)
Basophil, Week 28, Adj O, n=21
0.00
(-0.50 to 0.50)
Basophil, Week 28, Mono, n=61
0.00
(-0.80 to 0.90)
Basophil, Week 28, WD, n=33
0.00
(-0.50 to 0.90)
Eosinophil, Week 15, Adj M, n=89
0.20
(-4.40 to 10.90)
Eosinophil, Week 28, Adj O, n=21
0.10
(-1.50 to 4.30)
Eosinophil, Week 28, Mono, n=61
0.30
(-3.30 to 10.80)
Eosinophil, Week 28, WD, n=33
-0.20
(-2.90 to 17.60)
Hematocrit, Week 15, Adj M, n=85
-0.01
(-0.11 to 0.06)
Hematocrit, Week 28, Adj O, n=19
-0.02
(-0.07 to 0.02)
Hematocrit, Week 28, Mono, n=55
-0.01
(-0.09 to 0.04)
Hematocrit, Week 28, WD, n=33
-0.00
(-0.04 to 0.10)
Lymphocytes, Week 15, Adj M, n=89
-2.10
(-25.80 to 18.90)
Lymphocytes, Week 28, Adj O, n=21
-2.40
(-16.00 to 13.60)
Lymphocytes, Week 28, Mono, n=61
-1.50
(-23.90 to 12.40)
Lymphocytes, Week 28, WD, n=33
-1.60
(-14.20 to 8.10)
Monocytes, Week 15, Adj M, n=89
0.00
(-8.90 to 6.50)
Monocytes, Week 28, Adj O, n=21
0.10
(-10.90 to 5.10)
Monocytes, Week 28, Mono, n=61
-0.20
(-6.40 to 9.50)
Monocytes, Week 28, WD, n=33
-0.30
(-8.00 to 8.10)
Total Neutrophils, Week 15, Adj M, n=89
1.3
(-26.30 to 30.40)
Total Neutrophils, Week 28, Adj O, n=21
0.50
(-13.80 to 16.80)
Total Neutrophils, Week 28, Mono, n=61
0.50
(-13.80 to 24.20)
Total Neutrophils, Week 28, WD, n=33
1.20
(-12.00 to 19.20)
12.Secondary Outcome
Title Change From Baseline in the Mean Corpuscle Hemoglobin Concentration (MCHC), Albumin, and Total Protein at the Indicated Time Points in the Study
Hide Description The blood samples collected at the study visits were analyzed and assessed at the central laboratory, and the investigator reviewed and assessed the clinical significance. Change from Baseline was calculated by subtracting the values of MCHC, albumin, and total protein at the indicated time points in the study from the respective Baseline values.
Time Frame Baseline (Week 0) and Week 15 (Adj M Phase), Week 28 (Adj O Phase), Week 28 (Mono Phase), and Week 28 (WD)
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population. Only those participants with both a baseline and post-baseline value were analyzed.
Arm/Group Title LTG-XR Tablets
Hide Arm/Group Description:
LTG-XR tablets (25, 50, 100, and 200 milligrams [mg]) administered once a day (OD) in the 7-week (w) Dose-Escalation Phase and titrated to target doses of 300, 500, or 200 mg/day for participants (par.) depending on their concomitant antiepileptic drug (AED), followed by an 8-w Adjunctive Maintenance Phase in which LTG-XR tablets were administered OD at the target dose. Par. on a single concomitant AED who converted to LTG-XR monotherapy (based on investigator's judgment) entered the 5-w Conversion Phase, followed by an 8-w Monotherapy Phase, whereas par. who did not transition to monotherapy entered the 13-w Adjunctive Optimization Phase. At the end of the study, par. entered the 2- to 5-w Taper/Follow-Up Phase, in which par. either switched to commercial LTG (received same total daily dose of commercial LTG in 2 divided doses [BID]) or did not switch to commercial LTG (current dose was reduced by approximately one-fourth per week) with a final visit 2 weeks after last LTG-XR dose.
Overall Number of Participants Analyzed 87
Median (Full Range)
Unit of Measure: grams per liter
MCHC, Week 15, Adj M, n=85
-4.00
(-30.00 to 27.00)
MCHC, Week 28, Adj O, n=21
1.00
(-18.00 to 26.00)
MCHC, Week 28, Mono, n=61
-5.00
(-31.00 to 24.00)
MCHC, Week 28, WD, n=33
1.00
(-25.00 to 15.00)
Albumin, Week 15, Adj M, n=87
0.00
(-5.00 to 7.00)
Albumin, Week 28, Adj O, n=20
-1.00
(-8.00 to 3.00)
Albumin, Week 28, Mono, n=61
0.00
(-6.00 to 6.00)
Albumin, Week 28, WD, n=33
0.00
(-9.00 to 6.00)
Total Protein, Week 15, WD, n=87
-1.0
(-13.0 to 8.0)
Total Protein, Week 28, WD, n=20
-3.00
(-11.0 to 3.0)
Total Protein, Week 28, WD, n=61
-1.0
(-15.0 to 6.0)
Total Protein, Week 28, WD, n=33
-1.0
(-15.0 to 7.0)
13.Secondary Outcome
Title Change From Baseline in Mean Corpuscle Hemoglobin (MCH) at the Indicated Time Points in the Study
Hide Description The blood samples collected at the study visits were analyzed and assessed at the central laboratory, and the investigator reviewed and assessed the clinical significance. Change from Baseline was calculated by subtracting the value of MCH at the indicated time points in the study from the Baseline value.
Time Frame Baseline (Week 0) and Week 15 (Adj M Phase), Week 28 (Adj O Phase), Week 28 (Mono Phase), and Week 28 (WD)
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population. Only those participants with both a baseline and post-baseline value were analyzed.
Arm/Group Title LTG-XR Tablets
Hide Arm/Group Description:
LTG-XR tablets (25, 50, 100, and 200 milligrams [mg]) administered once a day (OD) in the 7-week (w) Dose-Escalation Phase and titrated to target doses of 300, 500, or 200 mg/day for participants (par.) depending on their concomitant antiepileptic drug (AED), followed by an 8-w Adjunctive Maintenance Phase in which LTG-XR tablets were administered OD at the target dose. Par. on a single concomitant AED who converted to LTG-XR monotherapy (based on investigator's judgment) entered the 5-w Conversion Phase, followed by an 8-w Monotherapy Phase, whereas par. who did not transition to monotherapy entered the 13-w Adjunctive Optimization Phase. At the end of the study, par. entered the 2- to 5-w Taper/Follow-Up Phase, in which par. either switched to commercial LTG (received same total daily dose of commercial LTG in 2 divided doses [BID]) or did not switch to commercial LTG (current dose was reduced by approximately one-fourth per week) with a final visit 2 weeks after last LTG-XR dose.
Overall Number of Participants Analyzed 85
Median (Full Range)
Unit of Measure: picograms
Week 15, Adj M, n=85
-0.10
(-3.30 to 2.60)
Week 28, Adj O, n=19
0.10
(-1.20 to 1.60)
Week 28, Mono, n=55
-0.20
(-2.30 to 1.40)
Week 28, WD, n=33
-0.20
(-1.90 to 3.50)
14.Secondary Outcome
Title Change From Baseline in Mean Corpuscle Volume (MCV) at the Indicated Time Points in the the Study
Hide Description The blood samples collected at the study visits were analyzed and assessed at the central laboratory, and the investigator reviewed and assessed the clinical significance. Change from Baseline was calculated by subtracting the value of MCV at the indicated time points in the study from the Baseline value.
Time Frame Baseline (Week 0) and Week 15 (Adj M Phase), Week 28 (Adj O Phase), Week 28 (Mono Phase), and Week 28 (WD)
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population. Only those participants with both a baseline and post-baseline value were analyzed.
Arm/Group Title LTG-XR Tablets
Hide Arm/Group Description:
LTG-XR tablets (25, 50, 100, and 200 milligrams [mg]) administered once a day (OD) in the 7-week (w) Dose-Escalation Phase and titrated to target doses of 300, 500, or 200 mg/day for participants (par.) depending on their concomitant antiepileptic drug (AED), followed by an 8-w Adjunctive Maintenance Phase in which LTG-XR tablets were administered OD at the target dose. Par. on a single concomitant AED who converted to LTG-XR monotherapy (based on investigator's judgment) entered the 5-w Conversion Phase, followed by an 8-w Monotherapy Phase, whereas par. who did not transition to monotherapy entered the 13-w Adjunctive Optimization Phase. At the end of the study, par. entered the 2- to 5-w Taper/Follow-Up Phase, in which par. either switched to commercial LTG (received same total daily dose of commercial LTG in 2 divided doses [BID]) or did not switch to commercial LTG (current dose was reduced by approximately one-fourth per week) with a final visit 2 weeks after last LTG-XR dose.
Overall Number of Participants Analyzed 85
Median (Full Range)
Unit of Measure: Femtoliters
Week 15, Adj M, n=85
0.00
(-7.00 to 9.00)
Week 28, Adj O, n=19
-1.00
(-7.00 to 5.00)
Week 28, Mono, n=55
1.00
(-9.00 to 7.00)
Week 28, WD, n=33
0.00
(-4.00 to 12.00)
15.Secondary Outcome
Title Change From Baseline in Red Blood Cell (RBC) Count at the Indicated Time Points in the Study
Hide Description The blood samples collected at the study visits were analyzed and assessed at the central laboratory, and the investigator reviewed and assessed the clinical significance. Change from Baseline was calculated by subtracting the value of RBC count at the indicated time points in the study from the Baseline value. Change from baseline is measured as the number of red blood cells x 10^12 per liter.
Time Frame Baseline (Week 0) and Week 15 (Adj M Phase), Week 28 (Adj O Phase), Week 28 (Mono Phase), and Week 28 (WD)
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population. Only those participants with both a baseline and post-baseline value were analyzed.
Arm/Group Title LTG-XR Tablets
Hide Arm/Group Description:
LTG-XR tablets (25, 50, 100, and 200 milligrams [mg]) administered once a day (OD) in the 7-week (w) Dose-Escalation Phase and titrated to target doses of 300, 500, or 200 mg/day for participants (par.) depending on their concomitant antiepileptic drug (AED), followed by an 8-w Adjunctive Maintenance Phase in which LTG-XR tablets were administered OD at the target dose. Par. on a single concomitant AED who converted to LTG-XR monotherapy (based on investigator's judgment) entered the 5-w Conversion Phase, followed by an 8-w Monotherapy Phase, whereas par. who did not transition to monotherapy entered the 13-w Adjunctive Optimization Phase. At the end of the study, par. entered the 2- to 5-w Taper/Follow-Up Phase, in which par. either switched to commercial LTG (received same total daily dose of commercial LTG in 2 divided doses [BID]) or did not switch to commercial LTG (current dose was reduced by approximately one-fourth per week) with a final visit 2 weeks after last LTG-XR dose.
Overall Number of Participants Analyzed 85
Median (Full Range)
Unit of Measure: Tera (10^12) cells per liter
Week 15, Adj M, n=85
-0.10
(-0.90 to 0.40)
Week 28, Adj O, n=19
-0.20
(-0.80 to 0.10)
Week 28, Mono, n=55
-0.10
(-0.70 to 0.40)
Week 28, WD, n=33
0.00
(-0.50 to 1.00)
16.Secondary Outcome
Title Change From Baseline in Alkaline Phosphatase (Alk P), Alanine Amino Transferase (Ala AT), and Aspartate Amino Transferase (Asp AT) at the Indicated Time Points in the Study
Hide Description The blood samples collected at the study visits were analyzed and assessed at the central laboratory, and the investigator reviewed and assessed the clinical significance. Change from Baseline was calculated by subtracting the value of Alk P, Ala AT, and Asp AT at the indicated time points in the study from the Baseline value.
Time Frame Baseline (Week 0) and Week 15 (Adj M Phase), Week 28 (Adj O Phase), Week 28 (Mono Phase), and Week 28 (WD)
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population. Only those participants with both a baseline and post-baseline value were analyzed.
Arm/Group Title LTG-XR Tablets
Hide Arm/Group Description:
LTG-XR tablets (25, 50, 100, and 200 milligrams [mg]) administered once a day (OD) in the 7-week (w) Dose-Escalation Phase and titrated to target doses of 300, 500, or 200 mg/day for participants (par.) depending on their concomitant antiepileptic drug (AED), followed by an 8-w Adjunctive Maintenance Phase in which LTG-XR tablets were administered OD at the target dose. Par. on a single concomitant AED who converted to LTG-XR monotherapy (based on investigator's judgment) entered the 5-w Conversion Phase, followed by an 8-w Monotherapy Phase, whereas par. who did not transition to monotherapy entered the 13-w Adjunctive Optimization Phase. At the end of the study, par. entered the 2- to 5-w Taper/Follow-Up Phase, in which par. either switched to commercial LTG (received same total daily dose of commercial LTG in 2 divided doses [BID]) or did not switch to commercial LTG (current dose was reduced by approximately one-fourth per week) with a final visit 2 weeks after last LTG-XR dose.
Overall Number of Participants Analyzed 89
Median (Full Range)
Unit of Measure: International units per liter
Alk P, Week 15, Adj M, n=87
1.00
(-86.0 to 141.00)
Alk P, Week 28, Adj O, n=20
-0.50
(-72.0 to 20.0)
Alk P, Week 28, Mono, n=61
-5.0
(-118.0 to 49.0)
Alk P, Week 28, WD, n=33
2.00
(-90.0 to 90.00)
Ala-AT Week 15, Adj M, n=87
-2.00
(-30.0 to 71.0)
Ala-AT, Week 28, Adj O, n=20
-1.0
(-10.0 to 23.0)
Ala-AT, Week 28, Mono, n=61
-2.0
(-32.0 to 55.0)
Ala-AT, Week 28, WD, n=33
-2.0
(-20.0 to 7.0)
Asp-AT, Week 15, Adj M, n=87
-1.0
(-19.0 to 47.0)
Asp-AT, Week 28, WD, n=32
-3.0
(-34.0 to 7.0)
Asp-AT, Week 28, Adj O, n=20
-2.0
(-13.0 to 18.0)
Asp-AT, Week 28, Mono, n=60
0.00
(-15.0 to 17.0)
17.Secondary Outcome
Title Change From Baseline in Direct Bilirubin (DB), Total Bilirubin (TB), and Creatinine at the Indicated Time Points in the Study
Hide Description The blood samples collected at the study visits were analyzed and assessed at the central laboratory, and the investigator reviewed and assessed the clinical significance. Change from Baseline was calculated by subtracting the value of DB, TB, and creatinine at the indicated time points in the study from the Baseline value.
Time Frame Baseline (Week 0) and Week 15 (Adj M Phase), Week 28 (Adj O Phase), Week 28 (Mono Phase), and Week 28 (WD)
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population. Only those participants with both a baseline and post-baseline value were analyzed.
Arm/Group Title LTG-XR Tablets
Hide Arm/Group Description:
LTG-XR tablets (25, 50, 100, and 200 milligrams [mg]) administered once a day (OD) in the 7-week (w) Dose-Escalation Phase and titrated to target doses of 300, 500, or 200 mg/day for participants (par.) depending on their concomitant antiepileptic drug (AED), followed by an 8-w Adjunctive Maintenance Phase in which LTG-XR tablets were administered OD at the target dose. Par. on a single concomitant AED who converted to LTG-XR monotherapy (based on investigator's judgment) entered the 5-w Conversion Phase, followed by an 8-w Monotherapy Phase, whereas par. who did not transition to monotherapy entered the 13-w Adjunctive Optimization Phase. At the end of the study, par. entered the 2- to 5-w Taper/Follow-Up Phase, in which par. either switched to commercial LTG (received same total daily dose of commercial LTG in 2 divided doses [BID]) or did not switch to commercial LTG (current dose was reduced by approximately one-fourth per week) with a final visit 2 weeks after last LTG-XR dose.
Overall Number of Participants Analyzed 88
Median (Full Range)
Unit of Measure: micromoles (µmol) per liter
DB, Week 15, Adj M, n=87
0.0
(-1.7 to 6.8)
DB, Week 28, Adj O, n=20
0.0
(-3.4 to 1.7)
DB, Week 28, Mono, n=61
0.0
(-1.7 to 12.0)
DB, Week 28, WD, n=33
0.0
(-1.7 to 1.7)
TB, Week 15, Adj M, n=88
0.0
(-8.6 to 15.4)
TB, Week 28, Adj O, n=20
0.0
(-3.4 to 1.7)
TB, Week 28, Mono, n=61
1.7
(-8.6 to 12.0)
TB, Week 28, WD, n=33
0.0
(-3.4 to 5.1)
Creatinine, Week 15, Adj M, n=88
8.8
(-17.7 to 53.0)
Creatinine, Week 28, Adj O, n=20
8.8
(0.0 to 203.3)
Creatinine, Week 28, Mono, n=61
8.8
(-17.7 to 53.0)
Creatinine, Week 28, WD, n=33
0.0
(-17.7 to 17.7)
18.Secondary Outcome
Title Change From Baseline in Cholesterol, High Density Lipoprotein (HDL) Cholesterol, Low Density Lipoprotein (LDL) Cholesterol, Glucose, Potassium, Sodium, Triglycerides, and Urea/Blood Urea Nitrogen (BUN) at the Indicated Time Points
Hide Description The blood samples collected at the study visits were analyzed and assessed at the central laboratory, and the investigator reviewed and assessed the clinical significance. Change from Baseline was calculated by subtracting the value of cholesterol, HDL cholesterol, LDL cholesterol, glucose, potassium, sodium, triglycerides, and urea/BUN at the indicated time points in the study from the Baseline value.
Time Frame Baseline (Week 0) and Week 15 (Adj M Phase), Week 28 (Adj O Phase), Week 28 (Mono Phase), and Week 28 (WD)
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population. Only those participants with both a baseline and post-baseline value were analyzed.
Arm/Group Title LTG-XR Tablets
Hide Arm/Group Description:
LTG-XR tablets (25, 50, 100, and 200 milligrams [mg]) administered once a day (OD) in the 7-week (w) Dose-Escalation Phase and titrated to target doses of 300, 500, or 200 mg/day for participants (par.) depending on their concomitant antiepileptic drug (AED), followed by an 8-w Adjunctive Maintenance Phase in which LTG-XR tablets were administered OD at the target dose. Par. on a single concomitant AED who converted to LTG-XR monotherapy (based on investigator's judgment) entered the 5-w Conversion Phase, followed by an 8-w Monotherapy Phase, whereas par. who did not transition to monotherapy entered the 13-w Adjunctive Optimization Phase. At the end of the study, par. entered the 2- to 5-w Taper/Follow-Up Phase, in which par. either switched to commercial LTG (received same total daily dose of commercial LTG in 2 divided doses [BID]) or did not switch to commercial LTG (current dose was reduced by approximately one-fourth per week) with a final visit 2 weeks after last LTG-XR dose.
Overall Number of Participants Analyzed 87
Median (Full Range)
Unit of Measure: millimoles (mmol) per liter
Cholesterol, Week 15, Adj M, n=87
-0.1
(-1.7 to 1.7)
Cholesterol, Week 28, Adj O, n=20
-0.1
(-2.2 to 0.9)
Cholesterol, Week 28, Mono, n=61
-0.3
(-2.5 to 1.2)
Cholesterol, Week 28, WD, n=33
-0.1
(-3.5 to 1.0)
HDL Cholesterol, Week 15, Adj M, n=87
0.1
(-1.0 to 0.6)
HDL Cholesterol, Week 28, Adj O, n=20
-0.0
(-0.4 to 0.6)
HDL Cholesterol, Week 28, Mono, n=61
0.0
(-0.7 to 0.7)
HDL Cholesterol, Week 28, WD, n=33
0.1
(-0.9 to 0.4)
LDL Cholesterol, Week 15, Adj M, n=86
-0.0
(-1.1 to 1.2)
LDL Cholesterol, Week 28, Adj O, n=19
-0.2
(-1.9 to 1.1)
LDL Cholesterol, Week 28, Mono, n=61
-0.1
(-1.8 to 1.6)
LDL Cholesterol, Week 28, WD, n=32
-0.1
(-0.8 to 1.7)
Glucose, Week 15, Adj M, n=87
-0.1
(-5.8 to 5.3)
Glucose, Week 28, Adj O, n=20
0.1
(-6.7 to 6.7)
Glucose, Week 28, Mono, n=61
0.1
(-3.6 to 6.4)
Glucose, Week 28, WD, n=33
0.3
(-5.2 to 4.2)
Potassium, Week 15, Adj M, n=87
0.0
(-1.2 to 1.1)
Potassium, Week 28, Adj O, n=20
-0.1
(-0.7 to 1.2)
Potassium, Week 28, Mono, n=60
0.0
(-1.3 to 1.2)
Potassium, Week 28, WD, n=32
0.0
(-1.0 to 0.9)
Sodium, Week 15, Adj M, n=87
0.0
(-4.0 to 6.0)
Sodium, Week 28, Adj O, n=20
0.5
(-7.0 to 4.0)
Sodium, Week 28, Mono, n=61
-1.0
(-5.0 to 9.0)
Sodium, Week 28, WD, n=33
1.0
(-3.0 to 7.0)
Triglyceride, Week 28, WD, n=87
-0.3
(-2.3 to 0.9)
Triglyceride, Week 28, WD, n=20
-0.1
(-1.7 to 1.6)
Triglyceride, Week 28, WD, n=61
-0.4
(-1.9 to 1.1)
Triglyceride, Week 28, WD, n=33
1.0
(-4.6 to 1.1)
Urea/BUN, Week 28, WD, n=87
0.0
(-10.4 to 5.4)
Urea/BUN, Week 28, WD, n=20
0.5
(-2.1 to 13.2)
Urea/BUN, Week 28, WD, n=61
0.0
(-6.4 to 6.8)
Urea/BUN, Week 28, WD, n=33
0.4
(-4.3 to 3.6)
19.Secondary Outcome
Title Serum LTG Concentrations at Different LTG Doses Based on the Concomitant AED Groups: Neutral (Without Known Enzyme-inducing AED [EIAED], Valproate [VPA]) With EIAED, and With VPA
Hide Description The blood samples were collected at the specified study visits; however, serum LTG concentrations were summarized by dose regimen, not by study week. The serum was assayed for LTG using an approved method under the management of Worldwide Bioanalysis, GlaxoSmithKline.
Time Frame Weeks 4, 7, 11, 15, 20, 24, and 28
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population. Participants with missing data were not analyzed. Not all participants received all doses at each blood draw; therefore, participants were only analyzed for the dose received at blood draw.
Arm/Group Title LTG-XR + Neutral LTG-XR + EIAEDs LTG-XR + VPA
Hide Arm/Group Description:
LTG-XR tablets (25, 50, 100, and 200 mg) were administered OD in the 7-week (w) Dose-Escalation Phase and titrated to target doses of 300, 500, or 200 mg/day for participants (par.) depending on their concomitant AED (does not include VPA or EIAEDs), followed by an 8-w Adjunctive Maintenance Phase in which LTG-XR tablets were administered OD at the target dose. Par. on a single concomitant AED who converted to LTG-XR monotherapy (based on investigator's judgment) entered the 5-w Conversion Phase, followed by an 8-w Monotherapy Phase, whereas par. who did not transition to monotherapy entered the 13-w Adjunctive Optimization Phase. At the end of the study, par. entered the 2- to 5-w Taper/Follow-Up Phase, in which par. either switched to commercial LTG (received same total daily dose of commercial LTG in 2 divided doses [BID]) or did not switch to commercial LTG (current dose was reduced by approximately one-fourth per week) with a final visit 2 weeks after last LTG-XR dose.
LTG-XR tablets (25, 50, 100, and 200 mg) were administered OD in the 7-w Dose-Escalation Phase and titrated to target doses of 300, 500, or 200 mg/day for participants (par.) depending on their concomitant AED (included EIAEDs), followed by an 8-w Adjunctive Maintenance Phase in which LTG-XR tablets were administered OD at the target dose. Par. on a single concomitant AED who converted to LTG-XR monotherapy (based on investigator's judgment) entered the 5-w Conversion Phase, followed by an 8-w Monotherapy Phase, whereas par. who did not transition to monotherapy entered the 13-w Adjunctive Optimization Phase. At the end of the study, par. entered the 2- to 5-w Taper/Follow-Up Phase, in which par. either switched to commercial LTG (received same total daily dose of commercial LTG in 2 divided doses [BID]) or did not switch to commercial LTG (current dose was reduced by approximately one-fourth per week) with a final visit 2 weeks after last LTG-XR dose.
LTG-XR tablets (25, 50, 100, and 200 mg) were administered OD in the 7-w Dose-Escalation Phase and titrated to target doses of 300, 500, or 200 mg/day for participants (par.) depending on their concomitant AED (included VPA), followed by an 8-w Adjunctive Maintenance Phase: LTG-XR tablets administered OD at the target dose. Par. on a single concomitant AED who converted to LTG-XR monotherapy (based on investigator's judgment) entered the 5-w Conversion Phase, followed by an 8-w Monotherapy Phase, whereas par. who did not transition to monotherapy entered the 13-w Adjunctive Optimization Phase. At the end of the study, par. entered the 2- to 5-w Taper/Follow-Up Phase, in which par. either switched to commercial LTG (received same total daily dose of commercial LTG in 2 divided doses [BID]) or did not switch to commercial LTG (current dose was reduced by approximately one-fourth per week) with a final visit 2 weeks after last LTG-XR dose.
Overall Number of Participants Analyzed 87 50 12
Overall Number of Units Analyzed
Type of Units Analyzed: Serum concentrations
439 243 54
Median (Full Range)
Unit of Measure: Micrograms per milliliter
12.5 mg, n=0, 0, 1
NA [1] 
(NA to NA)
NA [1] 
(NA to NA)
0.957 [2] 
(NA to NA)
25 mg, n=0, 0, 8
NA [1] 
(NA to NA)
NA [1] 
(NA to NA)
1.362
(0.817 to 2.885)
50 mg, n=30, 2, 8
1.281
(0.437 to 3.491)
0.731
(0.727 to 0.734)
2.972
(0.937 to 3.553)
100 mg, n=40, 32, 6
3.425
(0.717 to 5.825)
1.165
(0.442 to 4.254)
4.723
(3.870 to 6.419)
150 mg, n=11, 0, 6
5.653
(2.514 to 9.693)
NA [3] 
(NA to NA)
6.829
(3.549 to 10.804)
200 mg, n=74, 22, 25
5.499
(1.449 to 12.926)
1.583
(0.455 to 3.542)
5.350
(3.301 to 13.750)
225 mg, n=3, 0, 0
5.631
(4.815 to 5.642)
NA [3] 
(NA to NA)
NA [3] 
(NA to NA)
250 mg, n=18, 11, 0
5.059
(2.329 to 10.969)
4.073
(2.184 to 8.768)
NA [3] 
(NA to NA)
300 mg, n=193, 5, 0
5.493
(1.620 to 13.335)
2.837
(1.898 to 3.558)
NA [3] 
(NA to NA)
350 mg, n=0, 3, 0
NA [1] 
(NA to NA)
4.084
(3.794 to 4.165)
NA [3] 
(NA to NA)
400 mg, n=19, 46, 0
7.322
(2.899 to 13.843)
4.012
(1.459 to 9.675)
NA [3] 
(NA to NA)
450 mg, n=0, 1, 0
NA [1] 
(NA to NA)
2.975 [2] 
(NA to NA)
NA [3] 
(NA to NA)
500 mg, n=51, 121, 0
6.994
(0.931 to 13.412)
3.974
(0.905 to 11.451)
NA [3] 
(NA to NA)
[1]
No dose was given for this regimen.
[2]
No full range is provided for the median value because only one participant was analyzed.
[3]
No participants were analyzed in this group at this dose level.
20.Secondary Outcome
Title Apparent Clearance (CL/F) Based on the Concomitant AED Groups: Neutral, With EIAED, and With VPA
Hide Description Individual serum LTG concentration data were subjected to population pharmacokinetic methodologies based on the concomitant AED groups. Clearance is defined as the volume of LTG per unit time eliminated from serum. Serum LTG concentration-time data files incorporating, where appropriate, records of LTG administration, participant demography, and concomitant medication were supplied to Clinical Pharmacokinetics Modelling and Simulation, Clinical Pharmacology, and Discovery Medicine (CPDM) by Clinical Data Management as NONMEM compatible .csv files.
Time Frame Weeks 4, 7, 11, 15, 20, 24, and 28
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population. Participants with missing data were not analyzed. Not all participants received all doses at each blood draw; therefore, participants were only analyzed for the dose received at blood draw.
Arm/Group Title LTG-XR + Neutral LTG-XR + EIAEDs LTG-XR + VPA
Hide Arm/Group Description:
LTG-XR tablets (25, 50, 100, and 200 mg) were administered OD in the 7-week (w) Dose-Escalation Phase and titrated to target doses of 300, 500, or 200 mg/day for participants (par.) depending on their concomitant AED (does not include VPA or EIAEDs), followed by an 8-w Adjunctive Maintenance Phase in which LTG-XR tablets were administered OD at the target dose. Par. on a single concomitant AED who converted to LTG-XR monotherapy (based on investigator's judgment) entered the 5-w Conversion Phase, followed by an 8-w Monotherapy Phase, whereas par. who did not transition to monotherapy entered the 13-w Adjunctive Optimization Phase. At the end of the study, par. entered the 2- to 5-w Taper/Follow-Up Phase, in which par. either switched to commercial LTG (received same total daily dose of commercial LTG in 2 divided doses [BID]) or did not switch to commercial LTG (current dose was reduced by approximately one-fourth per week) with a final visit 2 weeks after last LTG-XR dose.
LTG-XR tablets (25, 50, 100, and 200 mg) were administered OD in the 7-w Dose-Escalation Phase and titrated to target doses of 300, 500, or 200 mg/day for participants (par.) depending on their concomitant AED (included EIAEDs), followed by an 8-w Adjunctive Maintenance Phase in which LTG-XR tablets were administered OD at the target dose. Par. on a single concomitant AED who converted to LTG-XR monotherapy (based on investigator's judgment) entered the 5-w Conversion Phase, followed by an 8-w Monotherapy Phase, whereas par. who did not transition to monotherapy entered the 13-w Adjunctive Optimization Phase. At the end of the study, par. entered the 2- to 5-w Taper/Follow-Up Phase, in which par. either switched to commercial LTG (received same total daily dose of commercial LTG in 2 divided doses [BID]) or did not switch to commercial LTG (current dose was reduced by approximately one-fourth per week) with a final visit 2 weeks after last LTG-XR dose.
LTG-XR tablets (25, 50, 100, and 200 mg) were administered OD in the 7-w Dose-Escalation Phase and titrated to target doses of 300, 500, or 200 mg/day for participants (par.) depending on their concomitant AED (included VPA), followed by an 8-w Adjunctive Maintenance Phase: LTG-XR tablets administered OD at the target dose. Par. on a single concomitant AED who converted to LTG-XR monotherapy (based on investigator's judgment) entered the 5-w Conversion Phase, followed by an 8-w Monotherapy Phase, whereas par. who did not transition to monotherapy entered the 13-w Adjunctive Optimization Phase. At the end of the study, par. entered the 2- to 5-w Taper/Follow-Up Phase, in which par. either switched to commercial LTG (received same total daily dose of commercial LTG in 2 divided doses [BID]) or did not switch to commercial LTG (current dose was reduced by approximately one-fourth per week) with a final visit 2 weeks after last LTG-XR dose.
Overall Number of Participants Analyzed 87 50 12
Mean (95% Confidence Interval)
Unit of Measure: Liters per hour
1.91
(1.73 to 2.09)
2.07
(1.69 to 2.46)
-0.698
(-0.96 to -0.441)
21.Secondary Outcome
Title Apparent Volume of Distribution (V/F) for Participants in All Concomitant AED Groups Combined: Neutral, With EIAED, and With VPA
Hide Description Individual serum LTG concentration data were subjected to population pharmacokinetic methodologies based on the concomitant AED groups. V/F is defined as the apparent volume in which a drug is distributed immediately after it has been injected intravenously and equilibrated between plasma and the surrounding tissues. Serum LTG concentration-time data files incorporating, where appropriate, records of LTG administration, participant demography, and concomitant medication were supplied to CPDM by Clinical Data Management as NONMEM compatible .csv files.
Time Frame Weeks 4, 7, 11, 15, 20, 24, and 28
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population. Participants with missing data were not analyzed. Not all participants received all doses at each blood draw; therefore, participants were only analyzed for the dose received at blood draw.
Arm/Group Title LTG-XR + Neutral, EIAEDs, and VPA
Hide Arm/Group Description:
LTG-XR tablets (25, 50, 100, and 200 mg) were administered OD in the 7-week (w) Dose-Escalation Phase and titrated to target doses of 300, 500, or 200 mg/day for participants (par.) depending on their concomitant AED (included VPA and EIAEDs), followed by an 8-w Adjunctive Maintenance Phase in which LTG-XR tablets were administered OD at the target dose. Par. on a single concomitant AED who converted to LTG-XR monotherapy (based on investigator's judgment) entered the 5-w Conversion Phase, followed by an 8-w Monotherapy Phase, whereas par. who did not transition to monotherapy entered the 13-w Adjunctive Optimization Phase. At the end of the study, par. entered the 2- to 5-w Taper/Follow-Up Phase, in which par. either switched to commercial LTG (received same total daily dose of commercial LTG in 2 divided doses [BID]) or did not switch to commercial LTG (current dose was reduced by approximately one-fourth per week) with a final visit 2 weeks after last LTG-XR dose.
Overall Number of Participants Analyzed 149
Mean (95% Confidence Interval)
Unit of Measure: liters
26.8
(7.40 to 46.6)
22.Secondary Outcome
Title Absorption Rate (KA) for Participants in All Concomitant AED Groups Combined: Neutral, With EIAED, and With VPA
Hide Description Individual serum LTG concentration data were subjected to population pharmacokinetic methodologies based on the concomitant AED groups. KA is defined as the rate at which a drug enters the body after administration. Serum LTG concentration-time data files incorporating, where appropriate, records of LTG administration, participant demography, and concomitant medication were supplied to CPDM by Clinical Data Management as NONMEM compatible .csv files.
Time Frame Weeks 4, 7, 11, 15, 20, 24, and 28
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population. Participants with missing data were not analyzed. Not all participants received all doses at each blood draw; therefore, participants were only analyzed for the dose received at blood draw.
Arm/Group Title LTG-XR + Neutral, EIAEDs, and VPA
Hide Arm/Group Description:
LTG-XR tablets (25, 50, 100, and 200 mg) were administered OD in the 7-week (w) Dose-Escalation Phase and titrated to target doses of 300, 500, or 200 mg/day for participants (par.) depending on their concomitant AED (included VPA and EIAEDs), followed by an 8-w Adjunctive Maintenance Phase in which LTG-XR tablets were administered OD at the target dose. Par. on a single concomitant AED who converted to LTG-XR monotherapy (based on investigator's judgment) entered the 5-w Conversion Phase, followed by an 8-w Monotherapy Phase, whereas par. who did not transition to monotherapy entered the 13-w Adjunctive Optimization Phase. At the end of the study, par. entered the 2- to 5-w Taper/Follow-Up Phase, in which par. either switched to commercial LTG (received same total daily dose of commercial LTG in 2 divided doses [BID]) or did not switch to commercial LTG (current dose was reduced by approximately one-fourth per week) with a final visit 2 weeks after last LTG-XR dose.
Overall Number of Participants Analyzed 149
Mean (95% Confidence Interval)
Unit of Measure: 1/h
0.0325
(0.0105 to 0.0549)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title LTG-XR Tablets
Hide Arm/Group Description LTG-XR tablets (25, 50, 100, and 200 milligrams [mg]) administered once a day (OD) in the 7-week (w) Dose-Escalation Phase and titrated to target doses of 300, 500, or 200 mg/day for participants (par.) depending on their concomitant antiepileptic drug (AED), followed by an 8-w Adjunctive Maintenance Phase in which LTG-XR tablets were administered OD at the target dose. Par. on a single concomitant AED who converted to LTG-XR monotherapy (based on investigator's judgment) entered the 5-w Conversion Phase, followed by an 8-w Monotherapy Phase, whereas par. who did not transition to monotherapy entered the 13-w Adjunctive Optimization Phase. At the end of the study, par. entered the 2- to 5-w Taper/Follow-Up Phase, in which par. either switched to commercial LTG (received same total daily dose of commercial LTG in 2 divided doses [BID]) or did not switch to commercial LTG (current dose was reduced by approximately one-fourth per week) with a final visit 2 weeks after last LTG-XR dose.
All-Cause Mortality
LTG-XR Tablets
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
LTG-XR Tablets
Affected / at Risk (%)
Total   22/121 (18.18%) 
Cardiac disorders   
Acute myocardial infarction  1  1/121 (0.83%) 
Cardiac failure congestive  1  1/121 (0.83%) 
Gastrointestinal disorders   
Colitis  1  1/121 (0.83%) 
Intestinal obstruction  1  1/121 (0.83%) 
Lower gastrointestinal haemorrhage  1  1/121 (0.83%) 
Nausea  1  1/121 (0.83%) 
Pancreatitis acute  1  1/121 (0.83%) 
Small intestinal obstruction  1  1/121 (0.83%) 
General disorders   
Non-cardiac chest pain  1  1/121 (0.83%) 
Infections and infestations   
Diverticulitis  1  1/121 (0.83%) 
Gastroenteritis  1  1/121 (0.83%) 
Pneumonia  1  1/121 (0.83%) 
Urinary tract infection  1  1/121 (0.83%) 
Injury, poisoning and procedural complications   
Hip fracture  1  3/121 (2.48%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
Small cell lung cancer stage unspecified  1  1/121 (0.83%) 
Nervous system disorders   
Ataxia  1  2/121 (1.65%) 
Convulsion  1  2/121 (1.65%) 
Status epilepticus  1  2/121 (1.65%) 
Balance disorder  1  1/121 (0.83%) 
Cerebrovascular accident  1  1/121 (0.83%) 
Grand mal convulsion  1  1/121 (0.83%) 
Lethargy  1  1/121 (0.83%) 
Syncope  1  1/121 (0.83%) 
Toxic encephalopathy  1  1/121 (0.83%) 
Renal and urinary disorders   
Nephrolithiasis  1  1/121 (0.83%) 
Vascular disorders   
Hypertension  1  1/121 (0.83%) 
Thrombosis  1  1/121 (0.83%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
LTG-XR Tablets
Affected / at Risk (%)
Total   98/121 (80.99%) 
Gastrointestinal disorders   
Nausea  1  17/121 (14.05%) 
Constipation  1  8/121 (6.61%) 
Decreased appetite  1  8/121 (6.61%) 
Injury, poisoning and procedural complications   
Fall  1  22/121 (18.18%) 
Musculoskeletal and connective tissue disorders   
Back pain  1  11/121 (9.09%) 
Pain In extremity  1  11/121 (9.09%) 
Muscular weakness  1  7/121 (5.79%) 
Nervous system disorders   
Dizziness  1  31/121 (25.62%) 
Balance disorder  1  25/121 (20.66%) 
Headache  1  21/121 (17.36%) 
Tremor  1  20/121 (16.53%) 
Fatigue  1  17/121 (14.05%) 
Ataxia  1  14/121 (11.57%) 
Gait disturbance  1  10/121 (8.26%) 
Somnolence  1  10/121 (8.26%) 
Arthralgia  1  9/121 (7.44%) 
Confusional state  1  8/121 (6.61%) 
Renal and urinary disorders   
Urinary tract infection  1  7/121 (5.79%) 
Respiratory, thoracic and mediastinal disorders   
Nasopharyngitis  1  12/121 (9.92%) 
Skin and subcutaneous tissue disorders   
All rash  1  14/121 (11.57%) 
Pruritus  1  7/121 (5.79%) 
Skin laceration  1  7/121 (5.79%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA
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: NCT00516139     History of Changes
Other Study ID Numbers: LEP105972
First Submitted: August 13, 2007
First Posted: August 15, 2007
Results First Submitted: July 15, 2011
Results First Posted: January 13, 2012
Last Update Posted: January 18, 2017