Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of this Phase III study is to evaluate the efficacy, safety and tolerability and health outcomes of retigabine Immediate Release (IR) as adjunctive therapy to each of the following monotherapy Antiepileptic Drug (AED) treatments: carbamazepine/oxcarbazepine, lamotrigine, levetiracetam, or valproic acid in adult subjects with partial-onset seizures (POS) using a flexible dosing regimen.
This is an open-label, multi-centre, flexible dose study of retigabine immediate release (IR). The study will enroll male and female outpatients (≥ 18 years of age) with partial-onset seizures (POS) who are inadequately controlled on their current monotherapy Antiepileptic Drug (AED). Following a Screening Period of up to 2 weeks, subjects will enter an 8-week Baseline Phase to determine baseline seizure frequency. At the end of the Baseline Phase, subjects who meet or exceed the minimum seizure frequency of 4 partial seizures per 56 days, will enter the Treatment Period (4 weeks Titration, 16 weeks Flexible Dose Evaluation Phase). All subjects will receive retigabine IR starting at 150 mg/day and will be titrated to 600 mg/day by Week 4. From Week 5 onwards, subjects' doses will be maintained between 300 to 1200 mg/day using a flexible dosing regimen to optimise response and tolerability. The maximum duration of the study is approximately 33 weeks (inclusive of a 3 week Taper/Follow-up Phase).
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Retigabine IR | Experimental | Open Label flexible dose between 300 mg/day (minimum) and 1200 mg/day (maximum). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Retigabine IR | Drug | Flexible dose between 300 mg/day (minimum) and 1200 mg/day (maximum). |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With a >=50% Reduction in Partial-onset Seizure (POS) Frequency From Baseline | The number of participants experiencing a >=50% reduction from Baseline (BL) in POS frequency during the Treatment Phase (TP) (i.e., Titration Phase and Flexible Dose Evaluation [FDE] Phase) was measured. A POS has its onset in a limited area on one side of the brain. POSs may remain limited or may spread to involve both sides of the brain. For both the Baseline Phase and the TP, seizure frequency was calculated as a 28-day rate using the following formula: 28 x {[(number of countable partial seizures in Phase) + (10 x number of days with innumerable seizures in Phase) + (number of occurrences of status epilepticus in Phase)] / number of applicable days in the Phase}, where all days in the Phase are considered applicable (including days with 0 seizures), except for days on which the participant failed to complete the Seizure Diary. >= 50% reduction from BL is calculated as 100 x (28-day partial seizure rate [PSR] for the TP - 28-day PSR for the BL Phase) / 28-day PSR for the BL Phase. | From Baseline through Week 20 (Day 140)/Early Withdrawal |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With the Indicated Reduction or Increase From Baseline in Partial-onset Seizure Frequency | Participants were assessed for the percent change from Baseline in seizure frequency; changes were categorized as Any Decrease (>0 to 25%, 25 to <50%, 50 to 75%, >75 to 100%) or No Change or Any Increase (>25%, 0 to 25%). A partial-onset seizure is a seizure that has its onset in a limited area on one side of the brain. Partial-onset seizures may remain limited or may spread to involve both sides of the brain. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials | GlaxoSmithKline | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GSK Investigational Site | Ghent | 9000 | Belgium | |||
| GSK Investigational Site |
Eligible participants were required to have had at least 4 partial seizures during the 8-week Baseline Phase and must have been receiving a stable dose of one of the prespecified monotherapy antiepileptic drug treatments.
Study 113905 was an open-label, multi-center, multi-country study of retigabine using a flexible dosing regimen in adult participants (>=18 years old) with partial-onset seizures. Eligible participants must have been taking one of the following antiepileptic drug treatments: carbamazepine/oxcarbazepine, lamotrigine, levetiracetam, or valproic acid.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | RTG Flexible Dose Plus C/O | Along with concurrent carbamazepine/oxcarbazepine (C/O), participants initiated treatment with retigabine (RTG) immediate release (IR) at 150 milligrams per day (mg/day) (50 mg thrice a day [TID]) and titrated to 600 mg/day (200 mg/day TID) over a 4-week Titration Phase. This was followed by a 16-week Flexible Dose Evaluation Phase, during which the dose could be increased or decreased on a weekly basis between 50 and 150 mg/day, depending on efficacy and tolerability, with the total dose staying between 300 and 1200 mg/day. Participants who were unable to tolerate a minimum dose of 300 mg/day were discontinued from the study. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| From Baseline through Week 20 (Day 140)/Early Withdrawal |
| Number of Participants With a >=25%, >=75%, or 100% Reduction in Partial-onset Seizure Frequency From Baseline | The number of participants experiencing a >=25%, >=75%, and 100% reduction from Baseline in partial-onset seizure frequency during the Treatment Phase (TP) (i.e., Titration Phase and Flexible Dose Evaluation [FDE] Phase) was measured. A partial-onset seizure is a seizure that has its onset in a limited area on one side of the brain. Partial-onset seizures may remain limited or may spread to involve both sides of the brain. | From Baseline through Week 20 (Day 140)/Early Withdrawal |
| Percent Change From Baseline in Partial-onset Seizure Frequency | Percent change from Baseline was calculated as the difference in the partial-onset seizure frequency (Treatment Phase minus the Baseline Phase) divided by the Baseline Phase frequency, multiplied by 100. Negative values indicate reductions from Baseline. A partial-onset seizure is a seizure that has its onset in a limited area on one side of the brain. Partial-onset seizures may remain limited or may spread to involve both sides of the brain. | From Baseline through Week 20 (Day 140)/Early Withdrawal |
| Functional Status Diary (FSD): Percent Change From Baseline in Epilepsy-related Worry | Participants were asked the following question daily: "How would you rate your epilepsy-related worry over the last 24 hours?" The original possible responses were 0-10, with 0="No worry" and 10="Worst worry imaginable." However, in the summarization, "1" was added to each participant's daily response, changing the possible values to 1-11, so that there would be no possibility of the percent change from Baseline being undefined. Baseline and Treatment Phase averages were calculated for each participant. The denominators for these by-phase averages were the number of non-missing days for each variable and phase. The by-phase averages were used as follows in the calculation of percent change from Baseline for each participant: 100 x Treatment Phase average - Baseline Phase average) / Baseline Phase average. A negative percent change from Baseline indicates a reduction from Baseline. | Baseline through Week 20/Early Withdrawal |
| Functional Status Diary (FSD): Percent Change From Baseline in Epilepsy-related Limitation of Ability to do What You Needed to | Participants were asked the following question daily: "How would you rate the extent to which epilepsy limited your ability to do what you needed to do over the last 24 hours?" The original possible responses were 0-10, with 0="Not at all limited" and 10="Unable to do anything I needed to." However, in the summarization, "1" was added to each participant's daily response, changing the possible values to 1-11, so that there would be no possibility of the percent change from Baseline being undefined. Baseline and Treatment Phase averages were calculated for each participant. The denominators for these by-phase averages were the number of non-missing days for each variable and phase. The by-phase averages were used as follows in the calculation of percent change from Baseline for each participant: 100 x Treatment Phase average - Baseline Phase average) / Baseline Phase average. A negative percent change from Baseline indicates a reduction from Baseline. | Baseline through Week 20/Early Withdrawal |
| Functional Status Diary (FSD): Percent Change From Baseline in Epilepsy-related Limitation of Ability to do What You Wanted to | Participants were asked the following question daily: "How would you rate the extent to which epilepsy limited your ability to do what you wanted to do over the last 24 hours?" The original possible responses were 0-10, with 0="Not at all limited" and 10="Unable to do anything I wanted to." However, in the summarization, "1" was added to each participant's daily response, changing the possible values to 1-11, so that there would be no possibility of the percent change from Baseline being undefined. Baseline and Treatment Phase averages were calculated for each participant. The denominators for these by-phase averages were the number of non-missing days for each variable and phase. The by-phase averages were used as follows in the calculation of percent change from Baseline for each participant: 100 x Treatment Phase average - Baseline Phase average) / Baseline Phase average. A negative percent change from Baseline indicates a reduction from Baseline. | Baseline through Week 20/Early Withdrawal |
| Percent Change From Baseline in Functional Status: Percentage of Days With no Missed Work or School Time | Participants were asked the following question daily: "Did you miss any time from work or school in the last 24 hours due to epilepsy?" Possible responses were Yes, No, and NA=Not Applicable (no planned work or school in the last 24 hours). The variable summarized is the percentage of days with no missed work or school. Baseline and Treatment Phase averages were calculated for each participant. The denominators for these by-phase averages were the number of non-missing days for each variable and phase. The by-phase averages were used as follows in the calculation of percent change from Baseline for each participant: 100 x Treatment Phase average - Baseline Phase average) / Baseline Phase average. A positive percent change from Baseline indicates a reduction from Baseline in missed work or school. | Baseline through Week 20/Early Withdrawal |
| Change From Baseline in the Short Form 36 Health Survey, Version 2 (SF-36v2) Domain Scores at Week 20/Early Withdrawal | The SF-36v2 health survey is a self-administered, generic, 36-item questionnaire designed to measure 8 domains of functional health status and well-being: physical functioning, role-physical, bodily pain, general health perceptions, vitality, social functioning, role-emotional, and mental health. Each domain is scored from 0 (poorer health) to 100 (better health). Change from Baseline was calculated as the post-Baseline score minus the Baseline score. Positive changes from Baseline indicate improvement. | Baseline through Week 20/Early Withdrawal |
| Change From Baseline in the SF-36v2 Physical Component Summary Score at Week 20/Early Withdrawal | The SF-36 v2 Health Survey is a self-administered, generic, 36-item questionnaire designed to measure 8 domains of functional health status and well-being: physical functioning, role-physical, bodily pain, general health perceptions, vitality, social functioning, role-emotional, and mental health. Each domain is scored from 0 (poorer health) to 100 (better health).The physical component summary (PCS) score is a summary score representing overall physical health, which is derived from the 8 domains. As with the domains, PCS scores range from 0 to 100; higher scores represent better health. Change from Baseline was calculated as the post-Baseline score minus the Baseline score. Positive changes from Baseline indicate improvement. | Baseline through Week 20/Early Withdrawal |
| Change From Baseline in the SF-36v2 Mental Component Summary Score at Week 20/Early Withdrawal | The SF-36 v2 Health Survey is a self-administered, generic, 36-item questionnaire designed to measure 8 domains of functional health status and well-being: physical functioning, role-physical, bodily pain, general health perceptions, vitality, social functioning, role-emotional, and mental health. Each domain is scored from 0 (poorer health) to 100 (better health).The mental component summary (MCS) score is a summary score representing overall mental health, which is derived from the 8 domains. As with the domains, MCS scores range from 0 to 100; higher scores represent better health. Change from Baseline was calculated as the post-Baseline score minus the Baseline score. Positive changes from Baseline indicate improvement. | Baseline through Week 20/Early Withdrawal |
| Number of Participants With the Indicated Response for the Epilepsy-related Worry Component of the Patient Global Impression of Change (PGI-C) Score | The PGI-C questionnaire was to be completed by the participant. Participants were asked the following question: Compared to before you started this study, how would you rate your current epilepsy-related worry: Much better, Moderately better, A little better, Unchanged, A little worse, Moderately worse, Much worse? | Baseline through Week 20/Early Withdrawal |
| Change From Baseline in the PGI-C Score: Epilepsy-related Worry | The PGI-C questionnaire was to be completed by the participant. Participants were asked the following question: Compared to before you started this study, how would you rate your current epilepsy-related worry: Much better, Moderately better, A little better, Unchanged, A little worse, Moderately worse, Much worse? Rating scores are integers from 1 to 7, with 1=Much better and 7=Much worse. | Baseline through Week 20/Early Withdrawal |
| Number of Participants With the Indicated Response for the Current Ability to do the Things You Need to do Component of the PGI-C Score | The PGI-C questionnaire was to be completed by the participant. Participants were asked the following question: Compared to before you started this study, how would you rate your current ability to do the things you need to do: Much better, Moderately better, A little better, Unchanged, A little worse, Moderately worse, Much worse? | Baseline through Week 20/Early Withdrawal |
| Change From Baseline in the PGI-C Score: Current Ability to do the Things You Need to do | The PGI-C questionnaire was to be completed by the participant. Participants were asked the following question: Compared to before you started this study, how would you rate your current ability to do the things you need to do: Much better, Moderately better, A little better, Unchanged, A little worse, Moderately worse, Much worse? Rating scores are integers from 1 to 7, with 1=Much better and 7=Much worse. | Baseline through Week 20/Early Withdrawal |
| Number of Participants With the Indicated Response for the Current Ability to do the Things You Want to do Component of the PGI-C Score | The PGI-C questionnaire was to be completed by the participant. Participants were asked the following question: Compared to before you started this study, how would you rate your current ability to do the things you want to do: Much better, Moderately better, A little better, Unchanged, A little worse, Moderately worse, Much worse. | Baseline through Week 20/Early Withdrawal |
| Change From Baseline in the PGI-C Score: Current Ability to do the Things You Want to do | The PGI-C questionnaire was to be completed by the participant. Participants were asked the following question: Compared to before you started this study, how would you rate your current ability to do the things you want to do: Much better, Moderately better, A little better, Unchanged, A little worse, Moderately worse, Much worse? Rating scores are integers from 1 to 7, with 1=Much better and 7=Much worse. | Baseline through Week 20/Early Withdrawal |
| Leuven |
| 3000 |
| Belgium |
| GSK Investigational Site | Liège | 4000 | Belgium |
| GSK Investigational Site | Pleven | 5800 | Bulgaria |
| GSK Investigational Site | Plovdiv | 4000 | Bulgaria |
| GSK Investigational Site | Sofia | 1113 | Bulgaria |
| GSK Investigational Site | Sofia | 1431 | Bulgaria |
| GSK Investigational Site | Dianalund | 4293 | Denmark |
| GSK Investigational Site | Glostrup Municipality | 2600 | Denmark |
| GSK Investigational Site | Koebenhavn Oe | 2100 | Denmark |
| GSK Investigational Site | Lille | 59037 | France |
| GSK Investigational Site | Limoges | 87042 | France |
| GSK Investigational Site | Lyon | 69677 | France |
| GSK Investigational Site | Nancy | 54035 | France |
| GSK Investigational Site | Rennes | 35033 | France |
| GSK Investigational Site | Strasbourg | 67098 | France |
| GSK Investigational Site | Kehl-Kork | Baden-Wurttemberg | 77694 | Germany |
| GSK Investigational Site | Stuttgart | Baden-Wurttemberg | 70372 | Germany |
| GSK Investigational Site | Tübingen | Baden-Wurttemberg | 72076 | Germany |
| GSK Investigational Site | Marburg | Hesse | 35043 | Germany |
| GSK Investigational Site | Bielefeld | North Rhine-Westphalia | 33617 | Germany |
| GSK Investigational Site | Bonn | North Rhine-Westphalia | 53105 | Germany |
| GSK Investigational Site | Kiel | Schleswig-Holstein | 24105 | Germany |
| GSK Investigational Site | Berlin | State of Berlin | 13509 | Germany |
| GSK Investigational Site | Foggia | Apulia | 71100 | Italy |
| GSK Investigational Site | Reggio Calabria | Calabria | 89100 | Italy |
| GSK Investigational Site | Bologna | Emilia-Romagna | 40139 | Italy |
| GSK Investigational Site | Rome | Lazio | 00163 | Italy |
| GSK Investigational Site | Rome | Lazio | 00185 | Italy |
| GSK Investigational Site | Genoa | Liguria | 16153 | Italy |
| GSK Investigational Site | Palermo | Sicily | 90129 | Italy |
| GSK Investigational Site | Torrette Di Ancona | The Marches | 60126 | Italy |
| GSK Investigational Site | Pisa | Tuscany | 56126 | Italy |
| GSK Investigational Site | Siena | Tuscany | 53100 | Italy |
| GSK Investigational Site | Breda | 4818 CK | Netherlands |
| GSK Investigational Site | Heemstede | 2103 SW | Netherlands |
| GSK Investigational Site | Heeze | 5591 VE | Netherlands |
| GSK Investigational Site | The Hague | 2512 VA | Netherlands |
| GSK Investigational Site | Iława | 13-300 | Poland |
| GSK Investigational Site | Katowice | 40-662 | Poland |
| GSK Investigational Site | Krakow | 31-209 Krakow | Poland |
| GSK Investigational Site | Warsaw | 00-453 | Poland |
| GSK Investigational Site | Warsaw | 02-952 | Poland |
| GSK Investigational Site | Belgorod | 308007 | Russia |
| GSK Investigational Site | Kazan' | 420064 | Russia |
| GSK Investigational Site | Krasnodar | 350007 | Russia |
| GSK Investigational Site | Moscow | 107150 | Russia |
| GSK Investigational Site | Moscow | 117049 | Russia |
| GSK Investigational Site | Saint Petersburg | 193019 | Russia |
| GSK Investigational Site | Samara | 443095 | Russia |
| GSK Investigational Site | Smolensk | 214 019 | Russia |
| GSK Investigational Site | Madrid | 28046 | Spain |
| GSK Investigational Site | Seville | 41009 | Spain |
| GSK Investigational Site | Valencia | 46026 | Spain |
| GSK Investigational Site | Vigo | 36204 | Spain |
| GSK Investigational Site | Bangkok | 10400 | Thailand |
| GSK Investigational Site | Khon Kaen | 40002 | Thailand |
| GSK Investigational Site | Songkhla | 90110 | Thailand |
| GSK Investigational Site | Dnipro | 49005 | Ukraine |
| GSK Investigational Site | Donetsk | 83037 | Ukraine |
| GSK Investigational Site | Kharkiv | 61068 | Ukraine |
| GSK Investigational Site | Luhansk | 91045 | Ukraine |
| GSK Investigational Site | Lviv | 79010 | Ukraine |
| GSK Investigational Site | Odesa | 65014 | Ukraine |
| GSK Investigational Site | Oleksandrivka Village, Odesa | 67513 | Ukraine |
| GSK Investigational Site | Poltava | Ukraine |
| FG001 | RTG Flexible Dose Plus Lamotrigine | Along with concurrent lamotrigine, participants initiated treatment with RTG IR at 150 mg/day (50 mg TID) and titrated to 600 mg/day (200 mg/day TID) over a 4-week Titration Phase. This was followed by a 16-week Flexible Dose Evaluation Phase, during which the dose could be increased or decreased on a weekly basis between 50 and 150 mg/day, depending on efficacy and tolerability, with the total dose staying between 300 and 1200 mg/day. Participants who were unable to tolerate a minimum dose of 300 mg/day were discontinued from the study. |
| FG002 | RTG Flexible Dose Plus Levetiracetam | Along with concurrent leveteracetam, participants initiated treatment with RTG IR at 150 mg/day (50 mg TID) and titrated to 600 mg/day (200 mg/day TID) over a 4-week Titration Phase. This was followed by a 16-week Flexible Dose Evaluation Phase, during which the dose could be increased or decreased on a weekly basis between 50 and 150 mg/day, depending on efficacy and tolerability, with the total dose staying between 300 and 1200 mg/day. Participants who were unable to tolerate a minimum dose of 300 mg/day were discontinued from the study. |
| FG003 | RTG Flexible Dose Plus Valproic Acid | Along with concurrent valproic acid, participants initiated treatment with RTG IR at 150 mg/day (50 mg TID) and titrated to 600 mg/day (200 mg/day TID) over a 4-week Titration Phase. This was followed by a 16-week Flexible Dose Evaluation Phase, during which the dose could be increased or decreased on a weekly basis between 50 and 150 mg/day, depending on efficacy and tolerability, with the total dose staying between 300 and 1200 mg/day. Participants who were unable to tolerate a minimum dose of 300 mg/day were discontinued from the study. |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | RTG Flexible Dose Plus C/O | Along with concurrent carbamazepine/oxcarbazepine (C/O), participants initiated treatment with retigabine (RTG) immediate release (IR) at 150 milligrams per day (mg/day) (50 mg thrice a day [TID]) and titrated to 600 mg/day (200 mg/day TID) over a 4-week Titration Phase. This was followed by a 16-week Flexible Dose Evaluation Phase, during which the dose could be increased or decreased on a weekly basis between 50 and 150 mg/day, depending on efficacy and tolerability, with the total dose staying between 300 and 1200 mg/day. Participants who were unable to tolerate a minimum dose of 300 mg/day were discontinued from the study. |
| BG001 | RTG Flexible Dose Plus Lamotrigine | Along with concurrent lamotrigine, participants initiated treatment with RTG IR at 150 mg/day (50 mg TID) and titrated to 600 mg/day (200 mg/day TID) over a 4-week Titration Phase. This was followed by a 16-week Flexible Dose Evaluation Phase, during which the dose could be increased or decreased on a weekly basis between 50 and 150 mg/day, depending on efficacy and tolerability, with the total dose staying between 300 and 1200 mg/day. Participants who were unable to tolerate a minimum dose of 300 mg/day were discontinued from the study. |
| BG002 | RTG Flexible Dose Plus Levetiracetam | Along with concurrent leveteracetam, participants initiated treatment with RTG IR at 150 mg/day (50 mg TID) and titrated to 600 mg/day (200 mg/day TID) over a 4-week Titration Phase. This was followed by a 16-week Flexible Dose Evaluation Phase, during which the dose could be increased or decreased on a weekly basis between 50 and 150 mg/day, depending on efficacy and tolerability, with the total dose staying between 300 and 1200 mg/day. Participants who were unable to tolerate a minimum dose of 300 mg/day were discontinued from the study. |
| BG003 | RTG Flexible Dose Plus Valproic Acid | Along with concurrent valproic acid, participants initiated treatment with RTG IR at 150 mg/day (50 mg TID) and titrated to 600 mg/day (200 mg/day TID) over a 4-week Titration Phase. This was followed by a 16-week Flexible Dose Evaluation Phase, during which the dose could be increased or decreased on a weekly basis between 50 and 150 mg/day, depending on efficacy and tolerability, with the total dose staying between 300 and 1200 mg/day. Participants who were unable to tolerate a minimum dose of 300 mg/day were discontinued from the study. |
| BG004 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Baseline data were collected in members of the Safety Population, comprised of those participants who took at least one dose of RTG. | Mean | Standard Deviation | Years |
| ||||||||||||||
| Sex: Female, Male | Baseline data were collected in members of the Safety Population, comprised of those participants who took at least one dose of RTG. | Count of Participants | Participants |
| |||||||||||||||
| Race/Ethnicity, Customized | Baseline data were collected in members of the Safety Population, comprised of those participants who took at least one dose of RTG. | Number | participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants With a >=50% Reduction in Partial-onset Seizure (POS) Frequency From Baseline | The number of participants experiencing a >=50% reduction from Baseline (BL) in POS frequency during the Treatment Phase (TP) (i.e., Titration Phase and Flexible Dose Evaluation [FDE] Phase) was measured. A POS has its onset in a limited area on one side of the brain. POSs may remain limited or may spread to involve both sides of the brain. For both the Baseline Phase and the TP, seizure frequency was calculated as a 28-day rate using the following formula: 28 x {[(number of countable partial seizures in Phase) + (10 x number of days with innumerable seizures in Phase) + (number of occurrences of status epilepticus in Phase)] / number of applicable days in the Phase}, where all days in the Phase are considered applicable (including days with 0 seizures), except for days on which the participant failed to complete the Seizure Diary. >= 50% reduction from BL is calculated as 100 x (28-day partial seizure rate [PSR] for the TP - 28-day PSR for the BL Phase) / 28-day PSR for the BL Phase. | Intent-to-Treat (ITT) Population: all participants in the Safety Population (all participants who took at least one dose of investigational product) who provided at least one post-Baseline efficacy assessment | Posted | Number | participants | From Baseline through Week 20 (Day 140)/Early Withdrawal |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With the Indicated Reduction or Increase From Baseline in Partial-onset Seizure Frequency | Participants were assessed for the percent change from Baseline in seizure frequency; changes were categorized as Any Decrease (>0 to 25%, 25 to <50%, 50 to 75%, >75 to 100%) or No Change or Any Increase (>25%, 0 to 25%). A partial-onset seizure is a seizure that has its onset in a limited area on one side of the brain. Partial-onset seizures may remain limited or may spread to involve both sides of the brain. | ITT Population | Posted | Number | participants | From Baseline through Week 20 (Day 140)/Early Withdrawal |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With a >=25%, >=75%, or 100% Reduction in Partial-onset Seizure Frequency From Baseline | The number of participants experiencing a >=25%, >=75%, and 100% reduction from Baseline in partial-onset seizure frequency during the Treatment Phase (TP) (i.e., Titration Phase and Flexible Dose Evaluation [FDE] Phase) was measured. A partial-onset seizure is a seizure that has its onset in a limited area on one side of the brain. Partial-onset seizures may remain limited or may spread to involve both sides of the brain. | ITT Population | Posted | Number | participants | From Baseline through Week 20 (Day 140)/Early Withdrawal |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percent Change From Baseline in Partial-onset Seizure Frequency | Percent change from Baseline was calculated as the difference in the partial-onset seizure frequency (Treatment Phase minus the Baseline Phase) divided by the Baseline Phase frequency, multiplied by 100. Negative values indicate reductions from Baseline. A partial-onset seizure is a seizure that has its onset in a limited area on one side of the brain. Partial-onset seizures may remain limited or may spread to involve both sides of the brain. | ITT Population | Posted | Mean | Standard Deviation | percent change | From Baseline through Week 20 (Day 140)/Early Withdrawal |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Functional Status Diary (FSD): Percent Change From Baseline in Epilepsy-related Worry | Participants were asked the following question daily: "How would you rate your epilepsy-related worry over the last 24 hours?" The original possible responses were 0-10, with 0="No worry" and 10="Worst worry imaginable." However, in the summarization, "1" was added to each participant's daily response, changing the possible values to 1-11, so that there would be no possibility of the percent change from Baseline being undefined. Baseline and Treatment Phase averages were calculated for each participant. The denominators for these by-phase averages were the number of non-missing days for each variable and phase. The by-phase averages were used as follows in the calculation of percent change from Baseline for each participant: 100 x Treatment Phase average - Baseline Phase average) / Baseline Phase average. A negative percent change from Baseline indicates a reduction from Baseline. | ITT Population. Only those participants available at the specified time points were analyzed. | Posted | Mean | Standard Deviation | Percent change | Baseline through Week 20/Early Withdrawal |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Functional Status Diary (FSD): Percent Change From Baseline in Epilepsy-related Limitation of Ability to do What You Needed to | Participants were asked the following question daily: "How would you rate the extent to which epilepsy limited your ability to do what you needed to do over the last 24 hours?" The original possible responses were 0-10, with 0="Not at all limited" and 10="Unable to do anything I needed to." However, in the summarization, "1" was added to each participant's daily response, changing the possible values to 1-11, so that there would be no possibility of the percent change from Baseline being undefined. Baseline and Treatment Phase averages were calculated for each participant. The denominators for these by-phase averages were the number of non-missing days for each variable and phase. The by-phase averages were used as follows in the calculation of percent change from Baseline for each participant: 100 x Treatment Phase average - Baseline Phase average) / Baseline Phase average. A negative percent change from Baseline indicates a reduction from Baseline. | ITT Population. Only those participants available at the specified time points were analyzed. | Posted | Mean | Standard Deviation | Percent change | Baseline through Week 20/Early Withdrawal |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Functional Status Diary (FSD): Percent Change From Baseline in Epilepsy-related Limitation of Ability to do What You Wanted to | Participants were asked the following question daily: "How would you rate the extent to which epilepsy limited your ability to do what you wanted to do over the last 24 hours?" The original possible responses were 0-10, with 0="Not at all limited" and 10="Unable to do anything I wanted to." However, in the summarization, "1" was added to each participant's daily response, changing the possible values to 1-11, so that there would be no possibility of the percent change from Baseline being undefined. Baseline and Treatment Phase averages were calculated for each participant. The denominators for these by-phase averages were the number of non-missing days for each variable and phase. The by-phase averages were used as follows in the calculation of percent change from Baseline for each participant: 100 x Treatment Phase average - Baseline Phase average) / Baseline Phase average. A negative percent change from Baseline indicates a reduction from Baseline. | ITT Population. Only those participants available at the specified time points were analyzed. | Posted | Mean | Standard Deviation | Percent change | Baseline through Week 20/Early Withdrawal |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percent Change From Baseline in Functional Status: Percentage of Days With no Missed Work or School Time | Participants were asked the following question daily: "Did you miss any time from work or school in the last 24 hours due to epilepsy?" Possible responses were Yes, No, and NA=Not Applicable (no planned work or school in the last 24 hours). The variable summarized is the percentage of days with no missed work or school. Baseline and Treatment Phase averages were calculated for each participant. The denominators for these by-phase averages were the number of non-missing days for each variable and phase. The by-phase averages were used as follows in the calculation of percent change from Baseline for each participant: 100 x Treatment Phase average - Baseline Phase average) / Baseline Phase average. A positive percent change from Baseline indicates a reduction from Baseline in missed work or school. | ITT Population. Only those participants available at the specified time points were analyzed. | Posted | Mean | Standard Deviation | Percent change | Baseline through Week 20/Early Withdrawal |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in the Short Form 36 Health Survey, Version 2 (SF-36v2) Domain Scores at Week 20/Early Withdrawal | The SF-36v2 health survey is a self-administered, generic, 36-item questionnaire designed to measure 8 domains of functional health status and well-being: physical functioning, role-physical, bodily pain, general health perceptions, vitality, social functioning, role-emotional, and mental health. Each domain is scored from 0 (poorer health) to 100 (better health). Change from Baseline was calculated as the post-Baseline score minus the Baseline score. Positive changes from Baseline indicate improvement. | ITT Population. Only those participants available at the specified time points were analyzed. | Posted | Mean | Standard Deviation | Scores on a scale | Baseline through Week 20/Early Withdrawal |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in the SF-36v2 Physical Component Summary Score at Week 20/Early Withdrawal | The SF-36 v2 Health Survey is a self-administered, generic, 36-item questionnaire designed to measure 8 domains of functional health status and well-being: physical functioning, role-physical, bodily pain, general health perceptions, vitality, social functioning, role-emotional, and mental health. Each domain is scored from 0 (poorer health) to 100 (better health).The physical component summary (PCS) score is a summary score representing overall physical health, which is derived from the 8 domains. As with the domains, PCS scores range from 0 to 100; higher scores represent better health. Change from Baseline was calculated as the post-Baseline score minus the Baseline score. Positive changes from Baseline indicate improvement. | ITT Population. Only those participants available at the specified time points were analyzed. | Posted | Mean | Standard Deviation | Scores on a scale | Baseline through Week 20/Early Withdrawal |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in the SF-36v2 Mental Component Summary Score at Week 20/Early Withdrawal | The SF-36 v2 Health Survey is a self-administered, generic, 36-item questionnaire designed to measure 8 domains of functional health status and well-being: physical functioning, role-physical, bodily pain, general health perceptions, vitality, social functioning, role-emotional, and mental health. Each domain is scored from 0 (poorer health) to 100 (better health).The mental component summary (MCS) score is a summary score representing overall mental health, which is derived from the 8 domains. As with the domains, MCS scores range from 0 to 100; higher scores represent better health. Change from Baseline was calculated as the post-Baseline score minus the Baseline score. Positive changes from Baseline indicate improvement. | ITT Population. Only those participants available at the specified time points were analyzed. | Posted | Mean | Standard Deviation | Scores on a scale | Baseline through Week 20/Early Withdrawal |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With the Indicated Response for the Epilepsy-related Worry Component of the Patient Global Impression of Change (PGI-C) Score | The PGI-C questionnaire was to be completed by the participant. Participants were asked the following question: Compared to before you started this study, how would you rate your current epilepsy-related worry: Much better, Moderately better, A little better, Unchanged, A little worse, Moderately worse, Much worse? | ITT Population. Only those participants available at the specified time points were analyzed. | Posted | Number | participants | Baseline through Week 20/Early Withdrawal |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in the PGI-C Score: Epilepsy-related Worry | The PGI-C questionnaire was to be completed by the participant. Participants were asked the following question: Compared to before you started this study, how would you rate your current epilepsy-related worry: Much better, Moderately better, A little better, Unchanged, A little worse, Moderately worse, Much worse? Rating scores are integers from 1 to 7, with 1=Much better and 7=Much worse. | ITT Population. Only those participants available at the specified time points were analyzed. | Posted | Mean | Standard Deviation | Scores on a scale | Baseline through Week 20/Early Withdrawal |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With the Indicated Response for the Current Ability to do the Things You Need to do Component of the PGI-C Score | The PGI-C questionnaire was to be completed by the participant. Participants were asked the following question: Compared to before you started this study, how would you rate your current ability to do the things you need to do: Much better, Moderately better, A little better, Unchanged, A little worse, Moderately worse, Much worse? | ITT Population. Only those participants available at the specified time points were analyzed. | Posted | Number | participants | Baseline through Week 20/Early Withdrawal |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in the PGI-C Score: Current Ability to do the Things You Need to do | The PGI-C questionnaire was to be completed by the participant. Participants were asked the following question: Compared to before you started this study, how would you rate your current ability to do the things you need to do: Much better, Moderately better, A little better, Unchanged, A little worse, Moderately worse, Much worse? Rating scores are integers from 1 to 7, with 1=Much better and 7=Much worse. | ITT Population. Only those participants available at the specified time points were analyzed. | Posted | Mean | Standard Deviation | Scores on a scale | Baseline through Week 20/Early Withdrawal |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With the Indicated Response for the Current Ability to do the Things You Want to do Component of the PGI-C Score | The PGI-C questionnaire was to be completed by the participant. Participants were asked the following question: Compared to before you started this study, how would you rate your current ability to do the things you want to do: Much better, Moderately better, A little better, Unchanged, A little worse, Moderately worse, Much worse. | ITT Population. Only those participants available at the specified time points were analyzed. | Posted | Number | participants | Baseline through Week 20/Early Withdrawal |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in the PGI-C Score: Current Ability to do the Things You Want to do | The PGI-C questionnaire was to be completed by the participant. Participants were asked the following question: Compared to before you started this study, how would you rate your current ability to do the things you want to do: Much better, Moderately better, A little better, Unchanged, A little worse, Moderately worse, Much worse? Rating scores are integers from 1 to 7, with 1=Much better and 7=Much worse. | ITT Population. Only those participants available at the specified time points were analyzed. | Posted | Mean | Standard Deviation | Scores on a scale | Baseline through Week 20/Early Withdrawal |
|
Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication through the end of the Follow-up Phase (up to Week 33). SAEs considered to be related to study participation were also to be collected prior to treatment.
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who took at least one dose of investigational product.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | RTG Flexible Dose Plus C/O | Along with concurrent carbamazepine/oxcarbazepine (C/O), participants initiated treatment with retigabine (RTG) immediate release (IR) at 150 milligrams per day (mg/day) (50 mg thrice a day [TID]) and titrated to 600 mg/day (200 mg/day TID) over a 4-week Titration Phase. This was followed by a 16-week Flexible Dose Evaluation Phase, during which the dose could be increased or decreased on a weekly basis between 50 and 150 mg/day, depending on efficacy and tolerability, with the total dose staying between 300 and 1200 mg/day. Participants who were unable to tolerate a minimum dose of 300 mg/day were discontinued from the study. | 0 | 56 | 39 | 56 | ||
| EG001 | RTG Flexible Dose Plus Lamotrigine | Along with concurrent lamotrigine, participants initiated treatment with RTG IR at 150 mg/day (50 mg TID) and titrated to 600 mg/day (200 mg/day TID) over a 4-week Titration Phase. This was followed by a 16-week Flexible Dose Evaluation Phase, during which the dose could be increased or decreased on a weekly basis between 50 and 150 mg/day, depending on efficacy and tolerability, with the total dose staying between 300 and 1200 mg/day. Participants who were unable to tolerate a minimum dose of 300 mg/day were discontinued from the study. | 4 | 51 | 33 | 51 | ||
| EG002 | RTG Flexible Dose Plus Levetiracetam | Along with concurrent leveteracetam, participants initiated treatment with RTG IR at 150 mg/day (50 mg TID) and titrated to 600 mg/day (200 mg/day TID) over a 4-week Titration Phase. This was followed by a 16-week Flexible Dose Evaluation Phase, during which the dose could be increased or decreased on a weekly basis between 50 and 150 mg/day, depending on efficacy and tolerability, with the total dose staying between 300 and 1200 mg/day. Participants who were unable to tolerate a minimum dose of 300 mg/day were discontinued from the study. | 4 | 44 | 23 | 44 | ||
| EG003 | RTG Flexible Dose Plus Valproic Acid | Along with concurrent valproic acid, participants initiated treatment with RTG IR at 150 mg/day (50 mg TID) and titrated to 600 mg/day (200 mg/day TID) over a 4-week Titration Phase. This was followed by a 16-week Flexible Dose Evaluation Phase, during which the dose could be increased or decreased on a weekly basis between 50 and 150 mg/day, depending on efficacy and tolerability, with the total dose staying between 300 and 1200 mg/day. Participants who were unable to tolerate a minimum dose of 300 mg/day were discontinued from the study. | 1 | 52 | 31 | 52 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cerebrovascular accident | Nervous system disorders | MedDRA | Systematic Assessment |
| |
| Convulsion | Nervous system disorders | MedDRA | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA | Systematic Assessment |
| |
| Epilepsy | Nervous system disorders | MedDRA | Systematic Assessment |
| |
| Grand mal convulsion | Nervous system disorders | MedDRA | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA | Systematic Assessment |
| |
| Partial seizures | Nervous system disorders | MedDRA | Systematic Assessment |
| |
| Partial seizures with secondary generalization | Nervous system disorders | MedDRA | Systematic Assessment |
| |
| Atrioventricular block second degree | Cardiac disorders | MedDRA | Systematic Assessment |
| |
| Vestibular disorder | Ear and labyrinth disorders | MedDRA | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Femoral neck fracture | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
| |
| Intervertebral disc disorder | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
| |
| Hypertensive crisis | Vascular disorders | MedDRA | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Dizziness | Nervous system disorders | MedDRA | Systematic Assessment |
| |
| Somnolence | Nervous system disorders | MedDRA | Systematic Assessment |
| |
| Vertigo | Ear and labyrinth disorders | MedDRA | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA | Systematic Assessment |
| |
| Disturbance in attention | Nervous system disorders | MedDRA | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA | Systematic Assessment |
| |
| Memory impairment | Nervous system disorders | MedDRA | Systematic Assessment |
| |
| Speech disorder | Nervous system disorders | MedDRA | Systematic Assessment |
| |
| Confusional state | Psychiatric disorders | MedDRA | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Convulsion | Nervous system disorders | MedDRA | Systematic Assessment |
| |
| Diplopia | Eye disorders | MedDRA | Systematic Assessment |
| |
| Ataxia | Nervous system disorders | MedDRA | Systematic Assessment |
| |
| Strangury | Renal and urinary disorders | MedDRA | Systematic Assessment |
|
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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| GSK Response Center | GlaxoSmithKline | 866-435-7343 |
| ID | Term |
|---|---|
| D004827 | Epilepsy |
| D012640 | Seizures |
| ID | Term |
|---|---|
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
| Male |
|
| Asian - South East Asian Heritage |
|
| White - White/Caucasian/European |
|
| OG004 | Total | All four antiepileptic drug treatment arms combined |
| percentage of participants |
| 32.0 |
| 2-Sided |
| 95 |
| 19.1 |
| 44.9 |
The estimated value represents the percentage of participants with a >=50% reduction in partial-onset seizure frequency from Baseline. |
| No |
| Superiority or Other |
| percentage of participants | 50.0 | 2-Sided | 95 | 35.2 | 64.8 | The estimated value represents the percentage of participants with a >=50% reduction in partial-onset seizure frequency from Baseline. | No | Superiority or Other |
| percentage of participants | 56.9 | 2-Sided | 95 | 43.3 | 70.5 | The estimated value represents the percentage of participants with a >=50% reduction in partial-onset seizure frequency from Baseline. | No | Superiority or Other |
| percentage of participants | 44.5 | 2-Sided | 95 | 37.6 | 51.4 | The estimated value represents the percentage of participants with a >=50% reduction in partial-onset seizure frequency from Baseline. | No | Superiority or Other |
| OG002 | RTG Flexible Dose Plus Levetiracetam | Along with concurrent leveteracetam, participants initiated treatment with RTG IR at 150 mg/day (50 mg TID) and titrated to 600 mg/day (200 mg/day TID) over a 4-week Titration Phase. This was followed by a 16-week Flexible Dose Evaluation Phase, during which the dose could be increased or decreased on a weekly basis between 50 and 150 mg/day, depending on efficacy and tolerability, with the total dose staying between 300 and 1200 mg/day. Participants who were unable to tolerate a minimum dose of 300 mg/day were discontinued from the study. |
| OG003 | RTG Flexible Dose Plus Valproic Acid | Along with concurrent valproic acid, participants initiated treatment with RTG IR at 150 mg/day (50 mg TID) and titrated to 600 mg/day (200 mg/day TID) over a 4-week Titration Phase. This was followed by a 16-week Flexible Dose Evaluation Phase, during which the dose could be increased or decreased on a weekly basis between 50 and 150 mg/day, depending on efficacy and tolerability, with the total dose staying between 300 and 1200 mg/day. Participants who were unable to tolerate a minimum dose of 300 mg/day were discontinued from the study. |
| OG004 | Total | All four antiepileptic drug treatment arms combined |
|
|
| OG002 | RTG Flexible Dose Plus Levetiracetam | Along with concurrent leveteracetam, participants initiated treatment with RTG IR at 150 mg/day (50 mg TID) and titrated to 600 mg/day (200 mg/day TID) over a 4-week Titration Phase. This was followed by a 16-week Flexible Dose Evaluation Phase, during which the dose could be increased or decreased on a weekly basis between 50 and 150 mg/day, depending on efficacy and tolerability, with the total dose staying between 300 and 1200 mg/day. Participants who were unable to tolerate a minimum dose of 300 mg/day were discontinued from the study. |
| OG003 | RTG Flexible Dose Plus Valproic Acid | Along with concurrent valproic acid, participants initiated treatment with RTG IR at 150 mg/day (50 mg TID) and titrated to 600 mg/day (200 mg/day TID) over a 4-week Titration Phase. This was followed by a 16-week Flexible Dose Evaluation Phase, during which the dose could be increased or decreased on a weekly basis between 50 and 150 mg/day, depending on efficacy and tolerability, with the total dose staying between 300 and 1200 mg/day. Participants who were unable to tolerate a minimum dose of 300 mg/day were discontinued from the study. |
| OG004 | Total | All four antiepileptic drug treatment arms combined |
|
|
| OG002 | RTG Flexible Dose Plus Levetiracetam | Along with concurrent leveteracetam, participants initiated treatment with RTG IR at 150 mg/day (50 mg TID) and titrated to 600 mg/day (200 mg/day TID) over a 4-week Titration Phase. This was followed by a 16-week Flexible Dose Evaluation Phase, during which the dose could be increased or decreased on a weekly basis between 50 and 150 mg/day, depending on efficacy and tolerability, with the total dose staying between 300 and 1200 mg/day. Participants who were unable to tolerate a minimum dose of 300 mg/day were discontinued from the study. |
| OG003 | RTG Flexible Dose Plus Valproic Acid | Along with concurrent valproic acid, participants initiated treatment with RTG IR at 150 mg/day (50 mg TID) and titrated to 600 mg/day (200 mg/day TID) over a 4-week Titration Phase. This was followed by a 16-week Flexible Dose Evaluation Phase, during which the dose could be increased or decreased on a weekly basis between 50 and 150 mg/day, depending on efficacy and tolerability, with the total dose staying between 300 and 1200 mg/day. Participants who were unable to tolerate a minimum dose of 300 mg/day were discontinued from the study. |
| OG004 | Total | All four antiepileptic drug treatment arms combined |
|
|
| OG001 | RTG Flexible Dose Plus Lamotrigine | Along with concurrent lamotrigine, participants initiated treatment with RTG IR at 150 mg/day (50 mg TID) and titrated to 600 mg/day (200 mg/day TID) over a 4-week Titration Phase. This was followed by a 16-week Flexible Dose Evaluation Phase, during which the dose could be increased or decreased on a weekly basis between 50 and 150 mg/day, depending on efficacy and tolerability, with the total dose staying between 300 and 1200 mg/day. Participants who were unable to tolerate a minimum dose of 300 mg/day were discontinued from the study. |
| OG002 | RTG Flexible Dose Plus Levetiracetam | Along with concurrent leveteracetam, participants initiated treatment with RTG IR at 150 mg/day (50 mg TID) and titrated to 600 mg/day (200 mg/day TID) over a 4-week Titration Phase. This was followed by a 16-week Flexible Dose Evaluation Phase, during which the dose could be increased or decreased on a weekly basis between 50 and 150 mg/day, depending on efficacy and tolerability, with the total dose staying between 300 and 1200 mg/day. Participants who were unable to tolerate a minimum dose of 300 mg/day were discontinued from the study. |
| OG003 | RTG Flexible Dose Plus Valproic Acid | Along with concurrent valproic acid, participants initiated treatment with RTG IR at 150 mg/day (50 mg TID) and titrated to 600 mg/day (200 mg/day TID) over a 4-week Titration Phase. This was followed by a 16-week Flexible Dose Evaluation Phase, during which the dose could be increased or decreased on a weekly basis between 50 and 150 mg/day, depending on efficacy and tolerability, with the total dose staying between 300 and 1200 mg/day. Participants who were unable to tolerate a minimum dose of 300 mg/day were discontinued from the study. |
| OG004 | Total | All four antiepileptic drug treatment arms combined |
|
|
| OG001 | RTG Flexible Dose Plus Lamotrigine | Along with concurrent lamotrigine, participants initiated treatment with RTG IR at 150 mg/day (50 mg TID) and titrated to 600 mg/day (200 mg/day TID) over a 4-week Titration Phase. This was followed by a 16-week Flexible Dose Evaluation Phase, during which the dose could be increased or decreased on a weekly basis between 50 and 150 mg/day, depending on efficacy and tolerability, with the total dose staying between 300 and 1200 mg/day. Participants who were unable to tolerate a minimum dose of 300 mg/day were discontinued from the study. |
| OG002 | RTG Flexible Dose Plus Levetiracetam | Along with concurrent leveteracetam, participants initiated treatment with RTG IR at 150 mg/day (50 mg TID) and titrated to 600 mg/day (200 mg/day TID) over a 4-week Titration Phase. This was followed by a 16-week Flexible Dose Evaluation Phase, during which the dose could be increased or decreased on a weekly basis between 50 and 150 mg/day, depending on efficacy and tolerability, with the total dose staying between 300 and 1200 mg/day. Participants who were unable to tolerate a minimum dose of 300 mg/day were discontinued from the study. |
| OG003 | RTG Flexible Dose Plus Valproic Acid | Along with concurrent valproic acid, participants initiated treatment with RTG IR at 150 mg/day (50 mg TID) and titrated to 600 mg/day (200 mg/day TID) over a 4-week Titration Phase. This was followed by a 16-week Flexible Dose Evaluation Phase, during which the dose could be increased or decreased on a weekly basis between 50 and 150 mg/day, depending on efficacy and tolerability, with the total dose staying between 300 and 1200 mg/day. Participants who were unable to tolerate a minimum dose of 300 mg/day were discontinued from the study. |
| OG004 | Total | All four antiepileptic drug treatment arms combined |
|
|
| OG001 | RTG Flexible Dose Plus Lamotrigine | Along with concurrent lamotrigine, participants initiated treatment with RTG IR at 150 mg/day (50 mg TID) and titrated to 600 mg/day (200 mg/day TID) over a 4-week Titration Phase. This was followed by a 16-week Flexible Dose Evaluation Phase, during which the dose could be increased or decreased on a weekly basis between 50 and 150 mg/day, depending on efficacy and tolerability, with the total dose staying between 300 and 1200 mg/day. Participants who were unable to tolerate a minimum dose of 300 mg/day were discontinued from the study. |
| OG002 | RTG Flexible Dose Plus Levetiracetam | Along with concurrent leveteracetam, participants initiated treatment with RTG IR at 150 mg/day (50 mg TID) and titrated to 600 mg/day (200 mg/day TID) over a 4-week Titration Phase. This was followed by a 16-week Flexible Dose Evaluation Phase, during which the dose could be increased or decreased on a weekly basis between 50 and 150 mg/day, depending on efficacy and tolerability, with the total dose staying between 300 and 1200 mg/day. Participants who were unable to tolerate a minimum dose of 300 mg/day were discontinued from the study. |
| OG003 | RTG Flexible Dose Plus Valproic Acid | Along with concurrent valproic acid, participants initiated treatment with RTG IR at 150 mg/day (50 mg TID) and titrated to 600 mg/day (200 mg/day TID) over a 4-week Titration Phase. This was followed by a 16-week Flexible Dose Evaluation Phase, during which the dose could be increased or decreased on a weekly basis between 50 and 150 mg/day, depending on efficacy and tolerability, with the total dose staying between 300 and 1200 mg/day. Participants who were unable to tolerate a minimum dose of 300 mg/day were discontinued from the study. |
| OG004 | Total | All four antiepileptic drug treatment arms combined |
|
|
| OG001 | RTG Flexible Dose Plus Lamotrigine | Along with concurrent lamotrigine, participants initiated treatment with RTG IR at 150 mg/day (50 mg TID) and titrated to 600 mg/day (200 mg/day TID) over a 4-week Titration Phase. This was followed by a 16-week Flexible Dose Evaluation Phase, during which the dose could be increased or decreased on a weekly basis between 50 and 150 mg/day, depending on efficacy and tolerability, with the total dose staying between 300 and 1200 mg/day. Participants who were unable to tolerate a minimum dose of 300 mg/day were discontinued from the study. |
| OG002 | RTG Flexible Dose Plus Levetiracetam | Along with concurrent leveteracetam, participants initiated treatment with RTG IR at 150 mg/day (50 mg TID) and titrated to 600 mg/day (200 mg/day TID) over a 4-week Titration Phase. This was followed by a 16-week Flexible Dose Evaluation Phase, during which the dose could be increased or decreased on a weekly basis between 50 and 150 mg/day, depending on efficacy and tolerability, with the total dose staying between 300 and 1200 mg/day. Participants who were unable to tolerate a minimum dose of 300 mg/day were discontinued from the study. |
| OG003 | RTG Flexible Dose Plus Valproic Acid | Along with concurrent valproic acid, participants initiated treatment with RTG IR at 150 mg/day (50 mg TID) and titrated to 600 mg/day (200 mg/day TID) over a 4-week Titration Phase. This was followed by a 16-week Flexible Dose Evaluation Phase, during which the dose could be increased or decreased on a weekly basis between 50 and 150 mg/day, depending on efficacy and tolerability, with the total dose staying between 300 and 1200 mg/day. Participants who were unable to tolerate a minimum dose of 300 mg/day were discontinued from the study. |
| OG004 | Total | All four antiepileptic drug treatment arms combined |
|
|
Along with concurrent lamotrigine, participants initiated treatment with RTG IR at 150 mg/day (50 mg TID) and titrated to 600 mg/day (200 mg/day TID) over a 4-week Titration Phase. This was followed by a 16-week Flexible Dose Evaluation Phase, during which the dose could be increased or decreased on a weekly basis between 50 and 150 mg/day, depending on efficacy and tolerability, with the total dose staying between 300 and 1200 mg/day. Participants who were unable to tolerate a minimum dose of 300 mg/day were discontinued from the study. |
| OG002 | RTG Flexible Dose Plus Levetiracetam | Along with concurrent leveteracetam, participants initiated treatment with RTG IR at 150 mg/day (50 mg TID) and titrated to 600 mg/day (200 mg/day TID) over a 4-week Titration Phase. This was followed by a 16-week Flexible Dose Evaluation Phase, during which the dose could be increased or decreased on a weekly basis between 50 and 150 mg/day, depending on efficacy and tolerability, with the total dose staying between 300 and 1200 mg/day. Participants who were unable to tolerate a minimum dose of 300 mg/day were discontinued from the study. |
| OG003 | RTG Flexible Dose Plus Valproic Acid | Along with concurrent valproic acid, participants initiated treatment with RTG IR at 150 mg/day (50 mg TID) and titrated to 600 mg/day (200 mg/day TID) over a 4-week Titration Phase. This was followed by a 16-week Flexible Dose Evaluation Phase, during which the dose could be increased or decreased on a weekly basis between 50 and 150 mg/day, depending on efficacy and tolerability, with the total dose staying between 300 and 1200 mg/day. Participants who were unable to tolerate a minimum dose of 300 mg/day were discontinued from the study. |
| OG004 | Total | All four antiepileptic drug treatment arms combined |
|
|
| OG001 | RTG Flexible Dose Plus Lamotrigine | Along with concurrent lamotrigine, participants initiated treatment with RTG IR at 150 mg/day (50 mg TID) and titrated to 600 mg/day (200 mg/day TID) over a 4-week Titration Phase. This was followed by a 16-week Flexible Dose Evaluation Phase, during which the dose could be increased or decreased on a weekly basis between 50 and 150 mg/day, depending on efficacy and tolerability, with the total dose staying between 300 and 1200 mg/day. Participants who were unable to tolerate a minimum dose of 300 mg/day were discontinued from the study. |
| OG002 | RTG Flexible Dose Plus Levetiracetam | Along with concurrent leveteracetam, participants initiated treatment with RTG IR at 150 mg/day (50 mg TID) and titrated to 600 mg/day (200 mg/day TID) over a 4-week Titration Phase. This was followed by a 16-week Flexible Dose Evaluation Phase, during which the dose could be increased or decreased on a weekly basis between 50 and 150 mg/day, depending on efficacy and tolerability, with the total dose staying between 300 and 1200 mg/day. Participants who were unable to tolerate a minimum dose of 300 mg/day were discontinued from the study. |
| OG003 | RTG Flexible Dose Plus Valproic Acid | Along with concurrent valproic acid, participants initiated treatment with RTG IR at 150 mg/day (50 mg TID) and titrated to 600 mg/day (200 mg/day TID) over a 4-week Titration Phase. This was followed by a 16-week Flexible Dose Evaluation Phase, during which the dose could be increased or decreased on a weekly basis between 50 and 150 mg/day, depending on efficacy and tolerability, with the total dose staying between 300 and 1200 mg/day. Participants who were unable to tolerate a minimum dose of 300 mg/day were discontinued from the study. |
| OG004 | Total | All four antiepileptic drug treatment arms combined |
|
|
| OG001 | RTG Flexible Dose Plus Lamotrigine | Along with concurrent lamotrigine, participants initiated treatment with RTG IR at 150 mg/day (50 mg TID) and titrated to 600 mg/day (200 mg/day TID) over a 4-week Titration Phase. This was followed by a 16-week Flexible Dose Evaluation Phase, during which the dose could be increased or decreased on a weekly basis between 50 and 150 mg/day, depending on efficacy and tolerability, with the total dose staying between 300 and 1200 mg/day. Participants who were unable to tolerate a minimum dose of 300 mg/day were discontinued from the study. |
| OG002 | RTG Flexible Dose Plus Levetiracetam | Along with concurrent leveteracetam, participants initiated treatment with RTG IR at 150 mg/day (50 mg TID) and titrated to 600 mg/day (200 mg/day TID) over a 4-week Titration Phase. This was followed by a 16-week Flexible Dose Evaluation Phase, during which the dose could be increased or decreased on a weekly basis between 50 and 150 mg/day, depending on efficacy and tolerability, with the total dose staying between 300 and 1200 mg/day. Participants who were unable to tolerate a minimum dose of 300 mg/day were discontinued from the study. |
| OG003 | RTG Flexible Dose Plus Valproic Acid | Along with concurrent valproic acid, participants initiated treatment with RTG IR at 150 mg/day (50 mg TID) and titrated to 600 mg/day (200 mg/day TID) over a 4-week Titration Phase. This was followed by a 16-week Flexible Dose Evaluation Phase, during which the dose could be increased or decreased on a weekly basis between 50 and 150 mg/day, depending on efficacy and tolerability, with the total dose staying between 300 and 1200 mg/day. Participants who were unable to tolerate a minimum dose of 300 mg/day were discontinued from the study. |
| OG004 | Total | All four antiepileptic drug treatment arms combined |
|
|
| OG002 | RTG Flexible Dose Plus Levetiracetam | Along with concurrent leveteracetam, participants initiated treatment with RTG IR at 150 mg/day (50 mg TID) and titrated to 600 mg/day (200 mg/day TID) over a 4-week Titration Phase. This was followed by a 16-week Flexible Dose Evaluation Phase, during which the dose could be increased or decreased on a weekly basis between 50 and 150 mg/day, depending on efficacy and tolerability, with the total dose staying between 300 and 1200 mg/day. Participants who were unable to tolerate a minimum dose of 300 mg/day were discontinued from the study. |
| OG003 | RTG Flexible Dose Plus Valproic Acid | Along with concurrent valproic acid, participants initiated treatment with RTG IR at 150 mg/day (50 mg TID) and titrated to 600 mg/day (200 mg/day TID) over a 4-week Titration Phase. This was followed by a 16-week Flexible Dose Evaluation Phase, during which the dose could be increased or decreased on a weekly basis between 50 and 150 mg/day, depending on efficacy and tolerability, with the total dose staying between 300 and 1200 mg/day. Participants who were unable to tolerate a minimum dose of 300 mg/day were discontinued from the study. |
| OG004 | Total | All four antiepileptic drug treatment arms combined |
|
|
| OG002 | RTG Flexible Dose Plus Levetiracetam | Along with concurrent leveteracetam, participants initiated treatment with RTG IR at 150 mg/day (50 mg TID) and titrated to 600 mg/day (200 mg/day TID) over a 4-week Titration Phase. This was followed by a 16-week Flexible Dose Evaluation Phase, during which the dose could be increased or decreased on a weekly basis between 50 and 150 mg/day, depending on efficacy and tolerability, with the total dose staying between 300 and 1200 mg/day. Participants who were unable to tolerate a minimum dose of 300 mg/day were discontinued from the study. |
| OG003 | RTG Flexible Dose Plus Valproic Acid | Along with concurrent valproic acid, participants initiated treatment with RTG IR at 150 mg/day (50 mg TID) and titrated to 600 mg/day (200 mg/day TID) over a 4-week Titration Phase. This was followed by a 16-week Flexible Dose Evaluation Phase, during which the dose could be increased or decreased on a weekly basis between 50 and 150 mg/day, depending on efficacy and tolerability, with the total dose staying between 300 and 1200 mg/day. Participants who were unable to tolerate a minimum dose of 300 mg/day were discontinued from the study. |
| OG004 | Total | All four antiepileptic drug treatment arms combined |
|
|
| OG002 | RTG Flexible Dose Plus Levetiracetam | Along with concurrent leveteracetam, participants initiated treatment with RTG IR at 150 mg/day (50 mg TID) and titrated to 600 mg/day (200 mg/day TID) over a 4-week Titration Phase. This was followed by a 16-week Flexible Dose Evaluation Phase, during which the dose could be increased or decreased on a weekly basis between 50 and 150 mg/day, depending on efficacy and tolerability, with the total dose staying between 300 and 1200 mg/day. Participants who were unable to tolerate a minimum dose of 300 mg/day were discontinued from the study. |
| OG003 | RTG Flexible Dose Plus Valproic Acid | Along with concurrent valproic acid, participants initiated treatment with RTG IR at 150 mg/day (50 mg TID) and titrated to 600 mg/day (200 mg/day TID) over a 4-week Titration Phase. This was followed by a 16-week Flexible Dose Evaluation Phase, during which the dose could be increased or decreased on a weekly basis between 50 and 150 mg/day, depending on efficacy and tolerability, with the total dose staying between 300 and 1200 mg/day. Participants who were unable to tolerate a minimum dose of 300 mg/day were discontinued from the study. |
| OG004 | Total | All four antiepileptic drug treatment arms combined |
|
|
| OG002 | RTG Flexible Dose Plus Levetiracetam | Along with concurrent leveteracetam, participants initiated treatment with RTG IR at 150 mg/day (50 mg TID) and titrated to 600 mg/day (200 mg/day TID) over a 4-week Titration Phase. This was followed by a 16-week Flexible Dose Evaluation Phase, during which the dose could be increased or decreased on a weekly basis between 50 and 150 mg/day, depending on efficacy and tolerability, with the total dose staying between 300 and 1200 mg/day. Participants who were unable to tolerate a minimum dose of 300 mg/day were discontinued from the study. |
| OG003 | RTG Flexible Dose Plus Valproic Acid | Along with concurrent valproic acid, participants initiated treatment with RTG IR at 150 mg/day (50 mg TID) and titrated to 600 mg/day (200 mg/day TID) over a 4-week Titration Phase. This was followed by a 16-week Flexible Dose Evaluation Phase, during which the dose could be increased or decreased on a weekly basis between 50 and 150 mg/day, depending on efficacy and tolerability, with the total dose staying between 300 and 1200 mg/day. Participants who were unable to tolerate a minimum dose of 300 mg/day were discontinued from the study. |
| OG004 | Total | All four antiepileptic drug treatment arms combined |
|
|
| OG002 | RTG Flexible Dose Plus Levetiracetam | Along with concurrent leveteracetam, participants initiated treatment with RTG IR at 150 mg/day (50 mg TID) and titrated to 600 mg/day (200 mg/day TID) over a 4-week Titration Phase. This was followed by a 16-week Flexible Dose Evaluation Phase, during which the dose could be increased or decreased on a weekly basis between 50 and 150 mg/day, depending on efficacy and tolerability, with the total dose staying between 300 and 1200 mg/day. Participants who were unable to tolerate a minimum dose of 300 mg/day were discontinued from the study. |
| OG003 | RTG Flexible Dose Plus Valproic Acid | Along with concurrent valproic acid, participants initiated treatment with RTG IR at 150 mg/day (50 mg TID) and titrated to 600 mg/day (200 mg/day TID) over a 4-week Titration Phase. This was followed by a 16-week Flexible Dose Evaluation Phase, during which the dose could be increased or decreased on a weekly basis between 50 and 150 mg/day, depending on efficacy and tolerability, with the total dose staying between 300 and 1200 mg/day. Participants who were unable to tolerate a minimum dose of 300 mg/day were discontinued from the study. |
| OG004 | Total | All four antiepileptic drug treatment arms combined |
|
|
| OG002 | RTG Flexible Dose Plus Levetiracetam | Along with concurrent leveteracetam, participants initiated treatment with RTG IR at 150 mg/day (50 mg TID) and titrated to 600 mg/day (200 mg/day TID) over a 4-week Titration Phase. This was followed by a 16-week Flexible Dose Evaluation Phase, during which the dose could be increased or decreased on a weekly basis between 50 and 150 mg/day, depending on efficacy and tolerability, with the total dose staying between 300 and 1200 mg/day. Participants who were unable to tolerate a minimum dose of 300 mg/day were discontinued from the study. |
| OG003 | RTG Flexible Dose Plus Valproic Acid | Along with concurrent valproic acid, participants initiated treatment with RTG IR at 150 mg/day (50 mg TID) and titrated to 600 mg/day (200 mg/day TID) over a 4-week Titration Phase. This was followed by a 16-week Flexible Dose Evaluation Phase, during which the dose could be increased or decreased on a weekly basis between 50 and 150 mg/day, depending on efficacy and tolerability, with the total dose staying between 300 and 1200 mg/day. Participants who were unable to tolerate a minimum dose of 300 mg/day were discontinued from the study. |
| OG004 | Total | All four antiepileptic drug treatment arms combined |
|
|