Epilepsy
Conditions
Keywords
Seizures, retigabine IR, GW582892, Epilepsy, Open label, flexible dose, Partial-onset seizures
Brief summary
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.
Detailed description
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).
Interventions
DRUGRetigabine IR
Flexible dose between 300 mg/day (minimum) and 1200 mg/day (maximum).
Sponsors
GlaxoSmithKline
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Is 18 years of age (men or women) * Has a confident diagnosis of epilepsy with partial-onset seizures i.e., simple or complex partial seizures with or without secondary generalization (International League Against Epilepsy (ILAE) classification; 1981) for more than 24 weeks prior to the start of Baseline phase. * Has experienced at least 4 partial-onset seizures (i.e., simple or complex partial seizures with or without secondary generalization) during an 8-week (i.e., 56 days) prospective Baseline Phase with at least one partial seizure occurring during each 4 week (i.e., 28-day) period. * Receiving a stable dose of one of the following AEDs: carbamazepine/oxcarbazepine, lamotrigine, levetiracetam or valproic acid. The AED dose must be stable 4 weeks prior to start of collection of baseline seizure data (retrospective or prospective) and during the Baseline period. * Is able and willing to maintain an accurate and complete daily written seizure calendar and functional status diary or has a caregiver who is able and willing to do so for the entire duration of the study. * Is able to comply with dosing of study drug, background AED and all study procedures. * Has given written informed consent, or has a legally authorized representative who has given written informed consent, prior to the performance of any study assessments. * A female subject is eligible to enter and participate in the study if she is either of non-childbearing potential or child-bearing potential but has a negative pregnancy test at Screening and agrees to satisfy one of the contraception methods as listed in the protocol, and is not pregnant or lactating or planning to become pregnant during the study. * French subjects only: In France, a subject will be eligible for inclusion in this study only if either affiliated to or a beneficiary of a social security category.
Exclusion criteria
* Has a history of generalised epilepsy (e.g. Lennox-Gastaut, Juvenile Myoclonic etc.) * Has had status epilepticus (other than simple partial status epilepticus) within the 24 weeks prior to Baseline Visit. * Has participated in a previous retigabine study (subjects with documented evidence of having received placebo will be eligible). * Is currently or has been abusing substance(s) or other medications in the 12 months prior to Baseline visit. * Has taken an investigational drug, or used an investigational device, within the previous 30 days prior to screening or plans to take an investigational drug anytime during the study. * Is currently following or planning to follow the ketogenic diet. * Has been treated with vigabatrin within the past 6 months prior to collection of baseline seizure data. * Is planning surgery or implantation of a Vagus Nerve Stimulator (VNS) to control seizures during the study. * Is suffering from acute or progressive neurological disease, severe psychiatric disease, or severe mental abnormalities that are likely to interfere with the objectives of the study. * Has any medical condition that, in the investigator's judgment, is considered to be clinically significant and could potentially affect subject safety or study outcome. * Has a QTc ≥450 millisecond (msec) or greater than or equal to 480 msec for subjects with Bundle Branch Block at the time of screening. * Has active suicidal plan/intent or has had active suicidal thoughts in the past 6 months. Has history of suicide attempt in the last 2 years or more than 1 lifetime suicide attempt. * French Subjects: the French subject has participated in any study using an investigational drug during the previous 30 days or 5 half-lives (whichever is longer).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With a >=50% Reduction in Partial-onset Seizure (POS) Frequency From Baseline | From Baseline through Week 20 (Day 140)/Early Withdrawal | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With a >=25%, >=75%, or 100% Reduction in Partial-onset Seizure Frequency From Baseline | From Baseline through Week 20 (Day 140)/Early Withdrawal | 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. |
| Percent Change From Baseline in Partial-onset Seizure Frequency | From Baseline through Week 20 (Day 140)/Early Withdrawal | 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. |
| Functional Status Diary (FSD): Percent Change From Baseline in Epilepsy-related Worry | Baseline through Week 20/Early Withdrawal | 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. |
| Functional Status Diary (FSD): Percent Change From Baseline in Epilepsy-related Limitation of Ability to do What You Needed to | Baseline through Week 20/Early Withdrawal | 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. |
| Functional Status Diary (FSD): Percent Change From Baseline in Epilepsy-related Limitation of Ability to do What You Wanted to | Baseline through Week 20/Early Withdrawal | 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. |
| Percent Change From Baseline in Functional Status: Percentage of Days With no Missed Work or School Time | Baseline through Week 20/Early Withdrawal | 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. |
| Change From Baseline in the Short Form 36 Health Survey, Version 2 (SF-36v2) Domain Scores at Week 20/Early Withdrawal | Baseline through 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. |
| Number of Participants With the Indicated Reduction or Increase From Baseline in Partial-onset Seizure Frequency | From Baseline through Week 20 (Day 140)/Early Withdrawal | 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. |
| Change From Baseline in the SF-36v2 Mental Component Summary Score at Week 20/Early Withdrawal | Baseline through 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. |
| Number of Participants With the Indicated Response for the Epilepsy-related Worry Component of the Patient Global Impression of Change (PGI-C) Score | Baseline through Week 20/Early Withdrawal | 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? |
| Change From Baseline in the PGI-C Score: Epilepsy-related Worry | Baseline through Week 20/Early Withdrawal | 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. |
| 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 | Baseline through Week 20/Early Withdrawal | 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? |
| Change From Baseline in the PGI-C Score: Current Ability to do the Things You Need to do | Baseline through Week 20/Early Withdrawal | 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. |
| 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 | Baseline through Week 20/Early Withdrawal | 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. |
| Change From Baseline in the PGI-C Score: Current Ability to do the Things You Want to do | Baseline through Week 20/Early Withdrawal | 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. |
| Change From Baseline in the SF-36v2 Physical Component Summary Score at Week 20/Early Withdrawal | Baseline through 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. |
Countries
Belgium, Bulgaria, Denmark, France, Germany, Italy, Netherlands, Poland, Russia, Spain, Thailand, Ukraine
Participant flow
Recruitment details
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.
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 56 |
| 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. | 51 |
| 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. | 44 |
| 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. | 52 |
| Total | 203 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Overall Study | Adverse Event | 12 | 8 | 11 | 4 |
| Overall Study | Lack of Efficacy | 1 | 2 | 2 | 1 |
| Overall Study | Lost to Follow-up | 0 | 0 | 1 | 2 |
| Overall Study | Physician Decision | 0 | 1 | 1 | 0 |
| Overall Study | Protocol Violation | 1 | 0 | 0 | 0 |
| Overall Study | Withdrawal by Subject | 4 | 2 | 4 | 3 |
Baseline characteristics
| Characteristic | RTG Flexible Dose Plus C/O | RTG Flexible Dose Plus Lamotrigine | RTG Flexible Dose Plus Levetiracetam | RTG Flexible Dose Plus Valproic Acid | Total |
|---|---|---|---|---|---|
| Age, Continuous | 40.6 Years STANDARD_DEVIATION 14.99 | 38.2 Years STANDARD_DEVIATION 11.91 | 37.0 Years STANDARD_DEVIATION 14.94 | 40.3 Years STANDARD_DEVIATION 14.05 | 39.1 Years STANDARD_DEVIATION 14 |
| Race/Ethnicity, Customized Asian - Central/South Asian Heritage | 1 participants | 1 participants | 0 participants | 0 participants | 2 participants |
| Race/Ethnicity, Customized Asian - South East Asian Heritage | 0 participants | 5 participants | 5 participants | 3 participants | 13 participants |
| Race/Ethnicity, Customized White - White/Caucasian/European | 55 participants | 45 participants | 39 participants | 49 participants | 188 participants |
| Sex: Female, Male Female | 33 Participants | 26 Participants | 25 Participants | 26 Participants | 110 Participants |
| Sex: Female, Male Male | 23 Participants | 25 Participants | 19 Participants | 26 Participants | 93 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 39 / 56 | 33 / 51 | 23 / 44 | 31 / 52 |
| serious Total, serious adverse events | 0 / 56 | 4 / 51 | 4 / 44 | 1 / 52 |
Outcome results
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.
Time frame: From Baseline through Week 20 (Day 140)/Early Withdrawal
Population: 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
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| RTG Flexible Dose Plus C/O | Number of Participants With a >=50% Reduction in Partial-onset Seizure (POS) Frequency From Baseline | 22 participants |
| RTG Flexible Dose Plus Lamotrigine | Number of Participants With a >=50% Reduction in Partial-onset Seizure (POS) Frequency From Baseline | 16 participants |
| RTG Flexible Dose Plus Levetiracetam | Number of Participants With a >=50% Reduction in Partial-onset Seizure (POS) Frequency From Baseline | 22 participants |
| RTG Flexible Dose Plus Valproic Acid | Number of Participants With a >=50% Reduction in Partial-onset Seizure (POS) Frequency From Baseline | 29 participants |
| Total | Number of Participants With a >=50% Reduction in Partial-onset Seizure (POS) Frequency From Baseline | 89 participants |
95% CI: [27.1, 52.9]
95% CI: [19.1, 44.9]
95% CI: [35.2, 64.8]
95% CI: [43.3, 70.5]
95% CI: [37.6, 51.4]
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.
Time frame: Baseline through Week 20/Early Withdrawal
Population: ITT Population. Only those participants available at the specified time points were analyzed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| RTG Flexible Dose Plus C/O | Change From Baseline in the PGI-C Score: Current Ability to do the Things You Need to do | 3.3 Scores on a scale | Standard Deviation 1.43 |
| RTG Flexible Dose Plus Lamotrigine | Change From Baseline in the PGI-C Score: Current Ability to do the Things You Need to do | 2.9 Scores on a scale | Standard Deviation 1.29 |
| RTG Flexible Dose Plus Levetiracetam | Change From Baseline in the PGI-C Score: Current Ability to do the Things You Need to do | 3.1 Scores on a scale | Standard Deviation 1.34 |
| RTG Flexible Dose Plus Valproic Acid | Change From Baseline in the PGI-C Score: Current Ability to do the Things You Need to do | 2.6 Scores on a scale | Standard Deviation 1.32 |
| Total | Change From Baseline in the PGI-C Score: Current Ability to do the Things You Need to do | 3.0 Scores on a scale | Standard Deviation 1.36 |
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.
Time frame: Baseline through Week 20/Early Withdrawal
Population: ITT Population. Only those participants available at the specified time points were analyzed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| RTG Flexible Dose Plus C/O | Change From Baseline in the PGI-C Score: Current Ability to do the Things You Want to do | 3.4 Scores on a scale | Standard Deviation 1.29 |
| RTG Flexible Dose Plus Lamotrigine | Change From Baseline in the PGI-C Score: Current Ability to do the Things You Want to do | 2.8 Scores on a scale | Standard Deviation 1.23 |
| RTG Flexible Dose Plus Levetiracetam | Change From Baseline in the PGI-C Score: Current Ability to do the Things You Want to do | 3.0 Scores on a scale | Standard Deviation 1.12 |
| RTG Flexible Dose Plus Valproic Acid | Change From Baseline in the PGI-C Score: Current Ability to do the Things You Want to do | 2.5 Scores on a scale | Standard Deviation 1.3 |
| Total | Change From Baseline in the PGI-C Score: Current Ability to do the Things You Want to do | 2.9 Scores on a scale | Standard Deviation 1.28 |
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.
Time frame: Baseline through Week 20/Early Withdrawal
Population: ITT Population. Only those participants available at the specified time points were analyzed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| RTG Flexible Dose Plus C/O | Change From Baseline in the PGI-C Score: Epilepsy-related Worry | 3.1 Scores on a scale | Standard Deviation 1.32 |
| RTG Flexible Dose Plus Lamotrigine | Change From Baseline in the PGI-C Score: Epilepsy-related Worry | 2.7 Scores on a scale | Standard Deviation 1.44 |
| RTG Flexible Dose Plus Levetiracetam | Change From Baseline in the PGI-C Score: Epilepsy-related Worry | 3.0 Scores on a scale | Standard Deviation 1.24 |
| RTG Flexible Dose Plus Valproic Acid | Change From Baseline in the PGI-C Score: Epilepsy-related Worry | 2.5 Scores on a scale | Standard Deviation 1.38 |
| Total | Change From Baseline in the PGI-C Score: Epilepsy-related Worry | 2.8 Scores on a scale | Standard Deviation 1.36 |
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.
Time frame: Baseline through Week 20/Early Withdrawal
Population: ITT Population. Only those participants available at the specified time points were analyzed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| RTG Flexible Dose Plus C/O | Change From Baseline in the SF-36v2 Mental Component Summary Score at Week 20/Early Withdrawal | -2.59 Scores on a scale | Standard Deviation 12.359 |
| RTG Flexible Dose Plus Lamotrigine | Change From Baseline in the SF-36v2 Mental Component Summary Score at Week 20/Early Withdrawal | 0.66 Scores on a scale | Standard Deviation 10.149 |
| RTG Flexible Dose Plus Levetiracetam | Change From Baseline in the SF-36v2 Mental Component Summary Score at Week 20/Early Withdrawal | 2.75 Scores on a scale | Standard Deviation 8.851 |
| RTG Flexible Dose Plus Valproic Acid | Change From Baseline in the SF-36v2 Mental Component Summary Score at Week 20/Early Withdrawal | 3.79 Scores on a scale | Standard Deviation 10.206 |
| Total | Change From Baseline in the SF-36v2 Mental Component Summary Score at Week 20/Early Withdrawal | 0.94 Scores on a scale | Standard Deviation 10.825 |
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.
Time frame: Baseline through Week 20/Early Withdrawal
Population: ITT Population. Only those participants available at the specified time points were analyzed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| RTG Flexible Dose Plus C/O | Change From Baseline in the SF-36v2 Physical Component Summary Score at Week 20/Early Withdrawal | 0.17 Scores on a scale | Standard Deviation 5.202 |
| RTG Flexible Dose Plus Lamotrigine | Change From Baseline in the SF-36v2 Physical Component Summary Score at Week 20/Early Withdrawal | 1.22 Scores on a scale | Standard Deviation 6.218 |
| RTG Flexible Dose Plus Levetiracetam | Change From Baseline in the SF-36v2 Physical Component Summary Score at Week 20/Early Withdrawal | -0.58 Scores on a scale | Standard Deviation 5.648 |
| RTG Flexible Dose Plus Valproic Acid | Change From Baseline in the SF-36v2 Physical Component Summary Score at Week 20/Early Withdrawal | 0.82 Scores on a scale | Standard Deviation 4.525 |
| Total | Change From Baseline in the SF-36v2 Physical Component Summary Score at Week 20/Early Withdrawal | 0.44 Scores on a scale | Standard Deviation 5.41 |
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.
Time frame: Baseline through Week 20/Early Withdrawal
Population: ITT Population. Only those participants available at the specified time points were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| RTG Flexible Dose Plus C/O | Change From Baseline in the Short Form 36 Health Survey, Version 2 (SF-36v2) Domain Scores at Week 20/Early Withdrawal | Physical Functioning | -0.54 Scores on a scale | Standard Deviation 5.461 |
| RTG Flexible Dose Plus C/O | Change From Baseline in the Short Form 36 Health Survey, Version 2 (SF-36v2) Domain Scores at Week 20/Early Withdrawal | Role-Physical | -1.31 Scores on a scale | Standard Deviation 9.563 |
| RTG Flexible Dose Plus C/O | Change From Baseline in the Short Form 36 Health Survey, Version 2 (SF-36v2) Domain Scores at Week 20/Early Withdrawal | Bodily Pain | 0.92 Scores on a scale | Standard Deviation 10.315 |
| RTG Flexible Dose Plus C/O | Change From Baseline in the Short Form 36 Health Survey, Version 2 (SF-36v2) Domain Scores at Week 20/Early Withdrawal | General Health | -0.35 Scores on a scale | Standard Deviation 7.303 |
| RTG Flexible Dose Plus C/O | Change From Baseline in the Short Form 36 Health Survey, Version 2 (SF-36v2) Domain Scores at Week 20/Early Withdrawal | Vitality | -2.94 Scores on a scale | Standard Deviation 10.657 |
| RTG Flexible Dose Plus C/O | Change From Baseline in the Short Form 36 Health Survey, Version 2 (SF-36v2) Domain Scores at Week 20/Early Withdrawal | Social Functioning | -1.83 Scores on a scale | Standard Deviation 12.022 |
| RTG Flexible Dose Plus C/O | Change From Baseline in the Short Form 36 Health Survey, Version 2 (SF-36v2) Domain Scores at Week 20/Early Withdrawal | Role-Emotional | -1.43 Scores on a scale | Standard Deviation 13.224 |
| RTG Flexible Dose Plus C/O | Change From Baseline in the Short Form 36 Health Survey, Version 2 (SF-36v2) Domain Scores at Week 20/Early Withdrawal | Mental Health | -2.04 Scores on a scale | Standard Deviation 10.51 |
| RTG Flexible Dose Plus Lamotrigine | Change From Baseline in the Short Form 36 Health Survey, Version 2 (SF-36v2) Domain Scores at Week 20/Early Withdrawal | Bodily Pain | 0.62 Scores on a scale | Standard Deviation 10.925 |
| RTG Flexible Dose Plus Lamotrigine | Change From Baseline in the Short Form 36 Health Survey, Version 2 (SF-36v2) Domain Scores at Week 20/Early Withdrawal | Social Functioning | 0.58 Scores on a scale | Standard Deviation 11.063 |
| RTG Flexible Dose Plus Lamotrigine | Change From Baseline in the Short Form 36 Health Survey, Version 2 (SF-36v2) Domain Scores at Week 20/Early Withdrawal | Physical Functioning | 0.89 Scores on a scale | Standard Deviation 6.665 |
| RTG Flexible Dose Plus Lamotrigine | Change From Baseline in the Short Form 36 Health Survey, Version 2 (SF-36v2) Domain Scores at Week 20/Early Withdrawal | General Health | 2.55 Scores on a scale | Standard Deviation 7.24 |
| RTG Flexible Dose Plus Lamotrigine | Change From Baseline in the Short Form 36 Health Survey, Version 2 (SF-36v2) Domain Scores at Week 20/Early Withdrawal | Role-Physical | 1.04 Scores on a scale | Standard Deviation 9.366 |
| RTG Flexible Dose Plus Lamotrigine | Change From Baseline in the Short Form 36 Health Survey, Version 2 (SF-36v2) Domain Scores at Week 20/Early Withdrawal | Mental Health | 0.72 Scores on a scale | Standard Deviation 9.48 |
| RTG Flexible Dose Plus Lamotrigine | Change From Baseline in the Short Form 36 Health Survey, Version 2 (SF-36v2) Domain Scores at Week 20/Early Withdrawal | Vitality | 0.52 Scores on a scale | Standard Deviation 9.722 |
| RTG Flexible Dose Plus Lamotrigine | Change From Baseline in the Short Form 36 Health Survey, Version 2 (SF-36v2) Domain Scores at Week 20/Early Withdrawal | Role-Emotional | 1.07 Scores on a scale | Standard Deviation 10.991 |
| RTG Flexible Dose Plus Levetiracetam | Change From Baseline in the Short Form 36 Health Survey, Version 2 (SF-36v2) Domain Scores at Week 20/Early Withdrawal | Role-Emotional | 2.19 Scores on a scale | Standard Deviation 9.258 |
| RTG Flexible Dose Plus Levetiracetam | Change From Baseline in the Short Form 36 Health Survey, Version 2 (SF-36v2) Domain Scores at Week 20/Early Withdrawal | Mental Health | 2.48 Scores on a scale | Standard Deviation 8.685 |
| RTG Flexible Dose Plus Levetiracetam | Change From Baseline in the Short Form 36 Health Survey, Version 2 (SF-36v2) Domain Scores at Week 20/Early Withdrawal | General Health | 0.68 Scores on a scale | Standard Deviation 6.342 |
| RTG Flexible Dose Plus Levetiracetam | Change From Baseline in the Short Form 36 Health Survey, Version 2 (SF-36v2) Domain Scores at Week 20/Early Withdrawal | Social Functioning | 1.84 Scores on a scale | Standard Deviation 9.787 |
| RTG Flexible Dose Plus Levetiracetam | Change From Baseline in the Short Form 36 Health Survey, Version 2 (SF-36v2) Domain Scores at Week 20/Early Withdrawal | Bodily Pain | 1.28 Scores on a scale | Standard Deviation 8.571 |
| RTG Flexible Dose Plus Levetiracetam | Change From Baseline in the Short Form 36 Health Survey, Version 2 (SF-36v2) Domain Scores at Week 20/Early Withdrawal | Role-Physical | 0.31 Scores on a scale | Standard Deviation 10.958 |
| RTG Flexible Dose Plus Levetiracetam | Change From Baseline in the Short Form 36 Health Survey, Version 2 (SF-36v2) Domain Scores at Week 20/Early Withdrawal | Physical Functioning | -0.70 Scores on a scale | Standard Deviation 4.974 |
| RTG Flexible Dose Plus Levetiracetam | Change From Baseline in the Short Form 36 Health Survey, Version 2 (SF-36v2) Domain Scores at Week 20/Early Withdrawal | Vitality | 0.47 Scores on a scale | Standard Deviation 6.838 |
| RTG Flexible Dose Plus Valproic Acid | Change From Baseline in the Short Form 36 Health Survey, Version 2 (SF-36v2) Domain Scores at Week 20/Early Withdrawal | Role-Physical | 1.87 Scores on a scale | Standard Deviation 7.644 |
| RTG Flexible Dose Plus Valproic Acid | Change From Baseline in the Short Form 36 Health Survey, Version 2 (SF-36v2) Domain Scores at Week 20/Early Withdrawal | Bodily Pain | 2.81 Scores on a scale | Standard Deviation 11.198 |
| RTG Flexible Dose Plus Valproic Acid | Change From Baseline in the Short Form 36 Health Survey, Version 2 (SF-36v2) Domain Scores at Week 20/Early Withdrawal | General Health | 2.45 Scores on a scale | Standard Deviation 7.749 |
| RTG Flexible Dose Plus Valproic Acid | Change From Baseline in the Short Form 36 Health Survey, Version 2 (SF-36v2) Domain Scores at Week 20/Early Withdrawal | Vitality | 1.56 Scores on a scale | Standard Deviation 8.318 |
| RTG Flexible Dose Plus Valproic Acid | Change From Baseline in the Short Form 36 Health Survey, Version 2 (SF-36v2) Domain Scores at Week 20/Early Withdrawal | Social Functioning | 2.10 Scores on a scale | Standard Deviation 10.107 |
| RTG Flexible Dose Plus Valproic Acid | Change From Baseline in the Short Form 36 Health Survey, Version 2 (SF-36v2) Domain Scores at Week 20/Early Withdrawal | Mental Health | 3.31 Scores on a scale | Standard Deviation 10.636 |
| RTG Flexible Dose Plus Valproic Acid | Change From Baseline in the Short Form 36 Health Survey, Version 2 (SF-36v2) Domain Scores at Week 20/Early Withdrawal | Physical Functioning | 0.46 Scores on a scale | Standard Deviation 5.465 |
| RTG Flexible Dose Plus Valproic Acid | Change From Baseline in the Short Form 36 Health Survey, Version 2 (SF-36v2) Domain Scores at Week 20/Early Withdrawal | Role-Emotional | 4.36 Scores on a scale | Standard Deviation 12.719 |
| Total | Change From Baseline in the Short Form 36 Health Survey, Version 2 (SF-36v2) Domain Scores at Week 20/Early Withdrawal | General Health | 1.30 Scores on a scale | Standard Deviation 7.269 |
| Total | Change From Baseline in the Short Form 36 Health Survey, Version 2 (SF-36v2) Domain Scores at Week 20/Early Withdrawal | Mental Health | 0.94 Scores on a scale | Standard Deviation 10.079 |
| Total | Change From Baseline in the Short Form 36 Health Survey, Version 2 (SF-36v2) Domain Scores at Week 20/Early Withdrawal | Bodily Pain | 1.39 Scores on a scale | Standard Deviation 10.324 |
| Total | Change From Baseline in the Short Form 36 Health Survey, Version 2 (SF-36v2) Domain Scores at Week 20/Early Withdrawal | Role-Emotional | 1.41 Scores on a scale | Standard Deviation 11.915 |
| Total | Change From Baseline in the Short Form 36 Health Survey, Version 2 (SF-36v2) Domain Scores at Week 20/Early Withdrawal | Physical Functioning | 0.04 Scores on a scale | Standard Deviation 5.689 |
| Total | Change From Baseline in the Short Form 36 Health Survey, Version 2 (SF-36v2) Domain Scores at Week 20/Early Withdrawal | Social Functioning | 0.53 Scores on a scale | Standard Deviation 10.904 |
| Total | Change From Baseline in the Short Form 36 Health Survey, Version 2 (SF-36v2) Domain Scores at Week 20/Early Withdrawal | Role-Physical | 0.42 Scores on a scale | Standard Deviation 9.39 |
| Total | Change From Baseline in the Short Form 36 Health Survey, Version 2 (SF-36v2) Domain Scores at Week 20/Early Withdrawal | Vitality | -0.23 Scores on a scale | Standard Deviation 9.253 |
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.
Time frame: Baseline through Week 20/Early Withdrawal
Population: ITT Population. Only those participants available at the specified time points were analyzed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| RTG Flexible Dose Plus C/O | Functional Status Diary (FSD): Percent Change From Baseline in Epilepsy-related Limitation of Ability to do What You Needed to | 10.2 Percent change | Standard Deviation 83.8 |
| RTG Flexible Dose Plus Lamotrigine | Functional Status Diary (FSD): Percent Change From Baseline in Epilepsy-related Limitation of Ability to do What You Needed to | -7.7 Percent change | Standard Deviation 25.24 |
| RTG Flexible Dose Plus Levetiracetam | Functional Status Diary (FSD): Percent Change From Baseline in Epilepsy-related Limitation of Ability to do What You Needed to | 2.5 Percent change | Standard Deviation 30.97 |
| RTG Flexible Dose Plus Valproic Acid | Functional Status Diary (FSD): Percent Change From Baseline in Epilepsy-related Limitation of Ability to do What You Needed to | 10.6 Percent change | Standard Deviation 98.84 |
| Total | Functional Status Diary (FSD): Percent Change From Baseline in Epilepsy-related Limitation of Ability to do What You Needed to | 4.1 Percent change | Standard Deviation 69.15 |
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.
Time frame: Baseline through Week 20/Early Withdrawal
Population: ITT Population. Only those participants available at the specified time points were analyzed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| RTG Flexible Dose Plus C/O | Functional Status Diary (FSD): Percent Change From Baseline in Epilepsy-related Limitation of Ability to do What You Wanted to | 6.3 Percent change | Standard Deviation 83.07 |
| RTG Flexible Dose Plus Lamotrigine | Functional Status Diary (FSD): Percent Change From Baseline in Epilepsy-related Limitation of Ability to do What You Wanted to | -5.0 Percent change | Standard Deviation 25.72 |
| RTG Flexible Dose Plus Levetiracetam | Functional Status Diary (FSD): Percent Change From Baseline in Epilepsy-related Limitation of Ability to do What You Wanted to | 3.2 Percent change | Standard Deviation 36.94 |
| RTG Flexible Dose Plus Valproic Acid | Functional Status Diary (FSD): Percent Change From Baseline in Epilepsy-related Limitation of Ability to do What You Wanted to | 7.1 Percent change | Standard Deviation 97.31 |
| Total | Functional Status Diary (FSD): Percent Change From Baseline in Epilepsy-related Limitation of Ability to do What You Wanted to | 2.9 Percent change | Standard Deviation 68.89 |
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.
Time frame: Baseline through Week 20/Early Withdrawal
Population: ITT Population. Only those participants available at the specified time points were analyzed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| RTG Flexible Dose Plus C/O | Functional Status Diary (FSD): Percent Change From Baseline in Epilepsy-related Worry | 0.8 Percent change | Standard Deviation 45.6 |
| RTG Flexible Dose Plus Lamotrigine | Functional Status Diary (FSD): Percent Change From Baseline in Epilepsy-related Worry | -7.5 Percent change | Standard Deviation 29.53 |
| RTG Flexible Dose Plus Levetiracetam | Functional Status Diary (FSD): Percent Change From Baseline in Epilepsy-related Worry | -9.1 Percent change | Standard Deviation 36.76 |
| RTG Flexible Dose Plus Valproic Acid | Functional Status Diary (FSD): Percent Change From Baseline in Epilepsy-related Worry | -2.0 Percent change | Standard Deviation 73.16 |
| Total | Functional Status Diary (FSD): Percent Change From Baseline in Epilepsy-related Worry | -4.1 Percent change | Standard Deviation 49.13 |
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.
Time frame: From Baseline through Week 20 (Day 140)/Early Withdrawal
Population: ITT Population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| RTG Flexible Dose Plus C/O | Number of Participants With a >=25%, >=75%, or 100% Reduction in Partial-onset Seizure Frequency From Baseline | >=25% | 27 participants |
| RTG Flexible Dose Plus C/O | Number of Participants With a >=25%, >=75%, or 100% Reduction in Partial-onset Seizure Frequency From Baseline | 100% | 0 participants |
| RTG Flexible Dose Plus C/O | Number of Participants With a >=25%, >=75%, or 100% Reduction in Partial-onset Seizure Frequency From Baseline | >=75% | 12 participants |
| RTG Flexible Dose Plus Lamotrigine | Number of Participants With a >=25%, >=75%, or 100% Reduction in Partial-onset Seizure Frequency From Baseline | >=75% | 8 participants |
| RTG Flexible Dose Plus Lamotrigine | Number of Participants With a >=25%, >=75%, or 100% Reduction in Partial-onset Seizure Frequency From Baseline | >=25% | 33 participants |
| RTG Flexible Dose Plus Lamotrigine | Number of Participants With a >=25%, >=75%, or 100% Reduction in Partial-onset Seizure Frequency From Baseline | 100% | 2 participants |
| RTG Flexible Dose Plus Levetiracetam | Number of Participants With a >=25%, >=75%, or 100% Reduction in Partial-onset Seizure Frequency From Baseline | >=75% | 8 participants |
| RTG Flexible Dose Plus Levetiracetam | Number of Participants With a >=25%, >=75%, or 100% Reduction in Partial-onset Seizure Frequency From Baseline | >=25% | 30 participants |
| RTG Flexible Dose Plus Levetiracetam | Number of Participants With a >=25%, >=75%, or 100% Reduction in Partial-onset Seizure Frequency From Baseline | 100% | 1 participants |
| RTG Flexible Dose Plus Valproic Acid | Number of Participants With a >=25%, >=75%, or 100% Reduction in Partial-onset Seizure Frequency From Baseline | >=25% | 37 participants |
| RTG Flexible Dose Plus Valproic Acid | Number of Participants With a >=25%, >=75%, or 100% Reduction in Partial-onset Seizure Frequency From Baseline | 100% | 2 participants |
| RTG Flexible Dose Plus Valproic Acid | Number of Participants With a >=25%, >=75%, or 100% Reduction in Partial-onset Seizure Frequency From Baseline | >=75% | 12 participants |
| Total | Number of Participants With a >=25%, >=75%, or 100% Reduction in Partial-onset Seizure Frequency From Baseline | >=75% | 40 participants |
| Total | Number of Participants With a >=25%, >=75%, or 100% Reduction in Partial-onset Seizure Frequency From Baseline | >=25% | 127 participants |
| Total | Number of Participants With a >=25%, >=75%, or 100% Reduction in Partial-onset Seizure Frequency From Baseline | 100% | 5 participants |
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.
Time frame: From Baseline through Week 20 (Day 140)/Early Withdrawal
Population: ITT Population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| RTG Flexible Dose Plus C/O | Number of Participants With the Indicated Reduction or Increase From Baseline in Partial-onset Seizure Frequency | Any decrease | 43 participants |
| RTG Flexible Dose Plus C/O | Number of Participants With the Indicated Reduction or Increase From Baseline in Partial-onset Seizure Frequency | >0 to <25% decrease | 16 participants |
| RTG Flexible Dose Plus C/O | Number of Participants With the Indicated Reduction or Increase From Baseline in Partial-onset Seizure Frequency | 25 to <50% decrease | 5 participants |
| RTG Flexible Dose Plus C/O | Number of Participants With the Indicated Reduction or Increase From Baseline in Partial-onset Seizure Frequency | 50 to 75% decrease | 10 participants |
| RTG Flexible Dose Plus C/O | Number of Participants With the Indicated Reduction or Increase From Baseline in Partial-onset Seizure Frequency | >75 to 100% decrease | 12 participants |
| RTG Flexible Dose Plus C/O | Number of Participants With the Indicated Reduction or Increase From Baseline in Partial-onset Seizure Frequency | No change or any increase | 12 participants |
| RTG Flexible Dose Plus C/O | Number of Participants With the Indicated Reduction or Increase From Baseline in Partial-onset Seizure Frequency | >25% increase | 10 participants |
| RTG Flexible Dose Plus C/O | Number of Participants With the Indicated Reduction or Increase From Baseline in Partial-onset Seizure Frequency | 0 to 25% increase | 2 participants |
| RTG Flexible Dose Plus Lamotrigine | Number of Participants With the Indicated Reduction or Increase From Baseline in Partial-onset Seizure Frequency | 25 to <50% decrease | 17 participants |
| RTG Flexible Dose Plus Lamotrigine | Number of Participants With the Indicated Reduction or Increase From Baseline in Partial-onset Seizure Frequency | No change or any increase | 7 participants |
| RTG Flexible Dose Plus Lamotrigine | Number of Participants With the Indicated Reduction or Increase From Baseline in Partial-onset Seizure Frequency | Any decrease | 43 participants |
| RTG Flexible Dose Plus Lamotrigine | Number of Participants With the Indicated Reduction or Increase From Baseline in Partial-onset Seizure Frequency | 50 to 75% decrease | 8 participants |
| RTG Flexible Dose Plus Lamotrigine | Number of Participants With the Indicated Reduction or Increase From Baseline in Partial-onset Seizure Frequency | >0 to <25% decrease | 10 participants |
| RTG Flexible Dose Plus Lamotrigine | Number of Participants With the Indicated Reduction or Increase From Baseline in Partial-onset Seizure Frequency | >25% increase | 4 participants |
| RTG Flexible Dose Plus Lamotrigine | Number of Participants With the Indicated Reduction or Increase From Baseline in Partial-onset Seizure Frequency | 0 to 25% increase | 3 participants |
| RTG Flexible Dose Plus Lamotrigine | Number of Participants With the Indicated Reduction or Increase From Baseline in Partial-onset Seizure Frequency | >75 to 100% decrease | 8 participants |
| RTG Flexible Dose Plus Levetiracetam | Number of Participants With the Indicated Reduction or Increase From Baseline in Partial-onset Seizure Frequency | >25% increase | 5 participants |
| RTG Flexible Dose Plus Levetiracetam | Number of Participants With the Indicated Reduction or Increase From Baseline in Partial-onset Seizure Frequency | 0 to 25% increase | 3 participants |
| RTG Flexible Dose Plus Levetiracetam | Number of Participants With the Indicated Reduction or Increase From Baseline in Partial-onset Seizure Frequency | 50 to 75% decrease | 14 participants |
| RTG Flexible Dose Plus Levetiracetam | Number of Participants With the Indicated Reduction or Increase From Baseline in Partial-onset Seizure Frequency | No change or any increase | 8 participants |
| RTG Flexible Dose Plus Levetiracetam | Number of Participants With the Indicated Reduction or Increase From Baseline in Partial-onset Seizure Frequency | 25 to <50% decrease | 8 participants |
| RTG Flexible Dose Plus Levetiracetam | Number of Participants With the Indicated Reduction or Increase From Baseline in Partial-onset Seizure Frequency | >0 to <25% decrease | 6 participants |
| RTG Flexible Dose Plus Levetiracetam | Number of Participants With the Indicated Reduction or Increase From Baseline in Partial-onset Seizure Frequency | Any decrease | 36 participants |
| RTG Flexible Dose Plus Levetiracetam | Number of Participants With the Indicated Reduction or Increase From Baseline in Partial-onset Seizure Frequency | >75 to 100% decrease | 8 participants |
| RTG Flexible Dose Plus Valproic Acid | Number of Participants With the Indicated Reduction or Increase From Baseline in Partial-onset Seizure Frequency | >0 to <25% decrease | 7 participants |
| RTG Flexible Dose Plus Valproic Acid | Number of Participants With the Indicated Reduction or Increase From Baseline in Partial-onset Seizure Frequency | 25 to <50% decrease | 8 participants |
| RTG Flexible Dose Plus Valproic Acid | Number of Participants With the Indicated Reduction or Increase From Baseline in Partial-onset Seizure Frequency | 50 to 75% decrease | 17 participants |
| RTG Flexible Dose Plus Valproic Acid | Number of Participants With the Indicated Reduction or Increase From Baseline in Partial-onset Seizure Frequency | >75 to 100% decrease | 12 participants |
| RTG Flexible Dose Plus Valproic Acid | Number of Participants With the Indicated Reduction or Increase From Baseline in Partial-onset Seizure Frequency | No change or any increase | 7 participants |
| RTG Flexible Dose Plus Valproic Acid | Number of Participants With the Indicated Reduction or Increase From Baseline in Partial-onset Seizure Frequency | 0 to 25% increase | 1 participants |
| RTG Flexible Dose Plus Valproic Acid | Number of Participants With the Indicated Reduction or Increase From Baseline in Partial-onset Seizure Frequency | Any decrease | 44 participants |
| RTG Flexible Dose Plus Valproic Acid | Number of Participants With the Indicated Reduction or Increase From Baseline in Partial-onset Seizure Frequency | >25% increase | 6 participants |
| Total | Number of Participants With the Indicated Reduction or Increase From Baseline in Partial-onset Seizure Frequency | 50 to 75% decrease | 49 participants |
| Total | Number of Participants With the Indicated Reduction or Increase From Baseline in Partial-onset Seizure Frequency | 0 to 25% increase | 9 participants |
| Total | Number of Participants With the Indicated Reduction or Increase From Baseline in Partial-onset Seizure Frequency | 25 to <50% decrease | 38 participants |
| Total | Number of Participants With the Indicated Reduction or Increase From Baseline in Partial-onset Seizure Frequency | >25% increase | 25 participants |
| Total | Number of Participants With the Indicated Reduction or Increase From Baseline in Partial-onset Seizure Frequency | Any decrease | 166 participants |
| Total | Number of Participants With the Indicated Reduction or Increase From Baseline in Partial-onset Seizure Frequency | >75 to 100% decrease | 40 participants |
| Total | Number of Participants With the Indicated Reduction or Increase From Baseline in Partial-onset Seizure Frequency | No change or any increase | 34 participants |
| Total | Number of Participants With the Indicated Reduction or Increase From Baseline in Partial-onset Seizure Frequency | >0 to <25% decrease | 39 participants |
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?
Time frame: Baseline through Week 20/Early Withdrawal
Population: ITT Population. Only those participants available at the specified time points were analyzed.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| RTG Flexible Dose Plus C/O | 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 | Much better | 5 participants |
| RTG Flexible Dose Plus C/O | 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 | Much worse | 2 participants |
| RTG Flexible Dose Plus C/O | 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 | Moderately worse | 2 participants |
| RTG Flexible Dose Plus C/O | 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 | A little better | 10 participants |
| RTG Flexible Dose Plus C/O | 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 | Moderately better | 13 participants |
| RTG Flexible Dose Plus C/O | 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 | Unchanged | 19 participants |
| RTG Flexible Dose Plus C/O | 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 | A little worse | 2 participants |
| RTG Flexible Dose Plus Lamotrigine | 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 | A little worse | 3 participants |
| RTG Flexible Dose Plus Lamotrigine | 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 | Unchanged | 17 participants |
| RTG Flexible Dose Plus Lamotrigine | 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 | Moderately better | 11 participants |
| RTG Flexible Dose Plus Lamotrigine | 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 | Much better | 9 participants |
| RTG Flexible Dose Plus Lamotrigine | 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 | Moderately worse | 0 participants |
| RTG Flexible Dose Plus Lamotrigine | 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 | A little better | 6 participants |
| RTG Flexible Dose Plus Lamotrigine | 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 | Much worse | 0 participants |
| RTG Flexible Dose Plus Levetiracetam | 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 | Unchanged | 17 participants |
| RTG Flexible Dose Plus Levetiracetam | 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 | Much better | 6 participants |
| RTG Flexible Dose Plus Levetiracetam | 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 | Moderately better | 9 participants |
| RTG Flexible Dose Plus Levetiracetam | 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 | A little better | 6 participants |
| RTG Flexible Dose Plus Levetiracetam | 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 | A little worse | 1 participants |
| RTG Flexible Dose Plus Levetiracetam | 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 | Moderately worse | 0 participants |
| RTG Flexible Dose Plus Levetiracetam | 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 | Much worse | 1 participants |
| RTG Flexible Dose Plus Valproic Acid | 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 | A little better | 9 participants |
| RTG Flexible Dose Plus Valproic Acid | 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 | Much worse | 1 participants |
| RTG Flexible Dose Plus Valproic Acid | 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 | A little worse | 1 participants |
| RTG Flexible Dose Plus Valproic Acid | 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 | Moderately better | 14 participants |
| RTG Flexible Dose Plus Valproic Acid | 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 | Moderately worse | 0 participants |
| RTG Flexible Dose Plus Valproic Acid | 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 | Much better | 10 participants |
| RTG Flexible Dose Plus Valproic Acid | 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 | Unchanged | 11 participants |
| Total | 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 | A little better | 31 participants |
| Total | 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 | Much better | 30 participants |
| Total | 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 | Unchanged | 64 participants |
| Total | 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 | A little worse | 7 participants |
| Total | 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 | Moderately better | 47 participants |
| Total | 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 | Moderately worse | 2 participants |
| Total | 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 | Much worse | 4 participants |
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.
Time frame: Baseline through Week 20/Early Withdrawal
Population: ITT Population. Only those participants available at the specified time points were analyzed.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| RTG Flexible Dose Plus C/O | 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 | Much better | 2 participants |
| RTG Flexible Dose Plus C/O | 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 | Much worse | 1 participants |
| RTG Flexible Dose Plus C/O | 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 | Moderately worse | 3 participants |
| RTG Flexible Dose Plus C/O | 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 | A little better | 11 participants |
| RTG Flexible Dose Plus C/O | 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 | Moderately better | 13 participants |
| RTG Flexible Dose Plus C/O | 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 | Unchanged | 20 participants |
| RTG Flexible Dose Plus C/O | 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 | A little worse | 3 participants |
| RTG Flexible Dose Plus Lamotrigine | 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 | A little worse | 1 participants |
| RTG Flexible Dose Plus Lamotrigine | 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 | Unchanged | 20 participants |
| RTG Flexible Dose Plus Lamotrigine | 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 | Moderately better | 13 participants |
| RTG Flexible Dose Plus Lamotrigine | 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 | Much better | 8 participants |
| RTG Flexible Dose Plus Lamotrigine | 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 | Moderately worse | 0 participants |
| RTG Flexible Dose Plus Lamotrigine | 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 | A little better | 4 participants |
| RTG Flexible Dose Plus Lamotrigine | 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 | Much worse | 0 participants |
| RTG Flexible Dose Plus Levetiracetam | 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 | Unchanged | 17 participants |
| RTG Flexible Dose Plus Levetiracetam | 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 | Much better | 4 participants |
| RTG Flexible Dose Plus Levetiracetam | 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 | Moderately better | 12 participants |
| RTG Flexible Dose Plus Levetiracetam | 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 | A little better | 6 participants |
| RTG Flexible Dose Plus Levetiracetam | 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 | A little worse | 1 participants |
| RTG Flexible Dose Plus Levetiracetam | 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 | Moderately worse | 0 participants |
| RTG Flexible Dose Plus Levetiracetam | 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 | Much worse | 0 participants |
| RTG Flexible Dose Plus Valproic Acid | 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 | A little better | 9 participants |
| RTG Flexible Dose Plus Valproic Acid | 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 | A little worse | 1 participants |
| RTG Flexible Dose Plus Valproic Acid | 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 | Moderately better | 16 participants |
| RTG Flexible Dose Plus Valproic Acid | 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 | Much worse | 1 participants |
| RTG Flexible Dose Plus Valproic Acid | 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 | Moderately worse | 0 participants |
| RTG Flexible Dose Plus Valproic Acid | 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 | Much better | 11 participants |
| RTG Flexible Dose Plus Valproic Acid | 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 | Unchanged | 8 participants |
| Total | 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 | A little better | 30 participants |
| Total | 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 | Much worse | 2 participants |
| Total | 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 | Moderately worse | 3 participants |
| Total | 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 | A little worse | 6 participants |
| Total | 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 | Moderately better | 54 participants |
| Total | 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 | Much better | 25 participants |
| Total | 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 | Unchanged | 65 participants |
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?
Time frame: Baseline through Week 20/Early Withdrawal
Population: ITT Population. Only those participants available at the specified time points were analyzed.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| RTG Flexible Dose Plus C/O | Number of Participants With the Indicated Response for the Epilepsy-related Worry Component of the Patient Global Impression of Change (PGI-C) Score | Much better | 7 participants |
| RTG Flexible Dose Plus C/O | Number of Participants With the Indicated Response for the Epilepsy-related Worry Component of the Patient Global Impression of Change (PGI-C) Score | Much worse | 1 participants |
| RTG Flexible Dose Plus C/O | Number of Participants With the Indicated Response for the Epilepsy-related Worry Component of the Patient Global Impression of Change (PGI-C) Score | Moderately worse | 0 participants |
| RTG Flexible Dose Plus C/O | Number of Participants With the Indicated Response for the Epilepsy-related Worry Component of the Patient Global Impression of Change (PGI-C) Score | A little better | 13 participants |
| RTG Flexible Dose Plus C/O | Number of Participants With the Indicated Response for the Epilepsy-related Worry Component of the Patient Global Impression of Change (PGI-C) Score | Moderately better | 11 participants |
| RTG Flexible Dose Plus C/O | Number of Participants With the Indicated Response for the Epilepsy-related Worry Component of the Patient Global Impression of Change (PGI-C) Score | Unchanged | 16 participants |
| RTG Flexible Dose Plus C/O | Number of Participants With the Indicated Response for the Epilepsy-related Worry Component of the Patient Global Impression of Change (PGI-C) Score | A little worse | 5 participants |
| RTG Flexible Dose Plus Lamotrigine | Number of Participants With the Indicated Response for the Epilepsy-related Worry Component of the Patient Global Impression of Change (PGI-C) Score | A little worse | 2 participants |
| RTG Flexible Dose Plus Lamotrigine | Number of Participants With the Indicated Response for the Epilepsy-related Worry Component of the Patient Global Impression of Change (PGI-C) Score | Unchanged | 11 participants |
| RTG Flexible Dose Plus Lamotrigine | Number of Participants With the Indicated Response for the Epilepsy-related Worry Component of the Patient Global Impression of Change (PGI-C) Score | Moderately better | 16 participants |
| RTG Flexible Dose Plus Lamotrigine | Number of Participants With the Indicated Response for the Epilepsy-related Worry Component of the Patient Global Impression of Change (PGI-C) Score | Much better | 9 participants |
| RTG Flexible Dose Plus Lamotrigine | Number of Participants With the Indicated Response for the Epilepsy-related Worry Component of the Patient Global Impression of Change (PGI-C) Score | Moderately worse | 1 participants |
| RTG Flexible Dose Plus Lamotrigine | Number of Participants With the Indicated Response for the Epilepsy-related Worry Component of the Patient Global Impression of Change (PGI-C) Score | A little better | 6 participants |
| RTG Flexible Dose Plus Lamotrigine | Number of Participants With the Indicated Response for the Epilepsy-related Worry Component of the Patient Global Impression of Change (PGI-C) Score | Much worse | 1 participants |
| RTG Flexible Dose Plus Levetiracetam | Number of Participants With the Indicated Response for the Epilepsy-related Worry Component of the Patient Global Impression of Change (PGI-C) Score | Unchanged | 13 participants |
| RTG Flexible Dose Plus Levetiracetam | Number of Participants With the Indicated Response for the Epilepsy-related Worry Component of the Patient Global Impression of Change (PGI-C) Score | Much better | 4 participants |
| RTG Flexible Dose Plus Levetiracetam | Number of Participants With the Indicated Response for the Epilepsy-related Worry Component of the Patient Global Impression of Change (PGI-C) Score | Moderately better | 15 participants |
| RTG Flexible Dose Plus Levetiracetam | Number of Participants With the Indicated Response for the Epilepsy-related Worry Component of the Patient Global Impression of Change (PGI-C) Score | A little better | 4 participants |
| RTG Flexible Dose Plus Levetiracetam | Number of Participants With the Indicated Response for the Epilepsy-related Worry Component of the Patient Global Impression of Change (PGI-C) Score | A little worse | 4 participants |
| RTG Flexible Dose Plus Levetiracetam | Number of Participants With the Indicated Response for the Epilepsy-related Worry Component of the Patient Global Impression of Change (PGI-C) Score | Moderately worse | 0 participants |
| RTG Flexible Dose Plus Levetiracetam | Number of Participants With the Indicated Response for the Epilepsy-related Worry Component of the Patient Global Impression of Change (PGI-C) Score | Much worse | 0 participants |
| RTG Flexible Dose Plus Valproic Acid | Number of Participants With the Indicated Response for the Epilepsy-related Worry Component of the Patient Global Impression of Change (PGI-C) Score | A little better | 11 participants |
| RTG Flexible Dose Plus Valproic Acid | Number of Participants With the Indicated Response for the Epilepsy-related Worry Component of the Patient Global Impression of Change (PGI-C) Score | A little worse | 0 participants |
| RTG Flexible Dose Plus Valproic Acid | Number of Participants With the Indicated Response for the Epilepsy-related Worry Component of the Patient Global Impression of Change (PGI-C) Score | Moderately better | 16 participants |
| RTG Flexible Dose Plus Valproic Acid | Number of Participants With the Indicated Response for the Epilepsy-related Worry Component of the Patient Global Impression of Change (PGI-C) Score | Much worse | 2 participants |
| RTG Flexible Dose Plus Valproic Acid | Number of Participants With the Indicated Response for the Epilepsy-related Worry Component of the Patient Global Impression of Change (PGI-C) Score | Moderately worse | 0 participants |
| RTG Flexible Dose Plus Valproic Acid | Number of Participants With the Indicated Response for the Epilepsy-related Worry Component of the Patient Global Impression of Change (PGI-C) Score | Much better | 11 participants |
| RTG Flexible Dose Plus Valproic Acid | Number of Participants With the Indicated Response for the Epilepsy-related Worry Component of the Patient Global Impression of Change (PGI-C) Score | Unchanged | 6 participants |
| Total | Number of Participants With the Indicated Response for the Epilepsy-related Worry Component of the Patient Global Impression of Change (PGI-C) Score | A little better | 34 participants |
| Total | Number of Participants With the Indicated Response for the Epilepsy-related Worry Component of the Patient Global Impression of Change (PGI-C) Score | Much worse | 4 participants |
| Total | Number of Participants With the Indicated Response for the Epilepsy-related Worry Component of the Patient Global Impression of Change (PGI-C) Score | Moderately worse | 1 participants |
| Total | Number of Participants With the Indicated Response for the Epilepsy-related Worry Component of the Patient Global Impression of Change (PGI-C) Score | A little worse | 11 participants |
| Total | Number of Participants With the Indicated Response for the Epilepsy-related Worry Component of the Patient Global Impression of Change (PGI-C) Score | Moderately better | 58 participants |
| Total | Number of Participants With the Indicated Response for the Epilepsy-related Worry Component of the Patient Global Impression of Change (PGI-C) Score | Much better | 31 participants |
| Total | Number of Participants With the Indicated Response for the Epilepsy-related Worry Component of the Patient Global Impression of Change (PGI-C) Score | Unchanged | 46 participants |
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.
Time frame: Baseline through Week 20/Early Withdrawal
Population: ITT Population. Only those participants available at the specified time points were analyzed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| RTG Flexible Dose Plus C/O | Percent Change From Baseline in Functional Status: Percentage of Days With no Missed Work or School Time | 53.5 Percent change | Standard Deviation 295.57 |
| RTG Flexible Dose Plus Lamotrigine | Percent Change From Baseline in Functional Status: Percentage of Days With no Missed Work or School Time | 4.9 Percent change | Standard Deviation 9.37 |
| RTG Flexible Dose Plus Levetiracetam | Percent Change From Baseline in Functional Status: Percentage of Days With no Missed Work or School Time | 3.7 Percent change | Standard Deviation 29.33 |
| RTG Flexible Dose Plus Valproic Acid | Percent Change From Baseline in Functional Status: Percentage of Days With no Missed Work or School Time | 4.5 Percent change | Standard Deviation 11.71 |
| Total | Percent Change From Baseline in Functional Status: Percentage of Days With no Missed Work or School Time | 17.0 Percent change | Standard Deviation 150.18 |
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.
Time frame: From Baseline through Week 20 (Day 140)/Early Withdrawal
Population: ITT Population
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| RTG Flexible Dose Plus C/O | Percent Change From Baseline in Partial-onset Seizure Frequency | -24.6 percent change | Standard Deviation 55.25 |
| RTG Flexible Dose Plus Lamotrigine | Percent Change From Baseline in Partial-onset Seizure Frequency | -27.8 percent change | Standard Deviation 59.97 |
| RTG Flexible Dose Plus Levetiracetam | Percent Change From Baseline in Partial-onset Seizure Frequency | -28.7 percent change | Standard Deviation 80.27 |
| RTG Flexible Dose Plus Valproic Acid | Percent Change From Baseline in Partial-onset Seizure Frequency | -27.1 percent change | Standard Deviation 102.1 |
| Total | Percent Change From Baseline in Partial-onset Seizure Frequency | -27.0 percent change | Standard Deviation 75.68 |