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| ID | Type | Description | Link |
|---|---|---|---|
| RTG115098 | Other Identifier | GlaxoSmithKline |
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The purpose of this study is to evaluate the safety and tolerability of long-term therapy with retigabine administered as adjunctive therapy in adult epilepsy patients with partial-onset seizures, who completed the VRX-RET-E22-301 double-blind study. The efficacy of long-term treatment with retigabine and patient quality of life will also be assessed.
This Phase 3 trial is an open-label extension study of the placebo-controlled, double-blind VRX-RET-E22-301 trial. Patients who have completed the VRX-RET-E22-301 trial and who meet inclusion and exclusion criteria will be treated with 600-1200 mg/day of retigabine as an adjunct therapy to their current antiepileptic drugs (AEDs) or vagal nerve stimulation. Treatment will be continued until retigabine is commercially available, or until the program is discontinued. Patients will be recruited from 45-50 sites in the United States, Canada, Mexico, Brazil, and Argentina. The safety and tolerability of long-term therapy with retigabine administered as adjunctive therapy in adult epilepsy patients with partial-onset seizures will be evaluated. In addition, the efficacy of long-term treatment with retigabine and patient quality of life will be assessed.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ezogabine: USAN Retigabine (International Nonproprietary Name) | Experimental | Film-coated tablets - 50mg, 100mg or 300mg |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ezogabine: USAN Retigabine (International Nonproprietary Name) | Drug | Film-coated tablets containing 50 mg, 100 mg, or 300 mg of retigabine per tablet. Dosage and frequency will be specific to each patient so long as the patient receives between 600 and 1200 mg of retigabine per day. The duration will be until the trial concludes or the patient leaves the trial. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Treatment-emergent Serious Adverse Event (SAE) and Adverse Event (AE) | An AE is any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An SAE is any untoward medical occurrence that, at any dose results in death, is life-threatening, requires hospitalization (unplanned hospital stay) or prolongation of existing hospitalization, results in disability/incapacity or is a congenital anomaly/birth defect. Treatment-emergent AE was defined as an AE with an onset on or after the day of first dose of the study medication and on or before 30 days after the last dose date. AEs reported during parent study and worsened after first dose of RTG in this OLE study were also reported. | Assessed up to a maximum of 9 years |
| Number of Participants With Treatment-emergent Adverse Events Leading to Withdrawal From Study Drug | Treatment-emergent AE was defined as an AE with an onset on or after the day of first dose of the study medication and on or before 30 days after the last dose date. AEs reported during parent study and worsened after first dose of RTG in this OLE study were also reported. | Assessed up to a maximum of 9 years |
| Kaplan-Meier Estimate of the Probability of Discontinuation (d/c) From Study Drug | The time frame of premature study discontinuation was defined as the time from the day of first the study medication to the time of withdrawal from study drug. For those who have a taper dose start date, the time of withdrawal was the day before the start of taper dose. For those without a taper dose start date, the time of withdrawal was the last dose date. Participants who switched to the commercial product were censored at the last dose of study drug in the Kaplan-Meier analysis. All participants who withdrew from study drug prematurely but didn't switch to commercial product were counted as "events". Kaplan-Meier estimate of the probability of discontinuation at the specified time or earlier. Number of Participants continuing on RTG at each time of withdrawal were analyzed (represented as n=X in category title). | Assessed up to a maximum of 9 years |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage Change From Baseline in the 28-day Partial Seizure | Twenty-eight-day total partial seizure frequency during the study is defined as the sum of total partial seizures from First date (Baseline visit date +1 if no seizures on Baseline or Baseline visit date if seizures reported on the Baseline) to Last date (last visit date for seizure record with non-missing response), divided by applicable days, standardized by 28 days. The applicable days are the days in which the subject had non-missing seizure data. Change from Baseline was calculated as post-Baseline value minus Baseline value. Only those participants available at the specified time points were analyzed. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials | GlaxoSmithKline | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alabama -- Department of Neurology/Epilepsy Center | Birmingham | Alabama | 35294 | United States | ||
IPD for this study will be made available via the Clinical Study Data Request site.
IPD is available via the Clinical Study Data Request site (click on the link provided below)
Access is provided after a research proposal is submitted and has received approval from the Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension can be granted, when justified, for up to another 12 months.
All participants who completed Study VRX-RET-E22-301(parent study) and did not have an ongoing serious adverse event (SAE) were eligible to participate in the study.
Eligible Participants (Par) who completed the Maintenance and Transition Phases of the parent study were enrolled in this open-label extension study. Par received 600-1200 mg/day retigabine as an adjunct therapy to current antiepileptic medication or vagal nerve stimulation until Par was withdrawn or withdrew consent or until study was terminated.
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo in Parent Study | Participants received retigabine tablets as a total dose of between 600 to 1200 mg/day (dose administered twice daily or TID) as an adjunct therapy to their ongoing antiepileptic drugs with or without vagal nerve stimulation until withdrawal, withdrawn consent or switched to commercial product. Participants who received placebo in parent study are included in this arm. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Primary Reporting Phase |
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| Change From Baseline in Blood Pressure | Systolic blood pressure (SBP) and diastolic blood pressure (DBP) was obtained in supine (Su) position and again in standing (St) position after the participant was standing for approximately 2 minutes at each study visit (Month 1, Month 3, Month 6, Month 9, Month 12 and every 4 months after Month 12). Baseline assessment in this study is defined as the last assessment for the endpoint in parent study taken prior to the first active treatment with Retigabine. Change from Baseline was calculated as post-Baseline value minus Baseline value. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Not Applicable (NA) indicates that data were not available. | Baseline and Up to Month 108 |
| Change From Baseline in Heart Rate | Heart rate (HR) was measured in supine (Su) position and again in standing (St) position after the participant was standing for approximately 2 minutes at each study visit (Month 1, Month 3, Month 6, Month 9, Month 12 and every 4 months after Month 12). Baseline assessment in this study is defined as the last assessment for the endpoint in parent study taken prior to the first active treatment with Retigabine. Change from Baseline was calculated as post-Baseline value minus Baseline value. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). NA indicates that data were not available. | Baseline and Up to Month 108 |
| Change From Baseline in Body Temperature | Body temperature was measured in degree Celsius at each study visit (Month 1, Month 3, Month 6, Month 9, Month 12 and every 4 months after Month 12). Baseline assessment in this study is defined as the last assessment for the endpoint in parent study taken prior to the first active treatment with Retigabine. Change from Baseline was calculated as post-Baseline value minus Baseline value. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). NA indicates that data were not available | Baseline and Up to Month 108 |
| Change From Baseline in Weight | Weight was measured in ordinary indoor clothing (without shoes) and was recorded at each study visit (On Month 1, Month 3, Month 6, Month 9, Month 12 and every 4 months after Month 12). Baseline assessment in this study is defined as the last assessment for the endpoint in parent study taken prior to the first active treatment with Retigabine. Change from Baseline was calculated as post-Baseline value minus Baseline value. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). NA indicates that data were not available. | Baseline and Up to Month 108 |
| Change From Baseline in the 12-lead Electrocardiogram (ECG) Parameters-PR Interval, QRS Duration, Uncorrected QT (uQT) Interval, Corrected QT (Bazett's Correction) Interval (QTcB), Corrected QT (Friedericia's Correction) Interval (QTcF) | A 12-lead ECG was performed at each study visit during the first year of the study (Month 1, Month 3, Month 6, Month 9, Month 12) and annually after one year. The following electrocardiogram parameters are presented PR Interval, QRS Duration, Uncorrected QT interval (uQT), Corrected QT (Bazett's correction) interval (QTcB), Corrected QT (Friedericia's correction) interval (QTcF). Baseline assessment in this study is defined as the last assessment for the endpoint in parent study taken prior to the first active treatment with Retigabine. Change from Baseline was calculated as post-Baseline value minus Baseline value. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). NA indicates that data were not available. | Baseline and Up to Month 108 |
| Change From Baseline in the 12-lead Electrocardiogram (ECG) Parameter-RR Interval | A 12-lead ECG was performed at each study visit during the first year of the study (Month 1, Month 3, Month 6, Month 9, Month 12) and annually after one year. The following electrocardiogram parameters are presented: RR Interval. Baseline assessment in this study is defined as the last assessment for the endpoint in parent study taken prior to the first active treatment with Retigabine. Change from Baseline was calculated as post-Baseline value minus Baseline value. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). | Baseline and Up to Month 108 |
| Change From Baseline in Electrocardiogram (ECG) Parameter-QRS Axis | A 12-lead ECG was performed at each study visit during the first year of the study (Month 1, Month 3, Month 6, Month 9, Month 12) and annually after one year. ECG parameter QRS Axis is presented here. Baseline assessment in this study is defined as the last assessment for the endpoint in parent study taken prior to the first active treatment with Retigabine. Change from Baseline was calculated as post-Baseline value minus Baseline value. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). | Baseline and Up to Month 108 |
| Change From Baseline in Hematology Parameters- Bands, Basophils, Eosinophils, Lymphocytes, Metamyelocyte, Monocytes, Neutrophils, Platelets, White Blood Cells Count (WBC) | Following hematology parameters were assessed, Bands (Band neutrophils), Basophils, Eosinophils, Lymphocytes, Metamyelocyte, Monocytes, Neutrophils, Platelets and WBC. Hematology parameters were assessed at Month 1, Month 2, Month 3, Month 6, Month 8, Month 9, Month 10, Month 12 and every 4 months after Month 12. Baseline assessment in this study is defined as the last assessment for the endpoint in parent study taken prior to the first active treatment with Retigabine. Change from Baseline was calculated as post-Baseline value minus Baseline value. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). NA indicates that data were not available. | Baseline and Up to Month 108 |
| Change From Baseline in Hematology Parameter-Red Blood Cell Count | Red Blood Cell count (RBC) was assessed at Month 1, Month 2, Month 3, Month 6, Month 8, Month 9, Month 10, Month 12 and every 4 months after Month 12. Baseline assessment in this study is defined as the last assessment for the endpoint in parent study taken prior to the first active treatment with Retigabine. Change from Baseline was calculated as post-Baseline value minus Baseline value. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). NA indicates that data were not available.. | Baseline and Up to Month 108 |
| Change From Baseline in Haematocrit | Haematocrit was assessed at Month 1, Month 2, Month 3, Month 6, Month 8, Month 9, Month 10, Month 12 and every 4 months after Month 12. Baseline assessment in this study is defined as the last assessment for the endpoint in parent study taken prior to the first active treatment with Retigabine. Change from Baseline was calculated as post-Baseline value minus Baseline value. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). | Baseline and Up to Month 108 |
| Change From Baseline in Haemoglobin | Haemoglobin was assessed at Month 1, Month 2, Month 3, , Month 6, Month 8, Month 9, Month 10, Month 12 and every 4 months after Month 12. Baseline assessment in this study is defined as the last assessment for the endpoint in parent study taken prior to the first active treatment with Retigabine. Change from Baseline was calculated as post-Baseline value minus Baseline value. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). NA indicates that data were not available.. | Baseline and Up to Month 108 |
| Change From Baseline in Chemistry Parameters-Alkaline Phosphatase (AP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) | Alkaline phosphatase (AP), Alanine aminotransferase (ALT), Aspartate aminotransferase (AST) were assessed at Month 1, Month 3, , Month 6, Month 9, Month 12 and every 4 months after Month 12. Baseline assessment in this study is defined as the last assessment for the endpoint in parent study taken prior to the first active treatment with Retigabine. Change from Baseline was calculated as post-Baseline value minus Baseline value. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). NA indicates that data were not available. | Baseline and Up to Month 108 |
| Change From Baseline in Chemistry Parameters-Bicarbonate, Blood Urea Nitrogen (BUN), Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium, Urea | Bicarbonate (Bic.), BUN, Calcium (Ca), Chloride (Cl), Cholesterol (Cho.), Non-fasting glucose (NFG), Phosphorus (P), Potassium (Ka), Sodium (Na), Urea were assessed at Month 1, Month 3, , Month 6, Month 9, Month 12 and every 4 months after Month 12. Baseline assessment in this study is defined as the last assessment for the endpoint in parent study taken prior to the first active treatment with Retigabine. Change from Baseline was calculated as post-Baseline value minus Baseline value. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). NA indicates that data were not available. | Baseline and Up to Month 108 |
| Change From Baseline in Chemistry Parameters -Creatinine, Total Bilirubin (TB), Uric Acid (UA) | Creatinine, Total bilirubin (TB), Uric acid (UA) were assessed at Month 1, Month 3, , Month 6, Month 9, Month 12 and every 4 months after Month 12. Baseline assessment in this study is defined as the last assessment for the endpoint in parent study taken prior to the first active treatment with Retigabine. Change from Baseline was calculated as post-Baseline value minus Baseline value. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). NA indicates that data were not available. | Baseline and Up to Month 108 |
| Change From Baseline in Chemistry Parameter-Total Protein | Total Protein (TP) was assessed at Month 1, Month 3, , Month 6, Month 9, Month 12 and every 4 months after Month 12. Baseline assessment in this study is defined as the last assessment for the endpoint in parent study taken prior to the first active treatment with Retigabine. Change from Baseline was calculated as post-Baseline value minus Baseline value. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles) | Baseline and Up to Month 108 |
| Change From Baseline in Urine Specific Gravity | Urine Specific gravity (USG) was assessed at Month 1, Month 3, , Month 6, Month 9, Month 12 and every 4 months after Month 12. Baseline assessment in this study is defined as the last assessment for the endpoint in parent study taken prior to the first active treatment with Retigabine. Change from Baseline was calculated as post-Baseline value minus Baseline value. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). NA indicates that data were not available. | Baseline and Up to Month 108 |
| Change From Baseline in Urine Power of Hydrogen (pH) | Urine pH was assessed at Month 1, Month 3, , Month 6, Month 9, Month 12 and every 4 months after Month 12. Baseline assessment in this study is defined as the last assessment for the endpoint in parent study taken prior to the first active treatment with Retigabine. Change from Baseline was calculated as post-Baseline value minus Baseline value. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). NA indicates that data were not available. | Baseline and Up to Month 108 |
| Change From Baseline in Post-void Residual Bladder Ultrasound Volume | Post-void residual (PVR) bladder was assessed using ultrasound scan to assess urinary retention at Month 1, Month 3, Month 12 and annually after Month 12. Baseline assessment in this study is defined as the last assessment for the endpoint in parent study taken prior to the first active treatment with Retigabine. Change from Baseline was calculated as post-Baseline value minus Baseline value. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles) | Baseline and Up to Month 108 |
| Change From Baseline in Overall American Urological Association (AUA) Symptom Index Score | An AUA Symptom Index is a 7-item Likert-scored scale describing urinary bladder function and was completed by the Investigator to assess the participant's urinary voiding function at Month 1, Month 3, Month 12 and annually after Month 12. The index scale ranges from 0-35, where higher scores are indicative of a worse issue. Scores are categorized as 0-7 mild, 8-19 moderate and >19 severe. Baseline assessment in this study is defined as the last assessment for the endpoint in parent study taken prior to the first active treatment with Retigabine. Change from Baseline was calculated as post-Baseline value minus Baseline value. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles) | Baseline and Up to Month 108 |
| Number of Participants With Abnormal Results in Physical Examination | A complete physical examination was performed at the end of each 12 month study cycle. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). If a participant had an abnormal result for at least one body system of exam, that participant was included in the 'Abnormal' category | Up to Month 108 |
| Number of Participants With Abnormal Results of Neurological Examination | Participants were assessed at Month 1, Month 3, Month 6, Month 9, Month 12 and every 4 months after Month 12. Participants in the worst category among the results of all neurological examination parameters are presented. Abnormal results were categorised as Abnormal not Clinically Significant (AbNCS)and Abnormal and Clinically Significant (AbCS). Only those participants available at the specified time points were analyzed (represented by n=X in the category titles) | Up to Month 108 |
| Number of Participants With Pigmentation of Non-retinal Ocular Tissue | The ophthalmologist/retina specialist determined the presence or absence of abnormal discoloration of all non-retinal ocular tissues. Only those participants available at the specified time points were analyzed. | Assessed up to a maximum of 9 years |
| Number of Participants With Pigmentation of Retinal Ocular Tissue | The ophthalmologist/retina specialist determined the presence or absence of abnormal discoloration of retinal ocular tissues. It included Pigmentary abnormalities in the macula, of peripheral retina as well as in both of them.. Only those participants available at the specified time points were analyzed. | Assessed up to a maximum of 9 years |
| Number of Participants With Abnormal Pigmentation of Skin, Including the Skin Around the Eyes and the Eyelids, Lips, Nails, or Mucosa | An assessment of the participant's nails, lips, skin and mucosa was completed by the investigator at the 4 monthly study visits. The assessment of the participant's skin included assessment of the skin around the eyes and the eyelids,lips, nails, and mucosa | Assessed up to a maximum of 9 years |
| Number of Participants With a Clinically Significant Decrease in Visual Acuity From Initial Examination | A comprehensive eye examination was conducted by retina specialist or general ophthalmologist to assess best corrected visual acuity. An initial comprehensive eye examination was completed by an ophthalmologist for all participants. This exam was not associated with a specific visit. Thereafter, eye examinations was performed approximately every 6 months. Eye examination was introduced following protocol amendment and was conducted in all participants. Participants discontinued before implementation of this amendment and who have not had a comprehensive eye examination and skin examination (and follow-up by a dermatologist, if clinically indicated) were asked to return to the clinic for an evaluation of their skin (and follow-up dermatology examination, if clinically indicated) and for a comprehensive eye examination. Number of Par. with both initial and at least one follow-up exam while on RTG treatment were analyzed. | Assessed up to a maximum of 9 years |
| Number of Participants With a Decrease in Confrontational Visual Field From Initial Examination | Decrease in confrontation visual field is defined as a participant having a normal initial exam and an abnormal exam thereafter or, a response of clinically significant worsening in either eye since the last assessment. | Assessed up to a maximum of 9 years |
| Number of Participants With Resolution of Abnormal Eye Pigmentation After Discontinuation of Retigabine | The ophthalmologist/retina specialist determined the presence or absence of retinal and non-retinal ocular abnormalities. Retinal abnormalities included abnormalities in the macula and/or the peripheral retina and non-retinal ocular pigmentary abnormality. | 2 years and 9 months |
| Number of Participants With Resolution of Dermatologist Confirmed Abnormal Discoloration After Discontinuation of Retigabine | An assessment of the participant's nails, lips, skin and mucosa was completed by the investigator at the 6 monthly SFUCP study visits. The assessment of the participant's skin included assessment of the skin around the eyes and the eyelids, lips, nails, and mucosa. | 2 years 9 months |
| Time From Discontinuation of Retigabine to Resolution of Abnormal Eye Pigmentation | Retinal pigmentary abnormality was determined by either an ophthalmologist or retina specialist. Retinal pigmentary abnormality included pigmentary abnormality of macula, pigmentary abnormality of the peripheral retina and non-retinal ocular pigmentary abnormality. If a participant had pigmentary abnormality of macula and pigmentary abnormality of the peripheral retina both should be resolved in order for retinal pigmentary abnormality to be considered resolved. If a participant had non-retinal ocular pigmentary abnormality in more than location (conjunctiva, sclera, cornea, iris or lens), all should be resolved for non-retinal pigmentary abnormality to be considered resolved. Only participants with resolution of the specified pigmentation are included in this analysis. | 2 years 9 months |
| Time From Discontinuation of Retigabine to Resolution of All Dermatologist-Confirmed Abnormal Discoloration | Assessments were at approximately 6-monthly intervals (timed relative to the participants previous dermatology assessment) until the abnormal discoloration either resolved or stabilized (as defined by no changes over 2 consecutive 6-monthly assessments performed by the dermatologist over at least 12 months after discontinuation of retigabine). The assessment of the participant's skin included assessment of the skin around the eyes and the eyelids, lips, nails, and mucosa. Only participants with resolution of the specified tissue are included in this analysis. | 2 years 9 months |
| Assessed up to a maximum of 9 years |
| Number of Responders | A participant was classified as a responder if there is an at least 50% reduction from Baseline in the 28-day total Partial Seizure frequency. Baseline was defined as the parent study Baseline. Only those participants available at the specified time points were analyzed. | Assessed up to a maximum of 9 years |
| Number of Participants Who Were Seizure Free for Any 6 Continuous Months | Number of seizure free days is defined as the number of applicable days without any seizures (partial, generalized or unclassified). Only the days in which a subject had non-missing seizure data were considered as applicable days. Duration of exposure is defined using a window range allowed for each scheduled visit. At least 6 months of exposure is defined as >= 173 days of exposure since the window range for Month 6 visit is +/- 7 days. Only those participants available at the specified time points were analyzed. | Assessed up to a maximum of 9 years |
| Number of Participants Who Were Seizure Free for Any 12 Continuous Months | Duration of exposure is defined using a window range allowed for each scheduled visit. At least 12 months of exposure is defined as >= 353 days of exposure since the window range for Month 12 visit is +/- 7 days. Only those participants available at the specified time points were analyzed. | Assessed up to a maximum of 9 years |
| Percentage of Seizure-free Days | Number of seizure free days is defined as the number of applicable days without any seizures (partial, generalized or unclassified). Only the days in which a participant had non-missing seizure data was considered as applicable days | Assessed up to a maximum of 9 years |
| Change From Baseline in Quality of Life in Epilepsy (QOLIE)-31-P Questionnaire | The QOLIE-31-P (Version 2.0) was utilized to assess quality of life. The QOLIE-31-P assessment was completed by the participants at Baseline, Month 3, Month 6, Month 9, Month 12 and annually after Month 12. The QOLIE has 7 sub scales as energy fatigue, emotional well being, social functioning, cognitive, medication effects, seizure worry and overall QOL. The assessment range for the overall score and the sub-scales is 0-100, where higher scores indicate greater well being. Change from Baseline was calculated as post-Baseline value minus Baseline value. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles) | Assessed up to a maximum of 9 years |
| North Alabama Neuroscience Research Associates |
| Huntsville |
| Alabama |
| 35801 |
| United States |
| Neurology Clinic | Northport | Alabama | 35476 | United States |
| Barrow Neurological Institute | Phoenix | Arizona | 85013 | United States |
| Clinical Trials Inc. | Little Rock | Arkansas | 72205 | United States |
| UCSD Thornton Hospital | La Jolla | California | 92037 | United States |
| University of Southern California -- Keck School of Medicine | Los Angeles | California | 90033 | United States |
| West Los Angeles VA Healthcare Center | Los Angeles | California | 90073 | United States |
| Delta Waves | Colorado Springs | Colorado | 80918 | United States |
| University of Colorado Department Of Neurology | Denver | Colorado | 80010 | United States |
| University of Florida -- Shands Jacksonville | Jacksonville | Florida | 32209 | United States |
| University of Miami | Miami | Florida | 33136 | United States |
| Lovelace Scientific Resources | Sarasota | Florida | 34233 | United States |
| McFarland Clinic | Ames | Iowa | 50010 | United States |
| University of Kentucky | Lexington | Kentucky | 40536 | United States |
| Mid-Atlantic Epilepsy and Sleep Center | Bethesda | Maryland | 20817 | United States |
| Henry Ford Hospital | Detroit | Michigan | 48202 | United States |
| Minnesota Epilepsy Group, P.A. | Saint Paul | Minnesota | 55102 | United States |
| The Comprehensive Epilepsy Care Center for Children and Adults | Chesterfield | Missouri | 63017 | United States |
| Beth Israel Medical Center | New York | New York | 10003 | United States |
| Asheville Neurology Specialists | Asheville | North Carolina | 28801 | United States |
| Medical University of Ohio at Toledo | Toledo | Ohio | 43614 | United States |
| Oregon Neurology PC | Tualatin | Oregon | 97062 | United States |
| Milton S. Hershey Medical Center | Hershey | Pennsylvania | 17033 | United States |
| Vanderbilt University Medical Center | Nashville | Tennessee | 37212 | United States |
| Medical City Dallas Hospital | Dallas | Texas | 75230 | United States |
| Neurological Clinic of Texas | Dallas | Texas | 75230 | United States |
| Memorial Hermann Hospital | Houston | Texas | 77030 | United States |
| University of Virginia Comprehensive Epilepsy Program | Charlottesville | Virginia | 22903 | United States |
| Virginia Commonwealth University Medical Center | Richmond | Virginia | 23298 | United States |
| Hospital Italiano de Buenos Aires | Capital Federal | CBA | C1181ACH | Argentina |
| Hospital General de Agudos "Dr. J.M. Ramos Mejia" | Capital Federal | CBA | Argentina |
| Hospital General de Agudos "Dr. Teodoro Alvarez" | Capital Federal | CBA | Argentina |
| Fundacion Lennox | Córdoba | CRD | 5000 | Argentina |
| Sanatorio del Salvador II | Córdoba | CRD | 5000 | Argentina |
| Hospital Privado Centro Medico de Cordoba | Córdoba | CRD | X5016KEH | Argentina |
| Hospital Universitario Prof Edgard Santos -- UFBA | Salvador | Estado de Bahia | 40110-060 | Brazil |
| Hospital das Clinicas de Ribeirao Preto -- Universidade de Sa Neurologia | Ribeirão Preto | São Paulo | 14048-900 | Brazil |
| Hospital Sao Paulo -- Escola Paulista de Medicina -- UNIFESP | São Paulo | São Paulo | 04024 002 | Brazil |
| Hospital das Clinicas da Fac de Medicina de Sao Paulo | São Paulo | São Paulo | 05403-900 | Brazil |
| Foothills Medical Center | Calgary | Alberta | T2N 2T9 | Canada |
| Glenrose Rehabilitation Center | Edmonton | Alberta | T5G 0B7 | Canada |
| Health Sciences Centre | St. John's | Newfoundland and Labrador | A1B 3V6 | Canada |
| CHUM -- Hôpital Notre-Dame | Montreal | Quebec | H2L 4M1 | Canada |
| Antiguo Hospital Civil de Guadalajara | Guadalajara | Jalisco | 44280 | Mexico |
| Instituto Nacional de Neurologia y Neurocirugia | La Fama | Mexico City | 42690 | Mexico |
| Centro Medico | Mexico City | Mexico City | 03229 | Mexico |
| Hospital de Psiquiatria San Fernando, IMSS | Mexico City | Mexico City | 14050 | Mexico |
| CIF BIOTEC, Medica Sur | Tlalpan | Mexico City | 14050 | Mexico |
| Hospital y Clinica OCA S.A. de C.V. | Monterrey | Nuevo León | 64000 | Mexico |
| Hospital Central Dr. Ignacio Morones Prieto | San Luis Potosí City | San Luis Potosí | 78250 | Mexico |
| FG001 | Retigabine in Parent Study | Participants received retigabine tablets as a total dose of between 600 to 1200 mg/day (dose administered twice daily or TID) as an adjunct therapy to their ongoing antiepileptic drugs with or without vagal nerve stimulation until withdrawal, withdrawn consent or switched to commercial product. Participants who received retigabine in parent study are included in this arm. |
| FG002 | Safety Follow-up Continuation Phase (SFUCP) | Participants who withdraw from retigabine and who were found to have abnormal pigmentation of the retina or unexplained vision loss, pigmentation of non-retinal ocular tissue or discoloration of skin, lips, nails or mucosa entered the SFUCP. During the SFUCP, participants underwent 6-monthly comprehensive eye examinations and/or skin assessments by the investigator, ophthalmologist, retinal specialist or dermatologist as appropriate. Participants were followed up in the SFUCP until the dermatology/ophthalmology finding(s) either resolved or stabilized. Stabilization was defined in the protocol as no changes on two consecutive 6-monthly assessments over at least over 12 months after discontinuation of retigabine. |
| COMPLETED |
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| NOT COMPLETED |
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| Safety Follow-up Continuation Phase |
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo in Parent Study | Participants received retigabine tablets as a total dose of between 600 to 1200 mg/day (dose administered twice daily or TID) as an adjunct therapy to their ongoing antiepileptic drugs with or without vagal nerve stimulation until withdrawal, withdrawn consent or switched to commercial product. Participants who received placebo in parent study are included in this arm. |
| BG001 | Retigabine in Parent Study | Participants received retigabine tablets as a total dose of between 600 to 1200 mg/day (dose administered twice daily or TID) as an adjunct therapy to their ongoing antiepileptic drugs with or without vagal nerve stimulation until withdrawal, withdrawn consent or switched to commercial product. Participants who received retigabine in parent study are included in this arm. |
| BG002 | 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 | Mean | Standard Deviation | Years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Number | Participants |
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| Number of Participants with Vagal nerve stimulator (VNS) use | Number | Participants |
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| Number of background AEDs | Number | Participants |
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| Mean Duration of Partial seizures | For this study specific outcome measure, Placebo in Parent Study N=101 and Retigabine in parent study N=79 | Mean | Standard Deviation | Years |
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| Mean Duration of Generalized Seizure | For this study specific outcome measure, Placebo in Parent Study N=12 and Retigabine in parent study N=8 | Mean | Standard Deviation | Years |
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| Clinical Global Impression (CGI) at Baseline | Number | Participants |
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| 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 | |||||||||||||||||||||||||||
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| Primary | Number of Participants With Treatment-emergent Serious Adverse Event (SAE) and Adverse Event (AE) | An AE is any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An SAE is any untoward medical occurrence that, at any dose results in death, is life-threatening, requires hospitalization (unplanned hospital stay) or prolongation of existing hospitalization, results in disability/incapacity or is a congenital anomaly/birth defect. Treatment-emergent AE was defined as an AE with an onset on or after the day of first dose of the study medication and on or before 30 days after the last dose date. AEs reported during parent study and worsened after first dose of RTG in this OLE study were also reported. | Safety Population included all participants who took at least 1 dose of study medication | Posted | Number | Participants | Assessed up to a maximum of 9 years |
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| Primary | Number of Participants With Treatment-emergent Adverse Events Leading to Withdrawal From Study Drug | Treatment-emergent AE was defined as an AE with an onset on or after the day of first dose of the study medication and on or before 30 days after the last dose date. AEs reported during parent study and worsened after first dose of RTG in this OLE study were also reported. | Safety Population | Posted | Number | Participants. | Assessed up to a maximum of 9 years |
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| Primary | Kaplan-Meier Estimate of the Probability of Discontinuation (d/c) From Study Drug | The time frame of premature study discontinuation was defined as the time from the day of first the study medication to the time of withdrawal from study drug. For those who have a taper dose start date, the time of withdrawal was the day before the start of taper dose. For those without a taper dose start date, the time of withdrawal was the last dose date. Participants who switched to the commercial product were censored at the last dose of study drug in the Kaplan-Meier analysis. All participants who withdrew from study drug prematurely but didn't switch to commercial product were counted as "events". Kaplan-Meier estimate of the probability of discontinuation at the specified time or earlier. Number of Participants continuing on RTG at each time of withdrawal were analyzed (represented as n=X in category title). | Safety Population | Posted | Number | Percentage Probability of d/c | Assessed up to a maximum of 9 years |
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| Primary | Change From Baseline in Blood Pressure | Systolic blood pressure (SBP) and diastolic blood pressure (DBP) was obtained in supine (Su) position and again in standing (St) position after the participant was standing for approximately 2 minutes at each study visit (Month 1, Month 3, Month 6, Month 9, Month 12 and every 4 months after Month 12). Baseline assessment in this study is defined as the last assessment for the endpoint in parent study taken prior to the first active treatment with Retigabine. Change from Baseline was calculated as post-Baseline value minus Baseline value. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Not Applicable (NA) indicates that data were not available. | Safety Population | Posted | Mean | Standard Deviation | Millimeter of mercury (mmHg) | Baseline and Up to Month 108 |
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| Primary | Change From Baseline in Heart Rate | Heart rate (HR) was measured in supine (Su) position and again in standing (St) position after the participant was standing for approximately 2 minutes at each study visit (Month 1, Month 3, Month 6, Month 9, Month 12 and every 4 months after Month 12). Baseline assessment in this study is defined as the last assessment for the endpoint in parent study taken prior to the first active treatment with Retigabine. Change from Baseline was calculated as post-Baseline value minus Baseline value. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). NA indicates that data were not available. | Safety Population | Posted | Mean | Standard Deviation | Beats per Minute | Baseline and Up to Month 108 |
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| Primary | Change From Baseline in Body Temperature | Body temperature was measured in degree Celsius at each study visit (Month 1, Month 3, Month 6, Month 9, Month 12 and every 4 months after Month 12). Baseline assessment in this study is defined as the last assessment for the endpoint in parent study taken prior to the first active treatment with Retigabine. Change from Baseline was calculated as post-Baseline value minus Baseline value. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). NA indicates that data were not available | Safety Population | Posted | Mean | Standard Deviation | Degree Celsius | Baseline and Up to Month 108 |
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| Primary | Change From Baseline in Weight | Weight was measured in ordinary indoor clothing (without shoes) and was recorded at each study visit (On Month 1, Month 3, Month 6, Month 9, Month 12 and every 4 months after Month 12). Baseline assessment in this study is defined as the last assessment for the endpoint in parent study taken prior to the first active treatment with Retigabine. Change from Baseline was calculated as post-Baseline value minus Baseline value. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). NA indicates that data were not available. | Safety Population | Posted | Mean | Standard Deviation | Kilograms | Baseline and Up to Month 108 |
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| Primary | Change From Baseline in the 12-lead Electrocardiogram (ECG) Parameters-PR Interval, QRS Duration, Uncorrected QT (uQT) Interval, Corrected QT (Bazett's Correction) Interval (QTcB), Corrected QT (Friedericia's Correction) Interval (QTcF) | A 12-lead ECG was performed at each study visit during the first year of the study (Month 1, Month 3, Month 6, Month 9, Month 12) and annually after one year. The following electrocardiogram parameters are presented PR Interval, QRS Duration, Uncorrected QT interval (uQT), Corrected QT (Bazett's correction) interval (QTcB), Corrected QT (Friedericia's correction) interval (QTcF). Baseline assessment in this study is defined as the last assessment for the endpoint in parent study taken prior to the first active treatment with Retigabine. Change from Baseline was calculated as post-Baseline value minus Baseline value. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). NA indicates that data were not available. | Safety Population | Posted | Mean | Standard Deviation | Milliseconds (msec) | Baseline and Up to Month 108 |
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| Primary | Change From Baseline in the 12-lead Electrocardiogram (ECG) Parameter-RR Interval | A 12-lead ECG was performed at each study visit during the first year of the study (Month 1, Month 3, Month 6, Month 9, Month 12) and annually after one year. The following electrocardiogram parameters are presented: RR Interval. Baseline assessment in this study is defined as the last assessment for the endpoint in parent study taken prior to the first active treatment with Retigabine. Change from Baseline was calculated as post-Baseline value minus Baseline value. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). | Safety Population | Posted | Mean | Standard Deviation | Seconds (sec) | Baseline and Up to Month 108 |
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| Primary | Change From Baseline in Electrocardiogram (ECG) Parameter-QRS Axis | A 12-lead ECG was performed at each study visit during the first year of the study (Month 1, Month 3, Month 6, Month 9, Month 12) and annually after one year. ECG parameter QRS Axis is presented here. Baseline assessment in this study is defined as the last assessment for the endpoint in parent study taken prior to the first active treatment with Retigabine. Change from Baseline was calculated as post-Baseline value minus Baseline value. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). | Safety Population | Posted | Mean | Standard Deviation | Degree | Baseline and Up to Month 108 |
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| Primary | Change From Baseline in Hematology Parameters- Bands, Basophils, Eosinophils, Lymphocytes, Metamyelocyte, Monocytes, Neutrophils, Platelets, White Blood Cells Count (WBC) | Following hematology parameters were assessed, Bands (Band neutrophils), Basophils, Eosinophils, Lymphocytes, Metamyelocyte, Monocytes, Neutrophils, Platelets and WBC. Hematology parameters were assessed at Month 1, Month 2, Month 3, Month 6, Month 8, Month 9, Month 10, Month 12 and every 4 months after Month 12. Baseline assessment in this study is defined as the last assessment for the endpoint in parent study taken prior to the first active treatment with Retigabine. Change from Baseline was calculated as post-Baseline value minus Baseline value. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). NA indicates that data were not available. | Safety Population | Posted | Mean | Standard Deviation | 10^9 cells/Liter | Baseline and Up to Month 108 |
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| Primary | Change From Baseline in Hematology Parameter-Red Blood Cell Count | Red Blood Cell count (RBC) was assessed at Month 1, Month 2, Month 3, Month 6, Month 8, Month 9, Month 10, Month 12 and every 4 months after Month 12. Baseline assessment in this study is defined as the last assessment for the endpoint in parent study taken prior to the first active treatment with Retigabine. Change from Baseline was calculated as post-Baseline value minus Baseline value. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). NA indicates that data were not available.. | Safety Population | Posted | Mean | Standard Deviation | 10^12 cells/Liter(L) | Baseline and Up to Month 108 |
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| Primary | Change From Baseline in Haematocrit | Haematocrit was assessed at Month 1, Month 2, Month 3, Month 6, Month 8, Month 9, Month 10, Month 12 and every 4 months after Month 12. Baseline assessment in this study is defined as the last assessment for the endpoint in parent study taken prior to the first active treatment with Retigabine. Change from Baseline was calculated as post-Baseline value minus Baseline value. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). | Safety Population | Posted | Mean | Standard Deviation | Volume/Volume (v/v) | Baseline and Up to Month 108 |
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| Primary | Change From Baseline in Haemoglobin | Haemoglobin was assessed at Month 1, Month 2, Month 3, , Month 6, Month 8, Month 9, Month 10, Month 12 and every 4 months after Month 12. Baseline assessment in this study is defined as the last assessment for the endpoint in parent study taken prior to the first active treatment with Retigabine. Change from Baseline was calculated as post-Baseline value minus Baseline value. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). NA indicates that data were not available.. | Safety Population | Posted | Mean | Standard Deviation | Grams/Liter (g/L) | Baseline and Up to Month 108 |
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| Primary | Change From Baseline in Chemistry Parameters-Alkaline Phosphatase (AP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) | Alkaline phosphatase (AP), Alanine aminotransferase (ALT), Aspartate aminotransferase (AST) were assessed at Month 1, Month 3, , Month 6, Month 9, Month 12 and every 4 months after Month 12. Baseline assessment in this study is defined as the last assessment for the endpoint in parent study taken prior to the first active treatment with Retigabine. Change from Baseline was calculated as post-Baseline value minus Baseline value. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). NA indicates that data were not available. | Safety Population | Posted | Mean | Standard Deviation | International units per litre (IU/L) | Baseline and Up to Month 108 |
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| Primary | Change From Baseline in Chemistry Parameters-Bicarbonate, Blood Urea Nitrogen (BUN), Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium, Urea | Bicarbonate (Bic.), BUN, Calcium (Ca), Chloride (Cl), Cholesterol (Cho.), Non-fasting glucose (NFG), Phosphorus (P), Potassium (Ka), Sodium (Na), Urea were assessed at Month 1, Month 3, , Month 6, Month 9, Month 12 and every 4 months after Month 12. Baseline assessment in this study is defined as the last assessment for the endpoint in parent study taken prior to the first active treatment with Retigabine. Change from Baseline was calculated as post-Baseline value minus Baseline value. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). NA indicates that data were not available. | Safety Population | Posted | Mean | Standard Deviation | Millimole per liter (mmol/L) | Baseline and Up to Month 108 |
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| Primary | Change From Baseline in Chemistry Parameters -Creatinine, Total Bilirubin (TB), Uric Acid (UA) | Creatinine, Total bilirubin (TB), Uric acid (UA) were assessed at Month 1, Month 3, , Month 6, Month 9, Month 12 and every 4 months after Month 12. Baseline assessment in this study is defined as the last assessment for the endpoint in parent study taken prior to the first active treatment with Retigabine. Change from Baseline was calculated as post-Baseline value minus Baseline value. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). NA indicates that data were not available. | Safety Population | Posted | Mean | Standard Deviation | Micromole per Liter (umol/L) | Baseline and Up to Month 108 |
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| Primary | Change From Baseline in Chemistry Parameter-Total Protein | Total Protein (TP) was assessed at Month 1, Month 3, , Month 6, Month 9, Month 12 and every 4 months after Month 12. Baseline assessment in this study is defined as the last assessment for the endpoint in parent study taken prior to the first active treatment with Retigabine. Change from Baseline was calculated as post-Baseline value minus Baseline value. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles) | Safety Population | Posted | Mean | Standard Deviation | Grams per liter (g/L) | Baseline and Up to Month 108 |
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| Primary | Change From Baseline in Urine Specific Gravity | Urine Specific gravity (USG) was assessed at Month 1, Month 3, , Month 6, Month 9, Month 12 and every 4 months after Month 12. Baseline assessment in this study is defined as the last assessment for the endpoint in parent study taken prior to the first active treatment with Retigabine. Change from Baseline was calculated as post-Baseline value minus Baseline value. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). NA indicates that data were not available. | Safety Population | Posted | Mean | Standard Deviation | Dimensionless unit | Baseline and Up to Month 108 |
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| Primary | Change From Baseline in Urine Power of Hydrogen (pH) | Urine pH was assessed at Month 1, Month 3, , Month 6, Month 9, Month 12 and every 4 months after Month 12. Baseline assessment in this study is defined as the last assessment for the endpoint in parent study taken prior to the first active treatment with Retigabine. Change from Baseline was calculated as post-Baseline value minus Baseline value. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). NA indicates that data were not available. | Safety Population | Posted | Mean | Standard Deviation | pH units | Baseline and Up to Month 108 |
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| Primary | Change From Baseline in Post-void Residual Bladder Ultrasound Volume | Post-void residual (PVR) bladder was assessed using ultrasound scan to assess urinary retention at Month 1, Month 3, Month 12 and annually after Month 12. Baseline assessment in this study is defined as the last assessment for the endpoint in parent study taken prior to the first active treatment with Retigabine. Change from Baseline was calculated as post-Baseline value minus Baseline value. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles) | Safety Population | Posted | Mean | Standard Deviation | Milliliter (mL) | Baseline and Up to Month 108 |
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| Primary | Change From Baseline in Overall American Urological Association (AUA) Symptom Index Score | An AUA Symptom Index is a 7-item Likert-scored scale describing urinary bladder function and was completed by the Investigator to assess the participant's urinary voiding function at Month 1, Month 3, Month 12 and annually after Month 12. The index scale ranges from 0-35, where higher scores are indicative of a worse issue. Scores are categorized as 0-7 mild, 8-19 moderate and >19 severe. Baseline assessment in this study is defined as the last assessment for the endpoint in parent study taken prior to the first active treatment with Retigabine. Change from Baseline was calculated as post-Baseline value minus Baseline value. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles) | Safety Population | Posted | Mean | Standard Deviation | Scores on a scale | Baseline and Up to Month 108 |
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| Primary | Number of Participants With Abnormal Results in Physical Examination | A complete physical examination was performed at the end of each 12 month study cycle. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). If a participant had an abnormal result for at least one body system of exam, that participant was included in the 'Abnormal' category | Safety Population | Posted | Number | Participants | Up to Month 108 |
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| Primary | Number of Participants With Abnormal Results of Neurological Examination | Participants were assessed at Month 1, Month 3, Month 6, Month 9, Month 12 and every 4 months after Month 12. Participants in the worst category among the results of all neurological examination parameters are presented. Abnormal results were categorised as Abnormal not Clinically Significant (AbNCS)and Abnormal and Clinically Significant (AbCS). Only those participants available at the specified time points were analyzed (represented by n=X in the category titles) | Safety Population | Posted | Number | Participants | Up to Month 108 |
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| Primary | Number of Participants With Pigmentation of Non-retinal Ocular Tissue | The ophthalmologist/retina specialist determined the presence or absence of abnormal discoloration of all non-retinal ocular tissues. Only those participants available at the specified time points were analyzed. | Safety Population | Posted | Number | Participants | Assessed up to a maximum of 9 years |
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| Primary | Number of Participants With Pigmentation of Retinal Ocular Tissue | The ophthalmologist/retina specialist determined the presence or absence of abnormal discoloration of retinal ocular tissues. It included Pigmentary abnormalities in the macula, of peripheral retina as well as in both of them.. Only those participants available at the specified time points were analyzed. | Safety Population | Posted | Number | Participants | Assessed up to a maximum of 9 years |
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| Primary | Number of Participants With Abnormal Pigmentation of Skin, Including the Skin Around the Eyes and the Eyelids, Lips, Nails, or Mucosa | An assessment of the participant's nails, lips, skin and mucosa was completed by the investigator at the 4 monthly study visits. The assessment of the participant's skin included assessment of the skin around the eyes and the eyelids,lips, nails, and mucosa | Safety Population | Posted | Number | Participants | Assessed up to a maximum of 9 years |
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| Primary | Number of Participants With a Clinically Significant Decrease in Visual Acuity From Initial Examination | A comprehensive eye examination was conducted by retina specialist or general ophthalmologist to assess best corrected visual acuity. An initial comprehensive eye examination was completed by an ophthalmologist for all participants. This exam was not associated with a specific visit. Thereafter, eye examinations was performed approximately every 6 months. Eye examination was introduced following protocol amendment and was conducted in all participants. Participants discontinued before implementation of this amendment and who have not had a comprehensive eye examination and skin examination (and follow-up by a dermatologist, if clinically indicated) were asked to return to the clinic for an evaluation of their skin (and follow-up dermatology examination, if clinically indicated) and for a comprehensive eye examination. Number of Par. with both initial and at least one follow-up exam while on RTG treatment were analyzed. | Safety Population | Posted | Number | Participants | Assessed up to a maximum of 9 years |
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| Primary | Number of Participants With a Decrease in Confrontational Visual Field From Initial Examination | Decrease in confrontation visual field is defined as a participant having a normal initial exam and an abnormal exam thereafter or, a response of clinically significant worsening in either eye since the last assessment. | Safety Population | Posted | Number | Participants | Assessed up to a maximum of 9 years |
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| Primary | Number of Participants With Resolution of Abnormal Eye Pigmentation After Discontinuation of Retigabine | The ophthalmologist/retina specialist determined the presence or absence of retinal and non-retinal ocular abnormalities. Retinal abnormalities included abnormalities in the macula and/or the peripheral retina and non-retinal ocular pigmentary abnormality. | All SFUCP Subjects Population included participants with one or more finding(s) of abnormal pigmentation of the retina or unexplained vision loss, pigmentation of non-retinal ocular tissue or discoloration of skin, lips, nails or mucosa at the treatment phase withdrawal/follow-up visit and who enter the SFUCP phase. | Posted | Number | Participants | 2 years and 9 months |
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| Primary | Number of Participants With Resolution of Dermatologist Confirmed Abnormal Discoloration After Discontinuation of Retigabine | An assessment of the participant's nails, lips, skin and mucosa was completed by the investigator at the 6 monthly SFUCP study visits. The assessment of the participant's skin included assessment of the skin around the eyes and the eyelids, lips, nails, and mucosa. | All SFUCP Subjects Population | Posted | Number | Participants | 2 years 9 months |
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| Primary | Time From Discontinuation of Retigabine to Resolution of Abnormal Eye Pigmentation | Retinal pigmentary abnormality was determined by either an ophthalmologist or retina specialist. Retinal pigmentary abnormality included pigmentary abnormality of macula, pigmentary abnormality of the peripheral retina and non-retinal ocular pigmentary abnormality. If a participant had pigmentary abnormality of macula and pigmentary abnormality of the peripheral retina both should be resolved in order for retinal pigmentary abnormality to be considered resolved. If a participant had non-retinal ocular pigmentary abnormality in more than location (conjunctiva, sclera, cornea, iris or lens), all should be resolved for non-retinal pigmentary abnormality to be considered resolved. Only participants with resolution of the specified pigmentation are included in this analysis. | All SFUCP Subjects Population | Posted | Median | Full Range | Days | 2 years 9 months |
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| Primary | Time From Discontinuation of Retigabine to Resolution of All Dermatologist-Confirmed Abnormal Discoloration | Assessments were at approximately 6-monthly intervals (timed relative to the participants previous dermatology assessment) until the abnormal discoloration either resolved or stabilized (as defined by no changes over 2 consecutive 6-monthly assessments performed by the dermatologist over at least 12 months after discontinuation of retigabine). The assessment of the participant's skin included assessment of the skin around the eyes and the eyelids, lips, nails, and mucosa. Only participants with resolution of the specified tissue are included in this analysis. | All SFUCP Subjects Population | Posted | Median | Full Range | Days | 2 years 9 months |
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| Secondary | Percentage Change From Baseline in the 28-day Partial Seizure | Twenty-eight-day total partial seizure frequency during the study is defined as the sum of total partial seizures from First date (Baseline visit date +1 if no seizures on Baseline or Baseline visit date if seizures reported on the Baseline) to Last date (last visit date for seizure record with non-missing response), divided by applicable days, standardized by 28 days. The applicable days are the days in which the subject had non-missing seizure data. Change from Baseline was calculated as post-Baseline value minus Baseline value. Only those participants available at the specified time points were analyzed. | Safety Population | Posted | Mean | Standard Deviation | Percent change | Assessed up to a maximum of 9 years |
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| Secondary | Number of Responders | A participant was classified as a responder if there is an at least 50% reduction from Baseline in the 28-day total Partial Seizure frequency. Baseline was defined as the parent study Baseline. Only those participants available at the specified time points were analyzed. | Safety Population | Posted | Number | Participants | Assessed up to a maximum of 9 years |
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| Secondary | Number of Participants Who Were Seizure Free for Any 6 Continuous Months | Number of seizure free days is defined as the number of applicable days without any seizures (partial, generalized or unclassified). Only the days in which a subject had non-missing seizure data were considered as applicable days. Duration of exposure is defined using a window range allowed for each scheduled visit. At least 6 months of exposure is defined as >= 173 days of exposure since the window range for Month 6 visit is +/- 7 days. Only those participants available at the specified time points were analyzed. | Safety Population | Posted | Number | Participants | Assessed up to a maximum of 9 years |
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| Secondary | Number of Participants Who Were Seizure Free for Any 12 Continuous Months | Duration of exposure is defined using a window range allowed for each scheduled visit. At least 12 months of exposure is defined as >= 353 days of exposure since the window range for Month 12 visit is +/- 7 days. Only those participants available at the specified time points were analyzed. | Safety Population | Posted | Number | Participants | Assessed up to a maximum of 9 years |
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| Secondary | Percentage of Seizure-free Days | Number of seizure free days is defined as the number of applicable days without any seizures (partial, generalized or unclassified). Only the days in which a participant had non-missing seizure data was considered as applicable days | Safety Population | Posted | Mean | Standard Deviation | Percentage of days | Assessed up to a maximum of 9 years |
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| Secondary | Change From Baseline in Quality of Life in Epilepsy (QOLIE)-31-P Questionnaire | The QOLIE-31-P (Version 2.0) was utilized to assess quality of life. The QOLIE-31-P assessment was completed by the participants at Baseline, Month 3, Month 6, Month 9, Month 12 and annually after Month 12. The QOLIE has 7 sub scales as energy fatigue, emotional well being, social functioning, cognitive, medication effects, seizure worry and overall QOL. The assessment range for the overall score and the sub-scales is 0-100, where higher scores indicate greater well being. Change from Baseline was calculated as post-Baseline value minus Baseline value. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles) | Safety Population | Posted | Mean | Standard Deviation | Scores on a scale | Assessed up to a maximum of 9 years |
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SAEs and non-serious AEs were collected from 1st dose of study medication in the OLE until 30 days after stopping study drug. Any AEs from parent study that worsened during the OLE are also captured (Assessed up to a maximum of 9 years).
SAEs and non-serious AEs were assessed in the Safety Population
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 | Overall Study | Participants received retigabine tablets for a total dose of between 600 to 1200 mg/day (dose administered twice daily or TID) as an adjunct therapy to their ongoing antiepileptic drugs with or without vagal nerve stimulation treatment until withdrawal, withdrawn consent or switched to commercial product. | 1 | 181 | 48 | 181 | 169 | 181 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Toxicity to various agents | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
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| Ankle fracture | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
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| Burns second degree | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
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| Facial bones fracture | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
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| Hand fracture | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
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| Head injury | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
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| Humerus fracture | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
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| Jaw fracture | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
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| Joint injury | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
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| Laceration | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
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| Lower limb fracture | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
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| Overdose | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
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| Postoperative ileus | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
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| Radius fracture | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
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| Splenic injury | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
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| Seizure | Nervous system disorders | MedDRA | Systematic Assessment |
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| Epilepsy | Nervous system disorders | MedDRA | Systematic Assessment |
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| Cerebrovascular accident | Nervous system disorders | MedDRA | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA | Systematic Assessment |
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| Hemiparesis | Nervous system disorders | MedDRA | Systematic Assessment |
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| Lumbar radiculopathy | Nervous system disorders | MedDRA | Systematic Assessment |
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| Partial seizures with secondary generalisation | Nervous system disorders | MedDRA | Systematic Assessment |
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| Postictal state | Nervous system disorders | MedDRA | Systematic Assessment |
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| Psychomotor hyperactivity | Nervous system disorders | MedDRA | Systematic Assessment |
| |
| Seizure cluster | Nervous system disorders | MedDRA | Systematic Assessment |
| |
| Status epilepticus | Nervous system disorders | MedDRA | Systematic Assessment |
| |
| Subarachnoid haemorrhage | Nervous system disorders | MedDRA | Systematic Assessment |
| |
| Tonic convulsion | Nervous system disorders | MedDRA | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Anal abscess | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Appendicitis perforated | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Confusional state | Psychiatric disorders | MedDRA | Systematic Assessment |
| |
| Conversion disorder | Psychiatric disorders | MedDRA | Systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA | Systematic Assessment |
| |
| Epileptic psychosis | Psychiatric disorders | MedDRA | Systematic Assessment |
| |
| Major depression | Psychiatric disorders | MedDRA | Systematic Assessment |
| |
| Mental status changes | Psychiatric disorders | MedDRA | Systematic Assessment |
| |
| Nervousness | Psychiatric disorders | MedDRA | Systematic Assessment |
| |
| Somatic Symptom Disorder | Psychiatric disorders | MedDRA | Systematic Assessment |
| |
| Small intestinal obstruction | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Abdominal adhesions | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Neutropenic Colitis | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Gastritis | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Benign neoplasm of thyroid gland | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
| |
| Breast cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
| |
| Fibroadenoma of breast | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
| |
| Insulinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
| |
| Parathyroid tumour benign | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
| |
| Bile duct obstruction | Hepatobiliary disorders | MedDRA | Systematic Assessment |
| |
| Biliary colic | Hepatobiliary disorders | MedDRA | Systematic Assessment |
| |
| Cholecystitis | Hepatobiliary disorders | MedDRA | Systematic Assessment |
| |
| Clostridium test positive | Investigations | MedDRA | Systematic Assessment |
| |
| Liver function test abnormal | Investigations | MedDRA | Systematic Assessment |
| |
| Transaminases increased | Investigations | MedDRA | Systematic Assessment |
| |
| Urinary retention | Renal and urinary disorders | MedDRA | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
| |
| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
| |
| Asphyxia | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA | Systematic Assessment |
| |
| Angina unstable | Cardiac disorders | MedDRA | Systematic Assessment |
| |
| Idiosyncratic drug reaction | General disorders | MedDRA | Systematic Assessment |
| |
| Hypoglycaemia | Metabolism and nutrition 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 |
| |
| Headache | Nervous system disorders | MedDRA | Systematic Assessment |
| |
| Urinary tract infection | Renal and urinary disorders | MedDRA | Systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Tremor | Nervous system disorders | MedDRA | Systematic Assessment |
| |
| Oral mucosal discolouration | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA | Systematic Assessment |
| |
| Seizure | Nervous system disorders | MedDRA | Systematic Assessment |
| |
| Skin discolouration | Skin and subcutaneous tissue disorders | MedDRA | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
| |
| Contusion | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
| |
| Dysarthria | Nervous system disorders | MedDRA | Systematic Assessment |
| |
| Paraesthesia | Nervous system disorders | MedDRA | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Lip discolouration | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Upper respiratory tract infection | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
| |
| Nail discolouration | Skin and subcutaneous tissue disorders | MedDRA | Systematic Assessment |
| |
| Nail pigmentation | Skin and subcutaneous tissue disorders | MedDRA | Systematic Assessment |
| |
| Pigmentation lip | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA | Systematic Assessment |
| |
| Memory impairment | Nervous system disorders | MedDRA | Systematic Assessment |
| |
| Viral Upper Respiratory Tract Infection | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Toothache | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Urinary retention | Renal and urinary disorders | MedDRA | Systematic Assessment |
| |
| Ataxia | Nervous system disorders | MedDRA | Systematic Assessment |
| |
| Laceration | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Amnesia | Nervous system disorders | MedDRA | Systematic Assessment |
| |
| Aphasia | Nervous system disorders | MedDRA | Systematic Assessment |
| |
| Retinal pigmentation | Eye disorders | MedDRA | Systematic Assessment |
| |
| Vertigo | Ear and labyrinth disorders | MedDRA | Systematic Assessment |
| |
| Vision blurred | Eye disorders | MedDRA | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
| |
| Diplopia | Eye disorders | MedDRA | Systematic Assessment |
| |
| Speech disorder | Nervous system disorders | MedDRA | Systematic Assessment |
| |
| Urinary hesitation | Renal and urinary disorders | MedDRA | Systematic Assessment |
| |
| Confusional state | Psychiatric 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 |
| D004828 | Epilepsies, Partial |
| 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
| ID | Term |
|---|---|
| C101866 | ezogabine |
Not provided
Not provided
Not provided
| Male |
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| Hispanic |
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| African-American (black) |
|
| Other |
|
| Yes |
|
| AED=2 |
|
| AED=3 |
|
| No Seizures |
|
| Very Mild Severity |
|
| Mild Severity |
|
| Moderate Severity |
|
| Marked Severity |
|
| Very Severe |
|
| Among the Most Extremely Severe |
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