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Open-Label Extension Study of the Phase 3 VRX-RET-E22-302 Double-Blind Trial. 115097

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ClinicalTrials.gov Identifier: NCT00310388
Recruitment Status : Active, not recruiting
First Posted : April 3, 2006
Results First Posted : June 6, 2018
Last Update Posted : June 6, 2018
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

Brief Summary:
This Phase 3 trial is an open-label extension study of the placebo-controlled, double-blind VRX-RET-E22-302 trial. Patients who have completed the VRX-RET-E22-302 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 the subject withdraws from the study or until the program is discontinued. Patients will be recruited from 55-60 sites in Europe, Israel, Australia, and South Africa. The primary objective of the 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 double-blind Study VRX-RET-E22-302. Secondary objectives are: to evaluate efficacy of long-term treatment with retigabine and patient quality of life and to evaluate whether retinal pigmentation, unexplained vision loss, pigmentation of non-retinal ocular tissue, and discoloration of nails, lips, skin or mucosa change over time after discontinuation of retigabine.

Condition or disease Intervention/treatment Phase
Epilepsy Drug: Retigabine (INN), Ezogabine (USAN) Phase 3

Detailed Description:
This Phase 3 trial is an open-label extension study of the placebo-controlled, double-blind VRX-RET-E22-302 trial. Patients who have completed the VRX-RET-E22-302 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 55-60 sites in Europe, Israel, Australia, and South Africa. 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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 376 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Multicenter, Open-Label, Long-Term, Safety, Tolerability and Efficacy Study of Retigabine in Adult Epilepsy Patients With Partial-Onset Seizures (Extension of Study VRX-RET-E22-302)
Actual Study Start Date : July 5, 2006
Actual Primary Completion Date : April 19, 2017
Estimated Study Completion Date : May 31, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Epilepsy Seizures
Drug Information available for: Ezogabine

Arm Intervention/treatment
Experimental: Retigabine (INN), Ezogabine (USAN)
Retigabine (Ezogabine): all subjects
Drug: Retigabine (INN), Ezogabine (USAN)
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 patients receives between 600 and 1200 mg of retigabine per day. The duration will be until the completion of the trial, or until the patient withdraws from the trial.
Other Names:
  • GW582892X
  • D-23129
  • GKE-841




Primary Outcome Measures :
  1. Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (TESAEs) [ Time Frame: Up to 122 months ]
    An AE is defined as 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. SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, other situations and is associated with impaired liver function. TEAEs refer to an AE for which the onset was on or after Retigabine dose in this study and on or before 30 days after the last Retigabine dose date. AEs that started in the parent study that worsened in this study were also considered as TEAEs. Analysis was performed on the safety population which included participants who took at least 1 dose of study medication after being enrolled in this OLE study.

  2. Number of Participants With TEAEs Leading to Treatment Discontinuation [ Time Frame: Up to 122 months ]
    An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. A summary of participants with treatment emergent AEs leading to treatment discontinuation up to 122 months have been presented.

  3. Kaplan-Meier Estimate of the Probability of Discontinuation From Study Drug [ Time Frame: Up to 122 months ]
    Kaplan-Meier estimate of the probability of discontinuation at the specified time for all participants is presented. 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 had a taper dose start date, the time of withdrawal was the day before the start of taper dose. Participants who switched to commercial product were censored at the last dose of study drug (excluding taper). All participants who withdrew from the study/treatment prematurely but did not switch to commercial product were counted as an event. Number of participants continuing on retigabine at each time of withdrawal were analyzed (represented by n=x in the category titles).

  4. Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Measurements in the Supine and Standing Position [ Time Frame: Baseline and up to 122 months ]
    Vital sign measurements (supine and standing blood pressure ) were obtained throughout the study at all visits during the Open-Label Treatment Phase of the study. Evaluations of blood pressure were performed supine at each study visit, and again after the participant had been standing for approximately 2 minutes. Baseline assessment in this OLE study was defined as the last assessment of that endpoint in VRX-RET-E22-302 taken prior to the first active treatment with retigabine. Change from Baseline was calculated by subtracting the Baseline value from the post Baseline values. NA indicates data was not available. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).

  5. Change From Baseline in Heart Rate (HR) Measurements in the Supine and Standing Position [ Time Frame: Baseline and up to 122 months ]
    Vital sign measurement HR was obtained throughout the study at all visits during the Open-Label Treatment Phase of the study. Evaluations of HR was performed supine at each study visit, and again after the participant had been standing for approximately 2 minutes. Baseline assessment in this OLE study was defined as the last assessment of that endpoint in VRX-RET-E22-302 taken prior to the first active treatment with retigabine. Change from Baseline was calculated by subtracting the Baseline value from the post Baseline values. NA indicates data was not available. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).

  6. Change From Baseline in Body Temperature [ Time Frame: Baseline and up to 122 months ]
    Vital sign measurement temperature was obtained throughout the study at all visits during the Open-Label Treatment Phase of the study. Baseline assessment in this OLE study was defined as the last assessment of that endpoint in VRX-RET-E22-302 taken prior to the first active treatment with retigabine. Change from Baseline was calculated by subtracting the Baseline value from the post Baseline values. NA indicates data was not available. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).

  7. Change From Baseline in Body Weight [ Time Frame: Baseline and up to 122 months ]
    Weight in pounds or kilograms was measured in ordinary indoor clothing (without shoes) and was recorded at all study visits during the Open-Label Treatment Phase of the study. Baseline assessment in this OLE study was defined as the last assessment of that endpoint in VRX-RET-E22-302 taken prior to the first active treatment with retigabine. Change from Baseline was calculated by subtracting the Baseline value from the post Baseline values. NA indicates data was not available. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).

  8. Change From Baseline in Electocardiogram (ECG) Parameters PR, QRS, QT, Corrected QT Interval (QTc) Bazett and QTc Friedericia [ Time Frame: Baseline and up to 122 months ]
    A 12-lead ECG was performed at all study visits during the Open-Label Treatment Phase during the first year of the open-label extension study (Months 1, 3, 6, 9, 12) and at the end of each 12 month study cycle that the participant was enrolled (i.e., second year, third year, fourth year, etc.). The ECG parameters that were assessed were PR interval, QRS interval, QRS duration, QT interval, and QTc interval. QT intervals were corrected using both Bazett's and Friedericia's formulas. Baseline assessment in this OLE study was defined as the last assessment of that endpoint in VRX-RET-E22-302 taken prior to the first active treatment with retigabine. Change from Baseline was calculated by subtracting the Baseline value from the post Baseline values. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).

  9. Change From Baseline in Alkaline Phosphatase (Alk. Phos.), Alanine Amino Transferase (ALT) and Aspartate Amino Transferase (AST) [ Time Frame: Baseline and up to 122 months ]
    Clinical chemistry parameters included Alk. Phos., ALT and AST. The clinical laboratory evaluations were performed at all study visits during the Open-Label Treatment Phase. Baseline assessment in this OLE study was defined as the last assessment of that endpoint in VRX-RET-E22-302 taken prior to the first active treatment with retigabine. Change from Baseline was calculated by subtracting the Baseline value from the post Baseline values. NA indicates data was not available. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).

  10. Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium and Urea [ Time Frame: Baseline and up to 122 months ]
    Clinical chemistry parameters included bicarbonate, calcium, chloride, cholesterol, Non-fasting Glucose, phosphorus, potassium, sodium and urea. Approximately 7-milliliter sample of blood was drawn for clinical chemistry assays. The clinical laboratory evaluations were performed at all study visits during the Open-Label Treatment Phase. Baseline assessment in this OLE study was defined as the last assessment of that endpoint in VRX-RET-E22-302 taken prior to the first active treatment with retigabine. Change from Baseline was calculated by subtracting the Baseline value from the post Baseline values. NA indicates data was not available. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).

  11. Change From Baseline in Creatinine, Total Bilirubin and Uric Acid [ Time Frame: Baseline and up to 122 months ]
    Clinical chemistry parameters included creatinine, total bilirubin and uric acid. The clinical laboratory evaluations were performed at all study visits during the Open-Label Treatment Phase. Baseline assessment in this OLE study was defined as the last assessment of that endpoint in VRX-RET-E22-302 taken prior to the first active treatment with retigabine. Change from Baseline was calculated by subtracting the Baseline value from the post Baseline values. NA indicates data was not available. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).

  12. Change From Baseline in Total Protein [ Time Frame: Baseline and up to 122 months ]
    Clinical chemistry parameter included total protein. The clinical laboratory evaluation were performed at all study visits during the Open-Label Treatment Phase. Baseline assessment in this OLE study was defined as the last assessment of that endpoint in VRX-RET-E22-302 taken prior to the first active treatment with retigabine. Change from Baseline was calculated by subtracting the Baseline value from the post Baseline values. NA indicates data was not available. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).

  13. Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count, White Blood Cells (WBC) [ Time Frame: Baseline and up to 122 months ]
    Hematology parameters included eosinophils, basophils lymphocytes, monocytes, neutrophils, platelet count , and WBC. The clinical laboratory evaluations were performed at all study visits during the Open-Label Treatment Phase. Baseline assessment in this OLE study was defined as the last assessment of that endpoint in VRX-RET-E22-302 taken prior to the first active treatment with retigabine. Change from Baseline was calculated by subtracting the Baseline value from the post Baseline values. NA indicates data was not available. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).

  14. Change From Baseline in Hematocrit [ Time Frame: Baseline and up to 122 months ]
    Blood samples for the assessment of clinical laboratory parameter hematocrit were collected at all study visits during the Open-Label Treatment Phase. Baseline assessment in this OLE study was defined as the last assessment of that endpoint in VRX-RET-E22-302 taken prior to the first active treatment with retigabine. Change from Baseline was calculated by subtracting the Baseline value from the post Baseline values. NA indicates data was not available. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).

  15. Change From Baseline in Hemoglobin [ Time Frame: Baseline and up to 122 months ]
    The hematology parameters included hemoglobin. The clinical laboratory evaluations were performed at all study visits during the Open-Label Treatment Phase. Baseline assessment in this OLE study was defined as the last assessment of that endpoint in VRX-RET-E22-302 taken prior to the first active treatment with retigabine. Change from Baseline was calculated by subtracting the Baseline value from the post Baseline values. NA indicates data was not available. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).

  16. Change From Baseline in Hematology Parameter Red Blood Cells (RBC) [ Time Frame: Baseline and up to 122 months ]
    The hematology parameters included RBC. The clinical laboratory evaluation were performed at all study visits during the Open-Label Treatment Phase. Baseline assessment in this OLE study was defined as the last assessment of that endpoint in VRX-RET-E22-302 taken prior to the first active treatment with retigabine. Change from Baseline was calculated by subtracting the Baseline value from the post Baseline values.NA indicates data was not available. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).

  17. Change From Baseline in Urine Specific Gravity [ Time Frame: Baseline and up to 122 months ]
    Urine specific gravity is a measure of the concentration of solutes in the urine. It measures the ratio of urine density compared with water density and provides information on the kidney's ability to concentrate urine. Urinalysis assessments were performed at all study visits during the Open-Label Treatment Phase. Baseline assessment in this OLE study was defined as the last assessment of that endpoint in VRX-RET-E22-302 taken prior to the first active treatment with retigabine. Change from Baseline was calculated by subtracting the Baseline value from the post Baseline values. NA indicates data was not available. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).

  18. Change From Baseline in Urine Potential of Hydrogen (pH) [ Time Frame: Baseline and up to 122 months ]
    Urinalysis parameters included urine pH. pH is calculated on a scale of 0 to 14, such that, the lower the number, more acidic the urine and higher the number, more alkaline the urine with 7 being neutral. Urinalysis assessments were performed at all study visits during the Open-Label Treatment Phase. Baseline assessment in this OLE study was defined as the last assessment of that endpoint in VRX-RET-E22-302 taken prior to the first active treatment with retigabine. Change from Baseline was calculated by subtracting the Baseline value from the post Baseline values. NA indicates that data was not available. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).

  19. Change From Baseline in Post-Void Residual (PVR) Bladder Ultrasound Volume [ Time Frame: Baseline and up to 122 months ]
    The post-void residual urine volume in the bladder was evaluated by transabdominal ultrasound. The urine bladder was sonicated from two directions perpendicular to one another, and the volume calculated automatically. A PVR bladder ultrasound to assess urinary retention was performed during the first year at Months 1, 3 and 12 and at the end of each 12 month study cycle that the participant was enrolled (i.e., second year, third year, fourth year, etc.) in the Open-Label Treatment Phase of the study. Baseline assessment in this OLE study was defined as the last assessment of that endpoint in VRX-RET-E22-302 taken prior to the first active treatment with retigabine. Change from Baseline was calculated by subtracting the Baseline value from the post Baseline values. NA indicates that data was not available. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).

  20. Change From Baseline in the Urinary Voiding Function [UVF] (Assessed Using the American Urological Association [AUA] Symptom Index) [ Time Frame: Baseline and up to 122 months ]
    AUA Symptom Index was completed by the Investigator during the first year at Months 1, 3 and 12 and at the end of each 12 month study cycle that the participant was enrolled in the Open-Label Treatment Phase ( second year, third year, fourth year) to assess the participant UVF. The questions were scored on a scale of 0 to 5, with 0 being (not at all) to 5 (almost always). A Symptom Index is determined by adding the scores. The lowest possible score is 0 and the highest possible score is 35, which would represent the highest level of pain and discomfort. Baseline assessment in this OLE study was defined as the last assessment of that endpoint in VRX-RET-E22-302 taken prior to the first active treatment with retigabine. Change from Baseline was calculated by subtracting the Baseline value from the post Baseline values. NA indicates data was not available. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category tittles.

  21. Change From Baseline in Quality of Life in Epilepsy-31-Problems (QOLIE-31-P) Questionnaire [ Time Frame: Baseline and up to 122 months ]
    The QOLIE-31-P questionnaire contained 30 items. The subscale scores (seizure worry, overall QOL, emotional well-being, energy-fatigue, cognitive, medication effects, social functioning), the final QOLIE-31-P score and the weighted total score (overall assessment) were calculated according to the scoring algorithm defined by the author. Scores range from 0 to 100 with higher scores indicating better function. Baseline was defined as the last assessment of that endpoint in VRX-RET-E22-302 taken prior to the first active treatment with retigabine. Change from Baseline was calculated by subtracting the Baseline value from the post Baseline values. NA indicates data was not available. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).

  22. Percentage of Participants With Abnormal Results of Physical Examination [ Time Frame: Baseline and up to 122 months ]
    A complete physical examination was performed at the end of each 12 month study cycle (i.e., first year, second year, third year, etc.) during the Open-Label Treatment Phase. The investigator assessed the skin at every clinic visit. If abnormal skin discoloration was confirmed, the participant continued to be followed by the dermatologist. If the abnormal skin discoloration was not confirmed, the investigator resumed assessing the participants skin at all scheduled clinic visits. Only data for abnormal values on physical examination have been presented. Only those participants available at the specified time points were analyzed.

  23. Percentage of Participants With Abnormal Results of Neurological Examination [ Time Frame: Baseline and up to 122 months ]
    A complete neurological examination was performed at the end of each 12 month study cycle (i.e., first year, second year, third year, etc.) during the Open-Label Treatment Phase. Abnormal results were categorized as Abnormal-Not Clinically Significant (A-NCS) and Abnormal and Clinically Significant (A-CS). Only data for abnormal values on neurological examination have been presented. Only those participants available at the specified time points were analyzed.


Secondary Outcome Measures :
  1. Percentage of Participants With Retinal Pigmentary Abnormalities (RPA) [ Time Frame: Up to 121 months ]
    RPA was determined by either an ophthalmologist or retina specialist. RPA is the composite endpoint assessed by its components: pigmentary abnormalities (PA) in the macula, PA in the peripheral retina (PR), PA in both macula and PR and PA at location unspecified. Only those participants with >=1 ophthalmology exam on or before last dose of retigabine are presented..

  2. Percentage of Participants With Pigmentation of Non-retinal Ocular Tissue (Non-ret. Pig. Abn) [ Time Frame: Up to 121 months ]
    Non-retinal ocular tissue abnormalities were determined by either an ophthalmologist or retina specialist. Non-ret. Pig. Abn is a composite endpoint assessed by its components: abnormal pigmentation (ABP) of the sclera and/or conjunctiva, ABP of the cornea, ABP of the iris and ABP of the lens. Only those participants with >=1 ophthalmology exam on or before last dose of retigabine are presented.

  3. Percentage of Participants With Abnormal Pigmentation of Skin, Including the Skin Around the Eyes and the Eyelids, Lips, Nails, or Mucosa [ Time Frame: Up to 121 months ]
    Abnormal discoloration of the skin was determined by a dermatologist. The parameters assessed were abnormal discoloration of the skin, abnormal discoloration of the lips, abnormal discoloration of the nails, abnormal discoloration of the mucosa, abnormal discoloration of sun-exposed tissue, abnormal discoloration of non sun-exposed tissue. Only those participants with at least one skin exam by the investigator or dermatologist on or before the last dose of retigabine or dermatologist-confirmed discoloration with start date on or before the date of last dose of retigabine are presented.

  4. Percentage of Participants With a Clinically Significant Decrease (CSD) in Visual Acuity (VA) From Initial Examination [ Time Frame: Up to 121 months ]
    VA refers to the clarity of vision. The parameters assessed were CSD in VA from initial examination which can be explained and CSD in VA from initial examination which cannot be explained. Only those participants with both initial and at least 1 follow-up exam while on retigabine are presented.

  5. Percentage of Participants With Decrease in Confrontational Visual Field From Initial Examination [ Time Frame: Up to 121 months ]
    The parameter assessed was decrease in confrontational visual field from initial examination. Only those participants with data available at the indicated time point were analyzed. Only those participants with both initial and at least 1 follow-up exam while on retigabine are presented.

  6. Percentage Change in the 28-day Partial Seizure Rate From the Baseline Phase (Obtained During the 8-week Baseline Period of Study VRX-RET-E22-302) to Open-label Treatment. [ Time Frame: Baseline and up to 121 months ]
    28-day partial seizure rate observed during the OLE period was compared to the 28-day partial seizure rate observed during the Baseline phase of the double-blind parent study VRX-R ET-E22-302. Percent change from Baseline in 28-day total partial seizure rate was calculated as ([28-day partial seizure frequency for the period of interest - Baseline 28-day partial seizure frequency] / Baseline 28-day partial seizure frequency) × 100 percent. A negative percent change indicated a reduction (improvement) from Baseline, so the best possible outcome was -100 percent. Only those participants with data available at the indicated time point were analyzed.

  7. Percentage of Participants With 50% Reduction in Seizure Frequency From Baseline Phase of the Parent Study (VRX-RET-E22-302) to Open Label Treatment [ Time Frame: Baseline and up to 121 months ]
    A Responder was defined as a participant with >=50 percent decrease from Baseline in the 28-day partial seizure frequency, i.e., a percent change from Baseline less than or equal to -50 percent. The percentage of responders from Baseline phase of the parent study (VRX-RET-E22-302) to open label treatment have been presented.

  8. Number of Participants Who Were Seizure Free for Any 6 Continuous Months [ Time Frame: Up to 6 continuous months within the 121 months period ]
    Seizure free for any continuous 6 months is defined as no seizures occuring during any consecutive 180 days between the first date (Baseline) and the last date (before tapering of dose). The number of participants who were seizure free for 6 continuous months within the 121 month OLE period have been presented.

  9. Number of Participants Who Were Seizure Free for Any 12 Continuous Months [ Time Frame: Up to 12 continuous months within the 121 months period ]
    Seizure free for any continuous 12 months is defined as no seizures occurring during any consecutive 360 days. Number of participants who were seizure free for 12 continuous months within the 121 month OLE period have been presented.

  10. Percentage of Seizure Free Days [ Time Frame: Up to 121 months ]
    A seizure free day 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. Percentage of seizure free days is calculated as Number of seizure free days / number of applicable days × 100 percent. Only those participants with data available at the indicated time point were analyzed.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patient has successfully completed the Maintenance and Transition phases of Study VRX-RET-E22-302 for the treatment of partial-onset seizures
  • Patient is expected to benefit from participation in the study in the opinion of the Investigator.

Exclusion Criteria:

  • Patient meets any of the withdrawal criteria in the previous VRX-RET-E22-302 study or is experiencing an ongoing serious adverse event.
  • Patient is receiving any investigational drug or using any experimental device in addition to Retigabine for treatment of epilepsy or any other medical condition.
  • Patient has any other condition that would prevent compliance with the study procedures or proper reporting of adverse events.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00310388


  Hide Study Locations
Locations
Australia, New South Wales
Institute of Clniical Neurosciences
Camperdown, New South Wales, Australia, 2050
Australia, Queensland
North Coast Neurology Centre
Maroochydore, Queensland, Australia, 4558
Australia, South Australia
Flinders Medical Centre
Bedford Park, South Australia, Australia, 5041
Australia, Victoria
Royal Melbourne Hospital
Parkville, Victoria, Australia, 3050
Austin & Repatriation Medical Centre
West Heidelberg, Victoria, Australia, 3081
Belgium
General Hospital Middelheim -- Department of Neurology
Antwerp, Belgium, B-2020
AZ Sint-Jan
Brugge, Belgium, 8000
Universitaire Ziekenhuizen Gasthuisberg -- Department Neurology
Leuven, Belgium, 3000
Centre Neurologique William Lennox
Ottignies, Belgium, 1340
France
Hopital Civil de Steasbourg Clinique Neurologie
Levallois-Perret, France, 92594
Hopital Neurologique Pierre Wertheimer
Lyon, France, 69003
CHU Pontchaillou
Rennes Cedex, France, 35033
Centre Medical de La Teppe
Tain L'Hermitage, 26, France, 26600
Germany
Zentrum Epilepsie Erlangen (ZEE) der Universitaet Erlangen
Erlangen, BY, Germany, 91054
Universitaet Giessen / Marburg Neurologie
Marburg, HE, Germany, 35033
Universitaetsklinik Mainz Neurologische Klinik
Mainz, RP, Germany, 55101
University of Bonn -- Department for Epileptplogy
Bonn, Germany, D-53105
Private Neurologische Paraxis
Muenchen, BY, Germany, 80333
Universitaetslinkum Ulm Poliklinik fuer Neurologie
Ulm, BW, Germany, 89081
Hungary
Pecs University of Science, Clinic of Neurology
Pecs, Ret, Hungary, U2
Orszagos Pszichiatriai es Neurologiai Intezet
Budapest, Hungary, 1021
Orszagos Idegsebeszeti Tudomanyos Intezet
Budapest, Hungary, 1145
Israel
Assaf Harofeh Medical Center
Beer Yaakov, Israel, 70300
Rambam Medical Center
Haifa, Israel, 31096
Wolfson Medical Center
Holon, Israel, 58100
Western Galilee Hospital
Nahariya, Israel, 22100
Chaim Sheba Medical Center
Ramat Gan, Israel, 52621
Kaplan Medical Center
Rechovot, Israel, 76100
Tel-Aviv Sourasky Medical Center
Tel Aviv, Israel, 64239
Poland
Specjalistyczna Przychodnia Lekarska Medikard
Padlewskiego 4, Plock, Poland, 09-402
Prywatna Wielospecjalistyczna Lecznica Medyczna "Zycie"
Plac Hallera 5, Warszawa, Poland, 03-464
Oddzial Neurologii -- Klinika Neurologii ICZMP
U1. Parzeczewska 35, Zgierz, Poland, 95-100
NZOZ Przychodnia Internistyczno - Stomatologiczna "Kendron"
Bialystok, Poland
Wojewodzki Szpital Specjalistyczny im.Mikolaja Kopernika
Gdansk, Poland, 80-803
WSS im.Kardynala S. Wyszynskiego
Lublin, Poland, 20-718
Instytut Psychiatrii i Neurologii II Oddzial Neurologii
Warszawa, Poland, 02-957
Russian Federation
Kazan State Medical University
Kazan, Russian Federation, 420012
City Hospital # 1
Moscow, Russian Federation, 117049
City Hospital # 33
Moscow, Russian Federation
District Antiepileptic Centre City Clinical Hospital # 71
Moscow, Russian Federation
Russian Military Medical Academy
St. Petersburg, Russian Federation, 194044
Pavlov State Medical University Clinic and Department of Neurology
St. Petersburg, Russian Federation
South Africa
Sunninghill & Kopano Clinical Trials
Johannesburg, Gauteng, South Africa, 2157
Wilgers MR & Medical Centre
Pretoria, Gauteng, South Africa, 0001
Panorama Medi-Clinic
Parow, W Cape, South Africa, 7550
Groote Schuur Hospital
Cape Town, WC, South Africa, 7925
Carl Bremer Hospital
Belville, W Cape, South Africa, 7531
Farmovs Parexel
BleomFontein, Free State, South Africa, 9300
Inkosi Albert Luthuli Central Hospital
Durban, KZ-Natal, South Africa, 4091
Johannesburg Hospital
Johannesburg, Gauteng, South Africa, 2193
Triple M Research
Port Elisabeth, E Cape, South Africa, 6001
Spain
Hospital Sta. Creu i S. Pau
Barcelona, Spain, 08025
Hospital de Cruces Neurology Department
Bilbao, Spain, 48903
Hosp. Virgen de las Nieves
Granada, Spain, 18014
Hospital Ruber Internacional de Madrid
Madrid, Spain, 28034
Fundacion Jimenez Diaz
Madrid, Spain, 28040
Hosp. de Donostia Neurology Department
San Sebastian, Spain, 20014
Hospital Universitario Lozano Blesa Neurology Service
Zaragoza, Spain, 50009
Ukraine
Psychosomatic Center of Dnepropetr. Regional Clinic
Dnepropetrovsk, Ukraine, 49616
Kharkov State Medical University
Kharkov, Ukraine, 31002
Institute of Neurology, Psychiatry and Narcology of AMS, Ukr
Kharkov, Ukraine, 31068
Epilepsy Center of Municipal Clinical Psychoneurological Hospital
Kiev, Ukraine, 04080
Odessa Regional Clinical Hospital Center for Neurology and Neurosurgery
Odessa, Ukraine, 65025
United Kingdom
The James Cook University Hospital
Middlesbrough, Mersyd, United Kingdom, TS4 3BY
Fylde Coast Hospital
Blackpool, United Kingdom, FY3 8BP
Western Infirmary (Epilepsy)
Glasgow, United Kingdom, G11 6NT
Royal London Hospital
London, United Kingdom, GT LON E1 1BB
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  Study Documents (Full-Text)

Documents provided by GlaxoSmithKline:
Study Protocol  [PDF] August 14, 2008
Statistical Analysis Plan  [PDF] February 26, 2007


Additional Information:
Study Data/Documents: Study Protocol  This link exits the ClinicalTrials.gov site
Identifier: VRX-RET-E22-304
For additional information about this study please refer to the GSK Clinical Study Register
Individual Participant Data Set  This link exits the ClinicalTrials.gov site
Identifier: VRX-RET-E22-304
For additional information about this study please refer to the GSK Clinical Study Register
Clinical Study Report  This link exits the ClinicalTrials.gov site
Identifier: VRX-RET-E22-304
For additional information about this study please refer to the GSK Clinical Study Register
Dataset Specification  This link exits the ClinicalTrials.gov site
Identifier: VRX-RET-E22-304
For additional information about this study please refer to the GSK Clinical Study Register
Informed Consent Form  This link exits the ClinicalTrials.gov site
Identifier: VRX-RET-E22-304
For additional information about this study please refer to the GSK Clinical Study Register
Annotated Case Report Form  This link exits the ClinicalTrials.gov site
Identifier: VRX-RET-E22-304
For additional information about this study please refer to the GSK Clinical Study Register
Statistical Analysis Plan  This link exits the ClinicalTrials.gov site
Identifier: VRX-RET-E22-304
For additional information about this study please refer to the GSK Clinical Study Register

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00310388     History of Changes
Other Study ID Numbers: VRX-RET-E22-304
EUDRACT No. 2006-000956-42
RTG115097 ( Other Identifier: GlaxoSmithKline )
First Posted: April 3, 2006    Key Record Dates
Results First Posted: June 6, 2018
Last Update Posted: June 6, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
URL: http://

Keywords provided by GlaxoSmithKline:
Partial Seizures
Epilepsy
RTG115097
Complex Partial Seizures
Anticonvulsant
Potassium Channels
Epilepsies, Partial

Additional relevant MeSH terms:
Epilepsy
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Ezogabine
Anticonvulsants
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action