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

NCT00310388 | Terminated Phase 3 Results

• 3 other identifiers: VRX-RET-E22-304EUDRACT No. 2006-000956-42RTG115097
• Study Type: interventional
• Target: 376
• Locations: 12 countries
• Sites: 67

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.

Conditions

Epilepsy

Keywords

Partial Seizures; Epilepsy; RTG115097; Complex Partial Seizures; Anticonvulsant; Potassium Channels; Epilepsies, Partial

Outcome Measures

Primary Outcomes (23)

• Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (TESAEs)

  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.

  Up to 122 months

• Number of Participants With TEAEs Leading to Treatment Discontinuation (Disc.)

  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 disc. up to 122 months have been presented.

  Up to 122 months

• Kaplan-Meier Estimate of the Probability of Disc. From Study Drug

  Kaplan-Meier estimate of the probability of disc. at the specified time for all participants is presented. The time frame of premature study disc. 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).

  Up to 122 months

• Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Measurements in the Supine and Standing Position

  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 standard deviation could not be calculated as only 1 participant was analyzed. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).

  Baseline and up to 122 months

• Change From Baseline in Heart Rate (HR) Measurements in the Supine and Standing Position

  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 standard deviation could not be calculated as only 1 participant was analyzed. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).

  Baseline and up to 122 months

• Change From Baseline in Body Temperature

  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 standard deviation could not be calculated as only 1 participant was analyzed. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).

  Baseline and up to 122 months

• Change From Baseline in Body Weight

  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 standard deviation could not be calculated as only 1 participant was analyzed. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).

  Baseline and up to 122 months

• Change From Baseline in Electocardiogram (ECG) Parameters PR, QRS, QT, Corrected QT Interval (QTc) Bazett and QTc Friedericia

  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. NA indicates standard deviation could not be calculated as only 1 participant was analyzed. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).

  Baseline and up to 122 months

• Change From Baseline in Alkaline Phosphatase (Alk. Phos.), Alanine Amino Transferase (ALT) and Aspartate Amino Transferase (AST)

  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 standard deviation could not be calculated as only 1 participant was analyzed. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).

  Baseline and up to 122 months

• Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium and Urea

  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 standard deviation could not be calculated as only 1 participant was analyzed. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).

  Baseline and up to 122 months

• Change From Baseline in Creatinine, Total Bilirubin and Uric Acid

  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 standard deviation could not be calculated as only 1 participant was analyzed. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).

  Baseline and up to 122 months

• Change From Baseline in Total Protein

  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 standard deviation could not be calculated as only 1 participant was analyzed. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).

  Baseline and up to 122 months

• Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count, White Blood Cells (WBC)

  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 standard deviation could not be calculated as only 1 participant was analyzed. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).

  Baseline and up to 122 months

• Change From Baseline in Hematocrit

  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 standard deviation could not be calculated as only 1 participant was analyzed. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).

  Baseline and up to 122 months

• Change From Baseline in Hemoglobin

  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 standard deviation could not be calculated as only 1 participant was analyzed. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).

  Baseline and up to 122 months

• Change From Baseline in Hematology Parameter Red Blood Cells (RBC)

  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 standard deviation could not be calculated as only 1 participant was analyzed. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).

  Baseline and up to 122 months

• Change From Baseline in Urine Specific Gravity

  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 standard deviation could not be calculated as only 1 participant was analyzed. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).

  Baseline and up to 122 months

• Change From Baseline in Urine Potential of Hydrogen (pH)

  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 standard deviation could not be calculated as only 1 participant was analyzed. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).

  Baseline and up to 122 months

• Change From Baseline in Post-Void Residual (PVR) Bladder Ultrasound Volume

  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. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).

  Baseline and up to 122 months

• Change From Baseline in the Urinary Voiding Function [UVF] (Assessed Using the American Urological Association [AUA] Symptom Index)

  AUA Symptom Index was completed during the first year at Months 1, 3, 12 and at the end of each 12 month study cycle that the participant was enrolled in the Open-Label Treatment Phase (second, third, fourth year) to assess the participant UVF. The questions were scored on a scale of 0 to 5, with 0 (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 standard deviation could not be calculated as only 1 participant was analyzed. Only those participants with data available at the specified time points were analyzed represented by (n=x).

  Baseline and up to 122 months

• Change From Baseline in Quality of Life in Epilepsy-31-Problems (QOLIE-31-P) Questionnaire

  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 standard deviation could not be calculated as only 1 participant was analyzed. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).

  Baseline and up to 122 months

• Percentage of Participants With Abnormal Results of Physical Examination

  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.

  Baseline and up to 122 months

• Percentage of Participants With Abnormal Results of Neurological Examination

  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.

  Baseline and up to 122 months

Secondary Outcomes (14)

• Percentage of Participants With Retinal Pigmentary Abnormalities (RPA)

  Up to 121 months

• Percentage of Participants With Pigmentation of Non-retinal Ocular Tissue (Non-ret. Pig. Abn)

  Up to 121 months

• Percentage of Participants With Abnormal Pigmentation of Skin, Including the Skin Around the Eyes and the Eyelids, Lips, Nails, or Mucosa

  Up to 121 months

• Percentage of Participants With a Clinically Significant Decrease (CSD) in Visual Acuity (VA) From Initial Examination

  Up to 121 months

• Percentage of Participants With Decrease in Confrontation Visual Field From Initial Examination

  Up to 121 months

Study Arms (1)

Retigabine (INN), Ezogabine (USAN)

EXPERIMENTAL

Retigabine (Ezogabine): all subjects

Drug: Retigabine (INN), Ezogabine (USAN)

Interventions

Retigabine (INN), Ezogabine (USAN) 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 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.

Also known as: GW582892X, D-23129, GKE-841

Retigabine (INN), Ezogabine (USAN)

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (67)

Institute of Clniical Neurosciences

Camperdown, New South Wales, 2050, Australia

Location

North Coast Neurology Centre

Maroochydore, Queensland, 4558, Australia

Location

Flinders Medical Centre

Bedford Park, South Australia, 5041, Australia

Location

Royal Melbourne Hospital

Parkville, Victoria, 3050, Australia

Location

Austin & Repatriation Medical Centre

West Heidelberg, Victoria, 3081, Australia

Location

General Hospital Middelheim -- Department of Neurology

Antwerp, B-2020, Belgium

Location

AZ Sint-Jan

Bruges, 8000, Belgium

Location

Universitaire Ziekenhuizen Gasthuisberg -- Department Neurology

Leuven, 3000, Belgium

Location

Centre Neurologique William Lennox

Ottignies, 1340, Belgium

Location

Hopital Civil de Steasbourg Clinique Neurologie

Levallois-Perret, 92594, France

Location

Hopital Neurologique Pierre Wertheimer

Lyon, 69003, France

Location

CHU Pontchaillou

Rennes, 35033, France

Location

Centre Medical de La Teppe

Tain-l'Hermitage, 26600, France

Location

Zentrum Epilepsie Erlangen (ZEE) der Universitaet Erlangen

Erlangen, Bavaria, 91054, Germany

Location

Universitaet Giessen / Marburg Neurologie

Marburg, Hesse, 35033, Germany

Location

Universitaetsklinik Mainz Neurologische Klinik

Mainz, Rhineland-Palatinate, 55101, Germany

Location

University of Bonn -- Department for Epileptplogy

Bonn, D-53105, Germany

Location

Private Neurologische Paraxis

Muenchen, by, 80333, Germany

Location

Universitaetslinkum Ulm Poliklinik fuer Neurologie

Ulm, BW, 89081, Germany

Location

Pecs University of Science, Clinic of Neurology

Pécs, Ret, U2, Hungary

Location

Orszagos Pszichiatriai es Neurologiai Intezet

Budapest, 1021, Hungary

Location

Orszagos Idegsebeszeti Tudomanyos Intezet

Budapest, 1145, Hungary

Location

Assaf Harofeh Medical Center

Beer Yaakov, 70300, Israel

Location

Rambam Medical Center

Haifa, 31096, Israel

Location

Wolfson Medical Center

Holon, 58100, Israel

Location

Western Galilee Hospital

Nahariya, 22100, Israel

Location

Chaim Sheba Medical Center

Ramat Gan, 52621, Israel

Location

Kaplan Medical Center

Rehovot, 76100, Israel

Location

Tel-Aviv Sourasky Medical Center

Tel Aviv, 64239, Israel

Location

Specjalistyczna Przychodnia Lekarska Medikard

Padlewskiego 4, Plock, 09-402, Poland

Location

Prywatna Wielospecjalistyczna Lecznica Medyczna "Zycie"

Plac Hallera 5, Warszawa, 03-464, Poland

Location

Oddzial Neurologii -- Klinika Neurologii ICZMP

U1. Parzeczewska 35, Zgierz, 95-100, Poland

Location

NZOZ Przychodnia Internistyczno - Stomatologiczna "Kendron"

Bialystok, Poland

Location

Wojewodzki Szpital Specjalistyczny im.Mikolaja Kopernika

Gdansk, 80-803, Poland

Location

WSS im.Kardynala S. Wyszynskiego

Lublin, 20-718, Poland

Location

Instytut Psychiatrii i Neurologii II Oddzial Neurologii

Warsaw, 02-957, Poland

Location

Kazan State Medical University

Kazan', 420012, Russia

Location

City Hospital # 1

Moscow, 117049, Russia

Location

City Hospital # 33

Moscow, Russia

Location

District Antiepileptic Centre City Clinical Hospital # 71

Moscow, Russia

Location

Russian Military Medical Academy

Saint Petersburg, 194044, Russia

Location

Pavlov State Medical University Clinic and Department of Neurology

Saint Petersburg, Russia

Location

Sunninghill & Kopano Clinical Trials

Johannesburg, Gauteng, 2157, South Africa

Location

Wilgers MR & Medical Centre

Pretoria, Gauteng, 0001, South Africa

Location

Panorama Medi-Clinic

Parow, W Cape, 7550, South Africa

Location

Groote Schuur Hospital

Cape Town, WC, 7925, South Africa

Location

Carl Bremer Hospital

Belville, W Cape, 7531, South Africa

Location

Farmovs Parexel

BleomFontein, Free State, 9300, South Africa

Location

Inkosi Albert Luthuli Central Hospital

Durban, KZ-Natal, 4091, South Africa

Location

Johannesburg Hospital

Johannesburg, Gauteng, 2193, South Africa

Location

Triple M Research

Port Elisabeth, E Cape, 6001, South Africa

Location

Hospital Sta. Creu i S. Pau

Barcelona, 08025, Spain

Location

Hospital de Cruces Neurology Department

Bilbao, 48903, Spain

Location

Hosp. de Donostia Neurology Department

Donostia / San Sebastian, 20014, Spain

Location

Hosp. Virgen de las Nieves

Granada, 18014, Spain

Location

Hospital Ruber Internacional de Madrid

Madrid, 28034, Spain

Location

Fundacion Jimenez Diaz

Madrid, 28040, Spain

Location

Hospital Universitario Lozano Blesa Neurology Service

Zaragoza, 50009, Spain

Location

Psychosomatic Center of Dnepropetr. Regional Clinic

Dnipro, 49616, Ukraine

Location

Kharkov State Medical University

Kharkiv, 31002, Ukraine

Location

Institute of Neurology, Psychiatry and Narcology of AMS, Ukr

Kharkiv, 31068, Ukraine

Location

Epilepsy Center of Municipal Clinical Psychoneurological Hospital

Kiev, 04080, Ukraine

Location

Odessa Regional Clinical Hospital Center for Neurology and Neurosurgery

Odesa, 65025, Ukraine

Location

The James Cook University Hospital

Middlesbrough, Mersyd, TS4 3BY, United Kingdom

Location

Fylde Coast Hospital

Blackpool, FY3 8BP, United Kingdom

Location

Western Infirmary (Epilepsy)

Glasgow, G11 6NT, United Kingdom

Location

Royal London Hospital

London, GT LON E1 1BB, United Kingdom

Location

Related Links

• Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.

MeSH Terms

Conditions

Epilepsy; Seizures; Epilepsies, Partial

Interventions

ezogabine

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: GSK Response Center
• Organization: GlaxoSmithKline

GSKClinicalSupportHD@gsk.com

866-435-7343

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 30, 2006
• First Posted: April 3, 2006
• Study Start: July 5, 2006
• Primary Completion: April 18, 2017
• Study Completion: May 24, 2018
• Last Updated: November 15, 2018
• Results First Posted: June 6, 2018

Record last verified: 2018-10

Data Sharing

• IPD Sharing: Will share

Locations

DE (6); IL (7); BE (4); PL (7); ZA (9); GB (4); RU (6); AU (5); HU (3); FR (4); UA (5); ES (7)