Open-label Extension Study of the Phase 3 VRX-RET-E22-301 Double-Blind Trial

NCT00310375 | Completed Phase 3 Results

• 2 other identifiers: VRX-RET-E22-303RTG115098
• Study Type: interventional
• Target: 181
• Locations: 5 countries
• Sites: 51

Brief Summary

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.

Conditions

Epilepsy

Keywords

Epilepsy; Partial Seizures; Potassium Channels; Anticonvulsant; Complex Partial Seizures; Epilepsies, Partial; RTG115098

Outcome Measures

Primary Outcomes (33)

• 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

• 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

Secondary Outcomes (6)

• Percentage Change From Baseline in the 28-day Partial Seizure

  Assessed up to a maximum of 9 years

• Number of Responders

  Assessed up to a maximum of 9 years

• Number of Participants Who Were Seizure Free for Any 6 Continuous Months

  Assessed up to a maximum of 9 years

• Number of Participants Who Were Seizure Free for Any 12 Continuous Months

  Assessed up to a maximum of 9 years

• Percentage of Seizure-free Days

  Assessed up to a maximum of 9 years

Study Arms (1)

Ezogabine: USAN Retigabine (International Nonproprietary Name)

EXPERIMENTAL

Film-coated tablets - 50mg, 100mg or 300mg

Drug: Ezogabine: USAN Retigabine (International Nonproprietary Name)

Interventions

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.

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

Ezogabine: USAN Retigabine (International Nonproprietary Name)

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-E22-301 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-E22-301 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 (51)

University of Alabama -- Department of Neurology/Epilepsy Center

Birmingham, Alabama, 35294, United States

Location

North Alabama Neuroscience Research Associates

Huntsville, Alabama, 35801, United States

Location

Neurology Clinic

Northport, Alabama, 35476, United States

Location

Barrow Neurological Institute

Phoenix, Arizona, 85013, United States

Location

Clinical Trials Inc.

Little Rock, Arkansas, 72205, United States

Location

UCSD Thornton Hospital

La Jolla, California, 92037, United States

Location

University of Southern California -- Keck School of Medicine

Los Angeles, California, 90033, United States

Location

West Los Angeles VA Healthcare Center

Los Angeles, California, 90073, United States

Location

Delta Waves

Colorado Springs, Colorado, 80918, United States

Location

University of Colorado Department Of Neurology

Denver, Colorado, 80010, United States

Location

University of Florida -- Shands Jacksonville

Jacksonville, Florida, 32209, United States

Location

University of Miami

Miami, Florida, 33136, United States

Location

Lovelace Scientific Resources

Sarasota, Florida, 34233, United States

Location

McFarland Clinic

Ames, Iowa, 50010, United States

Location

University of Kentucky

Lexington, Kentucky, 40536, United States

Location

Mid-Atlantic Epilepsy and Sleep Center

Bethesda, Maryland, 20817, United States

Location

Henry Ford Hospital

Detroit, Michigan, 48202, United States

Location

Minnesota Epilepsy Group, P.A.

Saint Paul, Minnesota, 55102, United States

Location

The Comprehensive Epilepsy Care Center for Children and Adults

Chesterfield, Missouri, 63017, United States

Location

Beth Israel Medical Center

New York, New York, 10003, United States

Location

Asheville Neurology Specialists

Asheville, North Carolina, 28801, United States

Location

Medical University of Ohio at Toledo

Toledo, Ohio, 43614, United States

Location

Oregon Neurology PC

Tualatin, Oregon, 97062, United States

Location

Milton S. Hershey Medical Center

Hershey, Pennsylvania, 17033, United States

Location

Vanderbilt University Medical Center

Nashville, Tennessee, 37212, United States

Location

Medical City Dallas Hospital

Dallas, Texas, 75230, United States

Location

Neurological Clinic of Texas

Dallas, Texas, 75230, United States

Location

Memorial Hermann Hospital

Houston, Texas, 77030, United States

Location

University of Virginia Comprehensive Epilepsy Program

Charlottesville, Virginia, 22903, United States

Location

Virginia Commonwealth University Medical Center

Richmond, Virginia, 23298, United States

Location

Hospital Italiano de Buenos Aires

Capital Federal, CBA, C1181ACH, Argentina

Location

Hospital General de Agudos "Dr. J.M. Ramos Mejia"

Capital Federal, CBA, Argentina

Location

Hospital General de Agudos "Dr. Teodoro Alvarez"

Capital Federal, CBA, Argentina

Location

Fundacion Lennox

Córdoba, CRD, 5000, Argentina

Location

Sanatorio del Salvador II

Córdoba, CRD, 5000, Argentina

Location

Hospital Privado Centro Medico de Cordoba

Córdoba, CRD, X5016KEH, Argentina

Location

Hospital Universitario Prof Edgard Santos -- UFBA

Salvador, Estado de Bahia, 40110-060, Brazil

Location

Hospital das Clinicas de Ribeirao Preto -- Universidade de Sa Neurologia

Ribeirão Preto, São Paulo, 14048-900, Brazil

Location

Hospital Sao Paulo -- Escola Paulista de Medicina -- UNIFESP

São Paulo, São Paulo, 04024 002, Brazil

Location

Hospital das Clinicas da Fac de Medicina de Sao Paulo

São Paulo, São Paulo, 05403-900, Brazil

Location

Foothills Medical Center

Calgary, Alberta, T2N 2T9, Canada

Location

Glenrose Rehabilitation Center

Edmonton, Alberta, T5G 0B7, Canada

Location

Health Sciences Centre

St. John's, Newfoundland and Labrador, A1B 3V6, Canada

Location

CHUM -- Hôpital Notre-Dame

Montreal, Quebec, H2L 4M1, Canada

Location

Antiguo Hospital Civil de Guadalajara

Guadalajara, Jalisco, 44280, Mexico

Location

Instituto Nacional de Neurologia y Neurocirugia

La Fama, Mexico City, 42690, Mexico

Location

Centro Medico

Mexico City, Mexico City, 03229, Mexico

Location

Hospital de Psiquiatria San Fernando, IMSS

Mexico City, Mexico City, 14050, Mexico

Location

CIF BIOTEC, Medica Sur

Tlalpan, Mexico City, 14050, Mexico

Location

Hospital y Clinica OCA S.A. de C.V.

Monterrey, Nuevo León, 64000, Mexico

Location

Hospital Central Dr. Ignacio Morones Prieto

San Luis Potosí City, San Luis Potosí, 78250, Mexico

Location

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

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: NA
• 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: May 1, 2006
• Primary Completion: November 30, 2016
• Study Completion: March 15, 2017
• Last Updated: July 31, 2020
• Results First Posted: November 25, 2016

Record last verified: 2020-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: IPD is available via the Clinical Study Data Request site (click on the link provided below)
• Access Criteria: 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.

Locations

BR (4); AR (6); CA (4); ME (7); US (30)