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Retigabine Efficacy and Safety Trial for Partial Onset Refractory Seizures in Epilepsy (RESTORE2)

Primary Purpose

Seizures

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Retigabine
Retigabine
Placebo
Sponsored by
GlaxoSmithKline
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Seizures focused on measuring Partial Seizures, Complex Partial Seizures, Epilepsy, Potassium Channels, Anticonvulsant

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Diagnosis of refractory epilepsy with simple or complex partial onset seizures with or without secondary generalization 28-day partial seizure frequency rate of four or more partial seizures over the 8-week baseline phase Currently treated with up to three established AEDs Vagal Nerve Stimulator may be included Exclusion Criteria: Existing medical or psychiatric condition which could affect patient's health or compromise ability to participate in the study Clinically significant abnormalities on physical exam, vital signs, ECG, or liver function tests Impaired renal function (creatinine clearance less than 50 mL/minute) Evidence of progressive central nervous disease, lesion, or encephalopathy History of primary generalized seizures History of clustering or flurries or status epilepticus within 12 months of study entry

Sites / Locations

  • Mid-Atlantic Epilepsy and Sleep Center
  • Neurological Clinic-Texas
  • Royal Prince Alfred Hospital
  • North Coast Neurology Centre
  • Monash Medical Centre
  • Royal Melbourne Hospital
  • Austin & Repatriation Medical Centre
  • A. Z. Middelheim -- Department of Neurology
  • AZ Sint-Jan
  • Universitaire Ziekenhuizen Gasthuisberg -- Department Neurology
  • Centre Neurologique William Lennox
  • Hopital Neurologique Pierre Wertheimer
  • CHU Pontchaillou
  • Hopital Civil de Strasbourg
  • Centre Medical de La Teppe
  • University of Bonn -- Department for Epileptplogy
  • Zentrum Epilepsie Erlangen (ZEE) der Universitaet Erlangen
  • Georg-August-Universitaet Goettingen
  • Universitaetsklinik Mainz Neurologische Klinik
  • Universitaet Giessen / Marburg Neurologie
  • Theatinerstrasse 44
  • Universitaetsklinikum Ulm
  • Natl. Inst. of Psychiatry and Neurology
  • Orszagos Idegsebeszeti Tudomanyos Intezet
  • Barzilai Medical Center
  • Assaf Harofeh Medical Center
  • Rambam Medical Center
  • Wolfson Medical Center
  • Western Galilee Hospital
  • Chaim Sheba Medical Center
  • Kaplan Medical Center
  • Tel-Aviv Sourasky Medical Center
  • Specjalistyczna Przychodnia Lekarska Medikard
  • NZOZ Przychodnia Internistyczno - Stomatologiczna "Kendron"
  • Wojewodzki Szpital Specjalistyczny im.Mikolaja Kopernika
  • Katedra i Klinika Neurologii Slaskiej Akademii Medycznej
  • WSS im.Kardynala S. Wyszynskiego
  • Instytut Psychiatrii i Neurologii II Oddzial Neurologii
  • Prywatna Wielospecjalistyczna Lecznica Medyczna "Zycie"
  • Interregional Clinical Diagnostic Centre
  • City Hospital # 1
  • Clinic of Nervous Diseases of Sechenov's Moscow Med. Academy
  • District Antiepileptic Centre City Clinical Hospital # 71
  • Military Medical Academy n.a. S.M.Kirov
  • St.Petersburg State Medical University n.a. I.P.Pavlov
  • Triple M Research
  • University of the Free State
  • Wilgers MR & Medical Centre
  • Sunninghill & Kopano Clinical Trials
  • Johannesburg Hospital
  • Inkosi Albert Luthuli Central Hospital
  • Carl Bremer Hospital
  • Groote Schuur Hospital
  • Panorama Medi-Clinic
  • Hospital de La Santa Creu i Sant Pau
  • Hospital de Cruces
  • Hosp. Virgen de las Nieves
  • Hospital Ruber Internacional de Madrid
  • Hosp de Donostia
  • Hosp. Clinico Univ. Lozano Blesa
  • Psychosomatic Center of Dnepropetr. Regional Clinic
  • Kharkiv State Medical University
  • Institute of Neurology, Psychiatry and Narcology of AMS, Ukr
  • Epilepsy Center of Municipal Clinical Psychoneurological Hospital
  • Odessa Regional Clinical Hospital
  • The James Cook University Hospital
  • Fylde Coast Hospital
  • Western Infirmary (Epilepsy)
  • Walton Centre for Neurology & Neurosurgery
  • Royal London Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Placebo Comparator

Experimental

Experimental

Arm Label

Placebo

Retigabine 600 mg

Retigabine 900 mg

Arm Description

Outcomes

Primary Outcome Measures

Percent Change in the 28-day Total Partial Seizure (PS) Frequency From Baseline (BL) to the End of the Double-blind (DB) Phase (Titration and Maintenance Phases)
28-day total PS (PSs [also called focal seizures] are seizures limited to a specific area of the brain) frequency in the BL period = (Number [No.] of total PSs reported in the BL period divided by the No. of days of available total PS data in the BL period) x 28 days. 28-day total PS frequency in the DB period = (No. of total PSs reported in the DB period divided by the No. of days of available total PS data in the DB period) x 28 days. Percent change = ([value in the DB period minus value at BL] divided by the BL value) x 100%. Negative valu es indicate a reduction in seizure frequency.
Number of Participants Classified as Responders and Non-responders During the Maintenance Phase
Responders were participants with at least a 50% reduction in the 28-day total partial seizure frequency in the Maintenance Phase as compared to the Baseline period.

Secondary Outcome Measures

Number of Participants Who Were Responders and Non-responders During the DB Phase
Responders were participants with at least a 50% reduction in the 28-day total partial seizure frequency in the DB Phase as compared to the Baseline period. Participants without any post-baseline data were considered non-responders.
Percent Change From Baseline (BL) in the 28-day Total Partial Seizure Frequency During the Maintenance Phase
28-day total partial seizure frequency in the BL period = (No. of total partial seizures reported in the BL period divided by the No. of days of available total partial seizure data in the BL period) x 28 days. 28-day total partial seizure frequency in the Maintenance Phase = (No. of total partial seizures reported in the Maintenance Phase divided by the No. of days of available total partial seizure data in the same phase) x 28 days. Percent change = (value in the Maintenance Phase minus value at BL divided by the BL value) x 100%. Negative values indicate a reduction in seizure frequency.
Number of Participants With a Reduction in the 28-day Total Partial Seizure Frequency From Baseline to the End of DB Phase (Titration and Maintenance Phases) by Indicated Quartile Reduction Categories
Participants who experienced a reduction from Baseline in the 28-day total partial seizure frequency were categorized as having a reduction of 75-100%, 50-<75%, 25-<50%, or <25%, in addition to having no reduction. This quartile cutting was specified in the study protocol. Participants without any post-baseline data are included in the "No reduction" category.
Number of Participants With a Reduction in the 28-day Total Partial Seizure Frequency From Baseline to the DB Phase (Titration and Maintenance Phases) by Indicated Decile Reduction and Increase Categories
Participants who experienced a reduction from Baseline in the 28-day total partial seizure frequency were categorized in decile cutting, i.e., reduction categories of 90-100%, 80-<90%, 70-<80%, 60-<70%, 50-<60%, 40-<50%, 30-<40%, 20-<30%, 10-<20%, >0-<10%, and increase categories of 0-10%, >10-20%, >20-30%, >30% (FDA endpoint). Participants without any post-baseline data were included in the category 0-10% increase category.
Number of Participants With the Indicated Reduction From Baseline in the 28-day Total Partial Seizure Frequency During the Maintenance Phase
Participants who experienced a reduction from Baseline in the 28-day total partial seizure frequency were categorized as having a >75%, a 50-75%, or a <50% reduction, in addition to having no reduction (EMEA endpoint).
Number of Participants Who Experienced the Indicated Level of Exacerbation and Reduction in the 28-day Total Partial Seizure Frequency From Baseline During the Maintenance Phase
Participants who experienced an exacerbation from Baseline in the 28-day total partial seizure frequency were categorized as having a 0-25% or a >25% increase (EMEA endpoint). The number of participants experiencing a >0% reduction from Baseline in the 28-day total partial seizure frequency are also presented.
Number of Participants Reporting New Seizure Types in the Indicated Categories During the DB Phase (Titration and Maintenance Phases) That Were Not Reported at Baseline
New seizure types included those seizures which were not reported by any participant at Baseline.
Number of Participants Who Were Seizure-free During the DB Phase (Titration and Maintenance Phases)
Participants were considered to be seizure-free if they had not reported any seizures during the DB treatment period (Weeks 1-18). For a participant to be seizure free during the DB Phase, the participant had to be seizure free both Week 7 to Week 18 and Week 1 to Week 6. A participant could be seizure free Week 7 to Week 18 (during the Maintenance Phase), but not seizure free Week 1 to Week 6. Hence, there are fewer participants being reported as seizure free from Week 1 to Week 18 than from Week 7 to Week 18.
Number of Participants Who Were Seizure-free During the Maintenance Phase
Participants were considered to be seizure-free if they had not reported any seizures during the Maintenance Phase.
Percentage of Seizure-free Days During the DB Phase (Titration and Maintenance Phases)
A seizure-free day was a day without any seizures. For a participant to be seizure free during the DB Phase, the participant had to be seizure free both Week 7 to Week 18 and Week 1 to Week 6. A participant could be seizure free Week 7 to Week 18 (during the Maintenance Phase), but not seizure free Week 1 to Week 6. Hence, there are fewer participants being reported as seizure free from Week 1 to Week 18 than from Week 7 to Week 18. The percentage of seizure-free days was calculated as the total number of days without seizures in the DB period divided by the number of days in DB period x 100%.
Percentage of Seizure-free Days During the Maintenance Phase
A seizure-free day was a day without any seizures. The percentage of seizure-free days was calculated as the total number of days without seizures in the Maintenance Phase divided by the number of days in the Maintenance Phase x 100%.
Clinical Global Impression-Improvement (CGI-I) Score at the End of the Maintenance Phase
Clinical Global Impression of Improvement (CGI-I) is a 7-point scale that requires the clinician to assess how much the participant's illness has improved or worsened relative to a baseline state at the beginning of the treatment. Scores on the scale are rated as: 1, very much improved; 2, much improved; 3, minimally improved; 4, no change; 5, minimally worse; 6, much worse; or 7, very much worse.
Patient Global Impression (PGI) Score at the End of the Maintenance Phase
PGI is a participant-rated scale of improvement that was administered at the end of the Maintenance Phase in order to assess the participant's impression of his or her own improvement. PGI assessments were scored using a 7-point scale: 1, very much improved; 2, much improved; 3, minimally improved; 4, no change; 5, minimally worse; 6, much worse; or 7, very much worse.
Quality of Life Assessed by Quality of Life in Epilepsy-Problems Questionnaire (QOLIE-31-P) at BL (Week 0) and Weeks 4, 8, and 16
The QOLIE-31-P is a 31-item questionnaire evaluating a participant's QOL perception in 7 domains: seizure worry, emotional well being, energy/fatigue, cognitive functioning, medication effects, social functioning, overall QOL. Precoded numeric values for some domains are such that a higher number reflects a more favorable health state; others are such that a higher number reflects a less favorable state. Precoded values are first converted to 0-100 point scores; higher converted scores always reflect better QOL. The overall score is derived by weighting and then summing the 7 domain scores.
Number of Participants Whose Clinical Laboratory Values Were Deemed an Adverse Event by the Investigator (>=2% in Any Treatment Arm)
Clinically important changes in laboratory values were to be reported as an adverse event if they met one of the following criteria: (1) intervention required; (2) change in dose of study drug required; (3) other treatment/therapy required; (4) association with other diagnoses.
Number of Participants Who Reported the Indicated Renal and Urinary Disorder Adverse Events at a Frequency Threshold of 2% (in Any Treatment Arm)
A summary of the adverse events classified as renal or urinary disorders and in which at least 2% (rounded to an integer) of participants in any treatment arm reported during the study is presented.
Change From Baseline in Post-void Residual Urine Volume at Weeks 8 and 16 of the Maintenance Phase
Post-void residual (PVR) urine refers to the amount of urine remaining in the bladder after normal urination. To investigate the possible effects of retigabine on bladder function, all participants underwent post-void residual bladder ultrasound at Baseline and during the Maintenance Phase. The PVR bladder ultrasound was performed by a urologist, a qualified ultrasound technician, or a qualified study nurse who was certified to do PVR bladder ultrasound. Change from Baseline in PVR residual volume was calculated as the values at Week 10 and Week 16 minus the value at Baseline.
Number of Participants With a >=7% Increase in Body Weight During Weeks 2 and 4 of theTitration Phase and Weeks 6, 8, 12, and 16 of the Maintenance Phase
The number of participants with recorded weight gain of >=7% over their baseline weight was measured.

Full Information

First Posted
October 6, 2005
Last Updated
March 23, 2017
Sponsor
GlaxoSmithKline
Collaborators
Bausch Health Americas, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT00235755
Brief Title
Retigabine Efficacy and Safety Trial for Partial Onset Refractory Seizures in Epilepsy
Acronym
RESTORE2
Official Title
Randomized, Double-Blind, Placebo-Controlled, Multicenter, Parallel-Group Phase 3 Study - Determine Efficacy and Safety of Two Doses of Retigabine (900 Mg/Day and 600 Mg/Day) Used as Adjunctive Therapy in Refractory Epilepsy Patients With Partial-Onset Seizures
Study Type
Interventional

2. Study Status

Record Verification Date
March 2017
Overall Recruitment Status
Completed
Study Start Date
December 2005 (undefined)
Primary Completion Date
April 2008 (Actual)
Study Completion Date
April 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
GlaxoSmithKline
Collaborators
Bausch Health Americas, Inc.

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
This Phase 3 study is being conducted to evaluate the efficacy and safety of retigabine dosed at 900 mg/day and 600 mg/day, in three equally divided doses, compared with placebo in patients with epilepsy who are receiving up to three established antiepileptic drugs (AEDs).
Detailed Description
This Phase 3 study is being conducted in Europe, Israel, Australia, and South Africa to evaluate the efficacy and safety of retigabine dosed at 900 mg/day and 600 mg/day, in three equally divided doses, compared with placebo in patients with epilepsy who are receiving up to three established antiepileptic drugs (AEDs). The primary objective is to demonstrate a superior change in total partial seizure frequency for four weeks from baseline to the double-blind period. The proportion of responders (greater than or equal to 50% reduction in seizure frequency for four weeks from baseline to the double-blind period) will also be evaluated.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Seizures
Keywords
Partial Seizures, Complex Partial Seizures, Epilepsy, Potassium Channels, Anticonvulsant

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
539 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Title
Retigabine 600 mg
Arm Type
Experimental
Arm Title
Retigabine 900 mg
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Retigabine
Other Intervention Name(s)
GKE-841, D-23129
Intervention Description
Oral tablet. The starting daily dose will be 300 mg/day administered orally in three equally divided doses. This dosage will be increased by 150 mg/day (50 mg/dose) at 1-week intervals (titration phase). At the beginning of Week 3, patients will enter a 12 week maintenance phase.
Intervention Type
Drug
Intervention Name(s)
Retigabine
Other Intervention Name(s)
GKE-841, D-23129
Intervention Description
Oral tablet. The starting daily dose will be 300 mg/day administered orally in three equally divided doses. This dosage will be increased by 150 mg/day (50 mg/dose) at 1-week intervals (titration phase). At the beginning of Week 5, patients will enter a 12 week maintenance phase.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Oral tablet.
Primary Outcome Measure Information:
Title
Percent Change in the 28-day Total Partial Seizure (PS) Frequency From Baseline (BL) to the End of the Double-blind (DB) Phase (Titration and Maintenance Phases)
Description
28-day total PS (PSs [also called focal seizures] are seizures limited to a specific area of the brain) frequency in the BL period = (Number [No.] of total PSs reported in the BL period divided by the No. of days of available total PS data in the BL period) x 28 days. 28-day total PS frequency in the DB period = (No. of total PSs reported in the DB period divided by the No. of days of available total PS data in the DB period) x 28 days. Percent change = ([value in the DB period minus value at BL] divided by the BL value) x 100%. Negative valu es indicate a reduction in seizure frequency.
Time Frame
Baseline (Week -7 through Week 0), DB Phase (Week 1 through Week 16)
Title
Number of Participants Classified as Responders and Non-responders During the Maintenance Phase
Description
Responders were participants with at least a 50% reduction in the 28-day total partial seizure frequency in the Maintenance Phase as compared to the Baseline period.
Time Frame
Week 5 through Week 16
Secondary Outcome Measure Information:
Title
Number of Participants Who Were Responders and Non-responders During the DB Phase
Description
Responders were participants with at least a 50% reduction in the 28-day total partial seizure frequency in the DB Phase as compared to the Baseline period. Participants without any post-baseline data were considered non-responders.
Time Frame
Week 1 through Week 16
Title
Percent Change From Baseline (BL) in the 28-day Total Partial Seizure Frequency During the Maintenance Phase
Description
28-day total partial seizure frequency in the BL period = (No. of total partial seizures reported in the BL period divided by the No. of days of available total partial seizure data in the BL period) x 28 days. 28-day total partial seizure frequency in the Maintenance Phase = (No. of total partial seizures reported in the Maintenance Phase divided by the No. of days of available total partial seizure data in the same phase) x 28 days. Percent change = (value in the Maintenance Phase minus value at BL divided by the BL value) x 100%. Negative values indicate a reduction in seizure frequency.
Time Frame
Baseline (Week -7 through Week 0), Week 5 through Week 16
Title
Number of Participants With a Reduction in the 28-day Total Partial Seizure Frequency From Baseline to the End of DB Phase (Titration and Maintenance Phases) by Indicated Quartile Reduction Categories
Description
Participants who experienced a reduction from Baseline in the 28-day total partial seizure frequency were categorized as having a reduction of 75-100%, 50-<75%, 25-<50%, or <25%, in addition to having no reduction. This quartile cutting was specified in the study protocol. Participants without any post-baseline data are included in the "No reduction" category.
Time Frame
Baseline (Week -7 through Week 0), Week 1 through Week 16
Title
Number of Participants With a Reduction in the 28-day Total Partial Seizure Frequency From Baseline to the DB Phase (Titration and Maintenance Phases) by Indicated Decile Reduction and Increase Categories
Description
Participants who experienced a reduction from Baseline in the 28-day total partial seizure frequency were categorized in decile cutting, i.e., reduction categories of 90-100%, 80-<90%, 70-<80%, 60-<70%, 50-<60%, 40-<50%, 30-<40%, 20-<30%, 10-<20%, >0-<10%, and increase categories of 0-10%, >10-20%, >20-30%, >30% (FDA endpoint). Participants without any post-baseline data were included in the category 0-10% increase category.
Time Frame
Baseline (Week -7 through Week 0), Week 1 through Week 16
Title
Number of Participants With the Indicated Reduction From Baseline in the 28-day Total Partial Seizure Frequency During the Maintenance Phase
Description
Participants who experienced a reduction from Baseline in the 28-day total partial seizure frequency were categorized as having a >75%, a 50-75%, or a <50% reduction, in addition to having no reduction (EMEA endpoint).
Time Frame
Baseline (Week -7 through Week 0), Week 5 through Week 16
Title
Number of Participants Who Experienced the Indicated Level of Exacerbation and Reduction in the 28-day Total Partial Seizure Frequency From Baseline During the Maintenance Phase
Description
Participants who experienced an exacerbation from Baseline in the 28-day total partial seizure frequency were categorized as having a 0-25% or a >25% increase (EMEA endpoint). The number of participants experiencing a >0% reduction from Baseline in the 28-day total partial seizure frequency are also presented.
Time Frame
Baseline (Week -7 through Week 0), Week 5 through Week 16
Title
Number of Participants Reporting New Seizure Types in the Indicated Categories During the DB Phase (Titration and Maintenance Phases) That Were Not Reported at Baseline
Description
New seizure types included those seizures which were not reported by any participant at Baseline.
Time Frame
Baseline (Week -7 through Week 0), Week 1 through Week 16
Title
Number of Participants Who Were Seizure-free During the DB Phase (Titration and Maintenance Phases)
Description
Participants were considered to be seizure-free if they had not reported any seizures during the DB treatment period (Weeks 1-18). For a participant to be seizure free during the DB Phase, the participant had to be seizure free both Week 7 to Week 18 and Week 1 to Week 6. A participant could be seizure free Week 7 to Week 18 (during the Maintenance Phase), but not seizure free Week 1 to Week 6. Hence, there are fewer participants being reported as seizure free from Week 1 to Week 18 than from Week 7 to Week 18.
Time Frame
Week 1 through Week 16
Title
Number of Participants Who Were Seizure-free During the Maintenance Phase
Description
Participants were considered to be seizure-free if they had not reported any seizures during the Maintenance Phase.
Time Frame
Week 5 through Week 16
Title
Percentage of Seizure-free Days During the DB Phase (Titration and Maintenance Phases)
Description
A seizure-free day was a day without any seizures. For a participant to be seizure free during the DB Phase, the participant had to be seizure free both Week 7 to Week 18 and Week 1 to Week 6. A participant could be seizure free Week 7 to Week 18 (during the Maintenance Phase), but not seizure free Week 1 to Week 6. Hence, there are fewer participants being reported as seizure free from Week 1 to Week 18 than from Week 7 to Week 18. The percentage of seizure-free days was calculated as the total number of days without seizures in the DB period divided by the number of days in DB period x 100%.
Time Frame
Week 1 through Week 16
Title
Percentage of Seizure-free Days During the Maintenance Phase
Description
A seizure-free day was a day without any seizures. The percentage of seizure-free days was calculated as the total number of days without seizures in the Maintenance Phase divided by the number of days in the Maintenance Phase x 100%.
Time Frame
Week 5 through Week 16
Title
Clinical Global Impression-Improvement (CGI-I) Score at the End of the Maintenance Phase
Description
Clinical Global Impression of Improvement (CGI-I) is a 7-point scale that requires the clinician to assess how much the participant's illness has improved or worsened relative to a baseline state at the beginning of the treatment. Scores on the scale are rated as: 1, very much improved; 2, much improved; 3, minimally improved; 4, no change; 5, minimally worse; 6, much worse; or 7, very much worse.
Time Frame
Week 16/end of treatment phase
Title
Patient Global Impression (PGI) Score at the End of the Maintenance Phase
Description
PGI is a participant-rated scale of improvement that was administered at the end of the Maintenance Phase in order to assess the participant's impression of his or her own improvement. PGI assessments were scored using a 7-point scale: 1, very much improved; 2, much improved; 3, minimally improved; 4, no change; 5, minimally worse; 6, much worse; or 7, very much worse.
Time Frame
Week 16/end of treatment phase
Title
Quality of Life Assessed by Quality of Life in Epilepsy-Problems Questionnaire (QOLIE-31-P) at BL (Week 0) and Weeks 4, 8, and 16
Description
The QOLIE-31-P is a 31-item questionnaire evaluating a participant's QOL perception in 7 domains: seizure worry, emotional well being, energy/fatigue, cognitive functioning, medication effects, social functioning, overall QOL. Precoded numeric values for some domains are such that a higher number reflects a more favorable health state; others are such that a higher number reflects a less favorable state. Precoded values are first converted to 0-100 point scores; higher converted scores always reflect better QOL. The overall score is derived by weighting and then summing the 7 domain scores.
Time Frame
End of Baseline (Week 0), Weeks 4, 8, and 16
Title
Number of Participants Whose Clinical Laboratory Values Were Deemed an Adverse Event by the Investigator (>=2% in Any Treatment Arm)
Description
Clinically important changes in laboratory values were to be reported as an adverse event if they met one of the following criteria: (1) intervention required; (2) change in dose of study drug required; (3) other treatment/therapy required; (4) association with other diagnoses.
Time Frame
Week 1 through Week 16
Title
Number of Participants Who Reported the Indicated Renal and Urinary Disorder Adverse Events at a Frequency Threshold of 2% (in Any Treatment Arm)
Description
A summary of the adverse events classified as renal or urinary disorders and in which at least 2% (rounded to an integer) of participants in any treatment arm reported during the study is presented.
Time Frame
Week 1 through Week 16
Title
Change From Baseline in Post-void Residual Urine Volume at Weeks 8 and 16 of the Maintenance Phase
Description
Post-void residual (PVR) urine refers to the amount of urine remaining in the bladder after normal urination. To investigate the possible effects of retigabine on bladder function, all participants underwent post-void residual bladder ultrasound at Baseline and during the Maintenance Phase. The PVR bladder ultrasound was performed by a urologist, a qualified ultrasound technician, or a qualified study nurse who was certified to do PVR bladder ultrasound. Change from Baseline in PVR residual volume was calculated as the values at Week 10 and Week 16 minus the value at Baseline.
Time Frame
Baseline (Week -7 through 0), Weeks 8 and 16
Title
Number of Participants With a >=7% Increase in Body Weight During Weeks 2 and 4 of theTitration Phase and Weeks 6, 8, 12, and 16 of the Maintenance Phase
Description
The number of participants with recorded weight gain of >=7% over their baseline weight was measured.
Time Frame
Weeks 2 and 4 of Titration Phase and Weeks 6, 8, 12, and 16 of Maintenance Phase

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Diagnosis of refractory epilepsy with simple or complex partial onset seizures with or without secondary generalization 28-day partial seizure frequency rate of four or more partial seizures over the 8-week baseline phase Currently treated with up to three established AEDs Vagal Nerve Stimulator may be included Exclusion Criteria: Existing medical or psychiatric condition which could affect patient's health or compromise ability to participate in the study Clinically significant abnormalities on physical exam, vital signs, ECG, or liver function tests Impaired renal function (creatinine clearance less than 50 mL/minute) Evidence of progressive central nervous disease, lesion, or encephalopathy History of primary generalized seizures History of clustering or flurries or status epilepticus within 12 months of study entry
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
GSK Clinical Trials
Organizational Affiliation
GlaxoSmithKline
Official's Role
Study Director
Facility Information:
Facility Name
Mid-Atlantic Epilepsy and Sleep Center
City
Bethesda
State/Province
Maryland
ZIP/Postal Code
20817
Country
United States
Facility Name
Neurological Clinic-Texas
City
Dallas
State/Province
Texas
ZIP/Postal Code
75230
Country
United States
Facility Name
Royal Prince Alfred Hospital
City
Camperdown
State/Province
New South Wales
ZIP/Postal Code
2050
Country
Australia
Facility Name
North Coast Neurology Centre
City
Maroochydore
State/Province
Queensland
ZIP/Postal Code
4558
Country
Australia
Facility Name
Monash Medical Centre
City
Clayton
State/Province
Victoria
ZIP/Postal Code
3168
Country
Australia
Facility Name
Royal Melbourne Hospital
City
Parkville
State/Province
Victoria
ZIP/Postal Code
3050
Country
Australia
Facility Name
Austin & Repatriation Medical Centre
City
West Heidelberg
State/Province
Victoria
ZIP/Postal Code
3084
Country
Australia
Facility Name
A. Z. Middelheim -- Department of Neurology
City
Antwerp
ZIP/Postal Code
2020
Country
Belgium
Facility Name
AZ Sint-Jan
City
Brugge
ZIP/Postal Code
8000
Country
Belgium
Facility Name
Universitaire Ziekenhuizen Gasthuisberg -- Department Neurology
City
Leuven
ZIP/Postal Code
3000
Country
Belgium
Facility Name
Centre Neurologique William Lennox
City
Ottignies
ZIP/Postal Code
1340
Country
Belgium
Facility Name
Hopital Neurologique Pierre Wertheimer
City
Lyon
State/Province
Lyonnais
ZIP/Postal Code
69003
Country
France
Facility Name
CHU Pontchaillou
City
Rennes Cedex
ZIP/Postal Code
35033
Country
France
Facility Name
Hopital Civil de Strasbourg
City
Strasbourg
ZIP/Postal Code
67 67091
Country
France
Facility Name
Centre Medical de La Teppe
City
Tain L'Hermitage
ZIP/Postal Code
26 26600
Country
France
Facility Name
University of Bonn -- Department for Epileptplogy
City
Bonn
ZIP/Postal Code
D-53105
Country
Germany
Facility Name
Zentrum Epilepsie Erlangen (ZEE) der Universitaet Erlangen
City
Erlangen
ZIP/Postal Code
BY 91054
Country
Germany
Facility Name
Georg-August-Universitaet Goettingen
City
Goettingen
ZIP/Postal Code
NI 37075
Country
Germany
Facility Name
Universitaetsklinik Mainz Neurologische Klinik
City
Mainz
ZIP/Postal Code
RP 55101
Country
Germany
Facility Name
Universitaet Giessen / Marburg Neurologie
City
Marburg
ZIP/Postal Code
HE 35033
Country
Germany
Facility Name
Theatinerstrasse 44
City
Munich
ZIP/Postal Code
BY 80333
Country
Germany
Facility Name
Universitaetsklinikum Ulm
City
Ulm
ZIP/Postal Code
BW 89081
Country
Germany
Facility Name
Natl. Inst. of Psychiatry and Neurology
City
Budapest
ZIP/Postal Code
1021
Country
Hungary
Facility Name
Orszagos Idegsebeszeti Tudomanyos Intezet
City
Budapest
ZIP/Postal Code
1145
Country
Hungary
Facility Name
Barzilai Medical Center
City
Ashkelon
ZIP/Postal Code
78306
Country
Israel
Facility Name
Assaf Harofeh Medical Center
City
Beer Yaakov
ZIP/Postal Code
70300
Country
Israel
Facility Name
Rambam Medical Center
City
Haifa
ZIP/Postal Code
31096
Country
Israel
Facility Name
Wolfson Medical Center
City
Holon
ZIP/Postal Code
58100
Country
Israel
Facility Name
Western Galilee Hospital
City
Nahariya
ZIP/Postal Code
22100
Country
Israel
Facility Name
Chaim Sheba Medical Center
City
Ramat Gan
ZIP/Postal Code
52621
Country
Israel
Facility Name
Kaplan Medical Center
City
Rechovot
ZIP/Postal Code
76100
Country
Israel
Facility Name
Tel-Aviv Sourasky Medical Center
City
Tel Aviv
ZIP/Postal Code
64239
Country
Israel
Facility Name
Specjalistyczna Przychodnia Lekarska Medikard
City
Padlewskiego 4
State/Province
Plock
ZIP/Postal Code
09-402
Country
Poland
Facility Name
NZOZ Przychodnia Internistyczno - Stomatologiczna "Kendron"
City
Bialystok
ZIP/Postal Code
15-420
Country
Poland
Facility Name
Wojewodzki Szpital Specjalistyczny im.Mikolaja Kopernika
City
Gdansk
ZIP/Postal Code
80-803
Country
Poland
Facility Name
Katedra i Klinika Neurologii Slaskiej Akademii Medycznej
City
Katowice
ZIP/Postal Code
40-752
Country
Poland
Facility Name
WSS im.Kardynala S. Wyszynskiego
City
Lublin
ZIP/Postal Code
20-718
Country
Poland
Facility Name
Instytut Psychiatrii i Neurologii II Oddzial Neurologii
City
Warsaw
ZIP/Postal Code
02-957
Country
Poland
Facility Name
Prywatna Wielospecjalistyczna Lecznica Medyczna "Zycie"
City
Warsaw
ZIP/Postal Code
03-464
Country
Poland
Facility Name
Interregional Clinical Diagnostic Centre
City
Kazan
ZIP/Postal Code
420048
Country
Russian Federation
Facility Name
City Hospital # 1
City
Moscow
ZIP/Postal Code
117049
Country
Russian Federation
Facility Name
Clinic of Nervous Diseases of Sechenov's Moscow Med. Academy
City
Moscow
ZIP/Postal Code
119021
Country
Russian Federation
Facility Name
District Antiepileptic Centre City Clinical Hospital # 71
City
Moscow
ZIP/Postal Code
121374
Country
Russian Federation
Facility Name
Military Medical Academy n.a. S.M.Kirov
City
St. Petersburg
ZIP/Postal Code
194044
Country
Russian Federation
Facility Name
St.Petersburg State Medical University n.a. I.P.Pavlov
City
St. Petersburg
ZIP/Postal Code
197022
Country
Russian Federation
Facility Name
Triple M Research
City
Port Elizabeth
State/Province
East Cape
ZIP/Postal Code
6001
Country
South Africa
Facility Name
University of the Free State
City
Bloemfontein
State/Province
Gauteng
ZIP/Postal Code
9300
Country
South Africa
Facility Name
Wilgers MR & Medical Centre
City
Pretoria
State/Province
Gauteng
ZIP/Postal Code
0041
Country
South Africa
Facility Name
Sunninghill & Kopano Clinical Trials
City
Sunninghill
State/Province
Gauteng
ZIP/Postal Code
2157
Country
South Africa
Facility Name
Johannesburg Hospital
City
Johannesburg
State/Province
Gauten
ZIP/Postal Code
2193
Country
South Africa
Facility Name
Inkosi Albert Luthuli Central Hospital
City
Durban
State/Province
KwaZulu-Natal
ZIP/Postal Code
4091
Country
South Africa
Facility Name
Carl Bremer Hospital
City
Belville
State/Province
West Cape
ZIP/Postal Code
7531
Country
South Africa
Facility Name
Groote Schuur Hospital
City
Cape Town
State/Province
Western Cape
ZIP/Postal Code
7925
Country
South Africa
Facility Name
Panorama Medi-Clinic
City
Cape Town
ZIP/Postal Code
7550
Country
South Africa
Facility Name
Hospital de La Santa Creu i Sant Pau
City
Barcelona
ZIP/Postal Code
08025
Country
Spain
Facility Name
Hospital de Cruces
City
Bilbao
ZIP/Postal Code
48903
Country
Spain
Facility Name
Hosp. Virgen de las Nieves
City
Granada
ZIP/Postal Code
18013
Country
Spain
Facility Name
Hospital Ruber Internacional de Madrid
City
Madrid
ZIP/Postal Code
28034
Country
Spain
Facility Name
Hosp de Donostia
City
San Sebastian
ZIP/Postal Code
20014
Country
Spain
Facility Name
Hosp. Clinico Univ. Lozano Blesa
City
Zaragoza
ZIP/Postal Code
50009
Country
Spain
Facility Name
Psychosomatic Center of Dnepropetr. Regional Clinic
City
Dnepropetrovsk
ZIP/Postal Code
49616
Country
Ukraine
Facility Name
Kharkiv State Medical University
City
Kharkiv
ZIP/Postal Code
61022
Country
Ukraine
Facility Name
Institute of Neurology, Psychiatry and Narcology of AMS, Ukr
City
Kharkov
ZIP/Postal Code
61068
Country
Ukraine
Facility Name
Epilepsy Center of Municipal Clinical Psychoneurological Hospital
City
Kiev
ZIP/Postal Code
04080
Country
Ukraine
Facility Name
Odessa Regional Clinical Hospital
City
Odessa
ZIP/Postal Code
65025
Country
Ukraine
Facility Name
The James Cook University Hospital
City
Middlesbrough
State/Province
Mersyd
ZIP/Postal Code
T&W TS4 3BW
Country
United Kingdom
Facility Name
Fylde Coast Hospital
City
Blackpool
ZIP/Postal Code
LANARK FY3 8BP
Country
United Kingdom
Facility Name
Western Infirmary (Epilepsy)
City
Glasgow
ZIP/Postal Code
G11 6NT
Country
United Kingdom
Facility Name
Walton Centre for Neurology & Neurosurgery
City
Liverpool
ZIP/Postal Code
L9 7LJ
Country
United Kingdom
Facility Name
Royal London Hospital
City
London
ZIP/Postal Code
GT LON E1 1BB
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
20944074
Citation
Brodie MJ, Lerche H, Gil-Nagel A, Elger C, Hall S, Shin P, Nohria V, Mansbach H; RESTORE 2 Study Group. Efficacy and safety of adjunctive ezogabine (retigabine) in refractory partial epilepsy. Neurology. 2010 Nov 16;75(20):1817-24. doi: 10.1212/WNL.0b013e3181fd6170. Epub 2010 Oct 13.
Results Reference
background
PubMed Identifier
23342983
Citation
Tompson DJ, Crean CS. Clinical pharmacokinetics of retigabine/ezogabine. Curr Clin Pharmacol. 2013 Nov;8(4):319-31. doi: 10.2174/15748847113089990053.
Results Reference
background
PubMed Identifier
22428574
Citation
Brickel N, Gandhi P, VanLandingham K, Hammond J, DeRossett S. The urinary safety profile and secondary renal effects of retigabine (ezogabine): a first-in-class antiepileptic drug that targets KCNQ (K(v)7) potassium channels. Epilepsia. 2012 Apr;53(4):606-12. doi: 10.1111/j.1528-1167.2012.03441.x. Epub 2012 Mar 16.
Results Reference
background
PubMed Identifier
22512894
Citation
Porter RJ, Burdette DE, Gil-Nagel A, Hall ST, White R, Shaikh S, DeRossett SE. Retigabine as adjunctive therapy in adults with partial-onset seizures: integrated analysis of three pivotal controlled trials. Epilepsy Res. 2012 Aug;101(1-2):103-12. doi: 10.1016/j.eplepsyres.2012.03.010. Epub 2012 Apr 16.
Results Reference
derived
Links:
URL
https://www.clinicalstudydatarequest.com
Description
Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.
Available IPD and Supporting Information:
Available IPD/Information Type
Study Protocol
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
VRX-RET-E22-302
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register
Available IPD/Information Type
Individual Participant Data Set
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
VRX-RET-E22-302
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register
Available IPD/Information Type
Annotated Case Report Form
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
VRX-RET-E22-302
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register
Available IPD/Information Type
Clinical Study Report
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
VRX-RET-E22-302
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register
Available IPD/Information Type
Statistical Analysis Plan
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
VRX-RET-E22-302
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register
Available IPD/Information Type
Dataset Specification
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
VRX-RET-E22-302
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register
Available IPD/Information Type
Informed Consent Form
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
VRX-RET-E22-302
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register

Learn more about this trial

Retigabine Efficacy and Safety Trial for Partial Onset Refractory Seizures in Epilepsy

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