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Retigabine (Adjunctive Therapy) Efficacy and Safety Study for Partial Onset Refractory Seizures in Epilepsy (RESTORE1)

Primary Purpose

Seizures

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
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, Anticonvulsant, Complex Partial Seizures, Potassium Channels, Epilepsy

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

  • University of Alabama -- Department of Neurology/Epilepsy Center
  • North Alabama Neuroscience Research Associates
  • Neurology Clinic
  • Barrow Neurological Institute
  • Clinical Trials Inc.
  • UCSD Thornton Hospital
  • University of Southern California
  • West Los Angeles VA Healthcare Center
  • Delta Waves
  • University of Colorado Health Science Center
  • University of Florida -- Shands Jacksonville
  • University of Miami
  • Lovelace Scientific Resources
  • McFarland Clinic
  • University of Kentucky
  • Mid-Atlantic Epilepsy and Sleep Center
  • Henry Ford Hospital
  • Minnesota Epilepsy Group, P.A.
  • The Comprehensive Epilepsy Care Center for Children and Adults
  • Beth Israel Medical Center
  • Asheville Neurology Specialists
  • Medical University of Ohio at Toledo
  • Oregon Neurology PC
  • Milton S. Hershey Medical Center
  • Hospital of the University of Pennsylvania
  • Meharry Medical College
  • Vanderbilt University Medical Center
  • Medical City Dallas Hospital
  • Neurological Clinic of Texas
  • Memorial Hermann Hospital
  • University of Virginia Comprehensive Epilepsy Program
  • Virginia Commonwealth University Medical Center
  • Hospital Italiano de Buenos Aires
  • Hospital General de Agudos "Dr. J.M. Ramos Mejia"
  • Hospital General de Agudos "Dr. Teodoro Alvarez"
  • Fundacion Lennox
  • Sanatorio del Salvador II
  • Hospital Privado Centro Medico de Cordoba
  • Hospital Universitario Prof Edgard Santos -- UFBA
  • Hospital das Clinicas de Ribeirao Preto -- Universidade de Sa Neurologia
  • Hospital Sao Paulo -- Escola Paulista de Medicina -- UNIFESP
  • Hospital das Clinicas da Fac de Medicina de Sao Paulo
  • Foothills Medical Center
  • Glenrose Rehabilitation Center
  • Health Sciences Centre
  • CHUM -- Hôpital Notre-Dame
  • Instituto Nacional de Neurologia y Neurocirugia
  • Centro Medico
  • Hospital de Psiquiatria San Fernando, IMSS
  • CIF BIOTEC, Medica Sur
  • Antiguo Hospital Civil de Guadalajara
  • Hospital y Clinica OCA S.A. de C.V.
  • Hospital Central Dr. Ignacio Morones Prieto
  • instituto Nacional de Neurologia y Neurocirugia

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

Placebo

Retigabine

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 values indicate a reduction in seizure frequency.
Number of Participants Who Were Responders and Non-responders in 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 in 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 were included in the "No reduction" category.
Number of Participants With a Reduction in the 28-day Total Partial Seizure Frequency From Baseline to the End of 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 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 DB period divided by the number of days in the DB period 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 (QOL) Assessed by QOL in Epilepsy-Problems Questionnaire (QOLIE-31-P) at Baseline (Week 0) and Weeks 6, 10, and 18
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 10 and 18 of the DB Treatment 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 18 minus the value at Baseline.
Number of Participants With a >=7% Increase in Body Weight During Weeks 2, 4, and 6 of theTitration Phase and Weeks 7, 8, 10, 14, and 18 of the Maintenance Phase
The number of participants with recorded weight gain of >=7% over their baseline weight was measured.

Full Information

First Posted
September 30, 2005
Last Updated
October 26, 2016
Sponsor
GlaxoSmithKline
Collaborators
Bausch Health Americas, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT00232596
Brief Title
Retigabine (Adjunctive Therapy) Efficacy and Safety Study for Partial Onset Refractory Seizures in Epilepsy
Acronym
RESTORE1
Official Title
A Randomized, Double-Blind, Placebo-Controlled, Multicenter, Parallel-Group Phase 3 Study to Determine the Efficacy and Safety of Retigabine (1200 mg/Day) Used as Adjunctive Therapy in Refractory Epilepsy Patients With Partial-Onset Seizures
Study Type
Interventional

2. Study Status

Record Verification Date
October 2016
Overall Recruitment Status
Completed
Study Start Date
September 2005 (undefined)
Primary Completion Date
January 2008 (Actual)
Study Completion Date
January 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 1200 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 North America, Argentina, and Brazil to evaluate the efficacy and safety of retigabine dosed at 1200 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 total partial 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, Anticonvulsant, Complex Partial Seizures, Potassium Channels, Epilepsy

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Title
Retigabine
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Retigabine
Other Intervention Name(s)
D-23129, GKE-841
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 7, 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 values indicate a reduction in seizure frequency.
Time Frame
Baseline (Week -7 through Week 0), Week 1 through Week 18
Title
Number of Participants Who Were Responders and Non-responders in 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 7 through Week 18
Secondary Outcome Measure Information:
Title
Number of Participants Who Were Responders and Non-responders in 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 18
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 7 through Week 18
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 were included in the "No reduction" category.
Time Frame
Baseline (Week -7 through Week 0), Week 1 through Week 18
Title
Number of Participants With a Reduction in the 28-day Total Partial Seizure Frequency From Baseline to the End of 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 0-10% increase category.
Time Frame
Baseline (Week -7 through Week 0), Week 1 through Week 18
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 7 through Week 18
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 7 through Week 18
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 18
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 18
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 7 through Week 18
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 18
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 DB period divided by the number of days in the DB period x 100%.
Time Frame
Week 7 through Week 18
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 18/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 18/end of treatment phase
Title
Quality of Life (QOL) Assessed by QOL in Epilepsy-Problems Questionnaire (QOLIE-31-P) at Baseline (Week 0) and Weeks 6, 10, and 18
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 6, 10, and 18
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 24
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 24
Title
Change From Baseline in Post-void Residual Urine Volume at Weeks 10 and 18 of the DB Treatment 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 18 minus the value at Baseline.
Time Frame
Baseline (Week -7 through Week 0), Weeks 10 and 18
Title
Number of Participants With a >=7% Increase in Body Weight During Weeks 2, 4, and 6 of theTitration Phase and Weeks 7, 8, 10, 14, and 18 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, 4, 6 of Titration Phase and Weeks 7, 8, 10, 14, and 18 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
University of Alabama -- Department of Neurology/Epilepsy Center
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294
Country
United States
Facility Name
North Alabama Neuroscience Research Associates
City
Huntsville
State/Province
Alabama
ZIP/Postal Code
35801
Country
United States
Facility Name
Neurology Clinic
City
Northport
State/Province
Alabama
ZIP/Postal Code
35476
Country
United States
Facility Name
Barrow Neurological Institute
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85013
Country
United States
Facility Name
Clinical Trials Inc.
City
Little rock
State/Province
Arkansas
ZIP/Postal Code
72205
Country
United States
Facility Name
UCSD Thornton Hospital
City
La Jolla
State/Province
California
ZIP/Postal Code
92037
Country
United States
Facility Name
University of Southern California
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033
Country
United States
Facility Name
West Los Angeles VA Healthcare Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90073
Country
United States
Facility Name
Delta Waves
City
Colorado Springs
State/Province
Colorado
ZIP/Postal Code
80918
Country
United States
Facility Name
University of Colorado Health Science Center
City
Denver
State/Province
Colorado
ZIP/Postal Code
80010
Country
United States
Facility Name
University of Florida -- Shands Jacksonville
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32209
Country
United States
Facility Name
University of Miami
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Facility Name
Lovelace Scientific Resources
City
Sarasota
State/Province
Florida
ZIP/Postal Code
34233
Country
United States
Facility Name
McFarland Clinic
City
Ames
State/Province
Iowa
ZIP/Postal Code
50010
Country
United States
Facility Name
University of Kentucky
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40536
Country
United States
Facility Name
Mid-Atlantic Epilepsy and Sleep Center
City
Bethesda
State/Province
Maryland
ZIP/Postal Code
20817
Country
United States
Facility Name
Henry Ford Hospital
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48202
Country
United States
Facility Name
Minnesota Epilepsy Group, P.A.
City
St. Paul
State/Province
Minnesota
ZIP/Postal Code
55102
Country
United States
Facility Name
The Comprehensive Epilepsy Care Center for Children and Adults
City
Chesterfield
State/Province
Missouri
ZIP/Postal Code
63017
Country
United States
Facility Name
Beth Israel Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10003
Country
United States
Facility Name
Asheville Neurology Specialists
City
Asheville
State/Province
North Carolina
ZIP/Postal Code
28801
Country
United States
Facility Name
Medical University of Ohio at Toledo
City
Toledo
State/Province
Ohio
ZIP/Postal Code
43614
Country
United States
Facility Name
Oregon Neurology PC
City
Tualatin
State/Province
Oregon
ZIP/Postal Code
97062
Country
United States
Facility Name
Milton S. Hershey Medical Center
City
Hershey
State/Province
Pennsylvania
ZIP/Postal Code
17033
Country
United States
Facility Name
Hospital of the University of Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
Meharry Medical College
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37208
Country
United States
Facility Name
Vanderbilt University Medical Center
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37212
Country
United States
Facility Name
Medical City Dallas Hospital
City
Dallas
State/Province
Texas
ZIP/Postal Code
75230
Country
United States
Facility Name
Neurological Clinic of Texas
City
Dallas
State/Province
Texas
ZIP/Postal Code
75230
Country
United States
Facility Name
Memorial Hermann Hospital
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
University of Virginia Comprehensive Epilepsy Program
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22903
Country
United States
Facility Name
Virginia Commonwealth University Medical Center
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23298
Country
United States
Facility Name
Hospital Italiano de Buenos Aires
City
Capital Federal
State/Province
CBA
ZIP/Postal Code
C1181ACH
Country
Argentina
Facility Name
Hospital General de Agudos "Dr. J.M. Ramos Mejia"
City
Capital Federal
State/Province
CBA
ZIP/Postal Code
C1221ADC
Country
Argentina
Facility Name
Hospital General de Agudos "Dr. Teodoro Alvarez"
City
Capital Federal
State/Province
CBA
ZIP/Postal Code
C1406FWY
Country
Argentina
Facility Name
Fundacion Lennox
City
Cordoba
State/Province
CRD
ZIP/Postal Code
5000
Country
Argentina
Facility Name
Sanatorio del Salvador II
City
Cordoba
State/Province
CRD
ZIP/Postal Code
5000
Country
Argentina
Facility Name
Hospital Privado Centro Medico de Cordoba
City
Cordoba
State/Province
CRD
ZIP/Postal Code
X5016KEH
Country
Argentina
Facility Name
Hospital Universitario Prof Edgard Santos -- UFBA
City
Salvador
State/Province
BA
ZIP/Postal Code
40110-060
Country
Brazil
Facility Name
Hospital das Clinicas de Ribeirao Preto -- Universidade de Sa Neurologia
City
Ribeirao Preto
State/Province
SP
ZIP/Postal Code
14048-900
Country
Brazil
Facility Name
Hospital Sao Paulo -- Escola Paulista de Medicina -- UNIFESP
City
Sao Paulo
State/Province
SP
ZIP/Postal Code
04024 002
Country
Brazil
Facility Name
Hospital das Clinicas da Fac de Medicina de Sao Paulo
City
Sao Paulo
State/Province
SP
ZIP/Postal Code
05403-900
Country
Brazil
Facility Name
Foothills Medical Center
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T2N 2T9
Country
Canada
Facility Name
Glenrose Rehabilitation Center
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T5G 0B7
Country
Canada
Facility Name
Health Sciences Centre
City
St. John's
State/Province
Newfoundland and Labrador
ZIP/Postal Code
A1B 3V6
Country
Canada
Facility Name
CHUM -- Hôpital Notre-Dame
City
Montréal
State/Province
Quebec
ZIP/Postal Code
H2L 4M1
Country
Canada
Facility Name
Instituto Nacional de Neurologia y Neurocirugia
City
La Fama
State/Province
DF
ZIP/Postal Code
42690
Country
Mexico
Facility Name
Centro Medico
City
Mexico
State/Province
DF
ZIP/Postal Code
03229
Country
Mexico
Facility Name
Hospital de Psiquiatria San Fernando, IMSS
City
Mexico
State/Province
DF
ZIP/Postal Code
14050
Country
Mexico
Facility Name
CIF BIOTEC, Medica Sur
City
Tlalpan
State/Province
DF
ZIP/Postal Code
14050
Country
Mexico
Facility Name
Antiguo Hospital Civil de Guadalajara
City
Guadalajara
State/Province
Jalisco
ZIP/Postal Code
44280
Country
Mexico
Facility Name
Hospital y Clinica OCA S.A. de C.V.
City
Monterrey
State/Province
Nuevo Leon
ZIP/Postal Code
64000
Country
Mexico
Facility Name
Hospital Central Dr. Ignacio Morones Prieto
City
San Luis Potosi
State/Province
SLP
ZIP/Postal Code
78250
Country
Mexico
Facility Name
instituto Nacional de Neurologia y Neurocirugia
City
Mexico, DF
Country
Mexico

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
Citations:
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
Clinical Study Report
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
VRX-RET-E22-301
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register
Available IPD/Information Type
Study Protocol
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
VRX-RET-E22-301
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-E22-301
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-E22-301
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-E22-301
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-E22-301
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-E22-301
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register

Learn more about this trial

Retigabine (Adjunctive Therapy) Efficacy and Safety Study for Partial Onset Refractory Seizures in Epilepsy

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