Retigabine (Adjunctive Therapy) Efficacy and Safety Study for Partial Onset Refractory Seizures in Epilepsy
RESTORE1
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
1 other identifier
interventional
306
5 countries
54
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Sep 2005
54 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2005
CompletedFirst Submitted
Initial submission to the registry
September 30, 2005
CompletedFirst Posted
Study publicly available on registry
October 4, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2008
CompletedResults Posted
Study results publicly available
October 25, 2011
CompletedDecember 8, 2016
October 1, 2016
2.3 years
September 30, 2005
July 7, 2011
October 26, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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.
Baseline (Week -7 through Week 0), Week 1 through Week 18
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.
Week 7 through Week 18
Secondary Outcomes (18)
Number of Participants Who Were Responders and Non-responders in the DB Phase
Week 1 through Week 18
Percent Change From Baseline (BL) in the 28-day Total Partial Seizure Frequency During the Maintenance Phase
Baseline (Week -7 through Week 0), Week 7 through Week 18
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
Baseline (Week -7 through Week 0), Week 1 through Week 18
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
Baseline (Week -7 through Week 0), Week 1 through Week 18
Number of Participants With the Indicated Reduction From Baseline in the 28-day Total Partial Seizure Frequency During the Maintenance Phase
Baseline (Week -7 through Week 0), Week 7 through Week 18
- +13 more secondary outcomes
Study Arms (2)
Placebo
PLACEBO COMPARATORRetigabine
EXPERIMENTALInterventions
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
Eligibility Criteria
You may qualify if:
- Diagnosis of refractory epilepsy with simple or complex partial onset seizures with or without secondary generalization
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- GlaxoSmithKlinelead
- Bausch Health Americas, Inc.collaborator
Study Sites (54)
University of Alabama -- Department of Neurology/Epilepsy Center
Birmingham, Alabama, 35294, United States
North Alabama Neuroscience Research Associates
Huntsville, Alabama, 35801, United States
Neurology Clinic
Northport, Alabama, 35476, United States
Barrow Neurological Institute
Phoenix, Arizona, 85013, United States
Clinical Trials Inc.
Little Rock, Arkansas, 72205, United States
UCSD Thornton Hospital
La Jolla, California, 92037, United States
University of Southern California
Los Angeles, California, 90033, United States
West Los Angeles VA Healthcare Center
Los Angeles, California, 90073, United States
Delta Waves
Colorado Springs, Colorado, 80918, United States
University of Colorado Health Science Center
Denver, Colorado, 80010, United States
University of Florida -- Shands Jacksonville
Jacksonville, Florida, 32209, United States
University of Miami
Miami, Florida, 33136, United States
Lovelace Scientific Resources
Sarasota, Florida, 34233, United States
McFarland Clinic
Ames, Iowa, 50010, United States
University of Kentucky
Lexington, Kentucky, 40536, United States
Mid-Atlantic Epilepsy and Sleep Center
Bethesda, Maryland, 20817, United States
Henry Ford Hospital
Detroit, Michigan, 48202, United States
Minnesota Epilepsy Group, P.A.
Saint Paul, Minnesota, 55102, United States
The Comprehensive Epilepsy Care Center for Children and Adults
Chesterfield, Missouri, 63017, United States
Beth Israel Medical Center
New York, New York, 10003, United States
Asheville Neurology Specialists
Asheville, North Carolina, 28801, United States
Medical University of Ohio at Toledo
Toledo, Ohio, 43614, United States
Oregon Neurology PC
Tualatin, Oregon, 97062, United States
Milton S. Hershey Medical Center
Hershey, Pennsylvania, 17033, United States
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, 19104, United States
Meharry Medical College
Nashville, Tennessee, 37208, United States
Vanderbilt University Medical Center
Nashville, Tennessee, 37212, United States
Medical City Dallas Hospital
Dallas, Texas, 75230, United States
Neurological Clinic of Texas
Dallas, Texas, 75230, United States
Memorial Hermann Hospital
Houston, Texas, 77030, United States
University of Virginia Comprehensive Epilepsy Program
Charlottesville, Virginia, 22903, United States
Virginia Commonwealth University Medical Center
Richmond, Virginia, 23298, United States
Hospital Italiano de Buenos Aires
Capital Federal, CBA, C1181ACH, Argentina
Hospital General de Agudos "Dr. J.M. Ramos Mejia"
Capital Federal, CBA, C1221ADC, Argentina
Hospital General de Agudos "Dr. Teodoro Alvarez"
Capital Federal, CBA, C1406FWY, Argentina
Fundacion Lennox
Córdoba, CRD, 5000, Argentina
Sanatorio del Salvador II
Córdoba, CRD, 5000, Argentina
Hospital Privado Centro Medico de Cordoba
Córdoba, CRD, X5016KEH, Argentina
Hospital Universitario Prof Edgard Santos -- UFBA
Salvador, Estado de Bahia, 40110-060, Brazil
Hospital das Clinicas de Ribeirao Preto -- Universidade de Sa Neurologia
Ribeirão Preto, São Paulo, 14048-900, Brazil
Hospital Sao Paulo -- Escola Paulista de Medicina -- UNIFESP
São Paulo, São Paulo, 04024 002, Brazil
Hospital das Clinicas da Fac de Medicina de Sao Paulo
São Paulo, São Paulo, 05403-900, Brazil
Foothills Medical Center
Calgary, Alberta, T2N 2T9, Canada
Glenrose Rehabilitation Center
Edmonton, Alberta, T5G 0B7, Canada
Health Sciences Centre
St. John's, Newfoundland and Labrador, A1B 3V6, Canada
CHUM -- Hôpital Notre-Dame
Montreal, Quebec, H2L 4M1, Canada
Antiguo Hospital Civil de Guadalajara
Guadalajara, Jalisco, 44280, Mexico
Instituto Nacional de Neurologia y Neurocirugia
La Fama, Mexico City, 42690, Mexico
Centro Medico
Mexico City, Mexico City, 03229, Mexico
Hospital de Psiquiatria San Fernando, IMSS
Mexico City, Mexico City, 14050, Mexico
CIF BIOTEC, Medica Sur
Tlalpan, Mexico City, 14050, Mexico
Hospital y Clinica OCA S.A. de C.V.
Monterrey, Nuevo León, 64000, Mexico
Hospital Central Dr. Ignacio Morones Prieto
San Luis Potosí City, San Luis Potosí, 78250, Mexico
instituto Nacional de Neurologia y Neurocirugia
Mexico City, Mexico
Related Publications (1)
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.
PMID: 22512894DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- GSK Response Center
- Organization
- GlaxoSmithKline
Study Officials
- STUDY DIRECTOR
GSK Clinical Trials
GlaxoSmithKline
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 30, 2005
First Posted
October 4, 2005
Study Start
September 1, 2005
Primary Completion
January 1, 2008
Study Completion
January 1, 2008
Last Updated
December 8, 2016
Results First Posted
October 25, 2011
Record last verified: 2016-10
Data Sharing
- IPD Sharing
- Will share
Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.