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

26. Oktober 2016 aktualisiert von: GlaxoSmithKline

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

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).

Studienübersicht

Status

Abgeschlossen

Bedingungen

Intervention / Behandlung

Detaillierte Beschreibung

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.

Studientyp

Interventionell

Einschreibung (Tatsächlich)

306

Phase

  • Phase 3

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienorte

  • Argentinien
    • CBA
      • Capital Federal, CBA, Argentinien, C1181ACH
        • Hospital Italiano de Buenos Aires
      • Capital Federal, CBA, Argentinien, C1221ADC
        • Hospital General de Agudos "Dr. J.M. Ramos Mejia"
      • Capital Federal, CBA, Argentinien, C1406FWY
        • Hospital General de Agudos "Dr. Teodoro Alvarez"
    • CRD
      • Cordoba, CRD, Argentinien, 5000
        • Fundacion Lennox
      • Cordoba, CRD, Argentinien, 5000
        • Sanatorio del Salvador II
      • Cordoba, CRD, Argentinien, X5016KEH
        • Hospital Privado Centro Medico de Cordoba
  • Brasilien
    • BA
      • Salvador, BA, Brasilien, 40110-060
        • Hospital Universitario Prof Edgard Santos -- UFBA
    • SP
      • Ribeirao Preto, SP, Brasilien, 14048-900
        • Hospital das Clinicas de Ribeirao Preto -- Universidade de Sa Neurologia
      • Sao Paulo, SP, Brasilien, 04024 002
        • Hospital Sao Paulo -- Escola Paulista de Medicina -- UNIFESP
      • Sao Paulo, SP, Brasilien, 05403-900
        • Hospital das Clinicas da Fac de Medicina de Sao Paulo
  • Kanada
    • Alberta
      • Calgary, Alberta, Kanada, T2N 2T9
        • Foothills Medical Center
      • Edmonton, Alberta, Kanada, T5G 0B7
        • Glenrose Rehabilitation Center
    • Newfoundland and Labrador
      • St. John's, Newfoundland and Labrador, Kanada, A1B 3V6
        • Health Sciences Centre
    • Quebec
      • Montréal, Quebec, Kanada, H2L 4M1
        • CHUM -- Hôpital Notre-Dame
  • Mexiko
      • Mexico, DF, Mexiko
        • Instituto Nacional de Neurologia y Neurocirugia
    • DF
      • La Fama, DF, Mexiko, 42690
        • Instituto Nacional de Neurologia y Neurocirugia
      • Mexico, DF, Mexiko, 03229
        • Centro Medico
      • Mexico, DF, Mexiko, 14050
        • Hospital de Psiquiatria San Fernando, IMSS
      • Tlalpan, DF, Mexiko, 14050
        • CIF BIOTEC, Medica Sur
    • Jalisco
      • Guadalajara, Jalisco, Mexiko, 44280
        • Antiguo Hospital Civil de Guadalajara
    • Nuevo Leon
      • Monterrey, Nuevo Leon, Mexiko, 64000
        • Hospital y Clinica OCA S.A. de C.V.
    • SLP
      • San Luis Potosi, SLP, Mexiko, 78250
        • Hospital Central Dr. Ignacio Morones Prieto
  • Vereinigte Staaten
    • Alabama
      • Birmingham, Alabama, Vereinigte Staaten, 35294
        • University of Alabama -- Department of Neurology/Epilepsy Center
      • Huntsville, Alabama, Vereinigte Staaten, 35801
        • North Alabama Neuroscience Research Associates
      • Northport, Alabama, Vereinigte Staaten, 35476
        • Neurology Clinic
    • Arizona
      • Phoenix, Arizona, Vereinigte Staaten, 85013
        • Barrow Neurological Institute
    • Arkansas
      • Little rock, Arkansas, Vereinigte Staaten, 72205
        • Clinical Trials Inc.
    • California
      • La Jolla, California, Vereinigte Staaten, 92037
        • UCSD Thornton Hospital
      • Los Angeles, California, Vereinigte Staaten, 90033
        • University of Southern California
      • Los Angeles, California, Vereinigte Staaten, 90073
        • West Los Angeles VA Healthcare Center
    • Colorado
      • Colorado Springs, Colorado, Vereinigte Staaten, 80918
        • Delta Waves
      • Denver, Colorado, Vereinigte Staaten, 80010
        • University of Colorado Health Science Center
    • Florida
      • Jacksonville, Florida, Vereinigte Staaten, 32209
        • University of Florida -- Shands Jacksonville
      • Miami, Florida, Vereinigte Staaten, 33136
        • University of Miami
      • Sarasota, Florida, Vereinigte Staaten, 34233
        • Lovelace Scientific Resources
    • Iowa
      • Ames, Iowa, Vereinigte Staaten, 50010
        • McFarland Clinic
    • Kentucky
      • Lexington, Kentucky, Vereinigte Staaten, 40536
        • University of Kentucky
    • Maryland
      • Bethesda, Maryland, Vereinigte Staaten, 20817
        • Mid-Atlantic Epilepsy and Sleep Center
    • Michigan
      • Detroit, Michigan, Vereinigte Staaten, 48202
        • Henry Ford Hospital
    • Minnesota
      • St. Paul, Minnesota, Vereinigte Staaten, 55102
        • Minnesota Epilepsy Group, P.A.
    • Missouri
      • Chesterfield, Missouri, Vereinigte Staaten, 63017
        • The Comprehensive Epilepsy Care Center for Children and Adults
    • New York
      • New York, New York, Vereinigte Staaten, 10003
        • Beth Israel Medical Center
    • North Carolina
      • Asheville, North Carolina, Vereinigte Staaten, 28801
        • Asheville Neurology Specialists
    • Ohio
      • Toledo, Ohio, Vereinigte Staaten, 43614
        • Medical University of Ohio at Toledo
    • Oregon
      • Tualatin, Oregon, Vereinigte Staaten, 97062
        • Oregon Neurology PC
    • Pennsylvania
      • Hershey, Pennsylvania, Vereinigte Staaten, 17033
        • Milton S. Hershey Medical Center
      • Philadelphia, Pennsylvania, Vereinigte Staaten, 19104
        • Hospital of the University of Pennsylvania
    • Tennessee
      • Nashville, Tennessee, Vereinigte Staaten, 37212
        • Vanderbilt University Medical Center
      • Nashville, Tennessee, Vereinigte Staaten, 37208
        • Meharry Medical College
    • Texas
      • Dallas, Texas, Vereinigte Staaten, 75230
        • Medical City Dallas Hospital
      • Dallas, Texas, Vereinigte Staaten, 75230
        • Neurological Clinic of Texas
      • Houston, Texas, Vereinigte Staaten, 77030
        • Memorial Hermann Hospital
    • Virginia
      • Charlottesville, Virginia, Vereinigte Staaten, 22903
        • University of Virginia Comprehensive Epilepsy Program
      • Richmond, Virginia, Vereinigte Staaten, 23298
        • Virginia Commonwealth University Medical Center

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

18 Jahre bis 75 Jahre (Erwachsene, Älterer Erwachsener)

Akzeptiert gesunde Freiwillige

Nein

Studienberechtigte Geschlechter

Alle

Beschreibung

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

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Behandlung
  • Zuteilung: Zufällig
  • Interventionsmodell: Parallele Zuordnung
  • Maskierung: Doppelt

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Placebo-Komparator: Placebo
Arzneimittel: Placebo
Orale Tablette.
Experimental: Retigabine
Arzneimittel: Retigabine
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
Andere Namen:
  • GKE-841
  • D-23129

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
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)
Zeitfenster: Baseline (Week -7 through Week 0), Week 1 through Week 18
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
Zeitfenster: Week 7 through Week 18
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

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Number of Participants Who Were Responders and Non-responders in the DB Phase
Zeitfenster: Week 1 through Week 18
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.
Week 1 through Week 18
Percent Change From Baseline (BL) in the 28-day Total Partial Seizure Frequency During the Maintenance Phase
Zeitfenster: Baseline (Week -7 through Week 0), Week 7 through Week 18
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.
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
Zeitfenster: Baseline (Week -7 through Week 0), Week 1 through Week 18
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.
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
Zeitfenster: Baseline (Week -7 through Week 0), Week 1 through Week 18
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.
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
Zeitfenster: Baseline (Week -7 through Week 0), Week 7 through Week 18
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).
Baseline (Week -7 through Week 0), Week 7 through Week 18
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
Zeitfenster: Baseline (Week -7 through Week 0), Week 7 through Week 18
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.
Baseline (Week -7 through Week 0), Week 7 through Week 18
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
Zeitfenster: Baseline (Week -7 through Week 0), Week 1 through Week 18
New seizure types included those seizures which were not reported by any participant at Baseline.
Baseline (Week -7 through Week 0), Week 1 through Week 18
Number of Participants Who Were Seizure-free During the DB Phase (Titration and Maintenance Phases)
Zeitfenster: Week 1 through Week 18
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.
Week 1 through Week 18
Number of Participants Who Were Seizure-free During the Maintenance Phase
Zeitfenster: Week 7 through Week 18
Participants were considered to be seizure-free if they had not reported any seizures during the Maintenance Phase.
Week 7 through Week 18
Percentage of Seizure-free Days During the DB Phase (Titration and Maintenance Phases)
Zeitfenster: Week 1 through Week 18
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%.
Week 1 through Week 18
Percentage of Seizure-free Days During the Maintenance Phase
Zeitfenster: Week 7 through Week 18
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%.
Week 7 through Week 18
Clinical Global Impression-Improvement (CGI-I) Score at the End of the Maintenance Phase
Zeitfenster: Week 18/end of treatment 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.
Week 18/end of treatment phase
Patient Global Impression (PGI) Score at the End of the Maintenance Phase
Zeitfenster: Week 18/end of treatment 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.
Week 18/end of treatment phase
Quality of Life (QOL) Assessed by QOL in Epilepsy-Problems Questionnaire (QOLIE-31-P) at Baseline (Week 0) and Weeks 6, 10, and 18
Zeitfenster: End of Baseline (Week 0), 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.
End of Baseline (Week 0), Weeks 6, 10, and 18
Number of Participants Whose Clinical Laboratory Values Were Deemed an Adverse Event by the Investigator (>=2% in Any Treatment Arm)
Zeitfenster: Week 1 through Week 24
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.
Week 1 through Week 24
Number of Participants Who Reported the Indicated Renal and Urinary Disorder Adverse Events at a Frequency Threshold of 2% (in Any Treatment Arm)
Zeitfenster: Week 1 through Week 24
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.
Week 1 through Week 24
Change From Baseline in Post-void Residual Urine Volume at Weeks 10 and 18 of the DB Treatment Phase
Zeitfenster: Baseline (Week -7 through Week 0), Weeks 10 and 18
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.
Baseline (Week -7 through Week 0), Weeks 10 and 18
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
Zeitfenster: Weeks 2, 4, 6 of Titration Phase and Weeks 7, 8, 10, 14, and 18 of Maintenance Phase
The number of participants with recorded weight gain of >=7% over their baseline weight was measured.
Weeks 2, 4, 6 of Titration Phase and Weeks 7, 8, 10, 14, and 18 of Maintenance Phase

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

GlaxoSmithKline

Mitarbeiter

Bausch Health Americas, Inc.

Publikationen und hilfreiche Links

Die Bereitstellung dieser Publikationen erfolgt freiwillig durch die für die Eingabe von Informationen über die Studie verantwortliche Person. Diese können sich auf alles beziehen, was mit dem Studium zu tun hat.

Allgemeine Veröffentlichungen

Nützliche Links

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn

1. September 2005

Primärer Abschluss (Tatsächlich)

1. Januar 2008

Studienabschluss (Tatsächlich)

1. Januar 2008

Studienanmeldedaten

Zuerst eingereicht

30. September 2005

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

30. September 2005

Zuerst gepostet (Schätzen)

4. Oktober 2005

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Schätzen)

8. Dezember 2016

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

26. Oktober 2016

Zuletzt verifiziert

1. Oktober 2016

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Schlüsselwörter

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • VRX-RET-E22-301

Plan für individuelle Teilnehmerdaten (IPD)

Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?

JA

Beschreibung des IPD-Plans

Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.

Studiendaten/Dokumente

  1. Klinischer Studienbericht
    Informationskennung: VRX-RET-E22-301
    Informationskommentare: For additional information about this study please refer to the GSK Clinical Study Register
  2. Studienprotokoll
    Informationskennung: VRX-RET-E22-301
    Informationskommentare: For additional information about this study please refer to the GSK Clinical Study Register
  3. Kommentiertes Fallberichtsformular
    Informationskennung: VRX-RET-E22-301
    Informationskommentare: For additional information about this study please refer to the GSK Clinical Study Register
  4. Datensatzspezifikation
    Informationskennung: VRX-RET-E22-301
    Informationskommentare: For additional information about this study please refer to the GSK Clinical Study Register
  5. Einzelner Teilnehmerdatensatz
    Informationskennung: VRX-RET-E22-301
    Informationskommentare: For additional information about this study please refer to the GSK Clinical Study Register
  6. Statistischer Analyseplan
    Informationskennung: VRX-RET-E22-301
    Informationskommentare: For additional information about this study please refer to the GSK Clinical Study Register
  7. Einwilligungserklärung
    Informationskennung: VRX-RET-E22-301
    Informationskommentare: For additional information about this study please refer to the GSK Clinical Study Register

Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .

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