Last updated: 07/14/2020 15:20:08
Open-label Extension Study of the Phase 3 VRX-RET-E22-301 Double-Blind Trial
GSK study ID
VRX-RET-E22-303
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Completed
Completed
Trial overview
Official title: A multicenter, open-label, long-term, safety, tolerability and efficacy study of retigabine in adult epilepsy patients with partial-onset seizures (Extension of study VRX-RET-E22-301)
Trial description: The purpose of this study is to evaluate the safety and tolerability of long-term therapy with retigabine administered as adjunctive therapy in adult epilepsy patients with partial-onset seizures, who completed the VRX-RET-E22-301 double-blind study. The efficacy of long-term treatment with retigabine and patient quality of life will also be assessed.
Primary purpose:
Treatment
Trial design:
Single Group Assignment
Masking:
None (Open Label)
Allocation:
Not applicable
Primary outcomes:
Number of participants with Treatment-emergent Serious Adverse Event (SAE) and Adverse Event (AE)
Timeframe: Assessed up to a maximum of 9 years
Number of participants with Treatment-emergent Adverse Events Leading to Withdrawal from Study Drug
Timeframe: Assessed up to a maximum of 9 years
Kaplan-Meier estimate of the Probability of Discontinuation (d/c) from Study Drug
Timeframe: Assessed up to a maximum of 9 years
Change from Baseline in Blood pressure
Timeframe: Baseline and Up to Month 108
Change from Baseline in heart rate
Timeframe: Baseline and Up to Month 108
Change from Baseline in body temperature
Timeframe: Baseline and Up to Month 108
Change from Baseline in weight
Timeframe: Baseline and Up to Month 108
Change from Baseline in the 12-lead electrocardiogram (ECG) parameters-PR Interval, QRS Duration, Uncorrected QT (uQT) Interval, Corrected QT (Bazett's correction) interval (QTcB), Corrected QT (Friedericia's correction) interval (QTcF)
Timeframe: Baseline and Up to Month 108
Change from Baseline in the 12-lead electrocardiogram (ECG) parameter-RR Interval
Timeframe: Baseline and Up to Month 108
Change from Baseline in electrocardiogram (ECG) parameter-QRS Axis
Timeframe: Baseline and Up to Month 108
Change from Baseline in hematology parameters- Bands, Basophils, Eosinophils, Lymphocytes, Metamyelocyte, Monocytes, Neutrophils, Platelets, White Blood Cells Count (WBC)
Timeframe: Baseline and Up to Month 108
Change from Baseline in hematology parameter-Red Blood Cell count
Timeframe: Baseline and Up to Month 108
Change from Baseline in Haematocrit
Timeframe: Baseline and Up to Month 108
Change from Baseline in Haemoglobin
Timeframe: Baseline and Up to Month 108
Change from Baseline in Chemistry parameters-Alkaline phosphatase (AP), Alanine aminotransferase (ALT), Aspartate aminotransferase (AST)
Timeframe: Baseline and Up to Month 108
Change from Baseline in Chemistry parameters-Bicarbonate, Blood urea nitrogen (BUN), Calcium, Chloride, Cholesterol, Non-fasting glucose, Phosphorus, Potassium, Sodium, Urea
Timeframe: Baseline and Up to Month 108
Change from Baseline in Chemistry parameters -Creatinine, Total bilirubin (TB), Uric acid (UA)
Timeframe: Baseline and Up to Month 108
Change from Baseline in Chemistry parameter-Total Protein
Timeframe: Baseline and Up to Month 108
Change from Baseline in Urine Specific gravity
Timeframe: Baseline and Up to Month 108
Change from Baseline in Urine power of hydrogen (pH)
Timeframe: Baseline and Up to Month 108
Change from Baseline in post-void residual bladder ultrasound volume
Timeframe: Baseline and Up to Month 108
Change from Baseline in Overall American Urological Association (AUA) Symptom Index Score
Timeframe: Baseline and Up to Month 108
Number of participants with Abnormal Results in Physical Examination
Timeframe: Up to Month 108
Number of participants with Abnormal Results of Neurological Examination
Timeframe: Up to Month 108
Number of participants with pigmentation of non-retinal ocular tissue
Timeframe: Assessed up to a maximum of 9 years
Number of participants with pigmentation of retinal ocular tissue
Timeframe: Assessed up to a maximum of 9 years
Number of participants with abnormal pigmentation of skin, including the skin around the eyes and the eyelids, lips, nails, or mucosa
Timeframe: Assessed up to a maximum of 9 years
Number of participants with a clinically significant decrease in visual acuity from initial examination
Timeframe: Assessed up to a maximum of 9 years
Number of participants with a decrease in confrontational visual field from initial examination
Timeframe: Assessed up to a maximum of 9 years
Number of Participants With Resolution of Abnormal Eye Pigmentation after Discontinuation of Retigabine
Timeframe: 2 years and 9 months
Number of Participants With Resolution of Dermatologist Confirmed Abnormal Discoloration after Discontinuation of Retigabine
Timeframe: 2 years 9 months
Time from Discontinuation of Retigabine to Resolution of Abnormal Eye Pigmentation
Timeframe: 2 years 9 months
Time from Discontinuation of Retigabine to Resolution of All Dermatologist-Confirmed Abnormal Discoloration
Timeframe: 2 years 9 months
Secondary outcomes:
Percentage change from Baseline in the 28-day partial seizure
Timeframe: Assessed up to a maximum of 9 years
Number of responders
Timeframe: Assessed up to a maximum of 9 years
Number of participants who were seizure free for any 6 continuous months
Timeframe: Assessed up to a maximum of 9 years
Number of participants who were seizure free for any 12 continuous months
Timeframe: Assessed up to a maximum of 9 years
Percentage of seizure-free days
Timeframe: Assessed up to a maximum of 9 years
Change from Baseline in quality of life in epilepsy (QOLIE)-31-P Questionnaire
Timeframe: Assessed up to a maximum of 9 years
Interventions:
Drug: Ezogabine: USAN Retigabine (International Nonproprietary Name)
Enrollment:
181
Observational study model:
Not applicable
Primary completion date:
2016-30-11
Time perspective:
Not applicable
Clinical publications:
Not applicable
Medical condition
Epilepsy
Product
retigabine
Collaborators
Not applicable
Study date(s)
May 2006 to March 2017
Type
Interventional
Phase
3
Participation criteria
Sex
Female & Male
Age
18 - 75 years
Accepts healthy volunteers
No
- Patient has successfully completed the Maintenance and Transition phases of Study VRX-RET-E22-301 for the treatment of partial-onset seizures
- Patient is expected to benefit from participation in the study in the opinion of the Investigator.
- Patient meets any of the withdrawal criteria in the previous VRX-RET-E22-301 study or is experiencing an ongoing serious adverse event.
- Patient is receiving any investigational drug or using any experimental device in addition to Retigabine for treatment of epilepsy or any other medical condition.
Inclusion and exclusion criteria
Inclusion criteria:
- Patient has successfully completed the Maintenance and Transition phases of Study VRX-RET-E22-301 for the treatment of partial-onset seizures
- Patient is expected to benefit from participation in the study in the opinion of the Investigator.
Exclusion criteria:
- Patient meets any of the withdrawal criteria in the previous VRX-RET-E22-301 study or is experiencing an ongoing serious adverse event.
- Patient is receiving any investigational drug or using any experimental device in addition to Retigabine for treatment of epilepsy or any other medical condition.
- Patient has any other condition that would prevent compliance with the study procedures or proper reporting of adverse events.
Trial location(s)
Location
West Los Angeles VA Healthcare Center
Los Angeles, California, United States, 90073
Status
Recruitment Complete
Location
Hospital Central Dr. Ignacio Morones Prieto
San Luis Potosi, SLP, Mexico, 78250
Status
Study Complete
Location
Minnesota Epilepsy Group, P.A.
St. Paul, Minnesota, United States, 55102
Status
Study Complete
Location
Milton S. Hershey Medical Center
Hershey, Pennsylvania, United States, 17033
Status
Study Complete
Location
Antiguo Hospital Civil de Guadalajara
Guadalajara, Jalisco, Mexico, 44280
Status
Recruitment Complete
Location
Hospital General de Agudos "Dr. J.M. Ramos Mejia"
Capital Federal, CBA, Argentina
Status
Recruitment Complete
Location
University of Virginia Comprehensive Epilepsy Program
Charlottesville, Virginia, United States, 22903
Status
Study Complete
Location
Medical University of Ohio at Toledo
Toledo, Ohio, United States, 43614
Status
Recruitment Complete
Location
Neurological Clinic of Texas
Dallas, Texas, United States, 75230
Status
Recruitment Complete
Location
Hospital Privado Centro Medico de Cordoba
Cordoba, CRD, Argentina, X5016KEH
Status
Recruitment Complete
Location
University of Southern California -- Keck School of Medicine
Los Angeles, California, United States, 90033
Status
Study Complete
Location
UCSD Thornton Hospital
La Jolla, California, United States, 92037
Status
Study Complete
Location
Hospital Sao Paulo -- Escola Paulista de Medicina -- UNIFESP
Sao Paulo, SP, Brazil, 04024 002
Status
Recruitment Complete
Location
Hospital das Clinicas da Fac de Medicina de Sao Paulo
Sao Paulo, SP, Brazil, 05403-900
Status
Recruitment Complete
Location
Hospital General de Agudos "Dr. Teodoro Alvarez"
Capital Federal, CBA, Argentina
Status
Recruitment Complete
Location
Beth Israel Medical Center
New York, New York, United States, 10003
Status
Study Complete
Location
North Alabama Neuroscience Research Associates
Huntsville, Alabama, United States, 35801
Status
Study Complete
Location
Mid-Atlantic Epilepsy and Sleep Center
Bethesda, Maryland, United States, 20817
Status
Recruitment Complete
Location
Lovelace Scientific Resources
Sarasota, Florida, United States, 34233
Status
Recruitment Complete
Location
Hospital Italiano de Buenos Aires
Capital Federal, CBA, Argentina, C1181ACH
Status
Study Complete
Location
Medical City Dallas Hospital
Dallas, Texas, United States, 75230
Status
Recruitment Complete
Location
Hospital y Clinica OCA S.A. de C.V.
Monterrey, Nuevo Leon, Mexico, 64000
Status
Recruitment Complete
Location
Virginia Commonwealth University Medical Center
Richmond, Virginia, United States, 23298
Status
Study Complete
Location
University of Colorado Department Of Neurology
Denver, Colorado, United States, 80010
Status
Recruitment Complete
Location
Health Sciences Centre
St. John's, Newfoundland, Canada, A1B 3V6
Status
Recruitment Complete
Location
Hospital das Clinicas de Ribeirao Preto -- Universidade de Sa Neurologia
Ribeirao Preto, SP, Brazil, 14048-900
Status
Recruitment Complete
Location
The Comprehensive Epilepsy Care Center for Children and Adults
Chesterfield, Missouri, United States, 63017
Status
Recruitment Complete
Location
Asheville Neurology Specialists
Asheville, North Carolina, United States, 28801
Status
Recruitment Complete
Location
University of Alabama -- Department of Neurology/Epilepsy Center
Birmingham, Alabama, United States, 35294
Status
Study Complete
Location
Hospital de Psiquiatria San Fernando, IMSS
Mexico, DF, Mexico, 14050
Status
Study Complete
Location
Clinical Trials Inc.
Little rock, Arkansas, United States, 72205
Status
Study Complete
Location
Glenrose Rehabilitation Center
Edmonton, Alberta, Canada, T5G 0B7
Status
Recruitment Complete
Location
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37212
Status
Recruitment Complete
Location
Barrow Neurological Institute
Phoenix, Arizona, United States, 85013
Status
Recruitment Complete
Location
University of Florida -- Shands Jacksonville
Jacksonville, Florida, United States, 32209
Status
Recruitment Complete
Location
Instituto Nacional de Neurologia y Neurocirugia
La Fama, DF, Mexico, 42690
Status
Recruitment Complete
Location
University of Kentucky
Lexington, Kentucky, United States, 40536
Status
Study Complete
Location
Hospital Universitario Prof Edgard Santos -- UFBA
Salvador, BA, Brazil, 40110-060
Status
Recruitment Complete
Study documents
No study documents available.
Results overview
Results posted on ClinicalTrials.gov
Recruitment status
Completed
Actual primary completion date
2016-30-11
Actual study completion date
2017-15-03
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.
Additional information about the trial
Additional information
Not applicable
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