Last updated: 07/14/2020 15:20:08

Open-label Extension Study of the Phase 3 VRX-RET-E22-301 Double-Blind Trial

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GSK study ID
VRX-RET-E22-303
Clinicaltrials.gov ID
NCT00310375
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EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

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
    Primary completion date:
    2016-30-11
    Observational study model:
    Not applicable
    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
    Status
    Contact us
    Contact us
    Location
    West Los Angeles VA Healthcare Center
    Los Angeles, California, United States, 90073
    Status
    Recruitment Complete
    Contact us
    Location
    Hospital Central Dr. Ignacio Morones Prieto
    San Luis Potosi, SLP, Mexico, 78250
    Status
    Study Complete
    Contact us
    Location
    Minnesota Epilepsy Group, P.A.
    St. Paul, Minnesota, United States, 55102
    Status
    Study Complete
    Contact us
    Location
    University of Miami
    Miami, Florida, United States, 33136
    Status
    Study Complete
    Contact us
    Location
    Milton S. Hershey Medical Center
    Hershey, Pennsylvania, United States, 17033
    Status
    Study Complete
    Contact us
    Location
    Antiguo Hospital Civil de Guadalajara
    Guadalajara, Jalisco, Mexico, 44280
    Status
    Recruitment Complete
    Contact us
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    Study documents

    No study documents available.

    Results overview

    Results posted on ClinicalTrials.gov

    Recruitment status
    Study complete
    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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