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.
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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