Phase 3
Completed N=181
Open-label Extension Study of the Phase 3 VRX-RET-E22-301 Double-Blind Trial
Source: ClinicalTrials.gov NCT00310375 ↗Enrolled (actual)
181
Serious AEs
26.5%
Results posted
Nov 2016
Primary outcomePrimary: Number of Participants With Treatment-emergent Serious Adverse Event (SAE) and Adverse Event (AE) — 48; 173 Participants
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
Summary
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Treatment-emergent Serious Adverse Event (SAE) and Adverse Event (AE) |
48; 173 | — |
| PRIMARY Number of Participants With Treatment-emergent Adverse Events Leading to Withdrawal From Study Drug |
52 | — |
| PRIMARY Kaplan-Meier Estimate of the Probability of Discontinuation (d/c) From Study Drug |
0.0; 0.6; 1.1; 1.7; 2.2; 2.8 | — |
| PRIMARY Change From Baseline in Blood Pressure |
-1.1; -0.7; -2.9; -2.6; -0.6; -2.3 | — |
| PRIMARY Change From Baseline in Heart Rate |
-1.0; -0.7; -0.2; -1.0; -0.1; 1.1 | — |
| PRIMARY Change From Baseline in Body Temperature |
-0.04; -0.08; -0.05; -0.06; -0.07; -0.01 | — |
| PRIMARY Change From Baseline in Weight |
1.94; 1.85; 1.68; 1.57; 1.31; 2.17 | — |
| PRIMARY 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) |
3.3; 5.8; 1.5; 2.2; 5.7; 5.9 | — |
| PRIMARY Change From Baseline in the 12-lead Electrocardiogram (ECG) Parameter-RR Interval |
0.0195; 0.0029; -0.0007; 0.0103; -0.0015; -0.0119 | — |
| PRIMARY Change From Baseline in Electrocardiogram (ECG) Parameter-QRS Axis |
-1.3; -2.9; -1.5; -2.3; -3.1; -1.9 | — |
| PRIMARY Change From Baseline in Hematology Parameters- Bands, Basophils, Eosinophils, Lymphocytes, Metamyelocyte, Monocytes, Neutrophils, Platelets, White Blood Cells Count (WBC) |
-0.135; -0.205; -0.095; -0.001; -0.015; 0.001 | — |
| PRIMARY Change From Baseline in Hematology Parameter-Red Blood Cell Count |
-0.09; 0.01; -0.06; -0.16; -0.04; -0.03 | — |
| PRIMARY Change From Baseline in Haematocrit |
-0.009; -0.001; -0.007; -0.012; -0.004; -0.005 | — |
| PRIMARY Change From Baseline in Haemoglobin |
-3.2; -0.9; -2.6; -5.7; -2.2; -1.9 | — |
| PRIMARY Change From Baseline in Chemistry Parameters-Alkaline Phosphatase (AP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) |
-5.5; -5.7; -7.3; -7.7; -6.1; -9.1 | — |
| PRIMARY Change From Baseline in Chemistry Parameters-Bicarbonate, Blood Urea Nitrogen (BUN), Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium, Urea |
0.843; 0.917; 0.823; 0.717; 0.973; 1.060 | — |
| PRIMARY Change From Baseline in Chemistry Parameters -Creatinine, Total Bilirubin (TB), Uric Acid (UA) |
3; 4; 4.9; 3.7; 4.5; 4.0 | — |
| PRIMARY Change From Baseline in Chemistry Parameter-Total Protein |
-1.1; -0.5; -1.0; -0.8; 0.2; 0.3 | — |
| PRIMARY Change From Baseline in Urine Specific Gravity |
-0.0018; -0.0016; 0.0002; 0.0002; -0.0000; 0.0006 | — |
| PRIMARY Change From Baseline in Urine Power of Hydrogen (pH) |
-0.13; -0.18; -0.13; -0.17; -0.11; -0.05 | — |
| PRIMARY Change From Baseline in Post-void Residual Bladder Ultrasound Volume |
6.5; 5.8; -2.8; 11.6; 13.6; 8.8 | — |
| PRIMARY Change From Baseline in Overall American Urological Association (AUA) Symptom Index Score |
-0.2; -0.0; 0.2; -0.1; 0.0; 0.5 | — |
| PRIMARY Number of Participants With Abnormal Results in Physical Examination |
59; 49; 34; 27; 25; 32 | — |
| PRIMARY Number of Participants With Abnormal Results of Neurological Examination |
60; 11; 49; 17; 42; 9 | — |
| PRIMARY Number of Participants With Pigmentation of Non-retinal Ocular Tissue |
11 | — |
| PRIMARY Number of Participants With Pigmentation of Retinal Ocular Tissue |
14 | — |
| PRIMARY Number of Participants With Abnormal Pigmentation of Skin, Including the Skin Around the Eyes and the Eyelids, Lips, Nails, or Mucosa |
23; 15; 16; 21; 17; 22 | — |
| PRIMARY Number of Participants With a Clinically Significant Decrease in Visual Acuity From Initial Examination |
2 | — |
| PRIMARY Number of Participants With a Decrease in Confrontational Visual Field From Initial Examination |
— | — |
| PRIMARY Number of Participants With Resolution of Abnormal Eye Pigmentation After Discontinuation of Retigabine |
1; 1; 3; 4 | — |
| PRIMARY Number of Participants With Resolution of Dermatologist Confirmed Abnormal Discoloration After Discontinuation of Retigabine |
1 | — |
| PRIMARY Time From Discontinuation of Retigabine to Resolution of Abnormal Eye Pigmentation |
317.0; 163.0; 317.0; 180.0 | — |
| PRIMARY Time From Discontinuation of Retigabine to Resolution of All Dermatologist-Confirmed Abnormal Discoloration |
439.0; 347.0; 284.5; 377.0; 468.0 | — |
| SECONDARY Percentage Change From Baseline in the 28-day Partial Seizure |
-34.2 | — |
| SECONDARY Number of Responders |
98 | — |
| SECONDARY Number of Participants Who Were Seizure Free for Any 6 Continuous Months |
20 | — |
| SECONDARY Number of Participants Who Were Seizure Free for Any 12 Continuous Months |
14 | — |
| SECONDARY Percentage of Seizure-free Days |
75.7 | — |
| SECONDARY Change From Baseline in Quality of Life in Epilepsy (QOLIE)-31-P Questionnaire |
-2; -2.95; -1.65; -2.77; -3.13; -2.43 | — |
Eligibility 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.
Data sourced from ClinicalTrials.gov (NCT00310375). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.