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Open-Label Extension Study of the Phase 3 VRX-RET-E22-302 Double-Blind Trial. 115097

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00310388
First Posted: April 3, 2006
Last Update Posted: August 17, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
GlaxoSmithKline
March 30, 2006
April 3, 2006
August 17, 2017
July 5, 2006
April 19, 2017   (Final data collection date for primary outcome measure)
  • Change from baseline in systolic blood pressure (SBP) and diastolic blood pressure (DBP) for supine and standing position [ Time Frame: Baseline (Month 0) and Month 1, 3, 6, 9, 12, 16, 20, 24 ]
    SBP and DBP measurements for supine and standing position were obtained at Baseline(Month 0) and Month 1, 3, 6, 9, 12, 16, 20, 24. For the standing position measurement, participant was asked to stand for approximately 2 minutes before taking the measurements. The change from Baseline was obtained by subtracting the Baseline value from the post-randomization value. Baseline was Month 0 value.
  • Change from baseline in supine and standing pulse rate [ Time Frame: Baseline(Month 0) and Month 1, 3, 6, 9, 12, 16, 20, 24 ]
    Pulse rate measurements for supine and standing position were obtained at Baseline(Month 0) and Month 1, 3, 6, 9, 12, 16, 20, 24. For the standing position measurement, participant was asked to stand for approximately 2 minutes before taking the measurements. The change from Baseline was obtained by subtracting the Baseline value from the post-randomization value. Baseline was Month 0 value.
  • Change from baseline in body weight [ Time Frame: Baseline(Month 0) and Month 1, 3, 6, 9, 12, 16, 20, 24 ]
    Weight measurements were obtained at Baseline(Month 0) and Month 1, 3, 6, 9, 12, 16, 20, 24. For measuring weight, participants were asked to be in ordinary indoor clothing (without shoes). The change from Baseline was obtained by subtracting the Baseline value from the post-randomization value. Baseline was Month 0 value.
  • Change from baseline in body temperature [ Time Frame: Baseline(Month 0) and Month 1, 3, 6, 9, 12, 16, 20, 24 ]
    Temperature measurements were obtained at Baseline(Month 0) and Month 1, 3, 6, 9, 12, 16, 20, 24. The change from Baseline was obtained by subtracting the Baseline value from the post randomization value. Baseline was Month 0 value.
  • Change from baseline in Hematology parameters- Basophils, Eosinophils, lymphocytes, Monocytes, Neutrophils, platelet count and white blood corpusles (WBC) [ Time Frame: Baseline(Month 0) and Month 1, 3, 6, 9, 12, 16, 20, 24 ]
    Blood samples were collected for the measurement of hematology parameters at Baseline(Month 0) and Month 1, 3, 6, 9, 12, 16, 20, 24. Change from baseline in Basophils, Eosinophils, lymphocytes, Monocytes, Neutrophils, platelet count and WBC is presented. The change from Baseline was obtained by subtracting the Baseline value from the post randomization value. Baseline was Month 0 value.
  • Change from baseline in Hematology parameters- Hematocrit [ Time Frame: Baseline(Month 0) and Month 1, 3, 6, 9, 12, 16, 20, 24 ]
    Blood samples were collected for the measurement of hematology parameters at Baseline(Month 0) and Month 1, 3, 6, 9, 12, 16, 20, 24. Change from baseline in hematocrit is presented.The change from Baseline was obtained by subtracting the Baseline value from the post randomization value. Baseline was Month 0 value.
  • Change from baseline in Hematology parameters- Hemoglobin [ Time Frame: Baseline(Month 0) and Month 1, 3, 6, 9, 12, 16, 20, 24 ]
    Blood samples were collected for the measurement of hematology parameters at Baseline(Month 0) and Month 1, 3, 6, 9, 12, 16, 20, 24. Change from baseline in hemoglobin is presented. The change from Baseline was obtained by subtracting the Baseline value from the post randomization value. Baseline was Month 0 value.
  • Change from baseline in Hematology parameters- red blood corpuscles(RBC) [ Time Frame: Baseline(Month 0) and Month 1, 3, 6, 9, 12, 16, 20, 24 ]
    Blood samples were collected for the measurement of hematology parameters at Baseline(Month 0) and Month 1, 3, 6, 9, 12, 16, 20, 24. Change from baseline in RBC is presented. The change from Baseline was obtained by subtracting the Baseline value from the post randomization value. Baseline was Month 0 value.
  • Change from baseline in clinical chemistry: Alkaline Phosphatase, alanine transaminase (ALT), aspartate transaminase (AST) [ Time Frame: Baseline(Month 0) and Month 1, 3, 6, 9, 12, 16, 20, 24 ]
    Blood samples were collected for the measurement of clinical chemistry parameters at Baseline(Month 0) and Month 1, 3, 6, 9, 12, 16, 20, 24. Change from baseline in Alkaline Phosphatase, ALT and AST is presented. The change from Baseline was obtained by subtracting the Baseline value from the post randomization value. Baseline was Month 0 value.
  • Change from baseline in clinical chemistry : bicarbonate, BUN, calcium, chloride, cholesterol, non-fasting glucose, phosphorus, potassium, sodium [ Time Frame: Baseline(Month 0) and Month 1, 3, 6, 9, 12, 16, 20, 24 ]
    Blood samples were collected for the measurement of clinical chemistry parameters at Baseline(Month 0) and Month 1, 3, 6, 9, 12, 16, 20, 24. Change from baseline in bicarbonate, BUN, calcium, chloride, cholesterol, non-fasting glucose, phosphorus, potassium, sodium is presented. The change from Baseline was obtained by subtracting the Baseline value from the post randomization value. Baseline was Month 0 value.
  • Change from baseline in clinical chemistry: Total Bilirubin, Creatinine, Uric acid [ Time Frame: Baseline(Month 0) and Month 1, 3, 6, 9, 12, 16, 20, 24 ]
    Blood samples were collected for the measurement of clinical chemistry parameters at Baseline(Month 0) and Month 1, 3, 6, 9, 12, 16, 20, 24. Change from baseline in total bilirubin, creatinine and uric acid is presented. The change from Baseline was obtained by subtracting the Baseline value from the post randomization value. Baseline was Month 0 value.
  • Change from baseline in clinical chemistry: Total protein [ Time Frame: Baseline(Month 0) and Month 1, 3, 6, 9, 12, 16, 20, 24 ]
    Blood samples were collected for the measurement of clinical chemistry parameters at Baseline(Month 0) and Month 1, 3, 6, 9, 12, 16, 20, 24. Change from baseline in total protein is presented. The change from Baseline was obtained by subtracting the Baseline value from the post randomization value. Baseline was Month 0 value.
  • ECG parameters assessment: PR interval, QRS interval, QT interval, and QTc interval [ Time Frame: Month 1, 3, 6, 9, 12 and 24 ]
    A 12-lead ECG was performed at Month 1, 3, 6, 9, 12 and 24. The ECG parameters assessed were PR interval, QRS interval, QT interval, and QTc interval. QT intervals were corrected using both Bazett's and Fridericia's formulas. Increases in Bazett's QTc interval of >60 from baseline or QTc interval of >500 anytime during the was confirmed on a repeat ECG.
  • Number of participants with abnormal Physical and neurological examinations [ Time Frame: Up to Month 24 ]
    Physical examination included skin, head, eyes, ears, nose, throat, mouth, neck, heart, lungs, breast, abdomen, genitalia, extremities and other. Neurological examination included level of consciousness, level of appearance, mental status, speech, vision, eye movements, jaw movements and facial sensation, facial motor, hearing, swallowing, pharynx, larynx, sternocleidomastoid, trapezius, tongue, biceps, brachioradials, triceps, knee, ankle, plantar, general movement, muscle bulk, muscle fasciculation, trunk, muscle strength upper extremities, muscle strength lower extremities, muscle tone upper extremities, muscle tone lower extremities, gait, hopping, romberg, nystagmus, tremor, finger-nose, heel-shin, rapid rhythmic movements, upper extremities pain/ temperature, upper extremities light touch, upper extremities position, upper extremities vibration, lower extremities pain/ temperature, lower extremities light touch, lower extremities position and lower extremities vibration.
  • Number of participants with Adverse Events (AEs) and Serious Adverse Events (SAEs) [ Time Frame: Up to 24 months ]
    An AE is defined as any untoward medical occurrence that occurred during the course of the trial after study treatment had started. An adverse event was therefore any unfavourable and unintended sign, symptom, or disease temporally associated with the use of study drug, whether or not considered related to the study drug. An SAE is any untoward medical occurrence that at any dose results in death, are life threatening, requires hospitalization or prolongation of hospitalization or results in disability/incapacity, and congenital anomaly/birth defect.
  • Change From Baseline in American Urological Association (AUA) Symptom Index Scores During Open-Label Retigabine Treatment [ Time Frame: Baseline (month 0) and Month 1, 3 and 12 ]
    AUA symptom index scores questionnaire had 7 questions. Responses to each of the 7 questions were scored 0 (not at all), 1 (less than 1 time), 2 (less than half the time), 3 (about half the time), 4 (more than half the time) and 5 (almost always), for a total possible score of 35. The total score for all questions was classified as mild (0-7), moderate (8-19) or severe (>19). Question 7 was scored as 0 (none), 1 (1 time), 2 (2 times), 3 (3 times), 4 (4 times) and 5 (5 times or more). Total score was range was 0-49.The change from Baseline was obtained by subtracting the Baseline value from the post randomization value. Baseline was Month 0 value.
  • Change From Baseline in Post-Void Residual Urine Volume by Study Time Point [ Time Frame: Baseline (month 0) and Month 1, 3 and 12 ]
    A post-void residual bladder ultrasound to assess urinary retention was performed at Baseline (month 0) and Month 1, 3 and 12. The change from Baseline was obtained by subtracting the Baseline value from the post randomization value. Baseline was Month 0 value.
  • Percentage change in the monthly seizure rate from the baseline phase to the open-label treatment phase.
  • Vital signs
  • Weight
  • Clinical Lab Evaluations (blood chemistry, hematology, and urinalysis)
  • 12-lead ECGs
  • Physical and neurological examinations
  • Evaluations of adverse events.
  • American Urological Association Symptom Index
  • Post-void residual bladder ultrasound
Complete list of historical versions of study NCT00310388 on ClinicalTrials.gov Archive Site
  • Change from baseline in Quality of life, evaluated through the Quality of Life in Epilepsy-Problems (QOLIE-31-P) [ Time Frame: Baseline (Month 0) and Month 24 ]
    The Quality of Life in Epilepsy Inventory-Form 31 (QOLIE-31-P) is an adaptation of the original QOLIE-31 instrument that includes 30 items grouped into 7 multi-item subscales: Seizure Worry (5 items), Overall Quality of Life (2 items), Emotional Well-being (5 items), Energy/Fatigue (4 items), Cognitive Functioning (6 items), Medication Effects (3 items) and Daily Activities/Social Functioning (5 items), and a Health Status item. In addition to the 31 items, the QOLIE-31-P contains 7 items asking the participants to rate the degree of 'distress' related to the topic of each subscale. The subscale scores, the total score and the Health Status item score were calculated according to the scoring algorithm defined by the author with scores ranging from 0 to 100 and higher scores indicating better function. The change from Baseline was obtained by subtracting the Baseline value from the post randomization value. Baseline was Month 0 value.
  • Percentage change in the monthly seizure rate from the baseline (Study 302) phase to the open-label treatment phase [ Time Frame: Baseline (Month 0) and Month 24 ]
    Monthly total seizure rates observed during the open-label extension period was compared to the monthly total seizure rates observed during the Baseline phase of the double-blind study VRX-RET-E22-302. Percent change from baseline was calculated as post randomization value divided by the baseline value and multiplied by 100. Baseline was Month 0 value of VRX-RET-E22-302 study.
  • Number of participants who were responders (participants experiencing ≥ 50% reduction in seizure frequency) from baseline to open-label treatment phase [ Time Frame: At Month 24 ]
    Responders were defined as participants with ≥50% reduction in 28-day total partial seizure frequency from Baseline in Study 302 to data cutoff in this Study 304. Number of participants who were responders are presented.
Proportion of responders (patients experiencing at least a 50% reduction in seizure frequency) from baseline to the open-label treatment phase.
Not Provided
Not Provided
 
Open-Label Extension Study of the Phase 3 VRX-RET-E22-302 Double-Blind Trial. 115097
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-E22-302)
This Phase 3 trial is an open-label extension study of the placebo-controlled, double-blind VRX-RET-E22-302 trial. Patients who have completed the VRX-RET-E22-302 trial and who meet inclusion and exclusion criteria will be treated with 600-1200 mg/day of retigabine as an adjunct therapy to their current antiepileptic drugs (AEDs) or vagal nerve stimulation. Treatment will be continued until the subject withdraws from the study or until the program is discontinued. Patients will be recruited from 55-60 sites in Europe, Israel, Australia, and South Africa. The primary objective of the 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 double-blind Study VRX-RET-E22-302. Secondary objectives are: to evaluate efficacy of long-term treatment with retigabine and patient quality of life and to evaluate whether retinal pigmentation, unexplained vision loss, pigmentation of non-retinal ocular tissue, and discoloration of nails, lips, skin or mucosa change over time after discontinuation of retigabine.
This Phase 3 trial is an open-label extension study of the placebo-controlled, double-blind VRX-RET-E22-302 trial. Patients who have completed the VRX-RET-E22-302 trial and who meet inclusion and exclusion criteria will be treated with 600-1200 mg/day of retigabine as an adjunct therapy to their current antiepileptic drugs (AEDs) or vagal nerve stimulation. Treatment will be continued until retigabine is commercially available, or until the program is discontinued. Patients will be recruited from 55-60 sites in Europe, Israel, Australia, and South Africa. The safety and tolerability of long-term therapy with retigabine administered as adjunctive therapy in adult epilepsy patients with partial-onset seizures will be evaluated. In addition, the efficacy of long-term treatment with retigabine and patient quality of life will be assessed.
Interventional
Phase 3
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Epilepsy
Drug: Retigabine (INN), Ezogabine (USAN)
Film-coated tablets containing 50 mg, 100 mg, or 300 mg of retigabine per tablet. Dosage and frequency will be specific to each patient so long as the patients receives between 600 and 1200 mg of retigabine per day. The duration will be until the completion of the trial, or until the patient withdraws from the trial.
Other Names:
  • GW582892X
  • D-23129
  • GKE-841
Experimental: Retigabine (INN), Ezogabine (USAN)
Retigabine (Ezogabine): all subjects
Intervention: Drug: Retigabine (INN), Ezogabine (USAN)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
376
April 19, 2018
April 19, 2017   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Patient has successfully completed the Maintenance and Transition phases of Study VRX-RET-E22-302 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-E22-302 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.
Sexes Eligible for Study: All
18 Years to 75 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Australia,   Belgium,   France,   Germany,   Hungary,   Israel,   Poland,   Russian Federation,   South Africa,   Spain,   Ukraine,   United Kingdom
 
 
NCT00310388
VRX-RET-E22-304
EUDRACT No. 2006-000956-42
RTG115097 ( Other Identifier: GlaxoSmithKline )
No
Not Provided
Not Provided
GlaxoSmithKline
GlaxoSmithKline
Not Provided
Study Director: GSK Clinical Trials GlaxoSmithKline
GlaxoSmithKline
August 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP