Last updated: 11/04/2018 13:41:16

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

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GSK study ID

VRX-RET-E22-304

See study documents

Clinicaltrials.gov ID

See results summary

EudraCT ID

EU CT Number

Not applicable

Trial status

Other

Other

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-E22-302)

Trial description: 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.

Primary purpose:

Treatment

Trial design:

Single Group Assignment

Masking:

None (Open Label)

Allocation:

Non-randomized

Primary outcomes:

Number of participants with treatment emergent adverse events (TEAEs) and Serious adverse events (TESAEs)

Timeframe: Up to 122 months

Number of participants with TEAEs leading to treatment discontinuation (disc.)

Timeframe: Up to 122 months

Kaplan-Meier estimate of the Probability of disc. from Study Drug

Timeframe: Up to 122 months

Change from Baseline in systolic blood pressure (SBP) and diastolic blood pressure (DBP) measurements in the supine and standing position

Timeframe: Baseline and up to 122 months

Change from Baseline in heart rate (HR) measurements in the supine and standing position

Timeframe: Baseline and up to 122 months

Change from Baseline in body temperature

Timeframe: Baseline and up to 122 months

Change from Baseline in body weight

Timeframe: Baseline and up to 122 months

Change from Baseline in Electocardiogram (ECG) parameters PR, QRS, QT, corrected QT interval (QTc) Bazett and QTc Friedericia

Timeframe: Baseline and up to 122 months

Change from Baseline in alkaline phosphatase (Alk. Phos.), alanine amino transferase (ALT) and aspartate amino transferase (AST)

Timeframe: Baseline and up to 122 months

Change from Baseline in bicarbonate, calcium, chloride, cholesterol, non-fasting glucose, phosphorus, potassium, sodium and urea

Timeframe: Baseline and up to 122 months

Change from Baseline in creatinine, total bilirubin and uric acid

Timeframe: Baseline and up to 122 months

Change from Baseline in total protein

Timeframe: Baseline and up to 122 months

Change from Baseline in basophils, eosinophils, lymphocytes, monocytes, neutrophils, platelet count, white blood cells (WBC)

Timeframe: Baseline and up to 122 months

Change from Baseline in hematocrit

Timeframe: Baseline and up to 122 months

Change from Baseline in hemoglobin

Timeframe: Baseline and up to 122 months

Change from Baseline in hematology parameter red blood cells (RBC)

Timeframe: Baseline and up to 122 months

Change from Baseline in urine specific gravity

Timeframe: Baseline and up to 122 months

Change from Baseline in urine potential of hydrogen (pH)

Timeframe: Baseline and up to 122 months

Change from Baseline in Post-Void Residual (PVR) bladder ultrasound volume

Timeframe: Baseline and up to 122 months

Change from Baseline in the urinary voiding function [UVF] (assessed using the American Urological Association [AUA] Symptom Index)

Timeframe: Baseline and up to 122 months

Change from Baseline in Quality of Life in Epilepsy-31-Problems (QOLIE-31-P) Questionnaire

Timeframe: Baseline and up to 122 months

Percentage of participants with Abnormal Results of Physical Examination

Timeframe: Baseline and up to 122 months

Percentage of participants with Abnormal Results of Neurological Examination

Timeframe: Baseline and up to 122 months

Secondary outcomes:

Percentage of participants with retinal pigmentary abnormalities (RPA)

Timeframe: Up to 121 months

Percentage of participants with pigmentation of non-retinal ocular tissue (Non-ret. Pig. Abn)

Timeframe: Up to 121 months

Percentage of participants with abnormal pigmentation of skin, including the skin around the eyes and the eyelids, lips, nails, or mucosa

Timeframe: Up to 121 months

Percentage of participants with a clinically significant decrease (CSD) in visual acuity (VA) from initial examination

Timeframe: Up to 121 months

Percentage of participants with decrease in confrontation visual field from initial examination

Timeframe: Up to 121 months

Number of Participants With Resolution of Abnormal Eye Pigmentation after Discontinuation of Retigabine

Timeframe: 3 years and 10 months

Number of Participants With Resolution of Dermatologist Confirmed Abnormal Discoloration after Discontinuation of Retigabine

Timeframe: 3 years and 10 months

Time from Discontinuation of Retigabine to Resolution of Abnormal Eye Pigmentation

Timeframe: 3 years and 10 months

Time from Discontinuation of Retigabine to Resolution of All Dermatologist-Confirmed Abnormal Discoloration

Timeframe: 3 years and 10 months

Percentage change in the 28-day partial seizure rate from the Baseline phase (obtained during the 8-week Baseline period of Study VRX-RET-E22-302) to open-label treatment.

Timeframe: Baseline and up to 121 months

Percentage of Participants with 50% Reduction in Seizure Frequency From Baseline Phase of the Parent Study (VRX-RET-E22-302) to Open Label Treatment

Timeframe: Baseline and up to 121 months

Number of participants who were seizure free for any 6 continuous months

Timeframe: Up to 6 continuous months within the 121 months period

Number of participants who were seizure free for any 12 continuous months

Timeframe: Up to 12 continuous months within the 121 months period

Percentage of seizure free days

Timeframe: Up to 121 months

Interventions:

Drug: Retigabine (INN), Ezogabine (USAN)

Enrollment:

376

Primary completion date:

2017-19-04

Observational study model:

Not applicable

Time perspective:

Not applicable

Clinical publications:

Not applicable

Medical condition

Epilepsy

Product

retigabine, ezogabine

Collaborators

Not applicable

Study date(s)

July 2006 to May 2018

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-E22-302 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-E22-302 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.

Trial location(s)

Location

Status

Contact us

Location

Royal Melbourne Hospital

Parkville, VIC, Australia, 3050

Status

Recruitment Complete

Location

Institute of Neurology, Psychiatry and Narcology of AMS, Ukr

Kharkov, Ukraine, 31068

Status

Recruitment Complete

Location

Inkosi Albert Luthuli Central Hospital

Durban, KZ-Natal, South Africa, 4091

Status

Recruitment Complete

Location

Royal London Hospital

London, United Kingdom, GT LON E1 1BB

Status

Study Complete

Location

Wolfson Medical Center

Holon, ISRAEL, Israel, 58100

Status

Study Complete

Location

Fylde Coast Hospital

Blackpool, United Kingdom, FY3 8BP

Status

Recruitment Complete

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Study documents

Protocol

Available language(s): English

Download document(s)

If you wish to request for full study report, please contact - [email protected]

Results overview

Results posted on ClinicalTrials.gov

Recruitment status

Other

Actual primary completion date

2017-19-04

Actual study completion date

2018-24-05

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

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