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Study in Pediatric Subjects With Epilepsy | Clinical Trials | Clareo Health

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TERMINATEDPhase 2NCT01494584

Study in Pediatric Subjects With Epilepsy

This is an open-label study to evaluate the pharmacokinetics, safety and tolerability of ezogabine/retigabine in subjects aged 12 years to less than 18 years with uncontrolled partial onset seizures o...

Lead sponsor: GlaxoSmithKline•4 U.S. locations•View source on ClinicalTrials.gov

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Sponsors

Lead Sponsor

GlaxoSmithKline

Collaborators

Bausch Health Americas, Inc.

Age

12 - 17 years

Sex

ALL

Healthy Volunteers

No

Inclusion Criteria

•Between 12 and 18 years of age.
•Diagnosis of uncontrolled partial onset seizures (with or without secondarily generalized seizures) or Lennox-Gastaut syndrome.
•Taking between one and three antiepileptic drugs.
•Able to swallow tablets.
•Females must be of : (1) Non-childbearing potential or (2) Child-bearing potential and agrees to use acceptable contraception.

Exclusion Criteria

•Epilepsy secondary to progressive cerebral disease, tumor or any progressive neurodegenerative disease.
•History of status epilepticus in the last six months.
•Currently treated with felbamate or has been treated with vigabatrin within the past 6 months.
•Following the ketogenic diet.
•Suicidal intent or history of suicide attempt in the last 2 years.
•Elevated liver enzymes or abnormal kidney function.
•Current disturbance of micturition or known urinary obstructions.
•History of vesicoureteric reflux.
•Abnormal post-void residual bladder ultrasound.
•Urinary retention and/or required urinary catheterization in the preceding 6 months.
•Abnormal urine sample at screening/.baseline.
•Abnormal blood sample at screening.
•Clinically significant arrhythmias.
•Abnormal ECG at screening.
•BMI lower than the 10th percentile for age and gender or subject weighs less than 30kg.

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Data from ClinicalTrials.govLast updated on ClinicalTrials.gov: November 30, 2020Terms

Trial snapshot

StatusTERMINATED

PhasePHASE2

Enrollment5

Start dateJul 2012

Last updatedNov 30, 2020

Condition

Locations shown

GSK Investigational Site

Los Angeles, California

GSK Investigational Site

Wellington, Florida

GSK Investigational Site

Memphis, Tennessee

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: November 30, 2020Data synced to Clareo: May 3, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions