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Study in Pediatric Subjects With Epilepsy

NCT ID: NCT01494584

Last Updated: 2020-11-30

Study Results

Results available

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

5 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-07-25

Study Completion Date

2013-04-29

Brief Summary

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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 or Lennos-Gastaut syndrome.

Detailed Description

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Conditions

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Epilepsy

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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ezogabine/retigabine

ezogabine dose escalation

Group Type EXPERIMENTAL

ezogabine/retigabine

Intervention Type DRUG

ezogabine dose escalation

Interventions

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ezogabine/retigabine

ezogabine dose escalation

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

12 Years

Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Bausch Health Americas, Inc.

INDUSTRY

Sponsor Role collaborator

GlaxoSmithKline

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

Locations

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GSK Investigational Site

Los Angeles, California, United States

Site Status

GSK Investigational Site

Wellington, Florida, United States

Site Status

GSK Investigational Site

Memphis, Tennessee, United States

Site Status

GSK Investigational Site

Dallas, Texas, United States

Site Status

Countries

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United States

References

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Tompson DJ, Buraglio M, Andrews SM, Wheless JW. Adolescent Clinical Development of Ezogabine/Retigabine as Adjunctive Therapy for Partial-Onset Seizures: Pharmacokinetics and Tolerability. J Pediatr Pharmacol Ther. 2016 Sep-Oct;21(5):404-412. doi: 10.5863/1551-6776-21.5.404.

Reference Type BACKGROUND
PMID: 27877093 (View on PubMed)

Other Identifiers

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113284

Identifier Type: -

Identifier Source: org_study_id