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Pediatric Epilepsy Study in Subjects 1-24 Months

Information source: GlaxoSmithKline
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Epilepsy

Intervention: lamotrigine (Drug)

Phase: Phase 2

Status: Completed

Sponsored by: GlaxoSmithKline

Official(s) and/or principal investigator(s):
GSK Clinical Trials, Study Director, Affiliation: GlaxoSmithKline

Summary

This study will evaluate the long-term safety of LAMICTAL(lamotrigine)in subjects with partial seizures previously enrolled in protocol LAM20006 and in subjects 1-24 months of age who have never received LAMICTAL(LAMICTAL-naive). For LAMICTAL-naive subjects, LAMICTAL will be added to the subject's current epilepsy medications.

Clinical Details

Official title: An Open-Label, Uncontrolled, Long-Term Study to Assess the Safety of LAMICTAL in Pediatric Subjects Previously Enrolled in Protocol LAM20006 and In LAMICTAL-naive Subjects (1-24 Months of Age)

Study design: Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: The long-term safety of LAMICTAL will be assessed by adverse events, ECGs, vital signs,and laboratory tests.

Secondary outcome: Effectiveness will be assessed by percent change from baseline in seizure frequency over the course of treatment. Investigators global evaluation of subjects status; standard pharmacokinetics.

Eligibility

Minimum age: 1 Month. Maximum age: 24 Months. Gender(s): Both.

Criteria:

Inclusion criteria:

- Must have completed the Open-Label Phase of protocol LAM20006 or meet criteria for

LAMICTAL naive subjects as follows:

- A confident diagnosis of epilepsy.

- 4 or more partial seizures per month.

- current treatment with 1 or 2 anti-epileptic drugs.

Exclusion criteria:

- Has seizures not related to epilepsy.

- Has a surgically implanted and functioning vagal nerve stimulator.

- Has previously been treated with lamotrigine.

- Is currently taking felbamate, ACTH (adrenocorticotrophic hormone) or is on the

ketogenic diet.

- Use of experimental medication within 30 days of enrollment.

Locations and Contacts

GSK Investigational Site, Beirut 11072020, Lebanon

GSK Investigational Site, Rotterdam 3015 GD, Netherlands

GSK Investigational Site, Coimbra 3000-075, Portugal

GSK Investigational Site, Lisboa 1150, Portugal

GSK Investigational Site, Porto 4099-001, Portugal

GSK Investigational Site, Ankara, Turkey

Additional Information

Starting date: September 2000
Last updated: April 14, 2015

Page last updated: August 23, 2015

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